Ctcae 4.02 2009-10-06

MedDRA
v12.0 Code CTCAE v4.0 SOC CTCAE v4.0 Term Grade 1
Hemoglobin (Hgb) <LLN -

Blood and lymphatic 10.0 g/dL; <LLN - 6.2
10002272 system disorders Anemia mmol/L; <LLN - 100 g/L
Mildly hypocellular or <=25%

Blood and lymphatic Bone marrow reduction from normal
10048580 system disorders hypocellular cellularity for age
Disseminated
Blood and lymphatic intravascular
10013442 system disorders coagulation -
Blood and lymphatic

10016288 system disorders Febrile neutropenia -
Laboratory evidence of
hemolysis only (e.g., direct
antiglobulin test; DAT;
Blood and lymphatic Coombs'; schistocytes;
10019491 system disorders Hemolysis decreased haptoglobin)
Evidence of RBC destruction

Blood and lymphatic Hemolytic uremic (schistocytosis) without
10019515 system disorders syndrome clinical consequences
Blood and lymphatic

10024378 system disorders Leukocytosis -
Blood and lymphatic

10025182 system disorders Lymph node pain Mild pain
Incidental findings (e.g.,

Howell-Jolly bodies); mild
Blood and lymphatic degree of thrombocytosis
10041633 system disorders Spleen disorder and leukocytosis
Thrombotic Evidence of RBC destruction

Blood and lymphatic thrombocytopenic (schistocytosis) without
10043648 system disorders purpura clinical consequences
Asymptomatic or mild
Blood and lymphatic symptoms; clinical or
Blood and lymphatic system disorders - diagnostic observations only;
10005329 system disorders Other, specify intervention not indicated
Acute coronary
10051592 Cardiac disorders syndrome -
Asymptomatic valvular
thickening with or without
mild valvular regurgitation or
10061589 Cardiac disorders Aortic valve disease stenosis by imaging
Periods of asystole; non-

urgent medical management
10003586 Cardiac disorders Asystole indicated
Asymptomatic, intervention
10003658 Cardiac disorders Atrial fibrillation not indicated
10003662 Cardiac disorders Atrial flutter not indicated
Atrioventricular block
10003673 Cardiac disorders complete
Atrioventricular block Asymptomatic, intervention

10003674 Cardiac disorders first degree not indicated
10007515 Cardiac disorders Cardiac arrest -
10008481 Cardiac disorders Chest pain - cardiac Mild pain
Mild symptoms; intervention

10010276 Cardiac disorders Conduction disorder not indicated
10010783 Cardiac disorders Constrictive pericarditis -
Asymptomatic with
laboratory (e.g., BNP [B-
Natriuretic Peptide ]) or
cardiac imaging
10019279 Cardiac disorders Heart failure abnormalities
Left ventricular systolic

10069501 Cardiac disorders dysfunction -
10061532 Cardiac disorders Mitral valve disease stenosis by imaging
Mobitz (type) II Asymptomatic, intervention

10027786 Cardiac disorders atrioventricular block not indicated
10027787 Cardiac disorders Mobitz type I not indicated
10028596 Cardiac disorders Myocardial infarction -
Asymptomatic with
cardiac imaging
10028606 Cardiac disorders Myocarditis abnormalities

10033557 Cardiac disorders Palpitations not indicated
Paroxysmal atrial Asymptomatic, intervention

10034040 Cardiac disorders tachycardia not indicated
10034474 Cardiac disorders Pericardial effusion -
10053565 Cardiac disorders Pericardial tamponade -
Asymptomatic, ECG or
physical findings (e.g., rub)
10034484 Cardiac disorders Pericarditis consistent with pericarditis
10061541 Cardiac disorders Pulmonary valve disease stenosis by imaging
Restrictive
10038748 Cardiac disorders cardiomyopathy -
Asymptomatic with
Right ventricular cardiac imaging
10058597 Cardiac disorders dysfunction abnormalities
10040639 Cardiac disorders Sick sinus syndrome not indicated
10040741 Cardiac disorders Sinus bradycardia not indicated
10040752 Cardiac disorders Sinus tachycardia not indicated
Supraventricular Asymptomatic, intervention

10042604 Cardiac disorders tachycardia not indicated
10061389 Cardiac disorders Tricuspid valve disease stenosis
10047281 Cardiac disorders Ventricular arrhythmia not indicated
10047290 Cardiac disorders Ventricular fibrillation -
10047302 Cardiac disorders Ventricular tachycardia -
Wolff-Parkinson-White Asymptomatic, intervention

10048015 Cardiac disorders syndrome not indicated
symptoms; clinical or
Cardiac disorders - diagnostic observations only;
10007541 Cardiac disorders Other, specify intervention not indicated
Congenital, familial and symptoms; clinical or
Congenital, familial and genetic disorders - diagnostic observations only;
10010331 genetic disorders Other, specify intervention not indicated
Ear and labyrinth

10014020 disorders Ear pain Mild pain
Ear and labyrinth External ear External otitis with erythema

10065837 disorders inflammation or dry desquamation
Ear and labyrinth

10065785 disorders External ear pain Mild pain
Adults enrolled on a
monitoring program (a 1, 2,
3, 4, 6 and 8 kHz audiogram):
threshold shift of 15 - 25 dB
averaged at 2 contiguous
test frequencies in at least
one ear or subjective change
in the absence of a Grade 1
threshold shift
Pediatric (a 1, 2, 3, 4, 6 and 8
kHz audiogram): >20 dB at
any frequency tested and
Ear and labyrinth does not meet criteria for
10019245 disorders Hearing impaired >Grade 2
Ear and labyrinth

10065838 disorders Middle ear inflammation Serous otitis
Ear and labyrinth Mild symptoms; intervention

10043882 disorders Tinnitus not indicated
Ear and labyrinth

10047340 disorders Vertigo Mild symptoms
Ear and labyrinth

10047386 disorders Vestibular disorder -
Ear and labyrinth symptoms; clinical or
Ear and labyrinth disorders - Other, diagnostic observations only;
10013993 disorders specify intervention not indicated
Asymptomatic; clinical or
diagnostic observations only;
10001367 Endocrine disorders Adrenal insufficiency intervention not indicated

10011655 Endocrine disorders Cushingoid not indicated
10012205 Endocrine disorders Delayed puberty -
10018746 Endocrine disorders Growth accelerated -

10020705 Endocrine disorders Hyperparathyroidism not indicated
10020850 Endocrine disorders Hyperthyroidism intervention not indicated
10021041 Endocrine disorders Hypoparathyroidism intervention not indicated
10021114 Endocrine disorders Hypothyroidism intervention not indicated
Physical signs of puberty
with no biochemical markers
for females <8 years and
10058084 Endocrine disorders Precocious puberty males <9 years

10047488 Endocrine disorders Virilization not indicated
Endocrine disorders - diagnostic observations only;
10014698 Endocrine disorders Other, specify intervention not indicated
10005886 Eye disorders Blurred vision Intervention not indicated
10007739 Eye disorders Cataract intervention not indicated
symptoms; intervention not
10010741 Eye disorders Conjunctivitis indicated
10048492 Eye disorders Corneal ulcer -
mild symptoms relieved by
10013774 Eye disorders Dry eye lubricants
Extraocular muscle Asymptomatic; clinical or

10015829 Eye disorders paresis diagnostic observations only
10015958 Eye disorders Eye pain Mild pain
10061145 Eye disorders Eyelid function disorder intervention not indicated
Symptomatic but not limiting
10016757 Eye disorders Flashing lights ADL

10016778 Eye disorders Floaters ADL
Elevated intraocular
pressure (EIOP) with single
topical agent for
intervention; no visual field
10018304 Eye disorders Glaucoma deficit
10023332 Eye disorders Keratitis -

10029404 Eye disorders Night blindness ADL
10061322 Eye disorders Optic nerve disorder diagnostic observations only
Asymptomatic; no visual
10033703 Eye disorders Papilledema field defects
10034960 Eye disorders Photophobia ADL
10038848 Eye disorders Retinal detachment Asymptomatic
10038897 Eye disorders Retinal tear -
10038901 Eye disorders Retinal vascular disorder -
10038923 Eye disorders Retinopathy diagnostic observations only
10061510 Eye disorders Scleral disorder diagnostic observations only
10046851 Eye disorders Uveitis diagnostic observations only
10047656 Eye disorders Vitreous hemorrhage diagnostic observations only
10047848 Eye disorders Watering eyes Intervention not indicated
Eye disorders - Other, diagnostic observations only;
10015919 Eye disorders specify intervention not indicated
Gastrointestinal diagnostic observations only;
10000060 disorders Abdominal distension intervention not indicated
Gastrointestinal
10000081 disorders Abdominal pain Mild pain
10002156 disorders Anal fistula intervention not indicated
Gastrointestinal Mild; intervention not

10055226 disorders Anal hemorrhage indicated
Gastrointestinal symptoms; intervention not
10065721 disorders Anal mucositis indicated
Gastrointestinal
10065722 disorders Anal necrosis -
Gastrointestinal
10002167 disorders Anal pain Mild pain
10002176 disorders Anal stenosis intervention not indicated
10002180 disorders Anal ulcer intervention not indicated
10003445 disorders Ascites intervention not indicated
Gastrointestinal No change in bowel function

10005265 disorders Bloating or oral intake
10065747 disorders Cecal hemorrhage indicated
10008417 disorders Cheilitis intervention not indicated
10009887 disorders Colitis intervention not indicated
10009995 disorders Colonic fistula intervention not indicated

10009998 disorders Colonic hemorrhage indicated
10010000 disorders Colonic obstruction intervention not indicated
Gastrointestinal
10010001 disorders Colonic perforation
10010004 disorders Colonic stenosis intervention not indicated
10010006 disorders Colonic ulcer intervention not indicated
Occasional or intermittent
symptoms; occasional use of
stool softeners, laxatives,
Gastrointestinal dietary modification, or
10010774 disorders Constipation enema
Gastrointestinal One or more dental caries,

10012318 disorders Dental caries not involving the root
Increase of <4 stools per day

over baseline; mild increase
Gastrointestinal in ostomy output compared
10012727 disorders Diarrhea to baseline
Symptomatic (e.g., dry or

thick saliva) without
significant dietary alteration;
Gastrointestinal unstimulated saliva flow >0.2
10013781 disorders Dry mouth ml/min
10013828 disorders Duodenal fistula intervention not indicated

10055242 disorders Duodenal hemorrhage indicated
10013830 disorders Duodenal obstruction intervention not indicated
Gastrointestinal
10013832 disorders Duodenal perforation -
10050094 disorders Duodenal stenosis intervention not indicated
10013836 disorders Duodenal ulcer intervention not indicated
Gastrointestinal Mild symptoms; intervention

10013946 disorders Dyspepsia not indicated
Gastrointestinal Symptomatic, able to eat

10013950 disorders Dysphagia regular diet
10014893 disorders Enterocolitis intervention not indicated
10062570 disorders Enterovesical fistula intervention not indicated
10065851 disorders Esophageal fistula intervention not indicated

10015384 disorders Esophageal hemorrhage indicated
Gastrointestinal
10065727 disorders Esophageal necrosis -
10015387 disorders Esophageal obstruction intervention not indicated
Gastrointestinal
10015388 disorders Esophageal pain Mild pain
Gastrointestinal
10055472 disorders Esophageal perforation -
10015448 disorders Esophageal stenosis intervention not indicated
10015451 disorders Esophageal ulcer intervention not indicated
Gastrointestinal Esophageal varices

10015453 disorders hemorrhage
10015461 disorders Esophagitis intervention not indicated
Gastrointestinal Occasional use of pads

10016296 disorders Fecal incontinence required
Gastrointestinal Mild symptoms; intervention

10016766 disorders Flatulence not indicated
10065713 disorders Gastric fistula intervention not indicated

10017789 disorders Gastric hemorrhage indicated
Gastrointestinal
10051886 disorders Gastric necrosis -
Gastrointestinal
10017815 disorders Gastric perforation -
10061970 disorders Gastric stenosis intervention not indicated
10017822 disorders Gastric ulcer intervention not indicated
10017853 disorders Gastritis intervention not indicated
Gastrointestinal Gastroesophageal reflux Mild symptoms; intervention

10066874 disorders disease not indicated
10017877 disorders Gastrointestinal fistula intervention not indicated
Gastrointestinal
10017999 disorders Gastrointestinal pain Mild pain
Mild nausea, early satiety

and bloating, able to
Gastrointestinal maintain caloric intake on
10018043 disorders Gastroparesis regular diet
Gastrointestinal
10018286 disorders Gingival pain Mild pain
Gastrointestinal Hemorrhoidal Mild; intervention not

10060640 disorders hemorrhage indicated
10019611 disorders Hemorrhoids intervention not indicated
10065728 disorders Ileal fistula intervention not indicated

10055287 disorders Ileal hemorrhage indicated
10065730 disorders Ileal obstruction intervention not indicated
Gastrointestinal
10021305 disorders Ileal perforation -
10021307 disorders Ileal stenosis intervention not indicated
10021309 disorders Ileal ulcer intervention not indicated
Gastrointestinal
10021328 disorders Ileus -
Gastrointestinal Intra-abdominal
10055291 disorders hemorrhage -
10065719 disorders Jejunal fistula intervention not indicated

10055300 disorders Jejunal hemorrhage indicated
10065732 disorders Jejunal obstruction intervention not indicated
Gastrointestinal
10023174 disorders Jejunal perforation -
10023176 disorders Jejunal stenosis intervention not indicated
10023177 disorders Jejunal ulcer intervention not indicated
Gastrointestinal
10024561 disorders Lip pain Mild pain
Gastrointestinal Lower gastrointestinal Mild; intervention not

Gastrointestinal
10025476 disorders Malabsorption -
10028130 disorders Mucositis oral indicated
Gastrointestinal Loss of appetite without

10028813 disorders Nausea alteration in eating habits
10029957 disorders Obstruction gastric intervention not indicated
10065720 disorders Oral cavity fistula intervention not indicated
Gastrointestinal Mild discomfort; not

10054520 disorders Oral dysesthesia interfering with oral intake

10030980 disorders Oral hemorrhage indicated
Gastrointestinal
10031009 disorders Oral pain Mild pain
10065703 disorders Pancreatic duct stenosis intervention not indicated
10049192 disorders Pancreatic fistula intervention not indicated

10033626 disorders Pancreatic hemorrhage indicated
Gastrointestinal
10058096 disorders Pancreatic necrosis -
Gastrointestinal
10033645 disorders Pancreatitis -
Gingival recession or
Gastrointestinal gingivitis; limited bleeding on
10034536 disorders Periodontal disease probing; mild local bone loss
Gastrointestinal
10065704 disorders Peritoneal necrosis -
Gastrointestinal Rectal discomfort,

10036774 disorders Proctitis intervention not indicated
10038062 disorders Rectal fistula intervention not indicated

10038064 disorders Rectal hemorrhage indicated
10063190 disorders Rectal mucositis indicated
Gastrointestinal
10065709 disorders Rectal necrosis -
10065707 disorders Rectal obstruction intervention not indicated
Gastrointestinal
10038072 disorders Rectal pain Mild pain
Gastrointestinal
10038073 disorders Rectal perforation -
10038079 disorders Rectal stenosis intervention not indicated
10038080 disorders Rectal ulcer intervention not indicated
Gastrointestinal Retroperitoneal
10038981 disorders hemorrhage -
Slightly thickened saliva;
Gastrointestinal Salivary duct slightly altered taste (e.g.,
10056681 disorders inflammation metallic)
10039411 disorders Salivary gland fistula intervention not indicated
Gastrointestinal Small intestinal symptoms; intervention not
10065710 disorders mucositis indicated
Gastrointestinal Small intestinal diagnostic observations only;
10041101 disorders obstruction intervention not indicated
Gastrointestinal Small intestinal

10041103 disorders perforation -
10062263 disorders Small intestinal stenosis intervention not indicated
10041133 disorders Small intestine ulcer intervention not indicated
Gastrointestinal
10042112 disorders Stomach pain Mild pain
Gastrointestinal Tooth development Asymptomatic; hypoplasia of

10044030 disorders disorder tooth or enamel
Gastrointestinal
10044031 disorders Tooth discoloration Surface stains
Gastrointestinal
10044055 disorders Toothache Mild pain
Gastrointestinal
10045271 disorders Typhlitis -
Gastrointestinal Upper gastrointestinal Mild; intervention not

Gastrointestinal 1 - 2 episodes (separated by

10047700 disorders Vomiting 5 minutes) in 24 hrs
Gastrointestinal symptoms; clinical or
Gastrointestinal disorders - Other, diagnostic observations only;
General disorders and

administration site Mild sensation of cold;
10008531 conditions Chills shivering; chattering of teeth

administration site
10011912 conditions Death neonatal -

administration site
10011914 conditions Death NOS -

administration site
10014222 conditions Edema face Localized facial edema
5 - 10% inter-limb
discrepancy in volume or
circumference at point of
greatest visible difference;
General disorders and swelling or obscuration of
administration site anatomic architecture on
10050068 conditions Edema limbs close inspection
General disorders and Swelling or obscuration of

administration site anatomic architecture on
10058720 conditions Edema trunk close inspection

administration site
10016059 conditions Facial pain Mild pain

administration site
10016256 conditions Fatigue Fatigue relieved by rest

administration site 38.0 - 39.0 degrees C (100.4
10016558 conditions Fever - 102.2 degrees F)

administration site Mild flu-like symptoms
10016791 conditions Flu like symptoms present
General disorders and Mild change in gait (e.g.,
administration site wide-based, limping or
10017577 conditions Gait disturbance hobbling)

administration site
10021113 conditions Hypothermia -
Mild transient reaction;

General disorders and infusion interruption not
administration site indicated; intervention not
10051792 conditions Infusion related reaction indicated

administration site Infusion site
10064774 conditions extravasation
General disorders and Tenderness with or without

administration site associated symptoms (e.g.,
10022095 conditions Injection site reaction warmth, erythema, itching)

administration site
10022998 conditions Irritability Mild; easily consolable
General disorders and Localized to dependent

administration site areas, no disability or
10062466 conditions Localized edema functional impairment
administration site Uneasiness or lack of well
10025482 conditions Malaise being

administration site
10028154 conditions Multi-organ failure -

administration site Asymptomatic localized neck
10054482 conditions Neck edema edema

administration site
10062501 conditions Non-cardiac chest pain Mild pain

administration site
10033371 conditions Pain Mild pain

administration site
10042435 conditions Sudden death NOS -
General disorders and Asymptomatic or mild

General disorders and administration site symptoms; clinical or
administration site conditions - Other, diagnostic observations only;
10018065 conditions specify intervention not indicated
10051341 Hepatobiliary disorders Bile duct stenosis intervention not indicated
10004665 Hepatobiliary disorders Biliary fistula -

10008612 Hepatobiliary disorders Cholecystitis -
Asymptomatic clinical or
10017631 Hepatobiliary disorders Gallbladder fistula intervention not indicated
10059446 Hepatobiliary disorders Gallbladder necrosis -
10017636 Hepatobiliary disorders Gallbladder obstruction intervention not indicated
10017638 Hepatobiliary disorders Gallbladder pain Mild pain
10017639 Hepatobiliary disorders Gallbladder perforation -
10019663 Hepatobiliary disorders Hepatic failure -
Mild; intervention not

10019678 Hepatobiliary disorders Hepatic hemorrhage indicated
10019692 Hepatobiliary disorders Hepatic necrosis -
10019705 Hepatobiliary disorders Hepatic pain Mild pain
10034405 Hepatobiliary disorders Perforation bile duct -

10036200 Hepatobiliary disorders Portal hypertension -
10036206 Hepatobiliary disorders Portal vein thrombosis -
Hepatobiliary disorders - diagnostic observations only;
10019805 Hepatobiliary disorders Other, specify intervention not indicated
Transient flushing or rash,

drug fever <38 degrees C
Immune system (<100.4 degrees F);
10001718 disorders Allergic reaction intervention not indicated
Immune system
10002218 disorders Anaphylaxis -
Asymptomatic; serologic or
other evidence of
autoimmune reaction, with
Immune system normal organ function;
10061664 disorders Autoimmune disorder intervention not indicated
Mild reaction; infusion
Immune system Cytokine release interruption not indicated;
10052015 disorders syndrome intervention not indicated
Immune system diagnostic observations only;
10040400 disorders Serum sickness intervention not indicated
Immune system symptoms; clinical or
Immune system disorders - Other, diagnostic observations only;
Infections and
10056519 infestations Abdominal infection -
Infections and Localized; local intervention

10061640 infestations Anorectal infection indicated
Infections and
10003011 infestations Appendicitis -
Infections and
10003012 infestations Appendicitis perforated -
Infections and
10065744 infestations Arteritis infective -
Infections and
10061695 infestations Biliary tract infection -
Infections and
10005047 infestations Bladder infection -
Infections and
10061017 infestations Bone infection -
Infections and
10006259 infestations Breast infection -
Infections and
10055078 infestations Bronchial infection -
Infections and Catheter related

10007810 infestations infection -
Infections and
10065761 infestations Cecal infection -
Infections and
10008330 infestations Cervicitis infection -
Infections and
10010742 infestations Conjunctivitis infective -
Infections and
10061788 infestations Corneal infection -
Infections and
10065765 infestations Cranial nerve infection -
Infections and
10064687 infestations Device related infection -
Infections and
10065752 infestations Duodenal infection -
Infections and
10014594 infestations Encephalitis infection -
Infections and Encephalomyelitis

Infections and
10014678 infestations Endocarditis infective -
Infections and
10014801 infestations Endophthalmitis -
Infections and
10058838 infestations Enterocolitis infectious -
Infections and
10058804 infestations Esophageal infection -
Infections and
10015929 infestations Eye infection -
Infections and
10062632 infestations Gallbladder infection -
Infections and Local therapy indicated

10018784 infestations Gum infection (swish and swallow)
Infections and
10056522 infestations Hepatic infection -
Infections and Asymptomatic, treatment
10019799 infestations Hepatitis viral not indicated
Infections and
10021918 infestations Infective myositis -
Infections and
10023216 infestations Joint infection -
Infections and
10023424 infestations Kidney infection -
Infections and
10023874 infestations Laryngitis -
Infections and Localized, local intervention

10065755 infestations Lip infection indicated
Infections and
10061229 infestations Lung infection -
Infections and
10050823 infestations Lymph gland infection -
Infections and
10057483 infestations Mediastinal infection -
Infections and
10027199 infestations Meningitis -

10065764 infestations Mucosal infection indicated

10061304 infestations Nail infection indicated
Infections and
10033072 infestations Otitis externa -
Infections and
10033078 infestations Otitis media -
Infections and
10055005 infestations Ovarian infection -
Infections and
10051741 infestations Pancreas infection -
Papules and/or pustules

covering <10% BSA, which
may or may not be
Infections and associated with symptoms of
10069138 infestations Papulopustular rash pruritus or tenderness
Nail fold edema or

Infections and erythema; disruption of the
10034016 infestations Paronychia cuticle
Infections and
10058674 infestations Pelvic infection -
Infections and
10061912 infestations Penile infection -
Infections and
10051472 infestations Periorbital infection -
Infections and Peripheral nerve

Infections and
10057262 infestations Peritoneal infection -
Infections and
10034835 infestations Pharyngitis -
Infections and
10056627 infestations Phlebitis infective -
Infections and
10061351 infestations Pleural infection -
Infections and
10050662 infestations Prostate infection -
Infections and
10037888 infestations Rash pustular -
Infections and
10059827 infestations Rhinitis infective -
Infections and
10039413 infestations Salivary gland infection -
Infections and
10062156 infestations Scrotal infection -
Infections and
10040047 infestations Sepsis -
Infections and
10040753 infestations Sinusitis -

10040872 infestations Skin infection indicated
Infections and
10065771 infestations Small intestine infection -
Infections and
10062255 infestations Soft tissue infection -
Infections and
10062112 infestations Splenic infection -

10064505 infestations Stoma site infection indicated
Infections and
10048762 infestations Tooth infection -
Infections and
10044302 infestations Tracheitis -
Infections and Upper respiratory

Infections and
10052298 infestations Urethral infection -
Infections and
10046571 infestations Urinary tract infection -
Infections and
10062233 infestations Uterine infection -
Infections and
10046914 infestations Vaginal infection -

10065772 infestations Vulval infection indicated
Infections and
10048038 infestations Wound infection -
Infections and symptoms; clinical or
Infections and infestations - Other, diagnostic observations only;
10021881 infestations specify intervention not indicated
Injury, poisoning and

procedural Mild; non-surgical
10002544 complications Ankle fracture intervention indicated

procedural
10002899 complications Aortic injury -
Injury, poisoning and Asymptomatic diagnostic
procedural finding; intervention not
10003162 complications Arterial injury indicated

procedural observations only;
10050458 complications Biliary anastomotic leak intervention not indicated

procedural Bladder anastomotic observations only;
10065802 complications leak intervention not indicated

procedural Localized or in a dependent
10006504 complications Bruising area

procedural Minimal symptoms;
10006634 complications Burn intervention not indicated

procedural Faint erythema or dry
10061103 complications Dermatitis radiation desquamation

procedural Esophageal anastomotic observations only;
Injury, poisoning and Minor with no resultant

procedural injuries; intervention not
10016173 complications Fall indicated
Injury, poisoning and Asymptomatic; clinical or

procedural Fallopian tube diagnostic observations only;
10065788 complications anastomotic leak intervention not indicated

procedural Fallopian tube observations only;
10065790 complications perforation intervention not indicated
procedural diagnostic observations only;
10017076 complications Fracture intervention not indicated

10065893 complications Gastric anastomotic leak intervention not indicated

procedural Gastrointestinal observations only;

procedural Gastrointestinal stoma
10065712 complications necrosis -

procedural
10020100 complications Hip fracture -

procedural
10022161 complications Injury to carotid artery -

procedural Injury to inferior vena
10022213 complications cava -

procedural
10065849 complications Injury to jugular vein -

procedural Injury to superior vena finding; intervention not
10022356 complications cava indicated

10059095 complications Intestinal stoma leak intervention not indicated
procedural Intestinal stoma
10059094 complications obstruction
Injury, poisoning and Minimal bleeding identified

procedural Intestinal stoma site on clinical exam;
10049468 complications bleeding intervention not indicated

procedural Intraoperative arterial Primary repair of injured
10065826 complications injury organ/structure indicated

procedural Intraoperative breast Primary repair of injured

procedural Intraoperative cardiac
10065843 complications injury -

procedural Primary repair of injured
10065844 complications Intraoperative ear injury organ/structure indicated

procedural Intraoperative endocrine Primary repair of injured

procedural Intraoperative Primary repair of injured
10065825 complications gastrointestinal injury organ/structure indicated

procedural Intraoperative head and Primary repair of injured
10065842 complications neck injury organ/structure indicated

procedural Intraoperative
10055298 complications hemorrhage -

10065827 complications hepatobiliary injury organ/structure indicated
10065829 complications musculoskeletal injury organ/structure indicated

10065830 complications neurological injury organ/structure indicated

procedural Intraoperative ocular Primary repair of injured

procedural Intraoperative renal Primary repair of injured

10065840 complications reproductive tract injury organ/structure indicated

10065832 complications respiratory injury organ/structure indicated

procedural Primary repair of injured
10065846 complications Intraoperative skin injury organ/structure indicated

procedural Intraoperative splenic
10065847 complications injury -

procedural Intraoperative urinary Primary repair of injured

procedural Intraoperative venous Primary repair of injured

10065803 complications Kidney anastomotic leak intervention not indicated
procedural Large intestinal observations only;

procedural Pancreatic anastomotic observations only;

procedural Pharyngeal anastomotic observations only;

procedural Postoperative on clinical exam;
10055322 complications hemorrhage intervention not indicated

procedural Postoperative thoracic
10056745 complications procedure complication -

procedural Prolapse of intestinal
10065745 complications stoma Asymptomatic; reducible

10065822 complications Prolapse of urostomy intervention not indicated

procedural Radiation recall reaction Faint erythema or dry
10037767 complications (dermatologic) desquamation
10065894 complications Rectal anastomotic leak intervention not indicated

10040102 complications Seroma intervention not indicated

procedural Small intestinal observations only;

procedural Spermatic cord observations only;
Injury, poisoning and Mild back pain;

procedural nonprescription analgesics
10041569 complications Spinal fracture indicated

procedural Stenosis of
10065898 complications gastrointestinal stoma -

10042127 complications Stomal ulcer intervention not indicated
Minimal bleeding identified

Injury, poisoning and on clinical or diagnostic
procedural exam; intervention not
10062548 complications Tracheal hemorrhage indicated
Partial asymptomatic
Injury, poisoning and obstruction on examination
procedural (e.g., visual, radiologic or
10044291 complications Tracheal obstruction endoscopic)
procedural Tracheostomy site on clinical exam;
10065749 complications bleeding intervention not indicated

procedural Ureteric anastomotic observations only;

procedural Urethral anastomotic observations only;

10065882 complications Urostomy leak intervention not indicated

10065883 complications Urostomy obstruction intervention not indicated

procedural on clinical exam;
10065748 complications Urostomy site bleeding intervention not indicated

procedural
10065885 complications Urostomy stenosis -

procedural Uterine anastomotic observations only;

10046810 complications Uterine perforation intervention not indicated

10065887 complications Vaginal anastomotic leak intervention not indicated
procedural Vas deferens observations only;

procedural Vascular access
10062169 complications complication -

procedural finding; intervention not
10047228 complications Venous injury indicated
Injury, poisoning and Incisional separation of

procedural <=25% of wound, no deeper
10053692 complications Wound complication than superficial fascia
Injury, poisoning and Incisional separation of

procedural <=25% of wound, no deeper
10048031 complications Wound dehiscence than superficial fascia

procedural Mild; non-surgical
10048049 complications Wrist fracture intervention indicated
Injury, poisoning and Asymptomatic or mild

Injury, poisoning and procedural symptoms; clinical or
procedural complications - Other, diagnostic observations only;
10022117 complications specify intervention not indicated
Activated partial
thromboplastin time
10000636 Investigations prolonged >1 - 1.5 x ULN
Alanine
aminotransferase
10001551 Investigations increased >ULN - 3.0 x ULN
Alkaline phosphatase
Aspartate
aminotransferase
Blood antidiuretic diagnostic observations only;
10005332 Investigations hormone abnormal intervention not indicated
10005364 Investigations Blood bilirubin increased >ULN - 1.5 x ULN
Blood corticotrophin diagnostic observations only;
10005452 Investigations decreased intervention not indicated
Blood gonadotrophin diagnostic observations only;
10005561 Investigations abnormal intervention not indicated
Blood prolactin diagnostic observations only;
3 - 5 units below LLN; for
Carbon monoxide follow-up, a decrease of 3 - 5
diffusing capacity units (ml/sec/mm Hg) below
10065906 Investigations decreased the baseline value
Levels above the upper limit

of normal and below the
level of myocardial infarction
Cardiac troponin I as defined by the
10007612 Investigations increased manufacturer
Levels above the upper limit

of normal and below the
level of myocardial infarction
Cardiac troponin T as defined by the
10007613 Investigations increased manufacturer
CD4 lymphocytes <LLN - 500/mm3; <LLN - 0.5
10007839 Investigations decreased x 10e9 /L
>ULN - 300 mg/dL; >ULN -
10008661 Investigations Cholesterol high 7.75 mmol/L
10011268 Investigations CPK increased >ULN - 2.5 x ULN

>1 - 1.5 x baseline; >ULN -
10011368 Investigations Creatinine increased 1.5 x ULN
Ejection fraction
10050528 Investigations decreased -
Electrocardiogram QT
corrected interval
10014383 Investigations prolonged QTc 450 - 480 ms
<1.0 - 0.75 x LLN or <25%

10016596 Investigations Fibrinogen decreased decrease from baseline
FEV1% (percentages of
observed FEV1 and FVC
related to their respective
Forced expiratory predicted values) 99 - 70%
10016987 Investigations volume decreased predicted
10056910 Investigations GGT increased >ULN - 2.5 x ULN
Growth hormone diagnostic observations only;
10019150 Investigations Haptoglobin decreased <LLN
Increase in >0 - 2 gm/dL

above ULN or above baseline
10055599 Investigations Hemoglobin increased if baseline is above ULN
>1 - 1.5 x ULN; >1 - 1.5 times

above baseline if on
10022402 Investigations INR increased anticoagulation
10024574 Investigations Lipase increased >ULN - 1.5 x ULN

Lymphocyte count <LLN - 800/mm3; <LLN x 0.8 -
10025256 Investigations decreased 10e9 /L
Lymphocyte count
10025258 Investigations increased
Neutrophil count <LLN - 1500/mm3; <LLN - 1.5
Pancreatic enzymes
10062646 Investigations decreased <LLN and asymptomatic
<LLN - 75,000/mm3; <LLN -

10035528 Investigations Platelet count decreased 75.0 x 10e9 /L
Serum amylase
10059895 Investigations Urine output decreased -
10047580 Investigations Vital capacity abnormal 90 - 75% of predicted value
10047896 Investigations Weight gain 5 - <10% from baseline

5 to <10% from baseline;
10047900 Investigations Weight loss intervention not indicated
White blood cell <LLN - 3000/mm3; <LLN - 3.0
Investigations - Other, diagnostic observations only;
10022891 Investigations specify intervention not indicated
Metabolism and
10000486 nutrition disorders Acidosis pH <normal, but =>7.3
Metabolism and
10001598 nutrition disorders Alcohol intolerance -
Metabolism and
10001680 nutrition disorders Alkalosis pH >normal, but <=7.5
Metabolism and Loss of appetite without

10002646 nutrition disorders Anorexia alteration in eating habits
Increased oral fluids

indicated; dry mucous
Metabolism and membranes; diminished skin
10012174 nutrition disorders Dehydration turgor
Metabolism and diagnostic observations only;
10052426 nutrition disorders Glucose intolerance intervention not indicated
>ULN - 11.5 mg/dL; >ULN -

Metabolism and 2.9 mmol/L; Ionized calcium
10020587 nutrition disorders Hypercalcemia >ULN - 1.5 mmol/L
Fasting glucose value >ULN -

Metabolism and 160 mg/dL; Fasting glucose
10020639 nutrition disorders Hyperglycemia value >ULN - 8.9 mmol/L
Metabolism and
10020647 nutrition disorders Hyperkalemia >ULN - 5.5 mmol/L
Metabolism and >ULN - 3.0 mg/dL; >ULN -

10020670 nutrition disorders Hypermagnesemia 1.23 mmol/L
Metabolism and
10020680 nutrition disorders Hypernatremia >ULN - 150 mmol/L
Metabolism and 150 mg/dL - 300 mg/dL; 1.71

10020870 nutrition disorders Hypertriglyceridemia mmol/L - 3.42 mmol/L
>ULN - 10 mg/dL; <=0.59

Metabolism and mmol/L without physiologic
10020907 nutrition disorders Hyperuricemia consequences
Metabolism and
10020943 nutrition disorders Hypoalbuminemia <LLN - 3 g/dL; <LLN - 30 g/L
<LLN - 8.0 mg/dL; <LLN - 2.0

Metabolism and mmol/L; Ionized calcium
10020949 nutrition disorders Hypocalcemia <LLN - 1.0 mmol/L
Metabolism and <LLN - 55 mg/dL; <LLN - 3.0

10021005 nutrition disorders Hypoglycemia mmol/L
Metabolism and
10021018 nutrition disorders Hypokalemia <LLN - 3.0 mmol/L
Metabolism and <LLN - 1.2 mg/dL; <LLN - 0.5

10021028 nutrition disorders Hypomagnesemia mmol/L
Metabolism and
10021038 nutrition disorders Hyponatremia <LLN - 130 mmol/L
Metabolism and <LLN - 2.5 mg/dL; <LLN - 0.8

10021059 nutrition disorders Hypophosphatemia mmol/L
Metabolism and
10065973 nutrition disorders Iron overload -
Metabolism and
10029883 nutrition disorders Obesity -
Metabolism and
10045152 nutrition disorders Tumor lysis syndrome -
Metabolism and symptoms; clinical or
Metabolism and nutrition disorders - diagnostic observations only;
10027433 nutrition disorders Other, specify intervention not indicated
Musculoskeletal and
connective tissue Abdominal soft tissue
10065775 disorders necrosis -
Musculoskeletal and
connective tissue
10003239 disorders Arthralgia Mild pain
Musculoskeletal and
connective tissue Mild pain with inflammation,
10003246 disorders Arthritis erythema, or joint swelling
Musculoskeletal and Asymptomatic; clinical or

connective tissue diagnostic observations only;
10066480 disorders Avascular necrosis intervention not indicated
Musculoskeletal and
connective tissue
10003988 disorders Back pain Mild pain
Musculoskeletal and
connective tissue
10006002 disorders Bone pain Mild pain
Musculoskeletal and
connective tissue
10048677 disorders Buttock pain Mild pain
Musculoskeletal and
connective tissue
10008496 disorders Chest wall pain Mild pain

10015688 disorders Exostosis intervention not indicated
Mild induration, able to

Musculoskeletal and move skin parallel to plane
connective tissue Fibrosis deep connective (sliding) and perpendicular
10065799 disorders tissue to skin (pinching up)
Musculoskeletal and
connective tissue
10016750 disorders Flank pain Mild pain
Musculoskeletal and Symptomatic; weakness

connective tissue Generalized muscle perceived by patient but not
10062572 disorders weakness evident on physical exam
Musculoskeletal and Reduction in growth velocity

connective tissue by 10 - 29% ideally measured
10018761 disorders Growth suppression over the period of a year
Musculoskeletal and
connective tissue
10065779 disorders Head soft tissue necrosis

10023215 disorders Joint effusion intervention not indicated
Musculoskeletal and <=25% loss of ROM (range of

connective tissue Joint range of motion motion); decreased ROM
10048706 disorders decreased limiting athletic activity
Musculoskeletal and Mild restriction of rotation or

connective tissue Joint range of motion flexion between 60 - 70
10065796 disorders decreased cervical spine degrees
Stiffness; difficulty bending
Musculoskeletal and to the floor to pick up a very
connective tissue Joint range of motion light object but able to do
10065800 disorders decreased lumbar spine athletic activity

10023509 disorders Kyphosis intervention not indicated

10024842 disorders Lordosis intervention not indicated
Musculoskeletal and Symptomatic; perceived by

connective tissue Muscle weakness left- patient but not evident on
10065780 disorders sided physical exam

connective tissue Muscle weakness lower patient but not evident on
10065776 disorders limb physical exam

connective tissue Muscle weakness right- patient but not evident on
10065794 disorders sided physical exam

connective tissue patient but not evident on
10065795 disorders Muscle weakness trunk physical exam

connective tissue Muscle weakness upper patient but not evident on
10065895 disorders limb physical exam
Musculoskeletal and
connective tissue Musculoskeletal Cosmetically and functionally
10065783 disorders deformity insignificant hypoplasia
Musculoskeletal and
connective tissue
10028411 disorders Myalgia Mild pain
Musculoskeletal and
connective tissue
10028653 disorders Myositis Mild pain
Musculoskeletal and
connective tissue
10028836 disorders Neck pain Mild pain
Musculoskeletal and
connective tissue
10065781 disorders Neck soft tissue necrosis -

10064658 disorders Osteonecrosis of jaw intervention not indicated
Radiologic evidence of
osteoporosis or Bone
Mineral Density (BMD) t-
Musculoskeletal and score -1 to -2.5 (osteopenia);
connective tissue no loss of height or
10031282 disorders Osteoporosis intervention indicated
Musculoskeletal and
connective tissue
10033425 disorders Pain in extremity Mild pain
Musculoskeletal and
connective tissue Pelvic soft tissue
10065793 disorders necrosis -
Musculoskeletal and
connective tissue <20 degrees; clinically
10039722 disorders Scoliosis undetectable
Musculoskeletal and
connective tissue Soft tissue necrosis
10065777 disorders lower limb -
Musculoskeletal and
connective tissue Soft tissue necrosis
10065778 disorders upper limb -

Musculoskeletal and move skin parallel to plane
connective tissue Superficial soft tissue (sliding) and perpendicular
10065798 disorders fibrosis to skin (pinching up)
Musculoskeletal and Decreased ROM (range of

connective tissue motion) without impaired
10044684 disorders Trismus eating
Musculoskeletal and
connective tissue Mild length discrepancy <2
10065738 disorders Unequal limb length cm
Musculoskeletal and Musculoskeletal and symptoms; clinical or
connective tissue connective tissue diagnostic observations only;
10028395 disorders disorder - Other, specify intervention not indicated
Neoplasms benign,
malignant and
unspecified (incl cysts Leukemia secondary to
10048293 and polyps) oncology chemotherapy -
Neoplasms benign,
malignant and
unspecified (incl cysts Myelodysplastic
10028533 and polyps) syndrome -
Neoplasms benign,
malignant and
unspecified (incl cysts Treatment related
10049737 and polyps) secondary malignancy -
Neoplasms benign,
malignant and
unspecified (incl cysts
10045158 and polyps) Tumor pain Mild pain
Neoplasms benign,
Neoplasms benign, malignant and Asymptomatic or mild
malignant and unspecified (incl cysts symptoms; clinical or
unspecified (incl cysts and polyps) - Other, diagnostic observations only;
10029104 and polyps) specify intervention not indicated
Nervous system diagnostic observations only;
10053662 disorders Abducens nerve disorder intervention not indicated
10060929 disorders Accessory nerve disorder intervention not indicated
Nervous system Acoustic nerve disorder diagnostic observations only;
10000521 disorders NOS intervention not indicated
Nervous system Mild restlessness or

10001540 disorders Akathisia increased motor activity
Nervous system
10001949 disorders Amnesia Mild; transient memory loss
Nervous system
10002953 disorders Aphonia -
Nervous system
10003074 disorders Arachnoiditis Mild symptoms
10003591 disorders Ataxia intervention not indicated
10065417 disorders Brachial plexopathy intervention not indicated
Nervous system Central nervous system diagnostic observations only;
10065784 disorders necrosis intervention not indicated
Post-craniotomy:
asymptomatic; Post-lumbar
puncture: transient
Nervous system Cerebrospinal fluid headache; postural care
10008164 disorders leakage indicated
Mild cognitive disability; not

interfering with
work/school/life
performance; specialized
Nervous system educational services/devices
10009845 disorders Cognitive disturbance not indicated
Mild inattention or
Nervous system Concentration decreased level of
10010250 disorders impairment concentration
Nervous system Depressed level of

10012373 disorders consciousness Decreased level of alertness
Nervous system Mild unsteadiness or

10013573 disorders Dizziness sensation of movement
Nervous system
10013887 disorders Dysarthria Mild slurred speech
Nervous system
10062872 disorders Dysesthesia Mild sensory alteration
Nervous system Altered taste but no change
10013911 disorders Dysgeusia in diet
Awareness of receptive or
expressive characteristics;
Nervous system not impairing ability to
10013951 disorders Dysphasia communicate
Nervous system
10014217 disorders Edema cerebral -
Nervous system
10014625 disorders Encephalopathy Mild symptoms
Nervous system
10015832 disorders Extrapyramidal disorder Mild involuntary movements
10051272 disorders Facial muscle weakness intervention not indicated
10061457 disorders Facial nerve disorder intervention not indicated
Nervous system Glossopharyngeal nerve diagnostic observations only;
10061185 disorders disorder intervention not indicated
Nervous system
10019211 disorders Headache Mild pain
10020508 disorders Hydrocephalus intervention not indicated
Nervous system Mild increased need for
10020765 disorders Hypersomnia sleep
Nervous system Hypoglossal nerve diagnostic observations only;
10022763 disorders Intracranial hemorrhage intervention not indicated
Nervous system Ischemia diagnostic observations only;
10023030 disorders cerebrovascular intervention not indicated
10065836 disorders IVth nerve disorder intervention not indicated
Nervous system Mild symptoms; reduced

10024264 disorders Lethargy alertness and awareness
Asymptomatic; small focal

T2/FLAIR hyperintensities;
involving periventricular
white matter or <1/3 of
susceptible areas of
cerebrum +/- mild increase
in subarachnoid space (SAS)
Nervous system and/or mild
10024382 disorders Leukoencephalopathy ventriculomegaly
Nervous system
10027175 disorders Memory impairment Mild memory impairment
Nervous system
10027198 disorders Meningismus Mild symptoms
Nervous system
10028041 disorders Movements involuntary Mild symptoms
Asymptomatic; mild signs
Nervous system (e.g., Babinski's reflex or
10028524 disorders Myelitis Lhermitte's sign)
Nervous system
10029223 disorders Neuralgia Mild pain
Nervous system
10029864 disorders Nystagmus -
Nervous system Oculomotor nerve diagnostic observations only;
Nervous system
10056388 disorders Olfactory nerve disorder -
Nervous system
10033987 disorders Paresthesia Mild symptoms
Nervous system Peripheral motor diagnostic observations only;
10034580 disorders neuropathy intervention not indicated
Asymptomatic; loss of deep

Nervous system Peripheral sensory tendon reflexes or
10034620 disorders neuropathy paresthesia
Nervous system
10056238 disorders Phantom pain Mild pain
Nervous system
10036653 disorders Presyncope
Nervous system Pyramidal tract diagnostic observations only;
Nervous system
10061928 disorders Radiculitis Mild symptoms
Nervous system Recurrent laryngeal diagnostic observations only;
10038130 disorders nerve palsy intervention not indicated
Reversible posterior Asymptomatic; clinical or
Nervous system leukoencephalopathy diagnostic observations only;
Nervous system Brief partial seizure; no loss

10039906 disorders Seizure of consciousness
Nervous system
10040747 disorders Sinus pain Mild pain
Nervous system Mild but more than usual

10041349 disorders Somnolence drowsiness or sleepiness
Nervous system Mild or slight increase in

10041416 disorders Spasticity muscle tone
Nervous system neurologic deficit;
10042244 disorders Stroke radiographic findings only
Nervous system
10042772 disorders Syncope -
Mild neurologic deficit with

Nervous system Transient ischemic or without imaging
10044391 disorders attacks confirmation
Nervous system
10044565 disorders Tremor Mild symptoms
Nervous system Trigeminal nerve diagnostic observations only;
10061403 disorders Vagus nerve disorder intervention not indicated
Nervous system
10047166 disorders Vasovagal reaction -
Nervous system symptoms; clinical or
Nervous system disorders - Other, diagnostic observations only;
Pregnancy, puerperium
and perinatal
10016479 conditions Fetal death -
and perinatal
10054746 conditions Fetal growth retardation -
and perinatal Delivery of a liveborn infant
10036595 conditions Premature delivery at >34 to 37 weeks gestation
and perinatal
10045542 conditions Unintended pregnancy -
Pregnancy, puerperium Pregnancy, puerperium symptoms; clinical or
and perinatal and perinatal conditions diagnostic observations only;
10036585 conditions - Other, specify intervention not indicated
10001497 Psychiatric disorders Agitation Mild mood alteration
Inability to achieve orgasm

not adversely affecting
10002652 Psychiatric disorders Anorgasmia relationship

10002855 Psychiatric disorders Anxiety not indicated
10010300 Psychiatric disorders Confusion Mild disorientation

Delay in achieving orgasm
10057066 Psychiatric disorders Delayed orgasm relationship
10012218 Psychiatric disorders Delirium Mild acute confusional state
10012260 Psychiatric disorders Delusions -
10012378 Psychiatric disorders Depression Mild depressive symptoms
10015533 Psychiatric disorders Euphoria Mild mood elevation
Mild hallucinations (e.g.,

10019077 Psychiatric disorders Hallucinations perceptual distortions)
Mild difficulty falling asleep,

staying asleep or waking up
10022437 Psychiatric disorders Insomnia early
Decrease in sexual interest

10024419 Psychiatric disorders Libido decreased relationship
Mild increase in sexual

interest not adversely
10024421 Psychiatric disorders Libido increased affecting relationship
Mild manic symptoms (e.g.,

elevated mood, rapid
thoughts, rapid speech,
10026749 Psychiatric disorders Mania decreased need for sleep)
10034719 Psychiatric disorders Personality change Mild personality change
10037234 Psychiatric disorders Psychosis Mild psychotic symptoms

10038743 Psychiatric disorders Restlessness not indicated
Increased thoughts of death

10042458 Psychiatric disorders Suicidal ideation but no wish to kill oneself
10042464 Psychiatric disorders Suicide attempt -
Psychiatric disorders - diagnostic observations only;
10037175 Psychiatric disorders Other, specify intervention not indicated
Creatinine level increase of

Renal and urinary >0.3 mg/dL; creatinine 1.5 -
10069339 disorders Acute kidney injury 2.0 x above baseline
Renal and urinary

10063575 disorders Bladder perforation -
Renal and urinary
10048994 disorders Bladder spasm Intervention not indicated
eGFR (estimated Glomerular

Filtration Rate) or CrCl
(creatinine clearance) <LLN -
60 ml/min/1.73 m2 or
Renal and urinary proteinuria 2+ present; urine
10064848 disorders Chronic kidney disease protein/creatinine >0.5
Microscopic hematuria;
minimal increase in
frequency, urgency, dysuria,
Renal and urinary or nocturia; new onset of
10063057 disorders Cystitis noninfective incontinence
Renal and urinary diagnostic observations only;
10019450 disorders Hematuria intervention not indicated
Renal and urinary diagnostic observations only;
10019489 disorders Hemoglobinuria intervention not indicated
Renal and urinary 1+ proteinuria; urinary

10037032 disorders Proteinuria protein <1.0 g/24 hrs
symptoms; occasional use of
Renal and urinary nonprescription analgesics
10038385 disorders Renal calculi indicated
Mild pain not interfering

Renal and urinary with activity; nonprescription
10038419 disorders Renal colic medication indicated
Renal and urinary Mild symptoms; intervention

10038463 disorders Renal hemorrhage not indicated
Renal and urinary
10065368 disorders Urinary fistula -
Renal and urinary

10046539 disorders Urinary frequency Present
Occasional (e.g., with

Renal and urinary coughing, sneezing, etc.),
10046543 disorders Urinary incontinence pads not indicated
Urinary, suprapubic or
intermittent catheter
placement not indicated;
Renal and urinary able to void with some
10046555 disorders Urinary retention residual
Renal and urinary Asymptomatic; clinical or

10061574 disorders Urinary tract obstruction diagnostic observations only
Renal and urinary

10062225 disorders Urinary tract pain Mild pain
Renal and urinary

10046593 disorders Urinary urgency Present
Renal and urinary
10046628 disorders Urine discoloration Present
Renal and urinary symptoms; clinical or
Renal and urinary disorders - Other, diagnostic observations only;
Reproductive system
10003883 and breast disorders Azoospermia -
Reproductive system Minimal asymmetry; minimal

10006179 and breast disorders Breast atrophy atrophy
Reproductive system
10006298 and breast disorders Breast pain Mild pain
Reproductive system Mild symptoms; intervention

10013934 and breast disorders Dysmenorrhea not indicated
Mild discomfort or pain

associated with vaginal
penetration; discomfort
Reproductive system relieved with use of vaginal
10013941 and breast disorders Dyspareunia lubricants or estrogen
Reproductive system
10014326 and breast disorders Ejaculation disorder Diminished ejaculation
Decrease in erectile function

(frequency or rigidity of
erections) but intervention
not indicated (e.g.,
medication or use of
Reproductive system mechanical device, penile
10061461 and breast disorders Erectile dysfunction pump)
Reproductive system Fallopian tube Diagnostic observations only;

10065789 and breast disorders obstruction intervention not indicated
Reproductive system diagnostic observations only;
10065791 and breast disorders Fallopian tube stenosis intervention not indicated
Reproductive system Female genital tract diagnostic observations only;
10061149 and breast disorders fistula intervention not indicated
Reproductive system Mild symptoms; intervention
10054382 and breast disorders Feminization acquired not indicated
Mild swelling or obscuration

Reproductive system of anatomic architecture on
10018146 and breast disorders Genital edema close inspection
Reproductive system Asymptomatic breast

10018801 and breast disorders Gynecomastia enlargement

on imaging study or
Reproductive system laparoscopy; intervention
10060602 and breast disorders Hematosalpinx not indicated
Intermittent menses with

Reproductive system skipped menses for no more
10022992 and breast disorders Irregular menstruation than 1 to 3 months
Mild changes in lactation,

not significantly affecting
Reproductive system production or expression of
10061261 and breast disorders Lactation disorder breast milk
Reproductive system Mild; iron supplements

10027313 and breast disorders Menorrhagia indicated
Asymptomatic; asymmetry
with slight retraction and/or
Reproductive system thickening of the nipple
10065823 and breast disorders Nipple deformity areolar complex
Reproductive system Sperm concentration >48

10030300 and breast disorders Oligospermia million/mL or motility >68%
on imaging study or
Reproductive system laproscopy; intervention not
10065763 and breast disorders Ovarian hemorrhage indicated
10033279 and breast disorders Ovarian rupture intervention not indicated
Reproductive system
10033314 and breast disorders Ovulation pain Mild pain
Reproductive system Pelvic floor muscle diagnostic observations only;
10064026 and breast disorders weakness intervention not indicated
Reproductive system
10034263 and breast disorders Pelvic pain Mild pain
Reproductive system
10034310 and breast disorders Penile pain Mild pain
Reproductive system
10061339 and breast disorders Perineal pain Mild pain
Reproductive system
10036601 and breast disorders Premature menopause

Reproductive system on imaging study;
10055325 and breast disorders Prostatic hemorrhage intervention not indicated
Reproductive system Diagnostic observations only;

10055026 and breast disorders Prostatic obstruction intervention not indicated
Reproductive system
10036968 and breast disorders Prostatic pain Mild pain
Reproductive system
10039757 and breast disorders Scrotal pain Mild pain
Reproductive system Spermatic cord on imaging study;
10065762 and breast disorders hemorrhage intervention not indicated
Reproductive system Spermatic cord Diagnostic observations only;

10065805 and breast disorders obstruction intervention not indicated
10043306 and breast disorders Testicular disorder intervention not indicated

10055347 and breast disorders Testicular hemorrhage intervention not indicated
Reproductive system
10043345 and breast disorders Testicular pain Mild pain
10065811 and breast disorders Uterine fistula intervention not indicated

10046789 and breast disorders Uterine hemorrhage intervention not indicated

10065928 and breast disorders Uterine obstruction intervention not indicated
Reproductive system
10046809 and breast disorders Uterine pain Mild pain
Mild vaginal discharge

Reproductive system (greater than baseline for
10046901 and breast disorders Vaginal discharge patient)
Mild vaginal dryness not

Reproductive system interfering with sexual
10046904 and breast disorders Vaginal dryness function
10065813 and breast disorders Vaginal fistula intervention not indicated

on clinical exam or imaging
Reproductive system study; intervention not
10046912 and breast disorders Vaginal hemorrhage indicated
Reproductive system Mild discomfort or pain,

10046916 and breast disorders Vaginal inflammation edema, or redness

10065817 and breast disorders Vaginal obstruction intervention not indicated
Reproductive system
10046937 and breast disorders Vaginal pain Mild pain
10065818 and breast disorders Vaginal perforation intervention not indicated
Reproductive system Asymptomatic; mild vaginal

10053496 and breast disorders Vaginal stricture shortening or narrowing
Mild discomfort or pain

associated with vaginal
spasm/tightening; no impact
Reproductive system upon sexual function or
10046947 and breast disorders Vaginismus physical examination
Reproductive system symptoms; clinical or
Reproductive system and breast disorders - diagnostic observations only;
10038604 and breast disorders Other, specify intervention not indicated
Respiratory, thoracic
and mediastinal Adult respiratory
10001409 disorders distress syndrome -
and mediastinal Mild symptoms; intervention
10001723 disorders Allergic rhinitis not indicated
and mediastinal
10002972 disorders Apnea -
Respiratory, thoracic Asymptomatic; clinical or

and mediastinal diagnostic observations only;
10003504 disorders Aspiration intervention not indicated

10003598 disorders Atelectasis intervention not indicated

10006437 disorders Bronchial fistula intervention not indicated
10006440 disorders Bronchial obstruction intervention not indicated

10063524 disorders Bronchial stricture intervention not indicated

10053481 disorders Bronchopleural fistula intervention not indicated
and mediastinal Bronchopulmonary Mild symptoms; intervention
10065746 disorders hemorrhage not indicated
10006482 disorders Bronchospasm not indicated
10051228 disorders Chylothorax intervention not indicated
Respiratory, thoracic Mild symptoms;

and mediastinal nonprescription intervention
10011224 disorders Cough indicated
and mediastinal Shortness of breath with
10013963 disorders Dyspnea moderate exertion
10015090 disorders Epistaxis not indicated
10020039 disorders Hiccups not indicated
Mild or intermittent voice

Respiratory, thoracic change; fully
and mediastinal understandable; self-
10020201 disorders Hoarseness resolves
and mediastinal
10021143 disorders Hypoxia -

10023838 disorders Laryngeal edema intervention not indicated
10065786 disorders Laryngeal fistula intervention not indicated
Respiratory, thoracic Mild cough or trace

and mediastinal hemoptysis; laryngoscopic
10065759 disorders Laryngeal hemorrhage findings
and mediastinal
10065735 disorders Laryngeal inflammation Mild sore throat; raspy voice
Respiratory, thoracic Endoscopic findings only;

and mediastinal mild discomfort with normal
10065880 disorders Laryngeal mucositis intake

10059639 disorders Laryngeal obstruction intervention not indicated

10023862 disorders Laryngeal stenosis intervention not indicated
and mediastinal Laryngopharyngeal Mild symptoms; no anxiety;
10062667 disorders dysesthesia intervention not indicated
and mediastinal
10023891 disorders Laryngospasm -
Respiratory, thoracic Radiologic evidence only;

and mediastinal minimal symptoms;
10056356 disorders Mediastinal hemorrhage intervention not indicated
10028735 disorders Nasal congestion not indicated

10034825 disorders Pharyngeal fistula intervention not indicated
10055315 disorders Pharyngeal hemorrhage not indicated
Endoscopic findings only;

Respiratory, thoracic minimal symptoms with
and mediastinal normal oral intake; mild pain
10065881 disorders Pharyngeal mucositis but analgesics not indicated
and mediastinal
10065706 disorders Pharyngeal necrosis -

10050028 disorders Pharyngeal stenosis intervention not indicated
and mediastinal
10034844 disorders Pharyngolaryngeal pain Mild pain

10035598 disorders Pleural effusion intervention not indicated
Respiratory, thoracic Asymptomatic; mild

and mediastinal hemorrhage confirmed by
10055319 disorders Pleural hemorrhage thoracentesis
and mediastinal
10035623 disorders Pleuritic pain Mild pain

10035742 disorders Pneumonitis intervention not indicated

10035759 disorders Pneumothorax intervention not indicated
10036402 disorders Postnasal drip not indicated
Respiratory, thoracic Occasional/minimal

and mediastinal production of sputum with
10036790 disorders Productive cough cough
and mediastinal Radiologic findings only;
10037375 disorders Pulmonary edema minimal dyspnea on exertion
Respiratory, thoracic Mild hypoxemia; radiologic

and mediastinal pulmonary fibrosis <25% of
10037383 disorders Pulmonary fibrosis lung volume

10065873 disorders Pulmonary fistula intervention not indicated
Respiratory, thoracic Minimal dyspnea; findings

and mediastinal on physical exam or other
10037400 disorders Pulmonary hypertension evaluation
and mediastinal
10038695 disorders Respiratory failure
Fluid retention; <3 kg of

Respiratory, thoracic weight gain; intervention
and mediastinal with fluid restriction and/or
10038921 disorders Retinoic acid syndrome diuretics indicated
Respiratory, thoracic Asymptomatic mucosal
and mediastinal crusting; blood-tinged
10062244 disorders Sinus disorder secretions
Respiratory, thoracic Snoring and nocturnal sleep

and mediastinal arousal without apneic
10040975 disorders Sleep apnea periods
10041232 disorders Sneezing not indicated
and mediastinal
10041367 disorders Sore throat Mild pain
and mediastinal
10042241 disorders Stridor -

10065787 disorders Tracheal fistula intervention not indicated
Respiratory, thoracic Endoscopic findings only;

and mediastinal minimal hemoptysis, pain, or
10065900 disorders Tracheal mucositis respiratory symptoms

10050816 disorders Tracheal stenosis intervention not indicated
and mediastinal Mild or intermittent change
10047681 disorders Voice alteration from normal voice
and mediastinal Detectable airway noise with
10047924 disorders Wheezing minimal symptoms
Respiratory, thoracic Respiratory, thoracic and symptoms; clinical or
and mediastinal mediastinal disorders - diagnostic observations only;
10038738 disorders Other, specify intervention not indicated
Hair loss of up to 50% of

normal for that individual
that is not obvious from a
distance but only on close
inspection; a different hair
style may be required to
cover the hair loss but it
Skin and subcutaneous does not require a wig or
10001760 tissue disorders Alopecia hair piece to camouflage
Mild odor; physician

Skin and subcutaneous intervention not indicated;
10005901 tissue disorders Body odor self care interventions
Skin and subcutaneous Asymptomatic; blisters

10006556 tissue disorders Bullous dermatitis covering <10% BSA
Covering <10% BSA and no
Skin and subcutaneous associated erythema or
10013786 tissue disorders Dry skin pruritus
Target lesions covering <10%

Skin and subcutaneous BSA and not associated with
10015218 tissue disorders Erythema multiforme skin tenderness
Skin and subcutaneous

10015277 tissue disorders Erythroderma -
Skin and subcutaneous Covering <10% BSA and

10016241 tissue disorders Fat atrophy asymptomatic
In women, increase in
length, thickness or density
of hair in a male distribution
that the patient is able to
camouflage by periodic
Skin and subcutaneous shaving, bleaching, or
10020112 tissue disorders Hirsutism removal of hair
Limited to one site (palms,

Skin and subcutaneous soles, or axillae); self care
10020642 tissue disorders Hyperhidrosis interventions
Increase in length, thickness
or density of hair that the
patient is either able to
camouflage by periodic
shaving or removal of hairs
or is not concerned enough
Skin and subcutaneous about the overgrowth to use
10020864 tissue disorders Hypertrichosis any form of hair removal

10021013 tissue disorders Hypohidrosis -
Skin and subcutaneous Asymptomatic and covering

10062315 tissue disorders Lipohypertrophy <10% BSA
Skin and subcutaneous diagnostic observations only;
10028691 tissue disorders Nail discoloration intervention not indicated
Asymptomatic separation of
Skin and subcutaneous the nail bed from the nail
10049281 tissue disorders Nail loss plate or nail loss
Skin and subcutaneous diagnostic observations only;
10062283 tissue disorders Nail ridging intervention not indicated

10033474 tissue disorders Pain of skin Mild pain
Minimal skin changes or
Palmar-plantar dermatitis (e.g., erythema,
Skin and subcutaneous erythrodysesthesia edema, or hyperkeratosis)
10054524 tissue disorders syndrome without pain

10054541 tissue disorders Periorbital edema Soft or non-pitting
Skin and subcutaneous Painless erythema and

10034966 tissue disorders Photosensitivity erythema covering <10% BSA
Skin and subcutaneous Mild or localized; topical

10037087 tissue disorders Pruritus intervention indicated
Skin and subcutaneous Combined area of lesions

10037549 tissue disorders Purpura covering <10% BSA
covering <10% BSA, which
may or may not be
Skin and subcutaneous associated with symptoms of
10037847 tissue disorders Rash acneiform pruritus or tenderness
Macules/papules covering
<10% BSA with or without
Skin and subcutaneous symptoms (e.g., pruritus,
10037868 tissue disorders Rash maculo-papular burning, tightness)

10049120 tissue disorders Scalp pain Mild pain
Covering <10% BSA;

associated with
Skin and subcutaneous telangiectasias or changes in
10040799 tissue disorders Skin atrophy skin color
Hyperpigmentation covering
Skin and subcutaneous <10% BSA; no psychosocial
10040865 tissue disorders Skin hyperpigmentation impact
Hypopigmentation or
depigmentation covering
Skin and subcutaneous <10% BSA; no psychosocial
10040868 tissue disorders Skin hypopigmentation impact

move skin parallel to plane
Skin and subcutaneous (sliding) and perpendicular
10051837 tissue disorders Skin induration to skin (pinching up)
Combined area of ulcers <1
cm; nonblanchable erythema
Skin and subcutaneous of intact skin with associated
10040947 tissue disorders Skin ulceration warmth or edema
Skin and subcutaneous Stevens-Johnson

10042033 tissue disorders syndrome
Skin and subcutaneous Telangiectasias covering

10043189 tissue disorders Telangiectasia <10% BSA
Skin and subcutaneous Toxic epidermal

10044223 tissue disorders necrolysis -
Urticarial lesions covering

Skin and subcutaneous <10% BSA; topical
10046735 tissue disorders Urticaria intervention indicated
Skin and subcutaneous symptoms; clinical or
Skin and subcutaneous tissue disorders - Other, diagnostic observations only;
10040785 tissue disorders specify intervention not indicated
Menopause occurring at age

10027308 Social circumstances Menopause 46 - 53 years of age
Social circumstances - diagnostic observations only;
10041244 Social circumstances Other, specify intervention not indicated
Surgical and medical symptoms; clinical or
Surgical and medical procedures - Other, diagnostic observations only;
10042613 procedures specify intervention not indicated
10007196 Vascular disorders Capillary leak syndrome -
10016825 Vascular disorders Flushing intervention not indicated

10019428 Vascular disorders Hematoma not indicated

10020407 Vascular disorders Hot flashes not indicated
Prehypertension (systolic BP
120 - 139 mm Hg or diastolic
10020772 Vascular disorders Hypertension BP 80 - 89 mm Hg)
10021097 Vascular disorders Hypotension not indicated
10065773 Vascular disorders Lymph leakage -
Trace thickening or faint

10025233 Vascular disorders Lymphedema discoloration
10048642 Vascular disorders Lymphocele intervention not indicated
10034578 Vascular disorders Peripheral ischemia -

10034879 Vascular disorders Phlebitis -
Superficial
10042554 Vascular disorders thrombophlebitis -
Superior vena cava Asymptomatic; incidental
10042569 Vascular disorders syndrome finding of SVC thrombosis
Venous thrombosis (e.g.,

10043565 Vascular disorders Thromboembolic event superficial thrombosis)
10047115 Vascular disorders Vasculitis not indicated
10054692 Vascular disorders Visceral arterial ischemia -
Vascular disorders - diagnostic observations only;
10047065 Vascular disorders Other, specify intervention not indicated
Grade 2 Grade 3 Grade 4 Grade 5
Hgb <10.0 - 8.0 g/dL; Hgb <8.0 - 6.5 g/dL; <4.9 - 4.0 Life-threatening
<6.2 - 4.9 mmol/L; mmol/L; <80 - 65 g/L; consequences; urgent
<100 - 80g/L transfusion indicated intervention indicated Death
Moderately
hypocellular or >25 -
<50% reduction from Severely hypocellular or >50 -
normal cellularity for <=75% reduction cellularity Aplastic persistent for
age from normal for age longer than 2 weeks Death
Life-threatening
Laboratory findings with Laboratory findings and consequences; urgent
no bleeding bleeding intervention indicated Death
Life-threatening
consequences; urgent
- Present intervention indicated Death
Evidence of hemolysis
and >=2 gm decrease in Transfusion or medical Life-threatening
hemoglobin, no intervention indicated (e.g., consequences; urgent
transfusion steroids) intervention indicated Death
Life-threatening
consequences, (e.g., CNS
Laboratory findings with hemorrhage or
clinical consequences (e.g., thrombosis/embolism or
- renal insufficiency, petechiae) renal failure) Death
Clinical manifestations of
leucostasis; urgent
- >100,000/mm3 intervention indicated Death
Moderate pain; limiting Severe pain; limiting self care

instrumental ADL ADL -
Life-threatening
Prophylactic antibiotics consequences; urgent
indicated - intervention indicated Death
Life-threatening
consequences, (e.g., CNS
Laboratory findings with hemorrhage or
clinical consequences (e.g., thrombosis/embolism or
- renal insufficiency, petechiae) renal failure) Death
Severe or medically significant
but not immediately life-
Moderate; minimal, threatening; hospitalization or
local or noninvasive prolongation of existing
intervention indicated; hospitalization indicated; Life-threatening
limiting age-appropriate disabling; limiting self care consequences; urgent
instrumental ADL ADL intervention indicated Death
Symptomatic, unstable
Symptomatic, Symptomatic, unstable angina angina and/or acute
progressive angina; and/or acute myocardial myocardial infarction,
cardiac enzymes infarction, cardiac enzymes cardiac enzymes
normal; abnormal, hemodynamically abnormal,
hemodynamically stable stable hemodynamically unstable Death
Life-threatening
Symptomatic; severe consequences; urgent
Asymptomatic; regurgitation or stenosis by intervention indicated
moderate regurgitation imaging; symptoms controlled (e.g., valve replacement,
or stenosis by imaging with medical intervention valvuloplasty) Death
Life-threatening
- - intervention indicated Death
Symptomatic and
incompletely controlled
medically, or controlled with Life-threatening
Non-urgent medical device (e.g., pacemaker), or consequences; urgent
intervention indicated ablation intervention indicated Death
Symptomatic and
medically, or controlled with Life-threatening
Non-urgent medical device (e.g., pacemaker), or consequences; urgent
intervention indicated ablation intervention indicated Death
Symptomatic and
incompletely controlled Life-threatening
Non-urgent medically, or controlled with consequences; urgent
intervention indicated device (e.g., pacemaker) intervention indicated Death
Non-urgent
intervention indicated -
Life-threatening
Moderate pain; limiting Pain at rest; limiting self care

instrumental ADL ADL - -
Life-threatening
Severe symptoms; consequences; urgent
Moderate symptoms intervention indicated intervention indicated Death
Symptomatic heart failure or Refractory heart failure or

other cardiac symptoms, other poorly controlled
- responsive to intervention cardiac symptoms Death
Life-threatening
Severe with symptoms at rest intervention indicated
Symptoms with mild to or with minimal activity or (e.g., continuous IV
moderate activity or exertion; intervention therapy or mechanical
exertion indicated hemodynamic support) Death
Refractory or poorly
controlled heart failure
due to drop in ejection
fraction; intervention such
as ventricular assist device,
Symptomatic due to drop in intravenous vasopressor
ejection fraction responsive to support, or heart
- intervention transplant indicated Death
Life-threatening
Symptomatic and
Symptomatic; medical medically, or controlled with consequences; urgent
Symptomatic and
Symptomatic; medical medically, or controlled with consequences; urgent
Asymptomatic and Severe symptoms; cardiac
cardiac enzymes enzymes abnormal;
minimally abnormal and hemodynamically stable; ECG Life-threatening
no evidence of ischemic changes consistent with consequences;
ECG changes infarction hemodynamically unstable Death
Life-threatening
Severe with symptoms at rest intervention indicated
Symptoms with mild to or with minimal activity or (e.g., continuous IV
moderate activity or exertion; intervention therapy or mechanical
exertion indicated hemodynamic support) Death
Intervention indicated - - -
Life-threatening
consequences;
Symptomatic; medical medically; cardioversion
management indicated IV medication indicated indicated Death
Life-threatening
Asymptomatic effusion Effusion with physiologic consequences; urgent
size small to moderate consequences intervention indicated Death
Life-threatening
Symptomatic Pericarditis with physiologic Life-threatening

pericarditis (e.g., chest consequences (e.g., consequences; urgent
pain) pericardial constriction) intervention indicated Death
Life-threatening
Symptomatic heart failure or Refractory heart failure or

other cardiac symptoms, other poorly controlled
- responsive to intervention cardiac symptoms Death
Life-threatening
intervention indicated
Symptoms with mild to Severe symptoms, associated (e.g., ventricular assist
moderate activity or with hypoxemia, right heart device); heart transplant
exertion failure; oxygen indicated indicated Death
Life-threatening
Non-urgent Severe, medically significant; consequences; urgent
intervention indicated medical intervention indicated intervention indicated Death
Life-threatening
Symptomatic, medical Severe, medically significant, consequences; urgent
Symptomatic; non-
urgent medical Urgent medical intervention
intervention indicated indicated - -
Life-threatening
Non-urgent medical Medical intervention consequences; urgent
intervention indicated indicated intervention indicated Death
Life-threatening
Asymptomatic; regurgitation or stenosis; intervention indicated
moderate regurgitation symptoms controlled with (e.g., valve replacement,
or stenosis by imaging medical intervention valvuloplasty) Death
Life-threatening
consequences;
hemodynamic
Non-urgent medical Medical intervention compromise; urgent
Life-threatening
consequences;
hemodynamic
compromise; urgent
Life-threatening
consequences;
hemodynamic
Non-urgent medical Medical intervention compromise; urgent
Symptomatic and
Non-urgent medical medically or controlled with consequences; urgent
intervention indicated procedure intervention indicated Death


External otitis with

moist desquamation,
edema, enhanced
cerumen or discharge; External otitis with
tympanic membrane mastoiditis; stenosis or
perforation; osteomyelitis; necrosis of soft Urgent operative
tympanostomy tissue or bone intervention indicated Death

Adults enrolled in monitoring
program (a 1, 2, 3, 4, 6 and 8
kHz audiogram): threshold
Adults enrolled in shift of >25 dB averaged at 3
monitoring program (a contiguous test frequencies in
1, 2, 3, 4, 6 and 8 kHz at least one ear; therapeutic
audiogram): threshold intervention indicated
shift of >25 dB averaged
at 2 contiguous test Adults not enrolled in
frequencies in at least monitoring program: hearing
one ear loss with hearing aid or
intervention indicated;
Adult not enrolled in limiting self care ADL Adults: profound bilateral
monitoring program: hearing loss (>80 dB at 2
hearing loss but hearing Pediatric (a 1, 2, 3, 4, 6 and 8 kHz and above); non-
aid or intervention not kHz audiogram): hearing loss serviceable hearing
indicated; limiting sufficient to indicate
instrumental ADL therapeutic intervention, Pediatric: audiologic
including hearing aids; >20 dB indication for cochlear
Pediatric (a 1, 2, 3, 4, 6 at 3 kHz and above in one ear; implant and additional
and 8 kHz audiogram): additional speech-language speech-language related
>20 dB at >4 kHz related services indicated services indicated -
Life-threatening
Serous otitis, medical Mastoiditis; necrosis of canal consequences; urgent
intervention indicated soft tissue or bone intervention indicated Death
Moderate symptoms;
limiting instrumental Severe symptoms; limiting self
ADL care ADL - -
Moderate symptoms;
ADL care ADL - -
Symptomatic; limiting Severe symptoms; limiting self

instrumental ADL care ADL - -
Moderate symptoms; Life-threatening

medical intervention Severe symptoms; consequences; urgent
indicated hospitalization indicated intervention indicated Death
Moderate symptoms; Severe symptoms, medical

medical intervention intervention or hospitalization
indicated indicated - -
No breast development No breast development by

by age 13 yrs for age 14 yrs for females; no
females; testes volume increase in testes volume or
of <3 cc or no Tanner no Tanner Stage 2 by age 16
Stage 2 development by yrs for males; hormone
age 14.5 yrs for males replacement indicated - -
>= +2 SD (standard
deviation) above mid
parental height or
target height - - -
Moderate symptoms;
medical intervention
indicated - - -
Symptomatic; thyroid
suppression therapy Severe symptoms; limiting self Life-threatening
indicated; limiting care ADL; hospitalization consequences; urgent
instrumental ADL indicated intervention indicated Death
Moderate symptoms; Severe symptoms; medical Life-threatening

medical intervention intervention or hospitalization consequences; urgent
indicated indicated intervention indicated Death
Symptomatic; thyroid
replacement indicated; Severe symptoms; limiting self Life-threatening
limiting instrumental care ADL; hospitalization consequences; urgent
ADL indicated intervention indicated Death
Physical signs and
biochemical markers of
puberty for females <8
years and males <9
years - - -
Moderate symptoms;
indicated - - -

Symptomatic; limiting
instrumental ADL Limiting self care ADL - -
Symptomatic with marked

decrease in visual acuity
(worse than 20/40 but better
Symptomatic; moderate than 20/200); operative
decrease in visual acuity intervention indicated (e.g., Blindness (20/200 or
(20/40 or better) cataract surgery) worse) in the affected eye -
Symptomatic; topical
(e.g., antibiotics);
limiting instrumental
ADL Limiting self care ADL - -
Symptomatic; medical
(e.g., topical agents); Limiting self care ADL; Perforation or blindness
limiting instrumental declining vision (worse than (20/200 or worse) in the
ADL 20/40 but better than 20/200) affected eye -
Symptomatic; multiple
agents indicated; Decrease in visual acuity
limiting instrumental (<20/40); limiting self care
ADL ADL - -
Symptomatic; limiting Limiting self care ADL;

instrumental ADL disabling - -
Symptomatic;
nonoperative
intervention indicated; Limiting self care ADL;
limiting instrumental operative intervention
ADL indicated - -
Limiting instrumental
EIOP causing early EIOP causing marked visual

visual field deficits; field deficits (e.g., involving
multiple topical or oral both superior and inferior
agents indicated; visual fields); operative
limiting instrumental intervention indicated; Blindness (20/200 or
ADL limiting self care ADL worse) in the affected eye -
(e.g., topical agents); Decline in vision (worse than Perforation or blindness
limiting instrumental 20/40 but better than (20/200 or worse) in the
ADL 20/200); limiting self care ADL affected eye -
Limiting instrumental Blindness (20/200 or

ADL Limiting self care ADL worse) in the affected eye -
Limiting vision of the Limiting vision in the affected

affected eye (20/40 or eye (worse than 20/40 but Blindness (20/200 or
better) better than 20/200) worse) in the affected eye -
Symptomatic decline in
vision; visual field Marked visual field defect
defect present sparing (worse than 20/40 but better Blindness (20/200 or
the central 20 degrees than 20/200) worse) in the affected eye -
Rhegmatogenous or exudative
detachment; operative
Exudative and visual decline in vision (worse than Blindness (20/200 or
acuity 20/40 or better 20/40 but better than 20/200) worse) in the affected eye -
Laser therapy or Vitroretinal surgical repair Blindness (20/200 or

pneumopexy indicated indicated worse) in the affected eye -
Intravitreal medication;
Topical medication operative intervention
Symptomatic with
moderate decrease in Symptomatic with marked
visual acuity (20/40 or decrease in visual acuity
better); limiting (worse than 20/40); disabling; Blindness (20/200 or
instrumental ADL limiting self care ADL worse) in the affected eye -
Symptomatic, limiting
instrumental ADL; Symptomatic, limiting self
moderate decrease in care ADL; marked decrease in
visual acuity (20/40 or visual acuity (worse than Blindness (20/200 or
better) 20/40) worse) in the affected eye -
Anterior uveitis;
medical intervention Blindness (20/200 or
indicated Posterior or pan-uveitis worse) in the affected eye -
Symptomatic; limiting Limiting self care ADL; Blindness (20/200 or

instrumental ADL vitrectomy indicated worse) in the affected eye -
Operative intervention
Intervention indicated indicated - -

but not immediately sight-
Moderate; minimal, threatening; hospitalization or Sight-threatening
local or noninvasive prolongation of existing consequences; urgent
intervention indicated; hospitalization indicated; intervention indicated;
limiting age-appropriate disabling; limiting self care blindness (20/200 or
instrumental ADL ADL worse) in the affected eye -
Symptomatic; limiting Severe discomfort; limiting

instrumental ADL self care ADL - -
Severely altered GI function;

tube feeding, TPN or
hospitalization indicated; Life-threatening
Symptomatic; altered GI elective operative consequences; urgent
function intervention indicated intervention indicated Death
Moderate symptoms; Transfusion, radiologic,

medical intervention or endoscopic, or elective Life-threatening
minor cauterization operative intervention consequences; urgent
intervention indicated; Life-threatening
limiting instrumental Severe symptoms; limiting self consequences; urgent
ADL care ADL intervention indicated Death
TPN or hospitalization Life-threatening

indicated; radiologic, consequences; urgent
endoscopic, or operative operative intervention
- intervention indicated indicated Death

Symptomatic and severely

altered GI function; non- Life-threatening
emergent operative consequences; urgent
Symptomatic; altered GI intervention indicated; TPN or operative intervention
function hospitalization indicated indicated Death

TPN indicated; elective Life-threatening
operative or endoscopic consequences; urgent
Symptomatic; altered GI intervention indicated; operative intervention
function disabling indicated Death
Life-threatening
Symptomatic; medical Severe symptoms; invasive operative intervention
intervention indicated intervention indicated indicated Death
Symptomatic,
decreased oral intake;
change in bowel
function - - -
Moderate symptoms; Severe symptoms; limiting self

limiting instrumental care ADL; intervention
ADL indicated - -
Severe abdominal pain;

change in bowel habits; Life-threatening
Abdominal pain; mucus medical intervention consequences; urgent
or blood in stool indicated; peritoneal signs intervention indicated Death

bowel rest, TPN or

Hospitalization indicated; Life-threatening

elective operative consequences; urgent
Severe symptoms; elective Life-threatening

Symptomatic; medical operative intervention consequences; urgent

tube feeding or Life-threatening
hospitalization indicated; consequences; urgent
Symptomatic; altered GI elective operative operative intervention
function intervention indicated indicated Death

Persistent symptoms
with regular use of
laxatives or enemas; Obstipation with manual Life-threatening
limiting instrumental evacuation indicated; limiting consequences; urgent
ADL self care ADL intervention indicated Death
Dental caries resulting in

Dental caries involving pulpitis or periapical abscess
the root or resulting in tooth loss - -
Increase of >=7 stools per day

Increase of 4 - 6 stools over baseline; incontinence;
per day over baseline; hospitalization indicated;
moderate increase in severe increase in ostomy Life-threatening
ostomy output output compared to baseline; consequences; urgent
compared to baseline limiting self care ADL intervention indicated Death
Moderate symptoms;
oral intake alterations
(e.g., copious water,
other lubricants, diet
limited to purees Inability to adequately
and/or soft, moist aliment orally; tube feeding or
foods); unstimulated TPN indicated; unstimulated
saliva 0.1 to 0.2 ml/min saliva <0.1 ml/min - -


Life-threatening
Hospitalization or elective consequences; urgent
Symptomatic; altered GI operative intervention operative intervention
function indicated; disabling indicated Death
Life-threatening
Severe symptoms; elective consequences; urgent
Symptomatic; medical operative intervention operative intervention
intervention indicated indicated indicated Death
Severely altered GI function; Life-threatening

tube feeding; hospitalization consequences; urgent
Symptomatic; altered GI indicated; elective operative operative intervention

TPN indicated; elective
Moderate symptoms; operative or endoscopic Life-threatening
medical intervention intervention indicated; consequences; urgent
indicated; limiting limiting self care ADL; operative intervention
instrumental ADL disabling indicated Death
Moderate symptoms;
medical intervention Severe symptoms; surgical
indicated intervention indicated
Severely altered
Symptomatic and eating/swallowing; tube Life-threatening
altered feeding or TPN or consequences; urgent
eating/swallowing hospitalization indicated intervention indicated Death
Severe or persistent Life-threatening

Abdominal pain; mucus abdominal pain; fever; ileus; consequences; urgent
or blood in stool peritoneal signs intervention indicated Death
Symptomatic; Life-threatening
noninvasive Severe, medically significant; consequences; urgent


Inability to aliment
adequately by GI tract; Life-threatening
radiologic, endoscopic, or consequences; urgent
operative intervention operative intervention
- indicated indicated Death
Hospitalization indicated;
elective operative
Symptomatic; altered GI intervention indicated; Life-threatening
function; limiting limiting self care ADL; consequences; urgent
instrumental ADL disabling intervention indicated Death

Life-threatening


operative or endoscopic Life-threatening
Symptomatic; altered GI intervention indicated; consequences; urgent
function; limiting limiting self care ADL; operative intervention
Transfusion, radiologic,
Self-limited; endoscopic, or elective Life-threatening
intervention not operative intervention consequences; urgent
Severely altered Life-threatening

Symptomatic; altered eating/swallowing; tube consequences; urgent
eating/swallowing; oral feeding, TPN or operative intervention
supplements indicated hospitalization indicated indicated Death
Severe symptoms; elective

Daily use of pads operative intervention
required indicated - -
Moderate; persistent;
psychosocial sequelae - - -
bowel rest; tube feeding, TPN Life-threatening
or hospitalization indicated; consequences; urgent

adequately by GI tract; Life-threatening
Life-threatening


Symptomatic; altered GI TPN indicated; elective
function; medical operative or endoscopic Life-threatening
intervention indicated; intervention indicated; consequences; urgent
limiting instrumental limiting self care ADL; operative intervention
ADL disabling indicated Death
Life-threatening
Symptomatic; altered GI Severely altered eating or consequences; urgent
function; medical gastric function; TPN or operative intervention
intervention indicated hospitalization indicated indicated Death
Moderate symptoms;
medical intervention Severe symptoms; surgical
indicated intervention indicated - -
Life-threatening
Severely altered GI function; consequences; urgent
Symptomatic; altered GI tube feeding, TPN or operative intervention
function hospitalization indicated indicated Death
Moderate symptoms;
able to maintain
nutrition with dietary
and lifestyle
modifications; may Weight loss; refractory to
need pharmacologic medical intervention; unable
intervention to maintain nutrition orally - -
Moderate pain
interfering with oral Severe pain; inability to
intake aliment orally - -

Severe symptoms; radiologic,

Symptomatic; banding endoscopic or elective
or medical intervention operative intervention

Symptomatic; altered GI indicated; elective operative consequences; urgent

elective operative Life-threatening
Life-threatening

Symptomatic; altered GI Life-threatening

function; bowel rest Severely altered GI function; consequences; urgent
indicated TPN indicated intervention indicated Death
Medical intervention or endoscopic, or elective Life-threatening


Life-threatening



Life-threatening
Altered diet; oral Inability to aliment consequences; urgent
intervention indicated adequately; TPN indicated intervention indicated Death
Moderate pain; not

interfering with oral Life-threatening
intake; modified diet Severe pain; interfering with consequences; urgent
indicated oral intake intervention indicated Death
Oral intake decreased

without significant Inadequate oral caloric or
weight loss, fluid intake; tube feeding,
dehydration or TPN, or hospitalization
malnutrition indicated - -

Moderate pain;
interfering with oral Disabling pain; tube feeding
intake or TPN indicated - -



tube feeding or TPN or Life-threatening

Tube feeding or TPN Life-threatening

Severe pain; vomiting;

medical intervention indicated Life-threatening
Enzyme elevation or (e.g., analgesia, nutritional consequences; urgent
radiologic findings only support) intervention indicated Death
Moderate gingival
recession or gingivitis; Spontaneous bleeding; severe
multiple sites of bone loss with or without
bleeding on probing; tooth loss; osteonecrosis of
moderate bone loss maxilla or mandible - -

Symptoms (e.g., rectal

discomfort, passing
blood or mucus);
medical intervention Severe symptoms; fecal Life-threatening
indicated; limiting urgency or stool incontinence; consequences; urgent
instrumental ADL limiting self care ADL intervention indicated Death

Symptomatic; medical Life-threatening

intervention indicated; consequences; urgent
limiting instrumental Severe symptoms; limiting self operative intervention
ADL care ADL indicated Death


Life-threatening


Symptomatic; altered GI TPN indicated; elective Life-threatening
function (e.g. altered operative or endoscopic consequences; urgent
dietary habits, vomiting, intervention indicated; operative intervention
diarrhea) disabling indicated Death
Transfusion, medical,
radiologic, endoscopic, or Life-threatening
Self-limited; elective operative consequences; urgent
intervention indicated intervention indicated intervention indicated Death
Thick, ropy, sticky Acute salivary gland necrosis;
saliva; markedly altered severe secretion-induced
taste; alteration in diet symptoms (e.g., thick
indicated; secretion- saliva/oral secretions or
induced symptoms; gagging); tube feeding or TPN Life-threatening
limiting instrumental indicated; limiting self care consequences; urgent
ADL ADL; disabling intervention indicated Death

Symptomatic; altered GI hospitalization indicated; consequences; urgent
function; tube feeding elective operative operative intervention
indicated intervention indicated indicated Death
Symptomatic; medical Severe pain; interfering with

intervention indicated; oral intake; tube feeding, TPN Life-threatening
limiting instrumental or hospitalization indicated; consequences; urgent
ADL limiting self care ADL intervention indicated Death
Life-threatening

altered GI function; tube
feeding, TPN or Life-threatening
hospitalization indicated; non- consequences; urgent
Symptomatic; altered GI emergent operative operative intervention

operative or endoscopic Life-threatening

Maldevelopment with
Impairment correctable impairment not surgically
with oral surgery correctable; disabling - -
- - - -

Symptomatic (e.g., abdominal Life-threatening

pain, fever, change in bowel consequences; urgent
habits with ileus); peritoneal operative intervention
- signs indicated Death

>=6 episodes (separated by 5

3 - 5 episodes minutes) in 24 hrs; tube Life-threatening
(separated by 5 feeding, TPN or consequences; urgent
minutes) in 24 hrs hospitalization indicated intervention indicated Death

Moderate tremor of the

entire body; narcotics Severe or prolonged, not
indicated responsive to narcotics - -
- - - Death
- - - Death
Moderate localized
facial edema; limiting Severe swelling; limiting self
>10 - 30% inter-limb
discrepancy in volume
or circumference at
point of greatest visible
difference; readily
apparent obscuration of
anatomic architecture;
obliteration of skin
folds; readily apparent
deviation from normal >30% inter-limb discrepancy
anatomic contour; in volume; gross deviation
limiting instrumental from normal anatomic
ADL contour; limiting self care ADL - -
Readily apparent
obscuration of
folds; readily apparent
deviation from normal
anatomic contour; Gross deviation from normal
limiting instrumental anatomic contour; limiting self
ADL care ADL - -

Fatigue not relieved by

rest; limiting Fatigue not relieved by rest,
instrumental ADL limiting self care ADL - -
>39.0 - 40.0 degrees C

(102.3 - 104.0 degrees >40.0 degrees C (>104.0 >40.0 degrees C (>104.0
F) degrees F) for <=24 hrs degrees F) for >24 hrs Death
Moderate symptoms;
ADL care ADL - -
Moderate change in
gait (e.g., wide-based,
limping or hobbling);
assistive device
indicated; limiting Disabling; limiting self care
<=28 degrees C; 82.4

degrees F; life-threatening
consequences (e.g., coma,
hypotension, pulmonary
35 - >32 degrees C; 95 - 32 - >28 degrees C; 89.6 - edema, acidemia,
>89.6 degrees F >82.4 degrees F ventricular fibrillation) Death
Therapy or infusion
interruption indicated
but responds promptly Prolonged (e.g., not rapidly
to symptomatic responsive to symptomatic
treatment (e.g., medication and/or brief
antihistamines, NSAIDS, interruption of infusion);
narcotics, IV fluids); recurrence of symptoms
prophylactic following initial improvement; Life-threatening
medications indicated hospitalization indicated for consequences; urgent
for <=24 hrs clinical sequelae intervention indicated Death
Erythema with
associated symptoms Ulceration or necrosis; severe Life-threatening
(e.g., edema, pain, tissue damage; operative consequences; urgent
induration, phlebitis) intervention indicated intervention indicated Death
Ulceration or necrosis; severe Life-threatening

Pain; lipodystrophy; tissue damage; operative consequences; urgent
edema; phlebitis intervention indicated intervention indicated Death
Moderate; limiting
instrumental ADL; Severe abnormal or excessive
increased attention response; limiting self care
indicated ADL; inconsolable - -
Moderate localized
edema and intervention Severe localized edema and
indicated; limiting intervention indicated;
Uneasiness or lack of
well being; limiting
instrumental ADL - - -
Life-threatening
consequences (e.g.,
vasopressor dependent
Shock with azotemia and acid- and oliguric or anuric or
base disturbances; significant ischemic colitis or lactic
- coagulation abnormalities acidosis) Death
Moderate neck edema;

slight obliteration of
anatomic landmarks; Generalized neck edema (e.g.,
limiting instrumental difficulty in turning neck);
ADL limiting self care ADL - -


- - - Death


Symptomatic; altered GI radiologic, endoscopic or consequences; urgent
function; IV fluids elective operative operative intervention
indicated <24 hrs intervention indicated indicated Death

TPN indicated; endoscopic Life-threatening
Symptomatic and intervention indicated; consequences; urgent
intervention not elective operative operative intervention
Severe symptoms; radiologic, Life-threatening
endoscopic or elective consequences; urgent
Symptomatic or severely
altered GI function; TPN
indicated; radiologic, Life-threatening
Symptomatic and endoscopic or elective consequences; urgent
intervention not operative intervention operative intervention
indicated indicated indicated Death
Life-threatening
radiologic or operative

altered GI function; tube
feeding, TPN or Life-threatening
Symptomatic; altered GI hospitalization indicated; non- consequences; urgent
function; IV fluids emergent operative operative intervention
indicated <24 hrs intervention indicated indicated Death

Life-threatening
Moderate to severe
Asterixis; mild encephalopathy; coma;
encephalopathy; limiting self life-threatening
- care ADL consequences Death
Life-threatening
Symptomatic; medical consequences; urgent
intervention indicated Transfusion indicated intervention indicated Death
Life-threatening
radiologic or operative

Life-threatening
Radiologic, endoscopic or consequences; urgent
elective operative operative intervention
Reversal/retrograde portal Life-threatening
Decreased portal vein vein flow; associated with consequences; urgent
flow varices and/or ascites intervention indicated Death
Life-threatening
Intervention not Medical intervention consequences; urgent

Prolonged (e.g., not rapidly

Intervention or infusion responsive to symptomatic
interruption indicated; medication and/or brief
responds promptly to interruption of infusion);
symptomatic treatment recurrence of symptoms
(e.g., antihistamines, following initial improvement;
NSAIDS, narcotics); hospitalization indicated for
prophylactic clinical sequelae (e.g., renal Life-threatening
medications indicated impairment, pulmonary consequences; urgent
for <=24 hrs infiltrates) intervention indicated Death
Symptomatic bronchospasm,
with or without urticaria;
parenteral intervention
indicated; allergy-related Life-threatening
edema/angioedema; consequences; urgent
- hypotension intervention indicated Death
Evidence of
autoimmune reaction
involving a non- Autoimmune reactions
essential organ or involving major organ (e.g., Life-threatening
function (e.g., colitis, anemia, myocarditis, consequences; urgent
hypothyroidism) kidney) intervention indicated Death
Therapy or infusion Prolonged (e.g., not rapidly
interruption indicated responsive to symptomatic
but responds promptly medication and/or brief
to symptomatic interruption of infusion);
treatment (e.g., recurrence of symptoms
antihistamines, NSAIDS, following initial improvement;
narcotics, IV fluids); hospitalization indicated for Life-threatening
prophylactic clinical sequelae (e.g., renal consequences; pressor or
medications indicated impairment, pulmonary ventilatory support
for <=24 hrs infiltrates) indicated Death
Moderate arthralgia; Life-threatening

fever, rash, urticaria, Severe arthralgia or arthritis; consequences; pressor or
antihistamines extensive rash; steroids or IV ventilatory support
indicated fluids indicated indicated Death

IV antibiotic, antifungal, or
antiviral intervention
indicated; radiologic or Life-threatening
operative intervention consequences; urgent
- indicated intervention indicated Death
Oral intervention antiviral intervention
indicated (e.g., indicated; radiologic, Life-threatening
antibiotic, antifungal, endoscopic, or operative consequences; urgent
antiviral) intervention indicated intervention indicated Death
Severe symptoms; elective Life-threatening

Local infection with

moderate symptoms;
oral intervention Severe infection; axillary
indicated (e.g., adenitis; IV antibacterial, Life-threatening
antibiotic, antifungal, antifungal, or antiviral consequences; urgent
Moderate symptoms; IV antibiotic, antifungal, or

oral intervention antiviral intervention
Localized; local
intervention indicated; IV antibiotic, antifungal, or
indicated (e.g., indicated; radiologic or Life-threatening
antibiotic, antifungal, operative intervention consequences; urgent
antiviral) indicated intervention indicated Death
endoscopic, or operative consequences; urgent
- intervention indicated intervention indicated Death
Localized; local antiviral intervention
intervention indicated indicated; radiologic or Life-threatening
(e.g., topical antibiotic, operative intervention consequences; urgent
antifungal, or antiviral) indicated intervention indicated Death
Moderate symptoms; antiviral intervention
medical intervention indicated; radiologic or Life-threatening
indicated (e.g., oral operative intervention consequences; urgent
antibiotics) indicated intervention indicated Death
indicated; severe changes in
mental status; self-limited Life-threatening
seizure activity; focal consequences; urgent
- neurologic abnormalities intervention indicated Death
Local intervention Systemic intervention or Blindness (20/200 or
indicated hospitalization indicated worse) -
indicated; radiologic,
endoscopic, or operative
Passage of >3 unformed profuse watery diarrhea with
stools per 24 hrs or signs of hypovolemia; bloody
duration of illness >48 diarrhea; fever; severe Life-threatening
hrs; moderate abdominal pain; consequences; urgent
abdominal pain hospitalization indicated intervention indicated Death
Local intervention antiviral intervention
indicated (e.g., oral indicated; radiologic or Life-threatening
Localized; local antiviral intervention Life-threatening
intervention indicated indicated; radiologic or consequences; urgent
(e.g., topical antibiotic, operative intervention intervention indicated;
antifungal, or antiviral) indicated enucleation Death

Symptomatic liver
dysfunction; fibrosis by Decompensated liver
biopsy; compensated function (e.g., ascites,
cirrhosis; reactivation of coagulopathy,
- chronic hepatitis encephalopathy, coma) Death
Localized; local
oral intervention
indicated (e.g.,
antibiotic, antifungal, Arthroscopic intervention
antiviral); needle indicated (e.g., drainage) or Life-threatening
aspiration indicated arthrotomy (e.g., open consequences; urgent
(single or multiple) surgical drainage) intervention indicated Death

indicated (e.g., indicated; radiologic or
antibiotic, antifungal, operative intervention
antiviral) indicated - -

indicated; radiologic or
operative intervention Life-threatening
indicated; focal neurologic consequences; urgent
- deficit intervention indicated Death
indicated (e.g., indicated; radiologic or
antibiotic, antifungal, operative intervention
antiviral) indicated - -

Papules and/or pustules covering any % BSA, which
covering 10-30% BSA, Papules and/or pustules may or may not be
which may or may not covering >30% BSA, which associated with symptoms
be associated with may or may not be associated of pruritus or tenderness
symptoms of pruritus or with symptoms of pruritus or and are associated with
tenderness; associated tenderness; limiting self-care extensive superinfection
with psychosocial ADL; associated with local with IV antibiotics
impact; limiting superinfection with oral indicated; life-threatening
instrumental ADL antibiotics indicated consequences Death
Localized intervention
indicated; oral
(e.g., antibiotic,
antifungal, antiviral);
nail fold edema or
erythema with pain;
associated with
discharge or nail plate Surgical intervention or IV
separation; limiting antibiotics indicated; limiting

intervention indicated indicated; radiologic, Life-threatening
(e.g., topical antibiotic, endoscopic, or operative consequences; urgent
antifungal, or antiviral) intervention indicated intervention indicated Death

intervention indicated indicated; radiologic or
(e.g., topical antibiotic, operative intervention
antifungal, or antiviral) indicated - -
Localized; local
(e.g., topical antibiotic,
antifungal, or antiviral) - - -

Life-threatening




ADL; operative Limiting self care ADL; elective
intervention indicated surgery indicated - -
Life-threatening
consequences; evidence of
Severe symptoms; limiting self end organ damage; urgent
care ADL; disabling; repair or operative intervention
- revision indicated indicated Death
Life-threatening
Symptomatic (e.g., Severe symptoms; limiting self end organ damage; urgent
claudication); repair or care ADL; disabling; repair or operative intervention
revision not indicated revision indicated indicated Death


Generalized - - -
Medical intervention; Moderate to major

minimal debridement debridement or Life-threatening
indicated reconstruction indicated consequences Death
Life-threatening
Moderate to brisk consequences; skin
erythema; patchy moist necrosis or ulceration of
desquamation, mostly Moist desquamation in areas full thickness dermis;
confined to skin folds other than skin folds and spontaneous bleeding
and creases; moderate creases; bleeding induced by from involved site; skin
edema minor trauma or abrasion graft indicated Death

Symptomatic;
noninvasive
intervention indicated Hospitalization indicated - -

Life-threatening
Symptomatic and Severe symptoms; elective operative intervention
intervention not operative intervention indicated (e.g., organ
indicated indicated resection) Death
Symptomatic but non- Severe symptoms; displaced
displaced; or open wound with bone Life-threatening
immobilization exposure; disabling; operative consequences; urgent
indicated intervention indicated intervention indicated Death


Severe symptoms;
Superficial necrosis; hospitalization or elective Life-threatening
Hairline fracture; mild Severe pain; hospitalization or

pain; limiting intervention indicated for pain Life-threatening
instrumental ADL; non- control (e.g., traction); consequences; symptoms
surgical intervention operative intervention associated with
indicated indicated neurovascular compromise -
Severe symptoms; limiting self

care ADL (e.g., transient Life-threatening
cerebral ischemia); repair or consequences; urgent
- revision indicated intervention indicated Death
Life-threatening
Symptomatic limiting self care Life-threatening

ADL; disabling; repair or consequences; urgent
- revision indicated intervention indicated Death
Life-threatening
Severe symptoms; limiting self end organ damage; urgent
Symptomatic; repair or care ADL; disabling; repair or operative intervention
revision not indicated revision indicated indicated Death

Severe symptoms; IV fluids, Life-threatening
Self-limited; tube feeding, or TPN indicated consequences; urgent
intervention not >=24 hrs; elective operative operative intervention
Severe bleeding; transfusion

Moderate bleeding; indicated; radiologic or Life-threatening
medical intervention endoscopic intervention consequences; urgent
Complete resection or
Partial resection of reconstruction of injured Life-threatening
injured organ/structure organ/structure indicated; consequences; urgent
indicated disabling intervention indicated Death
Life-threatening
Primary repair of injured consequences; urgent
- organ/structure indicated intervention indicated Death
Complete resection of injured

Partial resection of organ/structure indicated; Life-threatening
injured organ/structure disabling (e.g., impaired consequences; urgent
indicated hearing; impaired balance) intervention indicated Death
Postoperative radiologic, Life-threatening

Primary repair of Resection or reconstruction of Life-threatening

injured organ/structure injured organ/structure consequences; urgent
indicated indicated; disabling intervention indicated Death



Transfusion indicated of >=2

units (10 cc/kg for pediatrics)
pRBCs beyond protocol
Moderate bleeding; specification; urgent
radiologic, endoscopic, radiologic, endoscopic, or Life-threatening
or operative operative intervention consequences; urgent
Life-threatening airway
compromise; urgent
Extubated >72 hrs intervention indicated
Extubated within 24 - postoperatively, but before (e.g., tracheotomy or
72 hrs postoperatively tracheostomy indicated intubation) Death
Recurrent after manual

reduction; local
irritation or stool Severe symptoms; elective Life-threatening
leakage; difficulty to fit operative intervention consequences; urgent
appliance; limiting indicated; limiting self care operative intervention
instrumental ADL ADL indicated Death
Dysfunctional stoma; elective

Local care or operative intervention or Life-threatening
maintenance; minor major stomal revision consequences; urgent
revision indicated indicated intervention indicated Death
Life-threatening
Moderate to brisk consequences; skin
erythema; patchy moist necrosis or ulceration of
desquamation, mostly Moist desquamation in areas full thickness dermis;
confined to skin folds other than skin folds and spontaneous bleeding
and creases; moderate creases; bleeding induced by from involved site; skin
edema minor trauma or abrasion graft indicated Death
Symptomatic, elective
Symptomatic; simple radiologic or operative
aspiration indicated intervention indicated - -


Severe back pain;

Moderate back pain; hospitalization or intervention Life-threatening
prescription analgesics indicated for pain control consequences; symptoms
indicated; limiting (e.g., vertebroplasty); limiting associated with
instrumental ADL self care ADL; disability neurovascular compromise Death

Symptomatic; IV fluids tube feeding, TPN or Life-threatening
indicated <24 hrs; hospitalization indicated; consequences; urgent
manual dilation at elective operative operative intervention
bedside intervention indicated indicated Death

Symptomatic; medical operative intervention

Symptomatic (e.g.,
noisy airway breathing),
no respiratory distress; Life-threatening airway
medical intervention Stridor; radiologic or compromise; urgent
indicated (e.g., endoscopic intervention intervention indicated
steroids); limiting indicated (e.g., stent, laser); (e.g., tracheotomy or
instrumental ADL limiting self care ADL intubation) Death



Altered organ function (e.g.,

Symptomatic; dilation sepsis or hydronephrosis, or Life-threatening
or endoscopic repair or renal dysfunction); elective consequences; organ
stent placement operative intervention failure; urgent operative

Symptomatic but no
hydronephrosis, no
sepsis or no renal Symptomatic (e.g.,
dysfunction; dilation or hydronephrosis, or renal Life-threatening
endoscopic repair or dysfunction); elective consequences; urgent
stent placement operative intervention operative intervention

Symptomatic and Severe symptoms; elective Life-threatening


Deep vein or cardiac

Device dislodgement, thrombosis; intervention
blockage, leak, or indicated (e.g., Embolic event including
malposition; device anticoagulation, lysis, filter, pulmonary embolism or
replacement indicated invasive procedure) life-threatening thrombus Death
Life-threatening
Symptomatic (e.g., Severe symptoms; limiting self end organ damage; urgent
claudication); repair or care ADL; repair or revision operative intervention
revision not indicated indicated; disabling indicated Death
Hernia without evidence of

strangulation; fascial Hernia with evidence of
disruption/dehiscence; strangulation; major
Incisional separation primary wound closure or reconstruction flap,
>25% of wound; local revision by operative grafting, resection, or
care indicated intervention indicated amputation indicated Death
Life-threatening
consequences;
Incisional separation symptomatic hernia with
>25% of wound with Fascial disruption or evidence of strangulation;
local care; dehiscence without fascial disruption with
asymptomatic hernia or evisceration; primary wound evisceration; major
symptomatic hernia closure or revision by reconstruction flap,
without evidence of operative intervention grafting, resection, or
strangulation indicated amputation indicated Death
ADL; operative Limiting self care ADL; elective
intervention indicated surgery indicated - -

>1.5 - 2.5 x ULN >2.5 x ULN; hemorrhage - -
Asymptomatic with ALT

>3.0 - 5.0 x ULN; >3 x
ULN with the
appearance of
worsening of fatigue,
nausea, vomiting, right
upper quadrant pain or
tenderness, fever, rash, >5.0 - 20.0 x ULN; >5 x ULN
or eosinophilia for >2 weeks >20.0 x ULN -
>2.5 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN -
Asymptomatic with AST

>3.0 - 5.0 x ULN; >3 x
ULN with the
appearance of
worsening of fatigue,
nausea, vomiting, right
upper quadrant pain or
tenderness, fever, rash, >5.0 - 20.0 x ULN; >5 x ULN
or eosinophilia for >2 weeks >20.0 x ULN -
>1.5 - 3.0 x ULN >3.0 - 10.0 x ULN >10.0 x ULN -
ADL care ADL - -
Moderate symptoms;
ADL - - -
6 - 8 units below LLN; Asymptomatic decrease of >8
for follow-up, an units drop; >5 units drop
asymptomatic decrease along with the presence of
of >5 - 8 units pulmonary symptoms (e.g. ,
(ml/sec/mm Hg) below >Grade 2 hypoxia or >Grade 2
the baseline value or higher dyspnea) - -
Levels consistent with

myocardial infarction as
- defined by the manufacturer - -
Levels consistent with

myocardial infarction as
- defined by the manufacturer - -
<500 - 200/mm3; <0.5 - <200 - 50/mm3; <0.2 x 0.05 -
0.2 x 10e9 /L 10e9 /L <50/mm3; <0.05 x 10e9 /L -
>300 - 400 mg/dL; >7.75 >400 - 500 mg/dL; >10.34 - >500 mg/dL; >12.92
- 10.34 mmol/L 12.92 mmol/L mmol/L -
>2.5 x ULN - 5 x ULN >5 x ULN - 10 x ULN >10 x ULN -

>1.5 - 3.0 x baseline;
>1.5 - 3.0 x ULN >3.0 baseline; >3.0 - 6.0 x ULN >6.0 x ULN -
Resting ejection fraction Resting ejection fraction (EF)

(EF) 50 - 40%; 10 - 19% 39 - 20%; >20% drop from Resting ejection fraction
drop from baseline baseline (EF) <20% -
QTc >= 501 or >60 ms

change from baseline and
Torsade de pointes or
polymorphic ventricular
tachycardia or
QTc >= 501 ms on at least two signs/symptoms of serious
QTc 481 - 500 ms separate ECGs arrhythmia -
<0.75 - 0.5 x LLN or 25 - <0.25 x LLN or 75%

<50% decrease from <0.5 - 0.25 x LLN or 50 - <75% decrease from baseline or
baseline decrease from baseline absolute value <50 mg/dL -
FEV1 60 - 69% 50 - 59% <= 49% -

>2.5 - 5.0 x ULN >5.0 - 20.0 x ULN >20.0 x ULN -
ADL - - -
- - - -
Increase in >2 - 4 gm/dL

above ULN or above Increase in >4 gm/dL above
baseline if baseline is ULN or above baseline if
above ULN baseline is above ULN - -
>1.5 - 2.5 x ULN; >1.5 -

2.5 times above
baseline if on >2.5 x ULN; >2.5 times above
anticoagulation baseline if on anticoagulation - -
>1.5 - 2.0 x ULN >2.0 - 5.0 x ULN >5.0 x ULN -

<800 - 500/mm3; <0.8 - <500 - 200/mm3; <0.5 - 0.2 x
0.5 x 10e9 /L 10e9 /L <200/mm3; <0.2 x 10e9 /L -
>4000/mm3 -
20,000/mm3 >20,000/mm3 - -
<1500 - 1000/mm3; <1000 - 500/mm3; <1.0 - 0.5 x
<1.5 - 1.0 x 10e9 /L 10e9 /L <500/mm3; <0.5 x 10e9 /L -
Increase in stool
frequency, bulk, or Sequelae of absorption
odor; steatorrhea deficiency - -
<75,000 - 50,000/mm3; <50,000 - 25,000/mm3; <50.0 <25,000/mm3; <25.0 x

<75.0 - 50.0 x 10e9 /L - 25.0 x 10e9 /L 10e9 /L -
>1.5 - 2.0 x ULN >2.0 - 5.0 x ULN >5.0 x ULN -
- Oliguria (<80 ml in 8 hr) Anuria (<240 ml in 24 hr) -
<75 - 50% of predicted

value; limiting <50% of predicted value;
10 - <20% from baseline >=20% from baseline - -

10 - <20% from
baseline; nutritional >=20% from baseline; tube
support indicated feeding or TPN indicated - -
<3000 - 2000/mm3; <2000 - 1000/mm3; <2.0 - 1.0 <1000/mm3; <1.0 x
<3.0 - 2.0 x 10e9 /L x 10e9 /L 10e9 /L -

Life-threatening
- pH <7.3 consequences Death
Life-threatening
Severe symptoms; limiting self consequences; urgent
Present care ADL intervention indicated Death
Life-threatening
pH >7.5 consequences Death
Oral intake altered

without significant Associated with significant
weight loss or weight loss or malnutrition
malnutrition; oral (e.g., inadequate oral caloric Life-threatening
nutritional supplements and/or fluid intake); tube consequences; urgent
indicated feeding or TPN indicated intervention indicated Death
Life-threatening
IV fluids indicated <24 IV fluids or hospitalization consequences; urgent
hrs indicated intervention indicated Death
Symptomatic; dietary Life-threatening

modification or oral Severe symptoms; insulin consequences; urgent
agent indicated indicated intervention indicated Death
>11.5 - 12.5 mg/dL; >2.9 >12.5 - 13.5 mg/dL;>3.1 - 3.4 >13.5 mg/dL; >3.4 mmol/L;
- 3.1 mmol/L; Ionized mmol/L; Ionized calcium >1.6 Ionized calcium >1.8
calcium >1.5 - 1.6 - 1.8 mmol/L; hospitalization mmol/L; life-threatening
mmol/L; symptomatic indicated consequences Death
Fasting glucose value

>160 - 250 mg/dL; >250 - 500 mg/dL; >13.9 - >500 mg/dL; >27.8
Fasting glucose value 27.8 mmol/L; hospitalization mmol/L; life-threatening
>8.9 - 13.9 mmol/L indicated consequences Death
>6.0 - 7.0 mmol/L; >7.0 mmol/L; life-
>5.5 - 6.0 mmol/L hospitalization indicated threatening consequences Death
>8.0 mg/dL; >3.30 mmol/L;

>3.0 - 8.0 mg/dL; >1.23 - 3.30 life-threatening
- mmol/L consequences Death
>155 - 160 mmol/L; >160 mmol/L; life-

>150 - 155 mmol/L hospitalization indicated threatening consequences Death
>300 mg/dL - 500 >1000 mg/dL; >11.4

mg/dL; >3.42 mmol/L - >500 mg/dL - 1000 mg/dL; mmol/L; life-threatening
5.7 mmol/L >5.7 mmol/L - 11.4 mmol/L consequences Death
>ULN - 10 mg/dL; <=0.59 >10 mg/dL; >0.59 mmol/L;

mmol/L with physiologic life-threatening
- consequences consequences Death
Life-threatening
<3 - 2 g/dL; <30 - 20 g/L <2 g/dL; <20 g/L intervention indicated Death
<8.0 - 7.0 mg/dL; <2.0 - <7.0 - 6.0 mg/dL; <1.75 - 1.5 <6.0 mg/dL; <1.5 mmol/L;
1.75 mmol/L; Ionized mmol/L; Ionized calcium <0.9 Ionized calcium <0.8
calcium <1.0 - 0.9 - 0.8 mmol/L; hospitalization mmol/L; life-threatening
mmol/L; symptomatic indicated consequences Death
<30 mg/dL; <1.7 mmol/L;

<55 - 40 mg/dL; <3.0 - <40 - 30 mg/dL; <2.2 - 1.7 life-threatening
2.2 mmol/L mmol/L consequences; seizures Death
<LLN - 3.0 mmol/L;

symptomatic; <3.0 - 2.5 mmol/L; <2.5 mmol/L; life-
intervention indicated hospitalization indicated threatening consequences Death
<0.7 mg/dL; <0.3 mmol/L;

<1.2 - 0.9 mg/dL; <0.5 - <0.9 - 0.7 mg/dL; <0.4 - 0.3 life-threatening
0.4 mmol/L mmol/L consequences Death
<120 mmol/L; life-

- <130 - 120 mmol/L threatening consequences Death
<1.0 mg/dL; <0.3 mmol/L;

<2.5 - 2.0 mg/dL; <0.8 - <2.0 - 1.0 mg/dL; <0.6 - 0.3 life-threatening
0.6 mmol/L mmol/L consequences Death
intervention not Severe symptoms; consequences; urgent
BMI 25 - 29.9 kg/m2 BMI 30 - 39.9 kg/m2 BMI >=40 kg/m2
Life-threatening

Local wound care; Operative debridement or

medical intervention other invasive intervention
indicated (e.g., indicated (e.g. tissue Life-threatening
dressings or topical reconstruction, flap or consequences; urgent
medications) grafting) intervention indicated Death

Moderate pain Severe pain associated with

associated with signs of signs of inflammation,
inflammation, erythema, or joint swelling;
erythema, or joint irreversible joint damage;
swelling; limiting disabling; limiting self care
Severe symptoms; limiting self Life-threatening

Symptomatic; limiting care ADL; elective operative consequences; urgent
instrumental ADL intervention indicated intervention indicated Death




Symptomatic; limiting care ADL; elective operative
instrumental ADL intervention indicated - -
Moderate induration, Severe induration; unable to

able to slide skin, slide or pinch skin; limiting Generalized; associated
unable to pinch skin; joint or orifice movement (e.g. with signs or symptoms of
limiting instrumental mouth, anus); limiting self impaired breathing or
ADL care ADL feeding Death

Symptomatic; weakness
evident on physical
exam; weakness
limiting instrumental Weakness limiting self care
ADL ADL; disabling - -
Reduction in growth
velocity by 30 - 49%
ideally measured over
the period of a year or 0
- 49% reduction in Reduction in growth velocity
growth from the of >=50% ideally measured
baseline growth curve over the period of a year - -

indicated (e.g., indicated (e.g., tissue Life-threatening

care ADL; elective operative
Symptomatic; limiting intervention indicated;
>25 - 50% decrease in >50% decrease in ROM;

ROM; limiting limiting self care ADL;
Rotation <60 degrees to Ankylosed/fused over

right or left; <60 multiple segments with no C-
degrees of flexion spine rotation - -
<50% lumbar spine flexion;
Pain with range of associated with symptoms of
motion (ROM) in ankylosis or fused over
lumbar spine; requires a multiple segments with no L-
reaching aid to pick up a spine flexion (e.g., unable to
very light object from reach to floor to pick up a very
the floor light object) - -
Severe accentuation;
Moderate accentuation; operative intervention
limiting instrumental indicated; limiting self care
ADL ADL - -
Severe accentuation;
Moderate accentuation; operative intervention
ADL ADL - -
Symptomatic; evident
on physical exam;
limiting instrumental Limiting self care ADL;
ADL disabling - -
on physical exam;
ADL disabling - -
on physical exam;
ADL disabling - -
on physical exam;
ADL disabling - -
on physical exam;
ADL disabling - -
Deformity, hypoplasia,
or asymmetry able to Significant deformity,
be remediated by hypoplasia, or asymmetry,
prosthesis (e.g., shoe unable to be remediated by
insert) or covered by prosthesis or covered by
clothing clothing; disabling - -

Moderate pain
associated with Pain associated with severe
weakness; pain limiting weakness; limiting self care


(e.g., topical agents); Severe symptoms; limiting self Life-threatening
limiting instrumental care ADL; elective operative consequences; urgent
ADL intervention indicated intervention indicated Death
BMD t-score <-2.5; loss

of height <2 cm; anti-
osteoporotic therapy Loss of height >=2 cm;
indicated; limiting hospitalization indicated;


>45 degrees; scapular

>20 - 45 degrees; visible prominence in forward
by forward flexion; flexion; operative intervention
ADL ADL; disabling - -

Moderate induration, Severe induration; unable to

unable to pinch skin; joint or orifice movement with signs or symptoms of
limiting instrumental (e.g., mouth, anus); limiting impaired breathing or
ADL self care ADL feeding Death
Decreased ROM Decreased ROM with inability

requiring small bites, to adequately aliment or
soft foods or purees hydrate orally - -
Moderate length
discrepancy 2 - 5 cm; Severe length discrepancy >5
shoe lift indicated; cm; limiting self care ADL;
limiting instrumental disabling; operative
ADL intervention indicated - -

- - Present Death
Life-threatening
Acute life-threatening
Non life-threatening secondary malignancy;
- secondary malignancy blast crisis in leukemia Death

Moderate symptoms;
ADL care ADL - -
Moderate symptoms;
ADL care ADL - -
Moderate symptoms;
ADL care ADL - -
Moderate restlessness
or increased motor Severe restlessness or
activity; limiting increased motor activity;
Moderate; short term

memory loss; limiting Severe; long term memory
instrumental ADL loss; limiting self care ADL - -
Voicelessness; unable to
- speak - -


limiting instrumental care ADL; mechanical
ADL assistance indicated - -
Moderate symptoms;
ADL care ADL - -
corticosteroids Severe symptoms; medical consequences; urgent
Post-craniotomy:
moderate symptoms;
indicated; Post-lumbar
puncture: persistent Life-threatening
moderate symptoms; Severe symptoms; medical consequences; urgent
blood patch indicated intervention indicated intervention indicated Death
Moderate cognitive
disability; interfering
with work/school/life
performance but
capable of independent
living; specialized Severe cognitive disability;
resources on part time significant impairment of
basis indicated work/school/life performance - -
Moderate impairment
in attention or Severe impairment in
decreased level of attention or decreased level
concentration; limiting of concentration; limiting self
Sedation; slow response

to stimuli; limiting Life-threatening
instrumental ADL Difficult to arouse consequences Death
Moderate unsteadiness
or sensation of Severe unsteadiness or
movement; limiting sensation of movement;
Moderate impairment
of articulation or slurred Severe impairment of
speech articulation or slurred speech - -
Moderate sensory
alteration; limiting Severe sensory alteration;
Altered taste with
change in diet (e.g., oral
supplements); noxious
or unpleasant taste; loss
of taste - - -
Moderate receptive or
expressive
characteristics; Severe receptive or expressive
impairing ability to characteristics; impairing
communicate ability to read, write or
spontaneously communicate intelligibly - -
Life-threatening
- - intervention indicated

Moderate involuntary Severe involuntary Life-threatening

movements; limiting movements or torticollis; consequences; urgent
Moderate symptoms;
ADL care ADL - -
Moderate symptoms;
ADL care ADL - -


Moderate symptoms; Severe symptoms or Life-threatening

intervention not neurological deficit; consequences; urgent
Moderate increased Severe increased need for
need for sleep sleep - -
Moderate symptoms;
ADL care ADL - -
Ventriculostomy, ICP
Moderate symptoms; monitoring, intraventricular Life-threatening
medical intervention thrombolysis, or operative consequences; urgent
Moderate symptoms - - -
Moderate symptoms;
ADL care ADL - -
Moderate symptoms;
ADL - - -
Moderate symptoms;
focal T2/FLAIR
hyperintensities, Life-threatening
involving periventricular Severe symptoms; extensive consequences; extensive
white matter extending T2/FLAIR hyperintensities, T2/FLAIR hyperintensities,
into centrum semiovale involving periventricular white involving periventricular
or involving 1/3 to 2/3 matter involving 2/3 or more white matter involving
of susceptible areas of of susceptible areas of most of susceptible areas
cerebrum +/- moderate cerebrum +/- moderate to of cerebrum +/- moderate
increase in SAS and/or severe increase in SAS and/or to severe increase in SAS
moderate moderate to severe and/or moderate to severe
ventriculomegaly ventriculomegaly ventriculomegaly Death
Moderate memory
impairment; limiting Severe memory impairment;

Moderate symptoms;
ADL care ADL - -
Moderate weakness or Life-threatening
sensory loss; limiting Severe weakness or sensory consequences; urgent
instrumental ADL loss; limiting self care ADL intervention indicated Death

Moderate symptoms;
ADL care ADL - -
Moderate symptoms;
ADL care ADL - -
Moderate symptoms;
ADL care ADL - -
Moderate symptoms;
ADL care ADL - -
Moderate symptoms; Severe symptoms; limiting self Life-threatening

limiting instrumental care ADL; assistive device consequences; urgent
ADL indicated intervention indicated Death


Present (e.g., near
fainting) - - -

Moderate symptoms;
limiting instrumental Life-threatening
ADL; medical Severe symptoms; limiting self consequences; urgent
intervention indicated care ADL intervention indicated Death
Severe symptoms; medical

intervention indicated (e.g., Life-threatening
thyroplasty, vocal cord consequences; urgent
Moderate symptoms injection) intervention indicated Death
Moderate symptoms;
abnormal imaging Severe symptoms; very Life-threatening
studies; limiting abnormal imaging studies; consequences; urgent
Life-threatening;
Brief generalized Multiple seizures despite prolonged repetitive
seizure medical intervention seizures Death

Moderate sedation; Life-threatening

limiting instrumental consequences; urgent
ADL Obtundation or stupor intervention indicated Death
Moderate increase in
muscle tone and Severe increase in muscle
increase in resistance tone and increase in Life-threatening; unable to
through range of resistance through range of move active or passive
motion motion range of motion Death
Life-threatening
Moderate neurologic consequences; urgent
deficit Severe neurologic deficit intervention indicated Death
- Fainting; orthostatic collapse - -
Moderate neurologic
deficit with or without
imaging confirmation - - -
Moderate symptoms;
ADL care ADL - -
Moderate symptoms;
ADL care ADL - -

Life-threatening
Fetal loss at
any
gestational
- - - age
<10% percentile of
weight for gestational <5% percentile of weight for <1% percentile of weight
age gestational age for gestational age -
Delivery of a liveborn Delivery of a liveborn

infant at >28 to 34 Delivery of a liveborn infant at infant at 24 weeks of
weeks gestation 24 to 28 weeks gestation gestation or less -
- Unintended pregnancy - -

Moderate, local or threatening; hospitalization or
noninvasive prolongation of existing
limiting instrumental disabling; limiting self care consequences; urgent
ADL ADL intervention indicated Death
Life-threatening
Moderate mood Severe agitation; consequences; urgent
alteration hospitalization not indicated intervention indicated Death
Inability to achieve
orgasm adversely
affecting relationship - - -

limiting instrumental care ADL; hospitalization not Life-threatening;
ADL indicated hospitalization indicated Death
Moderate Life-threatening
disorientation; limiting Severe disorientation; limiting consequences; urgent
instrumental ADL self care ADL intervention indicated Death
Delay in achieving
orgasm adversely
Moderate and acute Life-threatening

confusional state; Severe and acute confusional consequences, threats of
limiting instrumental state; limiting self care ADL; harm to self or others;
ADL hospitalization indicated hospitalization indicated Death
Life-threatening
consequences, threats of
Moderate delusional Severe delusional symptoms; harm to self or others;
symptoms hospitalization not indicated hospitalization indicated Death
Life-threatening
Moderate depressive Severe depressive symptoms; consequences, threats of
symptoms; limiting limiting self care ADL; harm to self or others;
instrumental ADL hospitalization not indicated hospitalization indicated Death
Moderate mood Severe mood elevation (e.g.,
elevation hypomania) - -
Life-threatening
Moderate Severe hallucinations; harm to self or others;
hallucinations hospitalization not indicated hospitalization indicated Death
Moderate difficulty
falling asleep, staying Severe difficulty in falling
asleep or waking up asleep, staying asleep or
early waking up early - -
Decrease in sexual
interest adversely
Moderate increase in
sexual interest Severe increase in sexual
adversely affecting interest leading to dangerous
relationship behavior - -
Moderate manic
symptoms (e.g., Severe manic symptoms (e.g., Life-threatening
relationship and work hypomania; major sexual or consequences, threats of
difficulties; poor financial indiscretions); harm to self or others;
hygiene) hospitalization not indicated hospitalization indicated Death
Life-threatening
Moderate personality Severe personality change; harm to self or others;
change hospitalization not indicated hospitalization indicated Death
Moderate psychotic Severe psychotic symptoms Life-threatening

symptoms (e.g., (e.g., paranoid; extreme consequences, threats of
disorganized speech; disorganization); harm to self or others;
impaired reality testing) hospitalization not indicated hospitalization indicated Death
Moderate symptoms;
ADL care ADL - -
Specific plan to commit Specific plan to commit

Suicidal ideation with suicide without serious intent suicide with serious intent
no specific plan or to die which may not require to die which requires
intent hospitalization hospitalization -
Suicide attempt or gesture

without intent to die which Suicide attempt with
may not require intent to die which
- hospitalization requires hospitalization Death
Moderate; minimal,
local or noninvasive Severe or medically significant Life-threatening
intervention indicated; but not immediately life- consequences;
limiting age-appropriate threatening; disabling; hospitalization or urgent
Creatinine >3 x baseline or Life-threatening

Creatinine 2 - 3 x above >4.0 mg/dL; hospitalization consequences; dialysis
baseline indicated indicated Death
Intraperitoneal perforation; Life-threatening

Extraperitoneal elective radiologic, consequences; organ
perforation, indwelling endoscopic or operative failure; urgent operative
catheter indicated intervention indicated intervention indicated Death
Antispasmodics
indicated Hospitalization indicated - -
eGFR or CrCl <15

ml/min/1.73 m2; dialysis
eGFR or CrCl 59 - 30 eGFR or CrCl 29 - 15 or renal transplant
ml/min/1.73 m2 ml/min/1.73 m2 indicated Death
Moderate hematuria;
moderate increase in
frequency, urgency,
dysuria, nocturia or Gross hematuria; transfusion,
incontinence; urinary IV medications or
catheter placement or hospitalization indicated; Life-threatening
bladder irrigation elective endoscopic, consequences; urgent
indicated; limiting radiologic or operative radiologic or operative
instrumental ADL intervention indicated intervention indicated Death
Gross hematuria; transfusion,

IV medications or
Symptomatic; urinary hospitalization indicated;
catheter or bladder elective endoscopic, Life-threatening
irrigation indicated; radiologic or operative consequences; urgent
limiting instrumental intervention indicated; radiologic or operative
- - - -
Adults: 2+ proteinuria;
urinary protein 1.0 - 3.4
g/24 hrs; Pediatric: Adults: urinary protein >3.5
urine P/C g/24 hrs;
(Protein/Creatinine)
ratio 0.5 - 1.9 Pediatric: urine P/C >1.9 - -
Symptomatic; oral
antiemetics indicated;
around the clock Hospitalization indicated; IV Life-threatening
nonprescription intervention (e.g., analgesics, consequences; urgent
analgesics or any oral antiemetics); elective radiologic, endoscopic or
narcotic analgesics endoscopic or radiologic operative intervention
Moderate pain; limiting

instrumental ADL;
prescription medication Hospitalization indicated;
indicated limiting self care ADL - -
Transfusion, radiation, or
Analgesics and elective radiologic, consequences; urgent
hematocrit monitoring endoscopic or operative radiologic or operative
Noninvasive Limiting self care ADL; elective
intervention indicated; radiologic, endoscopic or Life-threatening
urinary or suprapubic operative intervention consequences; urgent
catheter placement indicated; permanent urinary radiologic or operative
indicated diversion indicated intervention indicated Death
ADL; medical
management indicated - - -
Intervention indicated (e.g.,

clamp, collagen injections);
Spontaneous; pads operative intervention
indicated; limiting indicated; limiting self care
Placement of urinary, Elective operative or

suprapubic or radiologic intervention Life-threatening
intermittent catheter indicated; substantial loss of consequences; organ
placement indicated; affected kidney function or failure; urgent operative
medication indicated mass intervention indicated Death
Symptomatic and altered

Symptomatic but no organ function (e.g.,
hydronephrosis, sepsis hydronephrosis, or renal
or renal dysfunction; dysfunction); elective
urethral dilation, radiologic, endoscopic or Life-threatening
urinary or suprapubic operative intervention consequences; urgent
catheter indicated indicated intervention indicated Death

ADL; medical
management indicated - - -
- - - -

Moderate, local or threatening; hospitalization or
noninvasive prolongation of existing
limiting instrumental disabling; limiting self care consequences; urgent
- Absence of sperm in ejaculate - -
Moderate asymmetry; Asymmetry >1/3 of breast

moderate atrophy volume; severe atrophy - -

Moderate symptoms;
ADL care ADL - -
Moderate discomfort or
pain associated with
vaginal penetration; Severe discomfort or pain
discomfort or pain associated with vaginal
partially relieved with penetration; discomfort or
use of vaginal lubricants pain unrelieved by vaginal
or estrogen lubricants or estrogen - -
Anejaculation or
retrograde ejaculation - -
Decrease in erectile function

Decrease in erectile (frequency/rigidity of
function erections) but erectile
(frequency/rigidity of intervention not helpful (e.g.,
erections), erectile medication or mechanical
intervention indicated, devices such as penile pump);
(e.g., medication or placement of a permanent
mechanical devices penile prosthesis indicated
such as penile pump) (not previously present) - -
Mild symptoms; Severe symptoms; elective

elective intervention operative intervention
Life-threatening
Symptomatic and Severe symptoms; elective operative intervention
intervention not operative intervention indicated (e.g., organ
indicated indicated resection) Death

Moderate symptoms;
indicated - - -
Readily apparent
obscuration of
folds; readily apparent Lymphorrhea; gross deviation
deviation from normal from normal anatomic
anatomic contour contour; limiting self care ADL - -

Symptomatic (e.g., pain operative intervention
or psychosocial impact) indicated - -
Severe bleeding; transfusion Life-threatening

Moderate bleeding; indicated; radiologic or consequences; urgent
medical intervention endoscopic intervention operative intervention
Intermittent menses
with skipped menses
for more than 4 to 6 Persistent amenorrhea for
months more than 6 months - -
Changes in lactation,
significantly affecting
breast production or
expression of breast
milk - - -
Moderate symptoms;
medical intervention Severe; transfusion indicated; Life-threatening
indicated (e.g., surgical intervention indicated consequences; urgent
hormones) (e.g., hysterectomy) intervention indicated Death
Symptomatic;
asymmetry of nipple
areolar complex with
moderate retraction
and/or thickening of the
nipple areolar complex - - -
Sperm concentration 13
- 48 million/mL or Sperm concentration <13
motility 32 - 68% million/mL or motility <32% - -
Symptomatic and endoscopic, or elective Life-threatening

Symptomatic, not
interfering with
bladder, bowel, or
vaginal function; Life-threatening



- Present - -





Symptomatic but not

interfering with
urination or sexual Severe symptoms; interfering
activities; intervention with urination or sexual Life-threatening
not indicated; limiting function; limiting self care consequences; urgent
instrumental ADL ADL; intervention indicated intervention indicated Death






Moderate to heavy
vaginal discharge; use
of perineal pad or
tampon indicated - - -
Moderate vaginal
dryness interfering with
sexual function or Severe vaginal dryness
causing frequent resulting in dyspareunia or
discomfort severe discomfort - -

Widespread areas of
Moderate discomfort or Severe discomfort or pain, mucosal ulceration; life-
pain, edema, or edema, or redness; limiting threatening consequences;
redness; limiting self care ADL; small areas of urgent intervention
instrumental ADL mucosal ulceration indicated Death



Vaginal narrowing and/or

Vaginal narrowing shortening interfering with
and/or shortening not the use of tampons, sexual
interfering with physical activity or physical
examination examination - Death
Moderate discomfort or
pain associated with
vaginal Severe discomfort or pain
spasm/tightening; associated with vaginal
disruption in sexual spasm/tightening; unable to
function and physical tolerate vaginal penetration
examination or physical examination - -

Life-threatening
respiratory or
hemodynamic
Present with radiologic compromise; intubation or
findings; intubation not urgent intervention
Moderate symptoms;
indicated - - -
Life-threatening
respiratory or
hemodynamic
compromise; intubation or
Present; medical intervention urgent intervention
Altered eating habits; Life-threatening

coughing or choking Dyspnea and pneumonia respiratory or
episodes after eating or symptoms (e.g., aspiration hemodynamic
swallowing; medical pneumonia); hospitalization compromise; intubation or
intervention indicated indicated; unable to aliment urgent intervention
(e.g., suction or oxygen) orally indicated Death
Symptomatic (e.g.,
dyspnea, cough);
medical intervention Life-threatening
indicated (e.g., chest respiratory or
physiotherapy, Oxygen indicated; hemodynamic
suctioning); hospitalization or elective compromise; intubation or
bronchoscopic operative intervention urgent intervention
suctioning indicated (e.g., stent, laser) indicated Death
Life-threatening
Symptomatic; tube Severe symptoms; limiting self operative intervention
thoracostomy or care ADL; endoscopic or with thoracoplasty,
medical management operative intervention chronic open drainage or
indicated; limiting indicated (e.g., stent or multiple thoracotomies
instrumental ADL primary closure) indicated Death
Symptomatic (e.g., mild
wheezing); endoscopic
evaluation indicated;
radiographic evidence Life-threatening
of atelectasis/lobar respiratory or
collapse; medical Shortness of breath with hemodynamic
management indicated stridor; endoscopic compromise; intubation or
(e.g., steroids, intervention indicated (e.g., urgent intervention
bronchodilators) laser, stent placement) indicated Death
Symptomatic (e.g.,
rhonchi or wheezing) Life-threatening
but without respiratory respiratory or
distress; medical Shortness of breath with hemodynamic
intervention indicated stridor; endoscopic compromise; intubation or
(e.g., steroids, intervention indicated (e.g., urgent intervention
bronchodilators) laser, stent placement) indicated Death
Life-threatening
thoracostomy or care ADL; endoscopic or with thoracoplasty,
medical intervention operative intervention chronic open drainage or
indicated; limiting indicated (e.g., stent or multiple thoracotomies
instrumental ADL primary closure) indicated Death
Life-threatening
respiratory or
Transfusion, radiologic, hemodynamic
Moderate symptoms; endoscopic, or operative compromise; intubation or
medical intervention intervention indicated (e.g., urgent intervention
indicated hemostasis of bleeding site) indicated Death
Life-threatening
respiratory or
Symptomatic; medical hemodynamic
intervention indicated; compromise; intubation or
limiting instrumental Limiting self care ADL; oxygen urgent intervention
ADL saturation decreased indicated Death
Life-threatening
respiratory or
hemodynamic
Symptomatic; Severe symptoms; elective compromise; intubation or
thoracentesis or tube operative intervention urgent intervention
drainage indicated indicated indicated Death
Moderate symptoms,
indicated; limiting Severe symptoms; limiting self
Shortness of breath
with minimal exertion; Life-threatening
limiting instrumental Shortness of breath at rest; consequences; urgent
Moderate symptoms;
indicated (e.g., nasal Transfusion, radiologic,
packing, cauterization; endoscopic, or operative Life-threatening
topical intervention indicated (e.g., consequences; urgent
vasoconstrictors) hemostasis of bleeding site) intervention indicated Death
Moderate symptoms;
medical intervention Severe symptoms; interfering
indicated; limiting with sleep; limiting self care
Moderate or persistent
voice changes; may
require occasional
repetition but
understandable on Severe voice changes
telephone; medical including predominantly
evaluation indicated whispered speech - -
Decreased oxygen Life-threatening airway

saturation with exercise compromise; urgent
(e.g., pulse oximeter Decreased oxygen saturation intervention indicated
<88%); intermittent at rest (e.g., pulse oximeter (e.g., tracheotomy or
supplemental oxygen <88% or PaO2 <=55 mm Hg) intubation) Death
Symptomatic; medical Life-threatening airway

intervention indicated compromise; urgent
(e.g., dexamethasone, intervention indicated
epinephrine, Stridor; respiratory distress; (e.g., tracheotomy or
antihistamines) hospitalization indicated intubation) Death
Life-threatening
thoracostomy or care ADL; endoscopic or indicated (e.g.,
medical management operative intervention thoracoplasty, chronic
indicated; limiting indicated (e.g., stent or open drainage or multiple
instrumental ADL primary closure) thoracotomies) Death
Transfusion, radiologic, compromise; urgent
Moderate symptoms; endoscopic, or operative intervention indicated
medical intervention intervention indicated (e.g., (e.g., tracheotomy or
indicated hemostasis of bleeding site) intubation) Death
Severe throat pain;

Moderate sore throat; endoscopic intervention
analgesics indicated indicated - -
compromise; urgent
Severe pain; severely altered intervention indicated
Moderate discomfort; eating/swallowing; medical (e.g., tracheotomy or
altered oral intake intervention indicated intubation) Death
Symptomatic (e.g.,
but causing no
respiratory distress;
medical management
indicated (e.g., Limiting self care ADL; stridor; Life-threatening
steroids); limiting endoscopic intervention consequences; urgent
instrumental ADL indicated (e.g., stent, laser) intervention indicated Death
Symptomatic (e.g.,
but causing no
respiratory distress; Limiting self care ADL; stridor; Life-threatening
medical management endoscopic intervention consequences; urgent
indicated (e.g., steroids) indicated (e.g., stent, laser) intervention indicated Death
Moderate symptoms;
mild anxiety, but no
dyspnea; short duration
of observation and or
anxiolytic indicated; Severe symptoms; dyspnea
limiting instrumental and swallowing difficulty; Life-threatening
ADL limiting self care ADL consequences Death
Persistent or severe
episodes associated with
Recurrent episodes; syncope; urgent
noninvasive intervention intervention indicated
Transient episode; indicated (e.g., breathing (e.g., fiberoptic
intervention not technique, pressure point laryngoscopy, intubation,
indicated massage) botox injection) Death
endoscopic, or elective
Moderate symptoms; operative intervention Life-threatening
medical intervention indicated (e.g., hemostasis of consequences; urgent
indicated bleeding site) intervention indicated Death
Moderate symptoms;
medical intervention Associated with bloody nasal
indicated discharge or epistaxis - -
Symptomatic; tube Severe symptoms; limiting self

thoracostomy or care ADL; endoscopic or
medical intervention operative intervention Life-threatening
indicated; limiting indicated (e.g., stent or consequences; urgent
instrumental ADL primary closure) intervention indicated Death
Life-threatening
respiratory or
Transfusion, radiologic, hemodynamic
Moderate symptoms; endoscopic, or operative compromise; intubation or
medical intervention intervention indicated (e.g., urgent intervention
indicated hemostasis of bleeding site) indicated Death
Moderate pain and

analgesics indicated;
altered oral intake; Severe pain; unable to Life-threatening
limiting instrumental adequately aliment or hydrate consequences; urgent
ADL orally; limiting self care ADL intervention indicated Death
adequately by GI tract; tube
feeding or TPN indicated; Life-threatening
Symptomatic (e.g.,
but causing no
respiratory distress; Life-threatening airway
medical management compromise; urgent
indicated (e.g., Limiting self care ADL; stridor; intervention indicated
steroids); limiting endoscopic intervention (e.g., tracheotomy or
instrumental ADL indicated (e.g., stent, laser) intubation) Death

instrumental ADL ADL
Life-threatening
Symptomatic; respiratory or
intervention indicated Symptomatic with respiratory hemodynamic
(e.g., diuretics or limited distress and hypoxia; surgical compromise; intubation or
therapeutic intervention including chest urgent intervention
thoracentesis) tube or pleurodesis indicated indicated Death
>1000 ml of blood evacuated; Life-threatening

persistent bleeding (150-200 respiratory or
Symptomatic or ml/hr for 2 - 4 hr); persistent hemodynamic
associated with transfusion indicated; elective compromise; intubation or
pneumothorax; chest operative intervention urgent intervention
tube drainage indicated indicated indicated Death

Life-threatening
respiratory compromise;
Symptomatic; medical urgent intervention
intervention indicated; indicated (e.g.,
limiting instrumental Severe symptoms; limiting self tracheotomy or
ADL care ADL; oxygen indicated intubation) Death
Symptomatic;
intervention indicated Sclerosis and/or operative Life-threatening
(e.g., tube placement intervention indicated; consequences; urgent
without sclerosis) hospitalization indicated intervention indicated Death
Moderate symptoms;
indicated - - -
Moderate sputum Persistent or copious

production; limiting production of sputum; limiting
Moderate dyspnea on Life-threatening

exertion; medical respiratory compromise;
intervention indicated; Severe dyspnea or dyspnea at urgent intervention or
limiting instrumental rest; oxygen indicated; intubation with ventilatory
ADL limiting self care ADL support indicated Death
Life-threatening
consequences (e.g.,
hemodynamic/pulmonary
Moderate hypoxemia; complications); intubation
evidence of pulmonary Severe hypoxemia; evidence with ventilatory support
hypertension; of right-sided heart failure; indicated; radiographic
radiographic pulmonary radiographic pulmonary pulmonary fibrosis >75%
fibrosis 25 - 50% fibrosis >50 - 75% with severe honeycombing Death
Symptomatic; tube
thoracostomy or Limiting self care ADL; Life-threatening
medical management endoscopic stenting or consequences; urgent
indicated; limiting operative intervention operative intervention
instrumental ADL indicated indicated Death
Moderate dyspnea, Life-threatening airway

cough; requiring consequences; urgent
evaluation by cardiac Severe symptoms, associated intervention indicated
catheterization and with hypoxemia, right heart (e.g., tracheotomy or
medical intervention failure; oxygen indicated intubation) Death
Life-threatening
intervention, intubation, or
ventilatory support
- - indicated Death
Moderate signs or Life-threatening

symptoms; steroids Severe symptoms; consequences; ventilatory
indicated hospitalization indicated support indicated Death
Symptomatic stenosis
or edema/narrowing
interfering with airflow; Stenosis with significant nasal Necrosis of soft tissue or
limiting instrumental obstruction; limiting self care bone; urgent operative
Moderate apnea and

oxygen desaturation;
excessive daytime Oxygen desaturation; Cardiovascular or
sleepiness; medical associated with hypertension; neuropsychiatric
evaluation indicated; medical intervention symptoms; urgent
limiting instrumental indicated; limiting self care operative intervention
ADL ADL indicated Death
Moderate symptoms;
indicated - - -
Severe pain; limiting self care

Moderate pain; limiting ADL; limiting ability to
instrumental ADL swallow - -
compromise; urgent
Respiratory distress limiting intervention indicated
self care ADL; medical (e.g., tracheotomy or
- intervention indicated intubation) Death
Life-threatening
thoracostomy or care ADL; endoscopic or indicated (e.g.,
medical intervention operative intervention thoracoplasty, chronic
indicated; limiting indicated (e.g., stent or open drainage or multiple
instrumental ADL primary closure) thoracotomies) Death
Moderate symptoms;
medical intervention Severe pain; hemorrhage or Life-threatening
indicated; limiting respiratory symptoms; consequences; urgent
Symptomatic (e.g.,
noisy airway breathing), Life-threatening airway
but causing no Stridor or respiratory distress compromise; urgent
respiratory distress; limiting self care ADL; intervention indicated
medical management endoscopic intervention (e.g., tracheotomy or
indicated (e.g., steroids) indicated (e.g., stent, laser) intubation) Death
Severe voice changes
including predominantly
whispered speech; may
Moderate or persistent require frequent repetition or
change from normal face-to-face contact for
voice; still understandability; may
understandable require assistive technology - -
Moderate symptoms; Severe respiratory symptoms

medical intervention limiting self care ADL; oxygen Life-threatening
indicated; limiting therapy or hospitalization consequences; urgent
instrumental ADL indicated intervention indicated Death

Hair loss of >50%

normal for that
individual that is readily
apparent to others; a
wig or hair piece is
necessary if the patient
desires to completely
camouflage the hair
loss; associated with
psychosocial impact - - -
Pronounced odor;
psychosocial impact;
patient seeks medical
intervention - - -
Blisters covering >30%

Blisters covering 10 - BSA; associated with fluid
30% BSA; painful or electrolyte
blisters; limiting Blisters covering >30% BSA; abnormalities; ICU care or
instrumental ADL limiting self care ADL burn unit indicated Death
Covering 10 - 30% BSA
and associated with
erythema or pruritus; Covering >30% BSA and
limiting instrumental associated with pruritus;
ADL limiting self care ADL - -
Target lesions covering

Target lesions covering >30% BSA; associated with
10 - 30% BSA and Target lesions covering >30% fluid or electrolyte
associated with skin BSA and associated with oral abnormalities; ICU care or
tenderness or genital erosions burn unit indicated Death
Erythema covering Erythema covering >90%

>90% BSA without Erythema covering >90% BSA BSA with associated fluid
associated symptoms; with associated symptoms or electrolyte
limiting instrumental (e.g., pruritus or tenderness); abnormalities; ICU care or
ADL limiting self care ADL burn unit indicated Death
Covering 10 - 30% BSA

and associated with Covering >30% BSA;
erythema or associated with erythema or
tenderness; limiting tenderness; limiting self-care
In women, increase in
length, thickness or
density of hair in a male
distribution that
requires daily shaving or
consistent destructive
means of hair removal
to camouflage;
associated with
psychosocial impact - - -
Involving >1 site; Generalized involving sites

patient seeks medical other than palms, soles, or
intervention; associated axillae; associated with
with psychosocial electrolyte/hemodynamic
impact imbalance - -
Increase in length,
thickness or density of
hair at least on the
usual exposed areas of
the body [face (not
limited to
beard/moustache area)
plus/minus arms] that
requires frequent
shaving or use of
destructive means of
hair removal to
camouflage; associated
with psychosocial
impact - - -
Symptomatic; limiting Increase in body temperature;

instrumental ADL limiting self care ADL Heat stroke Death
Covering >30% BSA and

Covering 10 - 30% BSA associated tenderness and
and associated narcotics or NSAIDs indicated;
tenderness; limiting lipohypertrophy; limiting self
- - -
Symptomatic
separation of the nail
bed from the nail plate
or nail loss; limiting
instrumental ADL - - -
- - - -

Skin changes (e.g.,
peeling, blisters, Severe skin changes (e.g.,
bleeding, edema, or peeling, blisters, bleeding,
hyperkeratosis) with edema, or hyperkeratosis)
pain; limiting with pain; limiting self care
Edema associated with visual

disturbance; increased
intraocular pressure,
glaucoma or retinal
Indurated or pitting hemorrhage; optic neuritis;
edema; topical diuretics indicated; operative
intervention indicated intervention indicated - -
Erythema covering >30% BSA

and erythema with blistering;
photosensitivity; oral
corticosteroid therapy
indicated; pain control Life-threatening
Tender erythema indicated (e.g., narcotics or consequences; urgent
covering 10 - 30% BSA NSAIDs) intervention indicated Death
Intense or widespread;
intermittent; skin
changes from scratching
(e.g., edema,
papulation,
excoriations, Intense or widespread;
lichenification, constant; limiting self care
oozing/crusts); oral ADL or sleep; oral
intervention indicated; corticosteroid or
limiting instrumental immunosuppressive therapy
ADL indicated - -
Combined area of
lesions covering 10 - Combined area of lesions
30% BSA; bleeding with covering >30% BSA;
trauma spontaneous bleeding - -
Papules and/or pustules covering any % BSA, which
covering 10 - 30% BSA, Papules and/or pustules may or may not be
which may or may not covering >30% BSA, which associated with symptoms
be associated with may or may not be associated of pruritus or tenderness
symptoms of pruritus or with symptoms of pruritus or and are associated with
tenderness; associated tenderness; limiting self care extensive superinfection
with psychosocial ADL; associated with local with IV antibiotics
impact; limiting superinfection with oral indicated; life-threatening
instrumental ADL antibiotics indicated consequences Death
Macules/papules
covering 10 - 30% BSA
with or without
symptoms (e.g., Macules/papules covering
pruritus, burning, >30% BSA with or without
tightness); limiting associated symptoms; limiting

Covering 10 - 30% BSA;

associated with striae
or adnexal structure Covering >30% BSA;
loss associated with ulceration - -
Hyperpigmentation
covering >10% BSA;
associated psychosocial
impact - - -
Hypopigmentation or
depigmentation
covering >10% BSA;
associated psychosocial
impact - - -
Moderate induration, Severe induration, unable to

unable to pinch skin; joint movement or orifice with signs or symptoms of
limiting instrumental (e.g., mouth, anus); limiting impaired breathing or
ADL self care ADL feeding Death
Any size ulcer with
Combined area of ulcers >2 extensive destruction,
Combined area of ulcers cm; full-thickness skin loss tissue necrosis, or damage
1 - 2 cm; partial involving damage to or to muscle, bone, or
thickness skin loss necrosis of subcutaneous supporting structures with
involving skin or tissue that may extend down or without full thickness
subcutaneous fat to fascia skin loss Death
Skin sloughing covering <10% Skin sloughing covering 10

BSA with associated signs - 30% BSA with associated
(e.g., erythema, purpura, signs (e.g., erythema,
epidermal detachment and purpura, epidermal
mucous membrane detachment and mucous
detachment) membrane detachment) Death
Telangiectasias covering
>10% BSA; associated
with psychosocial
impact - - -
Skin sloughing covering

>=30% BSA with
associated symptoms (e.g.,
erythema, purpura, or
- - epidermal detachment) Death
Urticarial lesions
covering 10 - 30% BSA; Urticarial lesions covering
oral intervention >30% BSA; IV intervention

Menopause occurring
at age 40 - 45 years of Menopause occurring before
age age 40 years of age - -

Life-threatening
Symptomatic; medical Severe symptoms; consequences; urgent
intervention indicated intervention indicated intervention indicated Death
Moderate symptoms; Symptomatic, associated with

medical intervention hypotension and/or
indicated; limiting tachycardia; limiting self care
Minimally invasive endoscopic, or elective Life-threatening
evacuation or aspiration operative intervention consequences; urgent
Moderate symptoms;
ADL care ADL - -
Stage 1 hypertension
(systolic BP 140 - 159
mm Hg or diastolic BP
90 - 99 mm Hg);
indicated; recurrent or
persistent (>=24 hrs);
symptomatic increase
by >20 mm Hg
(diastolic) or to >140/90Stage 2 hypertension (systolic Life-threatening
mm Hg if previously BP >=160 mm Hg or diastolic consequences (e.g.,
WNL; monotherapy BP >=100 mm Hg); medical malignant hypertension,
indicated intervention indicated; more transient or permanent
than one drug or more neurologic deficit,
Pediatric: recurrent or intensive therapy than hypertensive crisis); urgent
persistent (>=24 hrs) BP previously used indicated intervention indicated
>ULN; monotherapy
indicated Pediatric: Same as adult Pediatric: Same as adult Death
Life-threatening and
Non-urgent medical Medical intervention or urgent intervention
intervention indicated hospitalization indicated indicated Death

endoscopic or elective Life-threatening
Marked discoloration;
leathery skin texture;
papillary formation;
ADL care ADL - -

endoscopic or elective
Symptomatic; medical operative intervention
Brief (<24 hrs) episode Life-threatening

of ischemia managed consequences; evidence of
non-surgically and Recurring or prolonged (>=24 end organ damage; urgent
without permanent hrs) and/or invasive operative intervention
deficit intervention indicated indicated Death
Present - - -
Present - - -
Severe symptoms; multi- Life-threatening
Symptomatic; medical modality intervention consequences; urgent
intervention indicated indicated (e.g., multi-modality
(e.g., anticoagulation, anticoagulation, intervention indicated
radiation or chemotherapy, radiation, (e.g., lysis, thrombectomy,
chemotherapy) stenting) surgery) Death
Life-threatening (e.g.,
pulmonary embolism,
Thrombosis (e.g., cerebrovascular event,
Venous thrombosis uncomplicated pulmonary arterial insufficiency);
(e.g., uncomplicated embolism [venous], non- hemodynamic or
deep vein thrombosis), embolic cardiac mural neurologic instability;
medical intervention [arterial] thrombus), medical urgent intervention
Life-threatening; evidence
Moderate symptoms, Severe symptoms, medical of peripheral or visceral
medical intervention intervention indicated (e.g., ischemia; urgent
indicated steroids) intervention indicated Death
Life-threatening
Brief (<24 hrs) episode Prolonged (>=24 hrs) or consequences; evidence of
of ischemia managed recurring symptoms and/or end organ damage; urgent
medically and without invasive intervention operative intervention
permanent deficit indicated indicated Death

CTCAE v4.0 AE Term Definition
A disorder characterized by an reduction in the amount of hemoglobin in 100 ml

of blood. Signs and symptoms of anemia may include pallor of the skin and
mucous membranes, shortness of breath, palpitations of the heart, soft systolic
murmurs, lethargy, and fatigability.
A disorder characterized by the inability of the bone marrow to produce

hematopoietic elements.
A disorder characterized by systemic pathological activation of blood clotting

mechanisms which results in clot formation throughout the body. There is an
increase in the risk of hemorrhage as the body is depleted of platelets and
coagulation factors.
A disorder characterized by a decrease in neutrophils associated with fever.
A disorder characterized by laboratory test results that indicate widespread

erythrocyte cell membrane destruction.
A disorder characterized by a form of thrombotic microangiopathy with renal

failure, hemolytic anemia, and severe thrombocytopenia.
A disorder characterized by laboratory test results that indicate an increased

number of white blood cells in the blood.
A disorder characterized by a sensation of marked discomfort in a lymph node.
A disorder of the spleen.
A disorder characterized by the presence of microangiopathic hemolytic

anemia, thrombocytopenic purpura, fever, renal abnormalities and neurological
abnormalities such as seizures, hemiplegia, and visual disturbances. It is an
acute or subacute condition.
A disorder characterized by signs and symptoms related to acute ischemia of
the myocardium secondary to coronary artery disease. The clinical presentation
covers a spectrum of heart diseases from unstable angina to myocardial
infarction.
A disorder characterized by a defect in aortic valve function or structure.
A disorder characterized by a dysrhythmia without cardiac electrical activity.

Typically, this is accompanied by cessation of the pumping function of the heart.
A disorder characterized by a dysrhythmia without discernible P waves and an

irregular ventricular response due to multiple reentry circuits. The rhythm
disturbance originates above the ventricles.
A disorder characterized by a dysrhythmia with organized rhythmic atrial

contractions with a rate of 200-300 beats per minute. The rhythm disturbance
originates in the atria.
A disorder characterized by a dysrhythmia with complete failure of atrial

electrical impulse conduction through the AV node to the ventricles.
A disorder characterized by a dysrhythmia with a delay in the time required for
the conduction of an electrical impulse through the atrioventricular (AV) node
beyond 0.2 seconds; prolongation of the PR interval greater than 200
milliseconds.
A disorder characterized by cessation of the pumping function of the heart.
A disorder characterized by substernal discomfort due to insufficient myocardial

oxygenation.
A disorder characterized by pathological irregularities in the cardiac conduction

system.
A disorder characterized by a thickened and fibrotic pericardial sac; these

fibrotic changes impede normal myocardial function by restricting myocardial
muscle action.
A disorder characterized by the inability of the heart to pump blood at an

adequate volume to meet tissue metabolic requirements, or, the ability to do so
only at an elevation in the filling pressure.
A disorder characterized by failure of the left ventricle to produce adequate

output despite an increase in distending pressure and in end-diastolic volume.
Clinical manifestations may include dyspnea, orthopnea, and other signs and
symptoms of pulmonary congestion and edema.
A disorder characterized by a defect in mitral valve function or structure.
A disorder characterized by a dysrhythmia with relatively constant PR interval

prior to the block of an atrial impulse. This is the result of intermittent failure of
atrial electrical impulse conduction through the atrioventricular (AV) node to the
ventricles.
A disorder characterized by a dysrhythmia with a progressively lengthening PR

interval prior to the blocking of an atrial impulse. This is the result of intermittent
failure of atrial electrical impulse conduction through the atrioventricular (AV)
node to the ventricles.
A disorder characterized by gross necrosis of the myocardium; this is due to an
interruption of blood supply to the area.
A disorder characterized by inflammation of the muscle tissue of the heart.
A disorder characterized by an unpleasant sensation of irregular and/or forceful

beating of the heart.
A disorder characterized by a dysrhythmia with abrupt onset and sudden

termination of atrial contractions with a rate of 150-250 beats per minute. The
rhythm disturbance originates in the atria.
A disorder characterized by fluid collection within the pericardial sac, usually

due to inflammation.
A disorder characterized by an increase in intrapericardial pressure due to the

collection of blood or fluid in the pericardium.
A disorder characterized by irritation to the layers of the pericardium (the

protective sac around the heart).
A disorder characterized by a defect in pulmonary valve function or structure.
A disorder characterized by an inability of the ventricles to fill with blood

because the myocardium (heart muscle) stiffens and loses its flexibility.
A disorder characterized by impairment of right ventricular function associated

with low ejection fraction and a decrease in motility of the right ventricular wall.
A disorder characterized by a dysrhythmia with alternating periods of
bradycardia and atrial tachycardia accompanied by syncope, fatigue and
dizziness.
A disorder characterized by a dysrhythmia with a heart rate less than 60 beats

per minute that originates in the sinus node.
A disorder characterized by a dysrhythmia with a heart rate greater than 100

beats per minute that originates in the sinus node.

beats per minute that originates above the ventricles.
A disorder characterized by a defect in tricuspid valve function or structure.
A disorder characterized by a dysrhythmia that originates in the ventricles.
A disorder characterized by a dysrhythmia without discernible QRS complexes

due to rapid repetitive excitation of myocardial fibers without coordinated
contraction of the ventricles.

beats per minute that originates distal to the bundle of His.
A disorder characterized by the presence of an accessory conductive pathway

between the atria and the ventricles that causes premature ventricular
activation.
A disorder characterized by a sensation of marked discomfort in the ear.
A disorder characterized by inflammation, swelling and redness to the outer ear

and ear canal.
A disorder characterized by a sensation of marked discomfort in the external

ear region.
A disorder characterized by partial or complete loss of the ability to detect or
understand sounds resulting from damage to ear structures.
A disorder characterized by inflammation (physiologic response to irritation),

swelling and redness to the middle ear.
A disorder characterized by noise in the ears, such as ringing, buzzing, roaring

or clicking.
A disorder characterized by a sensation as if the external world were revolving

around the patient (objective vertigo) or as if he himself were revolving in space
(subjective vertigo).
A disorder characterized by dizziness, imbalance, nausea, and vision problems.

A disorder that occurs when the adrenal cortex does not produce enough of the
hormone cortisol and in some cases, the hormone aldosterone. It may be due to
a disorder of the adrenal cortex as in Addison's disease or primary adrenal
insufficiency.
A disorder characterized by signs and symptoms that resemble Cushing's

disease or syndrome: buffalo hump obesity, striations, adiposity, hypertension,
diabetes, and osteoporosis, usually due to exogenous corticosteroids.
A disorder characterized by unusually late sexual maturity.
A disorder characterized by greater growth than expected for age.
A disorder characterized by an increase in production of parathyroid hormone

by the parathyroid glands. This results in hypercalcemia (abnormally high levels
of calcium in the blood).
A disorder characterized by excessive levels of thyroid hormone in the body.

Common causes include an overactive thyroid gland or thyroid hormone
overdose.
A disorder characterized by a decrease in production of parathyroid hormone by

the parathyroid glands.
A disorder characterized by a decrease in production of thyroid hormone by the

thyroid gland.
A disorder characterized by unusually early development of secondary sexual
features; the onset of sexual maturation begins usually before age 8 for girls
and before age 9 for boys.
A disorder characterized by inappropriate masculinization occurring in a female

or prepubertal male.
A disorder characterized by visual perception of unclear or fuzzy images.
A disorder characterized by partial or complete opacity of the crystalline lens of

one or both eyes. This results in a decrease in visual acuity and eventual
blindness if untreated.
A disorder characterized by inflammation, swelling and redness to the

conjunctiva of the eye.
A disorder characterized by an area of epithelial tissue loss on the surface of

the cornea. It is associated with inflammatory cells in the cornea and anterior
chamber.
A disorder characterized by dryness of the cornea and conjunctiva.
A disorder characterized by incomplete paralysis of an extraocular muscle.

A disorder characterized by a sensation of marked discomfort in the eye.
A disorder characterized by impaired eyelid function.
A disorder characterized by a sudden or brief burst of light.
A disorder characterized by an individual seeing spots before their eyes. The

spots are shadows of opaque cell fragments in the vitreous humor or lens.
A disorder characterized by an increase in pressure in the eyeball due to

obstruction of the aqueous humor outflow.
A disorder characterized by inflammation to the cornea of the eye.
A disorder characterized by an inability to see clearly in dim light.
A disorder characterized by involvement of the optic nerve (second cranial

nerve).
A disorder characterized by swelling around the optic disc.
A disorder characterized by fear and avoidance of light.

A disorder characterized by the separation of the inner retina layers from the
underlying pigment epithelium.
A disorder characterized by a small laceration of the retina, this occurs when

the vitreous separates from the retina. Symptoms include flashes and floaters.
A disorder characterized by pathological retinal blood vessels that adversely

affects vision.
A disorder involving the retina.
A disorder characterized by involvement of the sclera of the eye.
A disorder characterized by inflammation to the uvea of the eye.
A disorder characterized by blood extravasation into the vitreous humor.

A disorder of excessive tearing in the eyes; it can be caused by overproduction
of tears or impaired drainage of the tear duct.
A disorder characterized by swelling of the abdomen.

A disorder characterized by a sensation of marked discomfort in the abdominal
region.
A disorder characterized by an abnormal communication between the opening

in the anal canal to the perianal skin.
A disorder characterized by bleeding from the anal region.
A disorder characterized by inflammation of the mucous membrane of the anus.
A disorder characterized by a necrotic process occurring in the anal region.
A disorder characterized by a sensation of marked discomfort in the anal region.
A disorder characterized by a narrowing of the lumen of the anal canal.
A disorder characterized by a circumscribed, inflammatory and necrotic erosive

lesion on the mucosal surface of the anal canal.
A disorder characterized by accumulation of serous or hemorrhagic fluid in the

peritoneal cavity.
A disorder characterized by subject-reported feeling of uncomfortable fullness of

the abdomen.
A disorder characterized by bleeding from the cecum.
A disorder characterized by inflammation of the lip.
A disorder characterized by inflammation of the colon.
A disorder characterized by an abnormal communication between the large

intestine and another organ or anatomic site.
A disorder characterized by bleeding from the colon.
A disorder characterized by blockage of the normal flow of the intestinal

contents in the colon.
A disorder characterized by a rupture in the colonic wall.
A disorder characterized by a narrowing of the lumen of the colon.

lesion on the mucosal surface of the colon.
A disorder characterized by irregular and infrequent or difficult evacuation of the
bowels.
A disorder characterized by the decay of a tooth, in which it becomes softened,

discolored and/or porous.
A disorder characterized by frequent and watery bowel movements.
A disorder characterized by reduced salivary flow in the oral cavity.
A disorder characterized by an abnormal communication between the

duodenum and another organ or anatomic site.
A disorder characterized by bleeding from the duodenum.
A disorder characterized by blockage of the normal flow of stomach contents

through the duodenum.
A disorder characterized by a rupture in the duodenal wall.
A disorder characterized by a narrowing of the lumen of the duodenum.

lesion on the mucosal surface of the duodenal wall.
A disorder characterized by an uncomfortable, often painful feeling in the

stomach, resulting from impaired digestion. Symptoms include burning stomach,
bloating, heartburn, nausea and vomiting.
A disorder characterized by difficulty in swallowing.
A disorder characterized by inflammation of the small and large intestines.
A disorder characterized by an abnormal communication between the urinary

bladder and the intestine.

esophagus and another organ or anatomic site.
A disorder characterized by bleeding from the esophagus.

A disorder characterized by a necrotic process occurring in the esophageal wall.
A disorder characterized by blockage of the normal flow of the contents in the

esophagus.
A disorder characterized by a sensation of marked discomfort in the esophageal

region.
A disorder characterized by a rupture in the wall of the esophagus.
A disorder characterized by a narrowing of the lumen of the esophagus.

lesion on the mucosal surface of the esophageal wall.
A disorder characterized by bleeding from esophageal varices.
A disorder characterized by inflammation of the esophageal wall.
A disorder characterized by inability to control the escape of stool from the

rectum.
A disorder characterized by a state of excessive gas in the alimentary canal.

A disorder characterized by an abnormal communication between the stomach
and another organ or anatomic site.
A disorder characterized by bleeding from the gastric wall.
A disorder characterized by a necrotic process occurring in the gastric wall.
A disorder characterized by a rupture in the stomach wall.
A disorder characterized by a narrowing of the lumen of the stomach.

lesion on the mucosal surface of the stomach.
A disorder characterized by inflammation of the stomach.
A disorder characterized by reflux of the gastric and/or duodenal contents into

the distal esophagus. It is chronic in nature and usually caused by
incompetence of the lower esophageal sphincter, and may result in injury to the
esophageal mucosal. Symptoms include heartburn and acid indigestion.
A disorder characterized by an abnormal communication between any part of

the gastrointestinal system and another organ or anatomic site.
A disorder characterized by a sensation of marked discomfort in the
gastrointestinal region.
A disorder characterized by an incomplete paralysis of the muscles of the

stomach wall resulting in delayed emptying of the gastric contents into the small
intestine.
A disorder characterized by a sensation of marked discomfort in the gingival

region.
A disorder characterized by bleeding from the hemorrhoids.
A disorder characterized by the presence of dilated veins in the rectum and

surrounding area.
A disorder characterized by an abnormal communication between the ileum and

another organ or anatomic site.
A disorder characterized by bleeding from the ileal wall.

contents in the ileum.
A disorder characterized by a rupture in the ileal wall.

A disorder characterized by a narrowing of the lumen of the ileum.

lesion on the mucosal surface of the ileum.
A disorder characterized by failure of the ileum to transport intestinal contents.
A disorder characterized by bleeding in the abdominal cavity.
A disorder characterized by an abnormal communication between the jejunum

A disorder characterized by bleeding from the jejunal wall.

contents in the jejunum.
A disorder characterized by a rupture in the jejunal wall.
A disorder characterized by a narrowing of the lumen of the jejunum.

lesion on the mucosal surface of the jejunum.
A disorder characterized by a sensation of marked discomfort of the lip.
A disorder characterized by bleeding from the lower gastrointestinal tract (small

intestine, large intestine, and anus).
A disorder characterized by inadequate absorption of nutrients in the small

intestine. Symptoms include abdominal marked discomfort, bloating and
diarrhea.
A disorder characterized by inflammation of the oral mucosal.
A disorder characterized by a queasy sensation and/or the urge to vomit.

stomach.
A disorder characterized by an abnormal communication between the oral

cavity and another organ or anatomic site.
A disorder characterized by a burning or tingling sensation on the lips, tongue or

entire mouth.
A disorder characterized by bleeding from the mouth.

A disorder characterized by a sensation of marked discomfort in the mouth,
tongue or lips.
A disorder characterized by a narrowing of the lumen of the pancreatic duct.
A disorder characterized by an abnormal communication between the pancreas

A disorder characterized by bleeding from the pancreas.
A disorder characterized by a necrotic process occurring in the pancreas.
A disorder characterized by inflammation of the pancreas.
A disorder in the gingival tissue around the teeth.
A disorder characterized by a necrotic process occurring in the peritoneum.
A disorder characterized by inflammation of the rectum.

A disorder characterized by an abnormal communication between the rectum
A disorder characterized by bleeding from the rectal wall and discharged from
the anus.
A disorder characterized by inflammation of the mucous membrane of the

rectum.
A disorder characterized by a necrotic process occurring in the rectal wall.

contents in the rectum.
A disorder characterized by a sensation of marked discomfort in the rectal

region.
A disorder characterized by a rupture in the rectal wall.
A disorder characterized by a narrowing of the lumen of the rectum.

lesion on the mucosal surface of the rectum.
A disorder characterized by bleeding from the retroperitoneal area.

A disorder characterized by inflammation of the salivary duct.
A disorder characterized by an abnormal communication between a salivary

gland and another organ or anatomic site.
A disorder characterized by inflammation of the mucous membrane of the small

intestine.

contents.
A disorder characterized by a rupture in the small intestine wall.
A disorder characterized by a narrowing of the lumen of the small intestine.

lesion on the mucosal surface of the small intestine.
A disorder characterized by a sensation of marked discomfort in the stomach.
A disorder characterized by a pathological process of the teeth occurring during

tooth development.
A disorder characterized by a change in tooth hue or tint.
A disorder characterized by a sensation of marked discomfort in the tooth.
A disorder characterized by inflammation of the cecum.
A disorder characterized by bleeding from the upper gastrointestinal tract (oral

cavity, pharynx, esophagus, and stomach).
A disorder characterized by the reflexive act of ejecting the contents of the

stomach through the mouth.
A disorder characterized by a sensation of cold that often marks a physiologic

response to sweating after a fever.
A disorder characterized by cessation of life occurring during the first 28 days of

life.
A cessation of life that cannot be attributed to a CTCAE term associated with

Grade 5.
A disorder characterized by swelling due to excessive fluid accumulation in

facial tissues.
A disorder characterized by swelling due to excessive fluid accumulation in the
upper or lower extremities.
A disorder characterized by swelling due to excessive fluid accumulation in the

trunk area.
A disorder characterized by a sensation of marked discomfort in the face.
A disorder characterized by a state of generalized weakness with a pronounced

inability to summon sufficient energy to accomplish daily activities.
A disorder characterized by elevation of the body's temperature above the

upper limit of normal.
A disorder characterized by a group of symptoms similar to those observed in

patients with the flu. It includes fever, chills, body aches, malaise, loss of
appetite and dry cough.
A disorder characterized by walking difficulties.
A disorder characterized by an abnormally low body temperature. Treatment is

required when the body temperature is 35C (95F) or below.
A disorder characterized by adverse reaction to the infusion of pharmacological

or biological substances.
A disorder characterized by leakage of a pharmacologic or a biologic substance

from the infusion site into the surrounding tissue. Signs and symptoms include
induration, erythema, swelling, burning sensation and marked discomfort at the
infusion site.
A disorder characterized by an intense adverse reaction (usually immunologic)

developing at the site of an injection.
A disorder characterized by an abnormal responsiveness to stimuli or

physiological arousal; may be in response to pain, fright, a drug, an emotional
situation or a medical condition.
A disorder characterized by swelling due to excessive fluid accumulation at a

specific anatomic site.
A disorder characterized by a feeling of general discomfort or uneasiness, an
out-of-sorts feeling.
A disorder characterized by progressive deterioration of the lungs, liver, kidney

and clotting mechanisms.
A disorder characterized by swelling due to an accumulation of excessive fluid

in the neck.
A disorder characterized by discomfort in the chest unrelated to a heart

disorder.
A disorder characterized by the sensation of marked discomfort, distress or

agony.
An unexpected cessation of life that cannot be attributed to a CTCAE term

associated with Grade 5.
A disorder characterized by a narrowing of the lumen of the bile duct.
A disorder characterized by an abnormal communication between the bile ducts

A disorder characterized by inflammation involving the gallbladder. It may be
associated with the presence of gallstones.

gallbladder and another organ or anatomic site.
A disorder characterized by a necrotic process occurring in the gallbladder.
A disorder characterized by blockage of the normal flow of the contents of the

gallbladder.
A disorder characterized by a sensation of marked discomfort in the gallbladder

region.
A disorder characterized by a rupture in the gallbladder wall.
A disorder characterized by the inability of the liver to metabolize chemicals in

the body. Laboratory test results reveal abnormal plasma levels of ammonia,
bilirubin, lactic dehydrogenase, and alkaline phosphatase.
A disorder characterized by bleeding from the liver.
A disorder characterized by a necrotic process occurring in the hepatic

parenchyma.
A disorder characterized by a sensation of marked discomfort in the liver region.
A disorder characterized by a rupture in the wall of the extrahepatic or

intrahepatic bile duct.
A disorder characterized by an increase in blood pressure in the portal venous
system.
A disorder characterized by the formation of a thrombus (blood clot) in the portal

vein.
A disorder characterized by an adverse local or general response from

exposure to an allergen.
A disorder characterized by an acute inflammatory reaction resulting from the

release of histamine and histamine-like substances from mast cells, causing a
hypersensitivity immune response. Clinically, it presents with breathing difficulty,
dizziness, hypotension, cyanosis and loss of consciousness and may lead to
death.
A disorder resulting from loss of function or tissue destruction of an organ or

multiple organs, arising from humoral or cellular immune responses of the
individual to his own tissue constituents.
A disorder characterized by nausea, headache, tachycardia, hypotension, rash,
and shortness of breath; it is caused by the release of cytokines from the cells.
A disorder characterized by a delayed-type hypersensitivity reaction to foreign

proteins derived from an animal serum. It occurs approximately six to twenty-
one days following the administration of the foreign antigen. Symptoms include
fever, arthralgias, myalgias, skin eruptions, lymphadenopathy, chest marked
discomfort and dyspnea.
A disorder characterized by an infectious process involving the abdominal

cavity.
A disorder characterized by an infectious process involving the anal area and

the rectum.
A disorder characterized by acute inflammation to the vermiform appendix

caused by a pathogenic agent.
A disorder characterized by acute inflammation to the vermiform appendix

caused by a pathogenic agent with gangrenous changes resulting in the rupture
of the appendiceal wall. The appendiceal wall rupture causes the release of
inflammatory and bacterial contents from the appendiceal lumen into the
abdominal cavity.
A disorder characterized by an infectious process involving an artery.
A disorder characterized by an infectious process involving the biliary tract.
A disorder characterized by an infectious process involving the bladder.
A disorder characterized by an infectious process involving the bones.
A disorder characterized by an infectious process involving the breast.
A disorder characterized by an infectious process involving the bronchi.
A disorder characterized by an infectious process that arises secondary to

catheter use.
A disorder characterized by an infectious process involving the cecum.

A disorder characterized by an infectious process involving the uterine cervix.
A disorder characterized by an infectious process involving the conjunctiva.

Clinical manifestations include pink or red color in the eyes.
A disorder characterized by an infectious process involving the cornea.
A disorder characterized by an infectious process involving a cranial nerve.
A disorder characterized by an infectious process involving the use of a medical

device.
A disorder characterized by an infectious process involving the duodenum.
A disorder characterized by an infectious process involving the brain tissue.
A disorder characterized by an infectious process involving the brain and spinal

cord tissues.
A disorder characterized by an infectious process involving the endocardial
layer of the heart.
A disorder characterized by an infectious process involving the internal
structures of the eye.
A disorder characterized by an infectious process involving the small and large

intestines.
A disorder characterized by an infectious process involving the esophagus.
A disorder characterized by an infectious process involving the eye.
A disorder characterized by an infectious process involving the gallbladder.
A disorder characterized by an infectious process involving the gums.
A disorder characterized by an infectious process involving the liver.

A disorder characterized by a viral pathologic process involving the liver
parenchyma.
A disorder characterized by an infectious process involving the skeletal

muscles.
A disorder characterized by an infectious process involving a joint.
A disorder characterized by an infectious process involving the kidney.
A disorder characterized by an inflammatory process involving the larynx.
A disorder characterized by an infectious process involving the lips.
A disorder characterized by an infectious process involving the lungs.

A disorder characterized by an infectious process involving the lymph nodes.
A disorder characterized by an infectious process involving the mediastinum.
A disorder characterized by acute inflammation of the meninges of the brain

and/or spinal cord.
A disorder characterized by an infectious process involving a mucosal surface.
A disorder characterized by an infectious process involving the nail.
A disorder characterized by an infectious process involving the outer ear and

ear canal. Contributory factors include excessive water exposure (swimmer's
ear infection) and cuts in the ear canal. Symptoms include fullness, itching,
swelling and marked discomfort in the ear and ear drainage.
A disorder characterized by an infectious process involving the middle ear.
A disorder characterized by an infectious process involving the ovary.

A disorder characterized by an infectious process involving the pancreas.
A disorder characterized by an eruption consisting of papules (a small, raised

pimple) and pustules (a small pus filled blister), typically appearing in face,
scalp, and upper chest and back Unlike acne, this rash does not present with
whiteheads or blackheads, and can be symptomatic, with itchy or tender
lesions.
A disorder characterized by an infectious process involving the soft tissues

around the nail.
A disorder characterized by an infectious process involving the pelvic cavity.
A disorder characterized by an infectious process involving the penis.

A disorder characterized by an infectious process involving the orbit of the eye.
A disorder characterized by an infectious process involving the peripheral

nerves.
A disorder characterized by an infectious process involving the peritoneum.
A disorder characterized by inflammation of the throat.
A disorder characterized by an infectious process involving the vein. Clinical

manifestations include erythema, marked discomfort, swelling, and induration
along the course of the infected vein.
A disorder characterized by an infectious process involving the pleura.
A disorder characterized by an infectious process involving the prostate gland.

A disorder characterized by a circumscribed and elevated skin lesion filled with
pus.
A disorder characterized by an infectious process involving the nasal mucosal.
A disorder characterized by an infectious process involving the salivary gland.
A disorder characterized by an infectious process involving the scrotum.
A disorder characterized by the presence of pathogenic microorganisms in the

blood stream that cause a rapidly progressing systemic reaction that may lead
to shock.
A disorder characterized by an infectious process involving the mucous

membranes of the paranasal sinuses.
A disorder characterized by an infectious process involving the skin.
A disorder characterized by an infectious process involving the small intestine.

A disorder characterized by an infectious process involving soft tissues.
A disorder characterized by an infectious process involving the spleen.
A disorder characterized by an infectious process involving a stoma (surgically

created opening on the surface of the body).
A disorder characterized by an infectious process involving a tooth.
A disorder characterized by an infectious process involving the trachea.
A disorder characterized by an infectious process involving the upper

respiratory tract (nose, paranasal sinuses, pharynx, larynx, or trachea).
A disorder characterized by an infectious process involving the urethra.
A disorder characterized by an infectious process involving the urinary tract,

most commonly the bladder and the urethra.
A disorder characterized by an infectious process involving the endometrium. It
may extend to the myometrium and parametrial tissues.
A disorder characterized by an infectious process involving the vagina.
A disorder characterized by an infectious process involving the vulva.
A disorder characterized by an infectious process involving the wound.
A finding of damage to the ankle joint characterized by a break in the continuity

of the ankle bone. Symptoms include marked discomfort, swelling and difficulty
moving the affected leg and foot.
A finding of damage to the aorta.

A finding of damage to an artery.
A finding of leakage of bile due to breakdown of a biliary anastomosis (surgical

connection of two separate anatomic structures).
A finding of leakage of urine due to breakdown of a bladder anastomosis

(surgical connection of two separate anatomic structures).
A finding of injury of the soft tissues or bone characterized by leakage of blood

into surrounding tissues.
A finding of impaired integrity to the anatomic site of an adverse thermal

reaction. Burns can be caused by exposure to chemicals, direct heat, electricity,
flames and radiation. The extent of damage depends on the length and intensity
of exposure and time until provision of treatment.
A finding of cutaneous inflammatory reaction occurring as a result of exposure

to biologically effective levels of ionizing radiation.
A finding of leakage due to breakdown of an esophageal anastomosis (surgical

A finding of sudden movement downward, usually resulting in injury.
A finding of leakage due to breakdown of a fallopian tube anastomosis (surgical

A finding of rupture of the fallopian tube wall.

A finding of traumatic injury to the bone in which the continuity of the bone is
broken.
A finding of leakage due to breakdown of a gastric anastomosis (surgical

A finding of leakage due to breakdown of a gastrointestinal anastomosis

A finding of a necrotic process occurring in the gastrointestinal tract stoma.
A finding of traumatic injury to the hip in which the continuity of either the
femoral head, femoral neck, intertrochanteric or subtrochanteric regions is
broken.
A finding of damage to the carotid artery.
A finding of damage to the inferior vena cava.
A finding of damage to the jugular vein.
A finding of damage to the superior vena cava.
A finding of leakage of contents from an intestinal stoma (surgically created

opening on the surface of the body).
A finding of blockage of the normal flow of the contents of the intestinal stoma.
A finding of blood leakage from the intestinal stoma.
A finding of damage to an artery during a surgical procedure.
A finding of damage to the breast parenchyma during a surgical procedure.
A finding of damage to the heart during a surgical procedure.
A finding of damage to the ear during a surgical procedure.
A finding of damage to the endocrine gland during a surgical procedure.
A finding of damage to the gastrointestinal system during a surgical procedure.
A finding of damage to the head and neck during a surgical procedure.
A finding of uncontrolled bleeding during a surgical procedure.
A finding of damage to the hepatic parenchyma and/or biliary tract during a

surgical procedure.
A finding of damage to the musculoskeletal system during a surgical procedure.
A finding of damage to the nervous system during a surgical procedure.
A finding of damage to the eye during a surgical procedure.
A finding of damage to the kidney during a surgical procedure.
A finding of damage to the reproductive organs during a surgical procedure.
A finding of damage to the respiratory system during a surgical procedure.
A finding of damage to the skin during a surgical procedure.
A finding of damage to the spleen during a surgical procedure.
A finding of damage to the urinary system during a surgical procedure.
A finding of damage to a vein during a surgical procedure.
A finding of leakage of urine due to breakdown of a kidney anastomosis

A finding of leakage due to breakdown of an anastomosis (surgical connection
of two separate anatomic structures) in the large intestine.
A finding of leakage due to breakdown of a pancreatic anastomosis (surgical

A finding of leakage due to breakdown of a pharyngeal anastomosis (surgical

A finding of bleeding occurring after a surgical procedure.
A finding of a previously undocumented problem that occurs after a thoracic

procedure.
A finding of protrusion of the intestinal stoma (surgically created opening on the

surface of the body) above the abdominal surface.
A finding of displacement of the urostomy.
A finding of acute skin inflammatory reaction caused by drugs, especially

chemotherapeutic agents, for weeks or months following radiotherapy. The
inflammatory reaction is confined to the previously irradiated skin and the
symptoms disappear after the removal of the pharmaceutical agent.
A finding of leakage due to breakdown of a rectal anastomosis (surgical
A finding of tumor-like collection of serum in the tissues.
A finding of leakage due to breakdown of an anastomosis (surgical connection

of two separate anatomic structures) in the small bowel.
A finding of leakage due to breakdown of a spermatic cord anastomosis

A finding of traumatic injury to the spine in which the continuity of a vertebral

bone is broken.
A finding of narrowing of the gastrointestinal stoma (surgically created opening

on the surface of the body).

lesion on the jejunal mucosal surface close to the anastomosis site following a
gastroenterostomy procedure.
A finding of bleeding from the trachea.
A finding of blockage of the lumen of the trachea.

A finding of blood leakage from the tracheostomy site.
A finding of leakage due to breakdown of a ureteral anastomosis (surgical

A finding of leakage due to breakdown of a urethral anastomosis (surgical

A finding of leakage of contents from a urostomy.
A finding of blockage of the urostomy.
A finding of bleeding from the urostomy site.
A finding of narrowing of the opening of a urostomy.
A finding of leakage due to breakdown of a uterine anastomosis (surgical

A disorder characterized by a rupture in the uterine wall.
A finding of leakage due to breakdown of a vaginal anastomosis (surgical

A finding of leakage due to breakdown of a vas deferens anastomosis (surgical
A finding of a previously undocumented problem related to the vascular access

site.
A finding of damage to a vein.
A finding of development of a new problem at the site of an existing wound.
A finding of separation of the approximated margins of a surgical wound.
A finding of traumatic injury to the wrist joint in which the continuity of a wrist
bone is broken.
An abnormal laboratory test result in which the partial thromboplastin time is
found to be greater than the control value. As a possible indicator of
coagulopathy, a prolonged partial thromboplastin time (PTT) may occur in a
variety of diseases and disorders, both primary and related to treatment.
A finding based on laboratory test results that indicate an increase in the level of
alanine aminotransferase (ALT or SGPT) in the blood specimen.
alkaline phosphatase in a blood specimen.
aspartate aminotransferase (AST or SGOT) in a blood specimen.
A finding based on laboratory test results that indicate abnormal levels of

antidiuretic hormone in the blood specimen.
A finding based on laboratory test results that indicate an abnormally high level
of bilirubin in the blood. Excess bilirubin is associated with jaundice.
A finding based on laboratory test results that indicate an decrease in levels of

corticotrophin in a blood specimen.

gonadotrophin hormone in a blood specimen.

prolactin hormone in a blood specimen.
A finding based on lung function test results that indicate a decrease in the
lung capacity to absorb carbon monoxide.
A laboratory test result which indicates increased levels of cardiac troponin I in

a biological specimen.
A laboratory test result which indicates increased levels of cardiac troponin T in

a biological specimen.
CD4 lymphocytes in a blood specimen.
A finding based on laboratory test results that indicate higher than normal levels
of cholesterol in a blood specimen.
A finding based on laboratory test results that indicate an increase in levels of
creatine phosphokinase in a blood specimen.
A finding based on laboratory test results that indicate increased levels of
creatinine in a biological specimen.
The percentage computed when the amount of blood ejected during a

ventricular contraction of the heart is compared to the amount that was present
prior to the contraction.
A finding of a cardiac dysrhythmia characterized by an abnormally long

corrected QT interval.

fibrinogen in a blood specimen.
A finding based on test results that indicate a relative decrease in the fraction of
the forced vital capacity that is exhaled in a specific number of seconds.
A finding based on laboratory test results that indicate higher than normal levels
of the enzyme gamma-glutamyltransferase in the blood specimen. GGT
(gamma-glutamyltransferase ) catalyzes the transfer of a gamma glutamyl
group from a gamma glutamyl peptide to another peptide, amino acids or water.

growth hormone in a biological specimen.
haptoglobin in a blood specimen.
A finding based on laboratory test results that indicate increased levels of

hemoglobin in a biological specimen.
A finding based on laboratory test results that indicate an increase in the ratio of
the patient's prothrombin time to a control sample in the blood.
lipase in a biological specimen.
A finding based on laboratory test results that indicate a decrease in number of
lymphocytes in a blood specimen.
A finding based on laboratory test results that indicate an abnormal increase in

the number of lymphocytes in the blood, effusions or bone marrow.
neutrophils in a blood specimen.

pancreatic enzymes in a biological specimen.

platelets in a blood specimen.
A finding based on laboratory test results that indicate an increase in the levels
of amylase in a serum specimen.
A finding based on test results that indicate urine production is less relative to
previous output.
A finding based on pulmonary function test results that indicate an abnormal

vital capacity (amount of exhaled after a maximum inhalation) when compared
to the predicted value.
A finding characterized by an increase in overall body weight; for pediatrics,

greater than the baseline growth curve.
A finding characterized by a decrease in overall body weight; for pediatrics, less
than the baseline growth curve.
A finding based on laboratory test results that indicate an decrease in number of
white blood cells in a blood specimen.
A disorder characterized by abnormally high acidity (high hydrogen-ion

concentration) of the blood and other body tissues.
A disorder characterized by an increase in sensitivity to the adverse effects of

alcohol, which can include nasal congestion, skin flushes, heart dysrhythmias,
nausea, vomiting, indigestion and headaches.
A disorder characterized by abnormally high alkalinity (low hydrogen-ion
concentration) of the blood and other body tissues.
A disorder characterized by a loss of appetite.
A disorder characterized by excessive loss of water from the body. It is usually

caused by severe diarrhea, vomiting or diaphoresis.
A disorder characterized by an inability to properly metabolize glucose.
A disorder characterized by laboratory test results that indicate an elevation in

the concentration of calcium in blood.

the concentration of blood sugar. It is usually an indication of diabetes mellitus
or glucose intolerance.
the concentration of potassium in the blood; associated with kidney failure or
sometimes with the use of diuretic drugs.

the concentration of magnesium in the blood.

the concentration of sodium in the blood.

the concentration of triglyceride concentration in the blood.

the concentration of uric acid.
A disorder characterized by laboratory test results that indicate a low

concentration of albumin in the blood.

concentration of calcium in the blood.

concentration of glucose in the blood.

concentration of potassium in the blood.

concentration of magnesium in the blood.

concentration of sodium in the blood.

concentration of phosphates in the blood.
A disorder characterized by accumulation of iron in the tissues.
A disorder characterized by having a high amount of body fat.
A disorder characterized by metabolic abnormalities that result from a

spontaneous or therapy-related cytolysis of tumor cells.
A disorder characterized by a necrotic process occurring in the soft tissues of

the abdominal wall.
A disorder characterized by a sensation of marked discomfort in a joint.
A disorder characterized by inflammation involving a joint.
A disorder characterized by necrotic changes in the bone tissue due to

interruption of blood supply. Most often affecting the epiphysis of the long
bones, the necrotic changes result in the collapse and the destruction of the
bone structure.
A disorder characterized by marked discomfort sensation in the back region.
A disorder characterized by marked discomfort sensation in the bones.
A disorder characterized by marked discomfort sensation in the buttocks.

A disorder characterized by marked discomfort sensation in the chest wall
region.
A disorder characterized by non-neoplastic overgrowth of bone.
A disorder characterized by fibrotic degeneration of the deep connective

tissues.
A disorder characterized by marked discomfort sensation on the lateral side of

the body in the region below the ribs and above the hip.
A disorder characterized by a reduction in the strength of muscles in multiple

anatomic sites.
A disorder characterized by of stature that is smaller than normal as expected

for age.

the head.
A disorder characterized by excessive fluid in a joint, usually as a result of joint

inflammation.
A disorder characterized by a decrease in joint flexibility of any joint.
A disorder characterized by a decrease in flexibility of a cervical spine joint.

A disorder characterized by a decrease in flexibility of a lumbar spine joint.
A disorder characterized by an abnormal increase in the curvature of the

thoracic portion of the spine.
A disorder characterized by an abnormal increase in the curvature of the lumbar

portion of the spine.
A disorder characterized by a reduction in the strength of the muscles on the left

side of the body.
A disorder characterized by a reduction in the strength of the lower limb

muscles.
A disorder characterized by a reduction in the strength of the muscles on the

right side of the body.
A disorder characterized by a reduction in the strength of the trunk muscles.
A disorder characterized by a reduction in the strength of the upper limb

muscles.
A disorder characterized by of a malformation of the musculoskeletal system.
A disorder characterized by marked discomfort sensation originating from a

muscle or group of muscles.
A disorder characterized by inflammation involving the skeletal muscles.
A disorder characterized by marked discomfort sensation in the neck area.

the neck.
A disorder characterized by a necrotic process occurring in the bone of the

mandible.
A disorder characterized by reduced bone mass, with a decrease in cortical

thickness and in the number and size of the trabeculae of cancellous bone (but
normal chemical composition), resulting in increased fracture incidence.
A disorder characterized by marked discomfort sensation in the upper or lower

extremities.

the pelvis.
A disorder characterized by a malformed, lateral curvature of the spine.

the lower extremity.
the upper extremity.
A disorder characterized by fibrotic degeneration of the superficial soft tissues.
A disorder characterized by lack of ability to open the mouth fully due to a

decrease in the range of motion of the muscles of mastication.
A disorder characterized by of a discrepancy between the lengths of the lower

or upper extremities.
A disorder characterized by leukemia arising as a result of the mutagenic effect

of chemotherapy agents.
A disorder characterized by insufficiently healthy hematapoietic cell production

by the bone marrow.
A disorder characterized by development of a malignancy most probably as a

result of treatment for a previously existing malignancy.
A disorder characterized by marked discomfort from a neoplasm that may be

pressing on a nerve, blocking blood vessels, inflamed or fractured from
metastasis.
-
A disorder characterized by involvement of the abducens nerve (sixth cranial

nerve).
A disorder characterized by involvement of the accessory nerve (eleventh

cranial nerve).
A disorder characterized by involvement of the acoustic nerve (eighth cranial

nerve).
A disorder characterized by an uncomfortable feeling of inner restlessness and

inability to stay still; this is a side effect of some psychotropic drugs.
A disorder characterized by systematic and extensive loss of memory.

A disorder characterized by the inability to speak. It may result from injuries to
the vocal cords or may be functional (psychogenic).
A disorder characterized by inflammation of the arachnoid membrane and

adjacent subarachnoid space.
A disorder characterized by lack of coordination of muscle movements resulting

in the impairment or inability to perform voluntary activities.
A disorder characterized by regional paresthesia of the brachial plexus, marked

discomfort and muscle weakness, and limited movement in the arm or hand.
A disorder characterized by a necrotic process occurring in the brain and/or
spinal cord.
A disorder characterized by loss of cerebrospinal fluid into the surrounding

tissues.
A disorder characterized by a conspicuous change in cognitive function.
A disorder characterized by a deterioration in the ability to concentrate.
A disorder characterized by a decrease in ability to perceive and respond.
A disorder characterized by a disturbing sensation of lightheadedness,

unsteadiness, giddiness, spinning or rocking.
A disorder characterized by slow and slurred speech resulting from an inability

to coordinate the muscles used in speech.
A disorder characterized by distortion of sensory perception, resulting in an

abnormal and unpleasant sensation.
A disorder characterized by abnormal sensual experience with the taste of
foodstuffs; it can be related to a decrease in the sense of smell.
A disorder characterized by impairment of verbal communication skills, often

resulting from brain damage.
A disorder characterized by swelling due to an excessive accumulation of fluid

in the brain.
A disorder characterized by a pathologic process involving the brain.
A disorder characterized by abnormal, repetitive, involuntary muscle

movements, frenzied speech and extreme restlessness.
A disorder characterized by a reduction in the strength of the facial muscles.
A disorder characterized by involvement of the facial nerve (seventh cranial

nerve).
A disorder characterized by involvement of the glossopharyngeal nerve (ninth

cranial nerve).
A disorder characterized by a sensation of marked discomfort in various parts of

the head, not confined to the area of distribution of any nerve.
A disorder characterized by an abnormal increase of cerebrospinal fluid in the

ventricles of the brain.
A disorder characterized by characterized by excessive sleepiness during the
daytime.
A disorder characterized by involvement of the hypoglossal nerve (twelfth
cranial nerve).
A disorder characterized by bleeding from the cranium.
A disorder characterized by a decrease or absence of blood supply to the brain

caused by obstruction (thrombosis or embolism) of an artery resulting in
neurological damage.
A disorder characterized by involvement of the trochlear nerve (fourth cranial

nerve).
A disorder characterized by a decrease in consciousness characterized by

mental and physical inertness.
A disorder characterized by diffuse reactive astrocytosis with multiple areas of

necrotic foci without inflammation.
A disorder characterized by a deterioration in memory function.
A disorder characterized by neck stiffness, headache, and photophobia

resulting from irritation of the cerebral meninges.
A disorder characterized by uncontrolled and purposeless movements.

A disorder characterized by inflammation involving the spinal cord. Symptoms
include weakness, paresthesia, sensory loss, marked discomfort and
incontinence.
A disorder characterized by intense painful sensation along a nerve or group of

nerves.
A disorder characterized by involuntary movements of the eyeballs.
A disorder characterized by involvement of the oculomotor nerve (third cranial

nerve).
A disorder characterized by involvement of the olfactory nerve (first cranial

nerve).
A disorder characterized by functional disturbances of sensory neurons

resulting in abnormal cutaneous sensations of tingling, numbness, pressure,
cold, and warmth that are experienced in the absence of a stimulus.
A disorder characterized by inflammation or degeneration of the peripheral

motor nerves.
A disorder characterized by inflammation or degeneration of the peripheral

sensory nerves.
A disorder characterized by marked discomfort related to a limb or an organ that

is removed from or is not physically part of the body.
A disorder characterized by an episode of lightheadedness and dizziness which
may precede an episode of syncope.
A disorder characterized by dysfunction of the corticospinal (pyramidal) tracts of

the spinal cord. Symptoms include an increase in the muscle tone in the lower
extremities, hyperreflexia, positive Babinski and a decrease in fine motor
coordination.
A disorder characterized by inflammation involving a nerve root. Patients

experience marked discomfort radiating along a nerve path because of spinal
pressure on the connecting nerve root.
A disorder characterized by paralysis of the recurrent laryngeal nerve.

A disorder characterized by headaches, mental status changes, visual
disturbances, and seizures associated with imaging findings of posterior
leukoencephalopathy. It has been observed in association with hypertensive
encephalopathy, eclampsia, and immunosuppressive and cytotoxic drug
treatment. It is an acute or subacute reversible condition.
A disorder characterized by a sudden, involuntary skeletal muscular

contractions of cerebral or brain stem origin.
A disorder characterized by marked discomfort in the face, between the eyes, or

upper teeth originating from the sinuses.
A disorder characterized by characterized by excessive sleepiness and

drowsiness.
A disorder characterized by increased involuntary muscle tone that affects the

regions interfering with voluntary movement. It results in gait, movement, and
speech disturbances.
A disorder characterized by a sudden loss of sensory function due to an

intracranial vascular event.
A disorder characterized by spontaneous loss of consciousness caused by
insufficient blood supply to the brain.
A disorder characterized by a brief attack (less than 24 hours) of cerebral

dysfunction of vascular origin, with no persistent neurological deficit.
A disorder characterized by the uncontrolled shaking movement of the whole

body or individual parts.
A disorder characterized by involvement of the trigeminal nerve (fifth cranial

nerve).
A disorder characterized by involvement of the vagus nerve (tenth cranial

nerve).
A disorder characterized by a sudden drop of the blood pressure, bradycardia,

and peripheral vasodilation that may lead to loss of consciousness. It results
from an increase in the stimulation of the vagus nerve.
-
A disorder characterized by death in utero; failure of the product of conception

to show evidence of respiration, heartbeat, or definite movement of a voluntary
muscle after expulsion from the uterus, without possibility of resuscitation.
A disorder characterized by inhibition of fetal growth resulting in the inability of

the fetus to achieve its potential weight.
A disorder characterized by delivery of a viable infant before the normal end of

gestation. Typically, viability is achievable between the twentieth and thirty-
seventh week of gestation.
A disorder characterized by an unexpected pregnancy at the time of conception.
A disorder characterized by a state of restlessness associated with unpleasant

feelings of irritability and tension.
A disorder characterized by an inability to achieve orgasm.
A disorder characterized by apprehension of danger and dread accompanied by

restlessness, tension, tachycardia, and dyspnea unattached to a clearly
identifiable stimulus.
A disorder characterized by a lack of clear and orderly thought and behavior.

A disorder characterized by sexual dysfunction characterized by a delay in
climax.
A disorder characterized by the acute and sudden development of confusion,

illusions, movement changes, inattentiveness, agitation, and hallucinations.
Usually, it is a reversible condition.
A disorder characterized by false personal beliefs held contrary to reality,

despite contradictory evidence and common sense.
A disorder characterized by melancholic feelings of grief or unhappiness.

A disorder characterized by an exaggerated feeling of well-being which is
disproportionate to events and stimuli.
A disorder characterized by a false sensory perception in the absence of an

external stimulus.
A disorder characterized by difficulty in falling asleep and/or remaining asleep.
A disorder characterized by a decrease in sexual desire.
A disorder characterized by an increase in sexual desire.
A disorder characterized by excitement of psychotic proportions manifested by

mental and physical hyperactivity, disorganization of behavior and elevation of
mood.
A disorder characterized by a conspicuous change in a person's behavior and
thinking.
A disorder characterized by personality change, impaired functioning, and loss

of touch with reality. It may be a manifestation of schizophrenia, bipolar disorder
or brain tumor.
A disorder characterized by an inability to rest, relax or be still.
A disorder characterized by thoughts of taking one's own life.
A disorder characterized by self-inflicted harm in an attempt to end one's own

life.
A disorder characterized by the acute loss of renal function and is traditionally

classified as pre-renal (low blood flow into kidney), renal (kidney damage) and
post-renal causes (ureteral or bladder outflow obstruction).
A disorder characterized by a rupture in the bladder wall.

A disorder characterized by a sudden and involuntary contraction of the bladder
wall.
A disorder characterized by gradual and usually permanent loss of kidney

function resulting in renal failure.
A disorder characterized by inflammation of the bladder which is not caused by
an infection of the urinary tract.
A disorder characterized by laboratory test results that indicate blood in the

urine.
A disorder characterized by laboratory test results that indicate the presence of

free hemoglobin in the urine.
A disorder characterized by laboratory test results that indicate the presence of

excessive protein in the urine. It is predominantly albumin, but also globulin.
A disorder characterized by the formation of crystals in the pelvis of the kidney.
A disorder characterized by paroxysmal and severe flank marked discomfort

radiating to the inguinal area. Often, the cause is the passage of kidney stones.
A disorder characterized by bleeding from the kidney.

A disorder characterized by an abnormal communication between any part of
the urinary system and another organ or anatomic site.
A disorder characterized by urination at short intervals.
A disorder characterized by inability to control the flow of urine from the bladder.
A disorder characterized by accumulation of urine within the bladder because of

the inability to urinate.
A disorder characterized by blockage of the normal flow of contents of the

urinary tract.
A disorder characterized by a sensation of marked discomfort in the urinary

tract.
A disorder characterized by a sudden compelling urge to urinate.
A disorder characterized by a change in the color of the urine.

A disorder characterized by laboratory test results that indicate complete
absence of spermatozoa in the semen.
A disorder characterized by underdevelopment of the breast.
A disorder characterized by marked discomfort sensation in the breast region.
A disorder characterized by abnormally painful abdominal cramps during

menses.
A disorder characterized by painful or difficult coitus.
A disorder characterized by problems related to ejaculation. This category

includes premature, delayed, retrograde and painful ejaculation.
A disorder characterized by the persistent or recurrent inability to achieve or to

maintain an erection during sexual activity.

fallopian tube.
A disorder characterized by a narrowing of the fallopian tube lumen.
A disorder characterized by an abnormal communication between a female

reproductive system organ and another organ or anatomic site.
A disorder characterized by the development of secondary female sex
characteristics in males due to extrinsic factors.

in the genitals.
A disorder characterized by excessive development of the breasts in males.
A disorder characterized by the presence of blood in a fallopian tube.
A disorder characterized by irregular cycle or duration of menses.
A disorder characterized by disturbances of milk secretion. It is not necessarily

related to pregnancy that is observed in females and can be observed in males.
A disorder characterized by abnormally heavy vaginal bleeding during menses.
A disorder characterized by a malformation of the nipple.
A disorder characterized by a decrease in the number of spermatozoa in the

semen.
A disorder characterized by bleeding from the ovary.
A disorder characterized by tearing or disruption of the ovarian tissue.
A disorder characterized by marked discomfort sensation in one side of the

abdomen between menstrual cycles, around the time of the discharge of the
ovum from the ovarian follicle.
A disorder characterized by a reduction in the strength of the muscles of the

pelvic floor.
A disorder characterized by marked discomfort sensation in the pelvis.
A disorder characterized by marked discomfort sensation in the penis.
A disorder characterized by a sensation of marked discomfort in the area

between the genital organs and the anus.
A disorder characterized by ovarian failure before the age of 40. Symptoms

include hot flashes, night sweats, mood swings and a decrease in sex drive.
A disorder characterized by bleeding from the prostate gland.
A disorder characterized by compression of the urethra secondary to

enlargement of the prostate gland. This results in voiding difficulties (straining to
void, slow urine stream, and incomplete emptying of the bladder).
A disorder characterized by a sensation of marked discomfort in the prostate

gland.
A disorder characterized by marked discomfort sensation in the scrotal area.

A disorder characterized by bleeding from the spermatic cord.
A disorder characterized by blockage of the normal flow of the contents of the

spermatic cord.
A disorder characterized by involvement of the testis.
A disorder characterized by bleeding from the testis.
A disorder characterized by a sensation of marked discomfort in the testis.
A disorder characterized by an abnormal communication between the uterus

A disorder characterized by bleeding from the uterus.
A disorder characterized by blockage of the uterine outlet.
A disorder characterized by a sensation of marked discomfort in the uterus.
A disorder characterized by vaginal secretions. Mucus produced by the cervical

glands is discharged from the vagina naturally, especially during the
childbearing years.
A disorder characterized by an uncomfortable feeling of itching and burning in

the vagina.
A disorder characterized by an abnormal communication between the vagina
A disorder characterized by bleeding from the vagina.
A disorder characterized by inflammation involving the vagina. Symptoms may

include redness, edema, marked discomfort and an increase in vaginal
discharge.
A disorder characterized by blockage of vaginal canal.
A disorder characterized by a sensation of marked discomfort in the vagina.
A disorder characterized by a rupture in the vaginal wall.
A disorder characterized by a narrowing of the vaginal canal.
A disorder characterized by involuntary spasms of the pelvic floor muscles,

resulting in pathologic tightness of the vaginal wall during penetration such as
during sexual intercourse.
-
A disorder characterized by progressive and life-threatening pulmonary distress
in the absence of an underlying pulmonary condition, usually following major
trauma or surgery.
A disorder characterized by an inflammation of the nasal mucous membranes

caused by an IgE-mediated response to external allergens. The inflammation
may also involve the mucous membranes of the sinuses, eyes, middle ear, and
pharynx. Symptoms include sneezing, nasal congestion, rhinorrhea and itching.
A disorder characterized by cessation of breathing.
A disorder characterized by inhalation of solids or liquids into the lungs.
A disorder characterized by the collapse of part or the entire lung.
A disorder characterized by an abnormal communication between the bronchus

A disorder characterized by blockage of a bronchus passage, most often by
bronchial secretions and exudates.
A disorder characterized by a narrowing of the bronchial tube.
A disorder characterized by an abnormal communication between a bronchus

and the pleural cavity.
A disorder characterized by bleeding from the bronchial wall and/or lung

parenchyma.
A disorder characterized by a sudden contraction of the smooth muscles of the

bronchial wall.
A disorder characterized by milky pleural effusion (abnormal collection of fluid)
resulting from accumulation of lymph fluid in the pleural cavity.
A disorder characterized by sudden, often repetitive, spasmodic contraction of

the thoracic cavity, resulting in violent release of air from the lungs and usually
accompanied by a distinctive sound.
A disorder characterized by an uncomfortable sensation of difficulty breathing.
A disorder characterized by bleeding from the nose.
A disorder characterized by repeated gulp sounds that result from an

involuntary opening and closing of the glottis. This is attributed to a spasm of
the diaphragm.
A disorder characterized by harsh and raspy voice arising from or spreading to

the larynx.
A disorder characterized by a decrease in the level of oxygen in the body.

in the larynx.
A disorder characterized by an abnormal communication between the larynx
A disorder characterized by bleeding from the larynx.
A disorder characterized by an inflammation involving the larynx.
A disorder characterized by an inflammation involving the mucous membrane of

the larynx.
A disorder characterized by blockage of the laryngeal airway.
A disorder characterized by a narrowing of the laryngeal airway.

A disorder characterized by an uncomfortable persistent sensation in the area
of the laryngopharynx.
A disorder characterized by paroxysmal spasmodic muscular contraction of the

vocal cords.
A disorder characterized by bleeding from the mediastinum.
A disorder characterized by obstruction of the nasal passage due to mucosal

edema.
A disorder characterized by an abnormal communication between the pharynx

A disorder characterized by bleeding from the pharynx.

the pharynx.
A disorder characterized by a necrotic process occurring in the pharynx.
A disorder characterized by a narrowing of the pharyngeal airway.
A disorder characterized by marked discomfort sensation in the

pharyngolaryngeal region.
A disorder characterized by an increase in amounts of fluid within the pleural

cavity. Symptoms include shortness of breath, cough and marked chest
discomfort.
A disorder characterized by bleeding from the pleural cavity.
A disorder characterized by marked discomfort sensation in the pleura.
A disorder characterized by inflammation focally or diffusely affecting the lung

parenchyma.
A disorder characterized by abnormal presence of air in the pleural cavity

resulting in the collapse of the lung.
A disorder characterized by excessive mucous secretion in the back of the
nasal cavity or throat, causing sore throat and/or coughing.
A disorder characterized by expectorated secretions upon coughing.
A disorder characterized by accumulation of fluid in the lung tissues that causes

a disturbance of the gas exchange that may lead to respiratory failure.
A disorder characterized by the replacement of the lung tissue by connective

tissue, leading to progressive dyspnea, respiratory failure or right heart failure.
A disorder characterized by an abnormal communication between the lung and

another organ or anatomic site.
A disorder characterized by an increase in pressure within the pulmonary

circulation due to lung or heart disorder.
A disorder characterized by impaired gas exchange by the respiratory system

resulting in hypoxemia and a decrease in oxygenation of the tissues that may
be associated with an increase in arterial levels of carbon dioxide.
A disorder characterized by weight gain, dyspnea, pleural and pericardial

effusions, leukocytosis and/or renal failure originally described in patients
treated with all-trans retinoic acid.
A disorder characterized by involvement of the paranasal sinuses.
A disorder characterized by cessation of breathing for short periods during

sleep.
A disorder characterized by the involuntary expulsion of air from the nose.
A disorder characterized by of marked discomfort in the throat
A disorder characterized by a high pitched breathing sound due to laryngeal or

upper airway obstruction.
A disorder characterized by an abnormal communication between the trachea


the trachea.
A disorder characterized by a narrowing of the trachea.

A disorder characterized by a change in the sound and/or speed of the voice.
A disorder characterized by a high-pitched, whistling sound during breathing. It

results from the narrowing or obstruction of the respiratory airways.
A disorder characterized by a decrease in density of hair compared to normal

for a given individual at a given age and body location.
A disorder characterized by an abnormal body smell resulting from the growth of

bacteria on the body.
A disorder characterized by inflammation of the skin characterized by the

presence of bullae which are filled with fluid.
A disorder characterized by flaky and dull skin; the pores are generally fine, the
texture is a papery thin texture.
A disorder characterized by target lesions (a pink-red ring around a pale center).
A disorder characterized by generalized inflammatory erythema and exfoliation.

The inflammatory process involves > 90% of the body surface area.
A disorder characterized by shrinking of adipose tissue.
A disorder characterized by the presence of excess hair growth in women in

anatomic sites where growth is considered to be a secondary male
characteristic and under androgen control (beard, moustache, chest, abdomen).
A disorder characterized by excessive perspiration.

A disorder characterized by hair density or length beyond the accepted limits of
normal in a particular body region, for a particular age or race.
A disorder characterized by reduced sweating.
A disorder characterized by hypertrophy of the subcutaneous adipose tissue at

the site of multiple subcutaneous injections of insulin.
A disorder characterized by a change in the color of the nail plate.
A disorder characterized by loss of all or a portion of the nail.
A disorder characterized by vertical or horizontal ridges on the nails.
A disorder characterized by marked discomfort sensation in the skin.

A disorder characterized by redness, marked discomfort, swelling, and tingling
in the palms of the hands or the soles of the feet.

around the orbits of the face.
A disorder characterized by an increase in sensitivity of the skin to light.
A disorder characterized by an intense itching sensation.
A disorder characterized by hemorrhagic areas of the skin and mucous

membrane. Newer lesions appear reddish in color. Older lesions are usually a
darker purple color and eventually become a brownish-yellow color.
A disorder characterized by an eruption of papules and pustules, typically
appearing in face, scalp, upper chest and back.
A disorder characterized by the presence of macules (flat) and papules

(elevated). Also known as morbillform rash, it is one of the most common
cutaneous adverse events, frequently affecting the upper trunk, spreading
centripetally and associated with pruritis.
A disorder characterized by marked discomfort sensation in the skin covering

the top and the back of the head.
A disorder characterized by the degeneration and thinning of the epidermis and

dermis.
A disorder characterized by darkening of the skin due to excessive melanin

deposition.
A disorder characterized by loss of skin pigment.
A disorder characterized by an area of hardness in the skin.

A disorder characterized by circumscribed, inflammatory and necrotic erosive
lesion on the skin.
A disorder characterized by less than 10% total body skin area separation of
dermis. The syndrome is thought to be a hypersensitivity complex affecting the
skin and the mucous membranes.
A disorder characterized by local dilatation of small vessels resulting in red

discoloration of the skin or mucous membranes.
A disorder characterized by greater than 30% total body skin area separation of
dermis. The syndrome is thought to be a hypersensitivity complex affecting the
skin and the mucous membranes.
A disorder characterized by an itchy skin eruption characterized by wheals with

pale interiors and well-defined red margins.
A disorder characterized by the permanent cessation of menses, usually

defined by 12 consecutive months of amenorrhea in a woman over 45 years of
age.
-
A disorder characterized by leakage of intravascular fluids into the extravascular

space. This syndrome is observed in patients who demonstrate a state of
generalized leaky capillaries following shock syndromes, low-flow states,
ischemia-reperfusion injuries, toxemias, medications, or poisoning. It can lead
to generalized edema and multiple organ failure.
A disorder characterized by episodic reddening of the face.
A disorder characterized by a localized collection of blood, usually clotted, in an

organ, space, or tissue, due to a break in the wall of a blood vessel.
A disorder characterized by an uncomfortable and temporary sensation of

intense body warmth, flushing, sometimes accompanied by sweating upon
cooling.
A disorder characterized by a pathological increase in blood pressure; a
repeatedly elevation in the blood pressure exceeding 140 over 90 mm Hg.
A disorder characterized by a blood pressure that is below the normal expected

for an individual in a given environment.
A disorder characterized by the loss of lymph fluid into the surrounding tissue or
body cavity.
A disorder characterized by excessive fluid collection in tissues that causes

swelling.
A disorder characterized by a cystic lesion containing lymph.
A disorder characterized by impaired circulation to an extremity.

A disorder characterized by inflammation of the wall of a vein.
A disorder characterized by a blood clot and inflammation involving a superficial
vein of the extremities.
A disorder characterized by obstruction of the blood flow in the superior vena
cava. Signs and symptoms include swelling and cyanosis of the face, neck, and
upper arms, cough, orthopnea and headache.
A disorder characterized by occlusion of a vessel by a thrombus that has

migrated from a distal site via the blood stream.
A disorder characterized by inflammation involving the wall of a vessel.
A disorder characterized by a decrease in blood supply due to narrowing or

blockage of a visceral (mesenteric) artery.

Ctcae 4.02 2009-10-06

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MedDRA

v12.0 Code CTCAE v4.0 SOC CTCAE v4.0 Term Grade 1

Hemoglobin (Hgb) <LLN -

Mildly hypocellular or <=25%

Blood and lymphatic

Evidence of RBC destruction

Blood and lymphatic

Blood and lymphatic

Incidental findings (e.g.,

Thrombotic Evidence of RBC destruction

Periods of asystole; non-

Atrioventricular block Asymptomatic, intervention

10008481 Cardiac disorders Chest pain - cardiac Mild pain

Mild symptoms; intervention

10010783 Cardiac disorders Constrictive pericarditis -

Left ventricular systolic

Mobitz (type) II Asymptomatic, intervention

Mild symptoms; intervention

Paroxysmal atrial Asymptomatic, intervention

10034474 Cardiac disorders Pericardial effusion -

10053565 Cardiac disorders Pericardial tamponade -

Supraventricular Asymptomatic, intervention

10047290 Cardiac disorders Ventricular fibrillation -

10047302 Cardiac disorders Ventricular tachycardia -

Wolff-Parkinson-White Asymptomatic, intervention

Ear and labyrinth

Ear and labyrinth External ear External otitis with erythema

Ear and labyrinth

Ear and labyrinth

Ear and labyrinth Mild symptoms; intervention

Ear and labyrinth

Ear and labyrinth

Mild symptoms; intervention

10012205 Endocrine disorders Delayed puberty -

10018746 Endocrine disorders Growth accelerated -

Mild symptoms; intervention

Mild symptoms; intervention

10005886 Eye disorders Blurred vision Intervention not indicated

10048492 Eye disorders Corneal ulcer -

Extraocular muscle Asymptomatic; clinical or

Symptomatic but not limiting

10023332 Eye disorders Keratitis -

Symptomatic but not limiting

10038897 Eye disorders Retinal tear -

10038901 Eye disorders Retinal vascular disorder -

10047848 Eye disorders Watering eyes Intervention not indicated

Gastrointestinal Mild; intervention not

Gastrointestinal No change in bowel function

Gastrointestinal Mild; intervention not

Gastrointestinal One or more dental caries,

Increase of <4 stools per day

Symptomatic (e.g., dry or

Gastrointestinal Mild; intervention not

Gastrointestinal Mild symptoms; intervention

Gastrointestinal Symptomatic, able to eat

Gastrointestinal Mild; intervention not

Gastrointestinal Esophageal varices

Gastrointestinal Occasional use of pads

Gastrointestinal Mild symptoms; intervention

Gastrointestinal Mild; intervention not

Gastrointestinal Gastroesophageal reflux Mild symptoms; intervention

Mild nausea, early satiety

Gastrointestinal Hemorrhoidal Mild; intervention not