12.1
Date end of study
12.2
Indicate whether the participant completed the full study as specified in the protocol or terminated the study early:
12.3
If terminated early, please indicate which reason is **most applicable**:
Only shown if field 12.2 is equal to 2
12.4
Specify Adverse Event (AE):
Only shown if field 12.3 is equal to 2
12.5
Date of death
Only shown if field 12.3 is equal to 3
12.6
Primary cause of death
Only shown if field 12.3 is equal to 3
12.7
Date of last contact with this participant in this study:
Only shown if field 12.3 is equal to 4
12.8
Date consent withdrawn
Only shown if field 12.3 is equal to 5
12.9
Reason consent withdrawn
Only shown if field 12.3 is equal to 5
12.10
Date of decision:
Only shown if field 12.3 is equal to 6
12.11
Reason of decision
Only shown if field 12.3 is equal to 6
12.12
Other reason
Only shown if field 12.3 is equal to 8
13.1
I declare that all entries in the electronic case report forms (CRFs), including corrections, were made by a trial staff member identified on the ‘sites signature and delegation Log‘ and that the collected data in the electronic case report forms corresponds to a truthful, careful and complete transcription of the source data, which were generated during the study.
EOS_complete
1: Completed
2: Discontinued
EOS_reason
1: Participant violates one or more of the inclusion/exclusion criteria
2: Adverse event (AE)
3: Participant died
4: Participant lost to follow up
5: Participant withdrew consent
6: Investigator’s and/or physician’s decision
7: Total study is early terminated
8: Other reason
YesNo
1: Yes
2: No