ADVERSE EXPERIENCES (Non-serious)
Record any adverse event (using standard medical terminology) observed or elicited by the following direct question to the subject: “Do you feel different in any way since starting the treatment or since the last visit?” Provide the diagnosis not symptoms where possible. (One adverse event per column) If no adverse events, please mark box and sign form below.
boolean
day month year
date
00:00-23:59
time
day month year
date
00:00-23:59
time
Outcome of AE
integer
Experience Course of AE
integer
Number of episodes
integer
INTENSITY (Maximum) Definition: 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
Action Taken with Respect to Investigational Drug
integer
Definition: 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 ‘Yes’, please record on Concomitant Medication form.
text
Patient withdrawn due to this specific AE
text
Investigator signature
text
day month year
date