Argus ID:

_____________________________

Country:

_____________________________

Adverse Event Report Form

Initial

MRD (Date in which Novartis is aware of the

information)

Follow-up

I. Patient details (in respect to Data Privacy Laws):

Initials

Country

Date of birth
(dd/mm/yyyy)

Age at time of
the event

Gender

Height (cm)

Weight (kg)

Ethnic Origin or
Race

II. Adverse event(s) information

Adverse event(s)

Onset date of
this event (Date
of start of the
symptoms)
(dd/mm/yyyy)

End date for

this event
(dd/mm/yyyy)

What was the outcome?

REC Completely recovered
SEQ Recovered with
sequelae
IMP Condition improving
UNC Condition unchanged
DET Condition deteriorating
FAT Fatal
UNK Outcome unknown

Indicate if any of the below

seriousness criteria apply to
the
reported
adverse
event(s)? Please indicate all
criteria that apply.

*(See key below)*

* Seriousness Criteria *

Further description of adverse event(s)

D. Patient died due to event(s) please specify

Date

of
death:
_______________________________________________

Cause
of
death:
_______________________________________________
Autopsy carried out? (Yes/No) ______ If yes, please summarize
results in field Further description of adverse event(s)
LT. Life threatening at the time the event(s) occurred
Any adverse event where the patient was at immediate risk of death
at the time the adverse event occurred
HOSP. Required hospitalization or prolonged hospitalization
Date

of
admission:
______________________________________________

Date

of
discharge:_________________________________________
______

DIS. Persistent or significant disability or incapacity

A substantial disruption of a person's ability to conduct normal life
functions, resulting in significant, persistent or permanent change,
impairment, damage or disruptions in the patient's body function,
physical activities and/or quality of life.
MS. Medically significant
An adverse event that may jeopardize the patient and may require
medical or surgical intervention to prevent one of the other serious
outcomes.
CA. Congenital anomaly or birth defect
NS. None of the above.

III. Medication information (Novartis and non-Novartis drugs)

Medication
name (name
as prescribed
or generic
name)

Route of
administratio
n

Dosing
Regimen or
Daily
Dosing

Dates of treatment
(dd/mm/yyyy) - If
treatment is ongoing, state
ONGOING. If unknown,
state the duration of use

Start Date

1/4

Stop Date

Indication for
use

Batch
No.

Expiry
Date

Suspect
drug
associate
d with
adverse
event?
(Yes/No)
Yes

No

Yes

No

Adverse Event Report Form Version 20 Jul 2015

Argus ID:

_____________________________

Country:

_____________________________

Yes

2/4

No

Adverse Event Report Form Version 20 Jul 2015

Argus ID:

_____________________________

Country:

IV. Additional drug information/measures taken

_____________________________

(please check all that apply)

Novartis drug continued

Novartis drug discontinued (if yes):

Temporarily or
Permanent

Dose reduction Novartis drug

Non-drug treatment of adverse event*

Drug treatment of adverse event*

Other (please specify)

No treatment
*If treatment was required, please describe:
Did the adverse event(s) abate after stopping the suspect drug?
Suspected drug____________________ Yes
No
Unk
Suspected drug____________________ Yes
No
Unk
Suspected drug____________________ Yes
No
Unk
Suspected drug____________________ Yes
No
Unk
Suspected drug____________________ Yes
No
Unk
Is the adverse event a quality complaint or lack of efficacy?
Yes

N.A.
N.A.
N.A.
N.A.
N.A.
No

Did the adverse event(s) recur on re-administration of the suspect drug?

Suspected drug____________________ Yes
No
Unk
N.A.
Suspected drug____________________ Yes
No
Unk
N.A.
Suspected drug____________________ Yes
No
Unk
N.A.
Suspected drug____________________ Yes
No
Unk
N.A.
Suspected drug____________________ Yes
No
Unk
N.A.

V. Further information:
Relevant medical history including concurrent and pre-existing conditions (please provide dates where possible):
Possible Risk factors:
Alcohol
Allergies
Drug abuse
Nicotine
If female, is patient pregnant?
No
Yes
Last Menstrual Period:
Expected Delivery Date: ____________

VI. Relevant laboratory and test data:

Test

Date (dd/mm/yyyy)

VII. Additional Information:

Results (with units)

Normal range

Please provide additional information from any previous section here.

VIII. Reporter information: Please PRINT or use stamp

Reporter type

Health Care Professional

Consumer

Other

(Specify :_______________________________________________)

Name:

Telephone:

Profession:

Fax:

Address

Email:

Consent to contact the reporter for the purpose of following up on the reported information
Yes

No

Not applicable

If reporter different than treating physician. Is there consent to contact the treating physician for the purpose of following up on the reported
information
Yes

No

Not applicable

If yes, please inform the contact details:

Name
Telephone
Fax
Email
Address
Completed by:
Printed Name: Khrystyne Shara L. Panlilio

3/4

Signature:

Date

Adverse Event Report Form Version 20 Jul 2015

Argus ID:

_____________________________

Country:

4/4

_____________________________

Adverse Event Report Form Version 20 Jul 2015