Adverse Event
No adverse event
boolean
Record any Adverse events (using standard medical terminology) observed or elicited by the following direct question to the subject: "Have you felt different in any way since starting the new treatment or since the last visit?" Provide the diagnosis NOT symptoms where possible. (One adverse event per column)
text
Comment for GSK
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
Outcome
integer
AE Event Course
integer
Number of Episodes
integer
MILD: An event which is easily tolerated MODERATE: An event which is sufficiently discomforting to interfere with daily activity SEVERE: An event which prevents normal everyday activities
integer
Action taken with respect to investigational drug
integer
NOT RELATED: The event is definitely not related to the study procedured UNLIKELY: There are other more likely causes and the study procedures are not suspected as a cause SUSPECTED (REASONABLE POSSIBILITY): A direct cause and effect relationship between the study procedures and the event has not been demonstrated but there is a reasonable possibility that the study procedures were involved PROBABLE: There probably is a direct cause and effect relationship between the event and the study procedures
integer
If "Yes", please record on Concomitant Medication form.
text
Subject withdrawn
text
Investigator's Signature
text
day month year
date