· Information about all AEs, whether volunteered by the patient,
discovered by investigator questioning or detected through physical
examination, laboratory test or other means, will be recorded on
the Adverse Event Page of the CRF and followed as appropriate.
· When eliciting experiences of AE from subject, ask a standard
non-leading question “Do you feel different in any way since starting
the new treatment/the last visit?”.. This question will be put to
patient in his/her own language at each study visit.
· All adverse events (AE) must be recorded in Adverse Event (AE)
page of CRF. Complete all columns for each adverse event.
· Enter the code provided in column header for classification of
AE.
· Evaluate AE as follows:
|
BLOCK ON AE CRF
|
INSTRUCTIONS
|
AE No.
|
Each AE will be assigned a number. Assign the
number started from 1. |
Description of Clinical AE
|
Documented in terms of a medical diagnosis (es).
When this is not possible, the AE should be documented in terms
of signs and/or symptoms observed by the investigator or reported
by the subject. |
Onset Date
|
Date when AE began. Any changes to AE parameters
require new onset date. |
AE Stop Date or Check Box if Continuing
|
Enter date symptoms stopped. If AE is still present,
check the box for continuing. |
Severity
|
|
1= Mild
|
Awareness of signs or symptoms,
but they are easily tolerated. |
2= Moderate
|
Enough discomfort to cause inteference
with usual activity. |
3= Severe
|
Incapacitating, with inability
to work or to do usual activity. |
4= Life Threatening
|
Subject at risk of death at
the time of event. |
| |
Note that a severe AE is not
necessarily serious. The term severe is a measure of the intensity
while a serious AE is determined based on regulatory criteria.
A life threatening AE is an SAE
|
| Action taken |
|
1= None
|
No action taken. |
2= Reduce dose
|
Dose of study medication reduced. |
3= Discontinued Temporarily
|
Study treatment stopped but after subject’s symptoms
abated, the subject was rechallenged with study treatment |
4= Discontinued permanently
|
Study treatment was permanently stopped |
5= Specific treatment
|
Specific treatment or procedure instituted for
the AE. |
6= Other actions
|
For example, hospitalsation |
|
|
Relationship
|
The degree of certainty with
which an AE is attributed to study treatment or alternative
cause like natural history of disease or concomitant treatment
should be guided by the following considerations:
· Time relationship between treatment and occurrence of AE
· Known pharmacology of drug
· Reaction of similar nature being previously observed with
this drug or class of drug
· Reaction having often been reported in literature for similar
drug as drug related eg. skin rashes, blood dyscrasia |
1= Very likely
|
· The adverse event follows
a reasonable temporal sequence from study treatment administration
· Abates upon discontinuation of study treatment
· Reappears on repeat exposure (rechallenge) |
2= Probably
|
· The adverse event follows
a reasonable temporal sequence from study treatment administration
· Abates upon discontinuation of study treatment
· Cannot reasonably be explained by known characteristics of
the subject’s clinical state. |
3= Possibly
|
· The adverse event follows
a reasonable temporal sequence from study treatment administration
· But could have been produced by the subject’s clinical state
or other mode of therapy administered to the subject |
4= Remote or doubtful
|
· The temporal association between
study treatment and adverse event is such that the study treatment
is not likely to have any reasonable association with the observed
event |
5= Very Unlikely
|
· The adverse event is definitely
produced by the subject’s clinical state or other mode of therapy
administered to the subject |
Outcome to Date
|
|
1= Recovered
|
The subject has fully recovered from the adverse
event with no residual effect observable |
2= Recovered with Sequelae
|
Residual effects of the adverse event are still
present and observable. |
3= Ongoing at Subject Study
|
The adverse event is still present and observable
at study conclusion for the subject |
4= Died
|
Died. Fill in the SAE page of CRF. |
5= Unknown
|
Data unknown |
Check if AE is serious
|
Check the box if the AE is serious.
If the box is checked, complete the SAE page of CRF. |
Date lab specimen obtained or special exam performed
|
Enter the date of the laboratory exam or special
safety exam on which the AE was noted. |
· All serious adverse event (SAE) must be recorded in Serious Adverse
Event (SAE) page of CRF.
· SAE must be reported to CRC by phone or fax with the Serious Adverse
Event (SAE) page of CRF within 24 hours. Ssee below for contact
persons and numbers.
· Investigator should not wait to receive additional information
to fully document the SAE before notifying CRC. Telephone report
of SAE should be followed by a full written summary detailing relevant
aspects of the SAE in question. Where applicable, information from
relevant medical records and autopsy reports should be obtained.
· Where required, the investigators must also inform the IRB/IEC
of any SAEs.
Investigators should follow-up subjects with AE until the event
has resolved (subject recovered) or until the condition has stabilised.
Otherwise, appropriate medical care should be arranged for the patient.
Abnormal test results should be repeated until return to baseline
levels.
Any follow-up information should be reported to CRC monitor as soon
as the relevant information becomes available
