CIOMS FORM

SUSPECT ADVERSE REACTION REPORT

MFR. CONTROL No. : 2014-BI-52810BI(2)
I.REACTION INFORMATION
1.PATIENT INITIALS

SOL
77 Kg
150 cm

1a.COUNTRY

2.DATE OF BIRTH
DA
MO

ID

13

JUN

YR

2a. AGE
YRS

3. SEX

1948 66

4.-6. REACTION ONSET

DA
MO
YR

28

OCT

8.-12. CHECK ALL

APPROPRIATE
TO ADVERSE
2014
REACTION

7.+13. DESCRIBE REACTION(S) (include relevant test/lab data)

PATIENT DIED

CHOLELITHIASIS (Cholelithiasis) [v.17.1] - Recovered

Case level outcome :Recovered

LIFE THREATENING
XINVOLVED OR

Information was received from an investigator in Indonesia concerning patient

number 54136 with centre number 62004, a 66 year old female patient with type 2
diabetes mellitus who was enrolled in clinical trial 1245.25, a Phase 3,
multicentre, international, randomized, parallel group, double blind
cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once
daily) compared to usual care in type 2 diabetes mellitus patients with increased
cardiovascular risk. Patients will be administered BI 10773 10 mg, BI 10773 25
mg, or placebo.
The study medication was started on an unknown date.

PROLONGED INPATIENT
HOSPITALIZATION

INVOLVED PERSISTENCE OR
SIGNIFICANT DISABILITY
OR INCAPACITY

CONGENITAL ANOMALY
OTHER MEDICALLY IMPORTANT

On 28Oct2014 at 0800 hours, the patient developed moderate cholelithiasis which

CONDITION

Cont...
II.SUSPECT DRUG(S) INFORMATION
14. SUSPECT DRUG(S) (include generic name)

Subject Unblinded :No

20.DID EVENT ABATE

AFTER STOPPING DRUG?

Blinded

YES
15. DAILY DOSE

16. ROUTE OF ADMINISTRATION

NO

NA

21.DID EVENT
REAPPEAR AFTER
REINTRODUCTION?

17. INDICATIONS FOR USE

YES
18. THERAPY DATES(From/To)

NO

19. THERAPY DURATION

III.CONCOMITANT DRUGS AND HISTORY

22.CONCOMITANT DRUGS AND DATES OF ADMINISTRATION (Exclude those used to treat event)

VALSATRAN(VALSARTAN)(TA)(VALSARTAN)

03-JAN-2012 -

dose per
application: 80;
daily dose: 80 (see
text)

Cont...

23. OTHER RELEVANT HISTORY

No Risk Factor Available

Past Disease:
SINUSITIS MAXILLARIS
Cont...
IV.

MANUFACTURER

24a. NAME AND ADDRESS OF MANUFACTURER

Boehringer Ingelheim

Global Pharmacovigilance

Binger Strasse 173

Ingelheim am Rhein 55216 GERMANY

EUDRACT no:2009-016178-33
24b. MFR. CONTROL NO.
Study no :1245.25
2014-BI-52810BI(2)
Center no :62004
Log No :2014-BI-52810BI
Cont...
24c. DATE RECEIVED BY
MANUFACTURER

15-DEC-2014
DATE OF THIS REPORT

18-DEC-2014

24d. REPORT SOURCE

X STUDY
LITERATURE
AUTHORITY
X HEALTH PROFESSIONAL OTHER
25a. REPORT TYPE

INITIAL

X FOLLOW UP

FINAL
Cont...

= Continuation attached sheet(s)

NA

Date : 18-DEC-2014
Page : 2 / 3

Boehringer Ingelheim
Global Pharmacovigilance
Binger Strasse 173
Ingelheim am Rhein55216
GERMANY

Continuation Sheet for CIOMS report

Mfr. Control No. : 2014-BI-52810BI(2)

Reaction Information ( Cont...)

Seq. No.
Reaction
Start Date
Stop Date
Duration
Event Location

:
:
:
:
:
:

1
CHOLELITHIASIS (Cholelithiasis) [v.17.1]
28-Oct-2014;08:00
31-Oct-2014;09:00
4 D
Hospital

Describe Reaction(s)(Include relevant test/lab data) ( Cont...)

was considered serious due to hospitalization. An elective surgery of cholelithectomy was performed on

30Oct2014. The pertinent laboratory results showed hemoglobin (Hgb) 13.2 g/dL, red blood cells (RBC)
4.74X10^6/uL, platelet count (PLT) 280X10^3/microliter, natrium 137 micromol/L, kalium 3.53 micromol/L,
chloride 113 micromol/L, partial prothrombin time (PPT) 9.4 seconds, International normalized ratio (INR)
0.81, activated partial thromboplastin time (APTT) 26.3 seconds, aspartate transaminase (AST) 13 U/L, alanine
transaminase (ALT) 10 U/L, albumin as 4.46 g/dL, urea 32.5 mg/dl, creatinine 0.97 mg/dL, uric acid 6.3 mg/dL,
old age,
and random blood sugar 63 mg/dL (without symptom and hypoglycaemia). The risk factors included female,
fertile and obese.
On 31Oct2014 at 0900 hours, the patient had recovered from the event cholelithiasis and on the same day, she
was discharged from the hospital by the doctor.

The study medication was continued.

Concomitant medications included Valsatran and Amlodipin as an anti-hypertensive, Sohobion as

vitamin/supplement, Aspilet for anti-platelet aggregation, and Urdafalk for cholelithiasis. Further concomitant
diseases included heart failure since Sep2007, hemorrhoid interna since July 2008, diabetic retinopathy,
diabetic neuropathy, dyslipidemia, left ventricular hypertrophy and obese.
Past disease included sinusitis maxillaris.
The investigator considers that there is no causal relationship between the study medication and the event
cholelithiasis.
For regulatory reporting purposes, Boehringer Ingelheim has assessed that there is not a reasonable possibility
of a causal association between the event cholelithiasis and study medication.

The following BI case ID is linked to this patient 2013-BI-13584BI.

Tracking of changes:
18Nov2014: Follow up information received. Updated Disease, Lab data and Narrative.
15Dec2014: Follow up information received. Updated event, and narrative.

Concomitant drugs(Cont...)
Seq. No.
Drug
Form of Admin.
Route of Admin.
Indication for use

:
:
:
:
:

1
VALSATRAN(VALSARTAN)(VALSARTAN)
1)TA
1)PO
1)ANTIHIPERTENSION

Seq. No.
Drug
Daily Dose
Form of Admin.
Route of Admin.
Indication for use
Therapy Dates/Duration

:
:
:
:
:
:
:

2
AMLODIPIN(AMLODIPINE)(AMLODIPINE)
1)dose per application: 10; daily dose: 10 (see text)
1)TA
1)PO
1)ANTIHIPERTENSION
1) 03-JAN-2012
-

Seq. No.
Drug

:
:

Daily Dose
Form of Admin.
Route of Admin.
Indication for use
Therapy Dates/Duration

:
:
:
:
:

3
SOHOBION(PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE,
CYANOCOBALAMIN)(PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE,
CYANOCOBALAMIN)
1)NR (NR)
1)TA
1)PO
1)VITAMIN/ SUPPLEMEN
1) 04-JUN-2013
-

Seq. No.
Drug
Daily Dose
Form of Admin.
Route of Admin.
Indication for use
Therapy Dates/Duration

:
:
:
:
:
:
:

4
ASPILET(ACETYLSALICYLIC ACID)(ACETYLSALICYLIC ACID)
1)dose per application:
80; daily dose: 80 (see text)

1)TA
1)PO

1)ANTI PLATELET AGGREGATION

1) 07-NOV-2013
-

:
:
:

5
URDAFALK(URSODEOXYCHOLIC ACID)(URSODEOXYCHOLIC ACID)
1)dose per application: 250; daily dose: 500 (see text)

Seq. No.
Drug
Daily Dose

Date : 18-DEC-2014
Page : 3 / 3

Boehringer Ingelheim
Global Pharmacovigilance
Binger Strasse 173
Ingelheim am Rhein55216
GERMANY

Continuation Sheet for CIOMS report

Form of Admin.
Route of Admin.
Indication for use
Therapy Dates/Duration

:
:
:
:

Mfr. Control No. : 2014-BI-52810BI(2)

1)TA
1)PO
1)CHOLELITHIASIS
1) 14-AUG-2014
-

Other relevant history (Cont...)

Concurrent Disease:
HEART FAILURE (-Sep-2007 - ) (Continuing: NR)
HAEMORHOID INTERNA (-Jul-2008 - ) (Continuing: NR)
HYPERTENSION (Continuing: NR)
DIABETIC RETINOPATHY (Continuing: NR)
DIABETIC NEUROPATHY (Continuing: NR)
DYSLIPIDEMIA (Continuing: NR)
CHOLELITHIASIS (Continuing: NR)
LEFT VENTRICULAR HYPERTROPHY (Continuing: NR)
OBESE (Continuing: NR)

Clinical Trial Identification ( Cont...)

Patient no
: 54136
Study identification for EUDRACT: 2009-016178-33

Additional information (continuation)

Lab Result :
Test name

Test date

ALBUMIN
ALT
APTT
AST
CHLORIDE
CREATININE
HEMOGLOBIN
INR
KALIUM
NATRIUM
PLATELET
PPT
RANDOM BLOOD SUGAR
RBC
UREA
URIC ACID

Test result

Normal value

4.46 g/dL
10 U/L
26.3 seconds
13 U/L
113 micromol/l
0.97 mg/dl
13.2 g/dl
0.81
3.53 micromol/l
137 micromol/l
280 10^3/microliter
9.4 seconds
63 mg/dl
4.74 10^6/uL
32.5 mg/dl
6.3 mg/dl

Classification