8.5.2023
EN
Official Journal of the European Union
C 163/11
Results of the investigation4 Participant flow12
Number of participants screened, enrolled, allocated and followed up to each intervention.
The use of this or similar flowchart is strongly recommended13.
Please note, the below flowchart is for randomised two arm studies.
The flowchart will need to be adjusted for different study designs.
Baseline demographic and clinical characteristics4
If available, description of age, sex, ethnic background, country, stage of disease, relevant co-morbidities and any other disease-influencing factors in participants.
When applicable, description of care providers (case volume, qualification, expertise, etc.) and centres (volume) in each group.
Outcome of the intervention4
Results on primary endpoint including in absolute numbers when feasible (e.g. 10/20, not 50 %), estimated effect size and the precision of the result.
Please include whether an analysis is intention-to-treat or per protocol.
Results of secondary endpoints or additional analyses can be reported, but the dangers of drawing conclusions from these results should be discussed.