1.1
Describe the adverse event
1.2
Start date of adverse event
1.3
Stop date of AE
1.4
Severity
1.5
Relationship to intervention
1.6
Action taken regarding intervention
1.7
Outcome of AE
1.8
Expected?
1.9
Serious Adverse Event?
Severity
1: Mild
2: Moderate
3: Severe
4: Life-threatening
AE Relationship
0: Not related
1: Unlikely related
2: Possibly related
3: Probably related
4: Definitely related
Action AE
0: None
1: Dose modification
2: Medical intervention
3: Hospitalization
4: Intervention discontinued
5: Other
AE Outcome
1: Resolved
2: Recovered with minor sequelae
3: Recovered with major sequelae
4: Ongoing / continuing treatment
5: Condition worsening
6: Death
7: Unknown
Yes/No
1: Yes
0: No