1.1
Date of the SAE report
1.2
What is the year of birth of the patient?
1.3
Age of the patient
1.4
What is the gender of the subject?
1.5
What are the consequences for the conduct of the study
1.5.1
If you choose ‘other’ please explain the consequences
Only shown if field 1.5 is equal to Other
1.6
Under which category does this SAE belong?
1.6.1
If you choose ‘other’ please explain the other category
Only shown if field 1.6 is equal to Other
1.7
Give a description of the event
1.8
On which date did the event occur/start?
1.9
Under which category does the event belong?
1.10
Did the patient recover?
1.11
On which date did the patient recover?
1.12
Additional remarks
Man/Woman
0: Man
1: Woman
implications_SAE
0: Suspend investigation or putting the research ‘on hold’
1: Termination of the research
2: Adapting the information for participants
3: Adjust the dose
4: Adjust in and exclusion criteria
5: Other
Category SAE
0: Unexpected outcome of an expected serious adverse reaction
1: A SAE related to study treatment or procedure
2: A SAE related to a medical device
3: A SAE related to failure of equipment
4: Other
Category_Event_SAE
0: Death
1: Life threatening
2: (Extending) hospitalization
3: Congenital abnormalities
4: Permanent disability or incapacity for work
5: Other
Recovery SAE
0: Yes
1: Is recovering
2: No
3: Recovered with residual symptoms
4: Deceased
5: Unknown