Non-serious Adverse Event
Non-serious Adverse Event
boolean
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
date
00:00-23:59
time
Outcome
integer
Experience 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
NOT RELATED: The event is definitely not related to the study procedures 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’, record details in the Concomitant Medication section and/or Healthcare Resource Utilisation form if appropriate
text
patient withdrawn due to this specific AE
text
Investigator signature
text
day month year
date