No event
Adverse Event
Record any Baseline events (using standard medical terminology) observed or elicited by the following direct question to the subject: "How do you feel?" Provide the diagnosis NOT symptoms where possible. (One Baseline event per column)
text
day month year
date
00:00-23:59
time
day month year (If ongoing, please leave blank)
date
00:00-23:59 (If ongoing, please leave blank)
time
If subject died, please inform GSK within 24 hours and complete form D
integer
Event Course
integer
No. of Episodes
integer
MILD: Adverse Event which is easily tolerated. MODERATE: Adverse Event sufficiently discomforting to interfere with daily activity. SEVERE: Adverse Event which prevents normal everyday activities.
integer
NOT RELATED: The adverse event is definitely not related to the test drug. UNLIKELY: There are more likely causes and the drug is not suspected as a cause. SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the drug and the adverse event has not been demonstrated but there is a reasonable possibility that the event was caused by the drug. PROBABLE: There is probably a direct cause and effect relationship between the adverse event and the study drug.
integer
If you tick yes, please record on Prior Medication form.
text
Subject withdrawn
text
Investigator's Signature
text
day month year
date