Table 1 Comparison of reporting of design factors, statistical analysis and reporting of efficacy and safety outcomes across all three data sources
Key information based on reporting of design aspects and statistical analysis, and reporting of efficacy and safety sections | CSR (N = 35) | Trial registry (N = 34) | Journal Publication(s) (N = 33) |
|---|---|---|---|
Method and design | |||
 Randomisation | 30 (86%) | 0 (0%) | 21 (64%) |
 Allocation concealment | 28 (80%) | 1 (3%) | 11 (33%) |
 Blinding | 35 (100%) | 2 (6%) | 19 (58%) |
 Sample size calculation | 32 (91%) | 1 (3%) | 17 (52%) |
 Inclusion criteria specified | 35 (100%) | 32 (94%) | 32 (97%) |
 Definition of causality provided | 30 (86%) | 1 (3%) | 5 (15%) |
 Intervention and comparator | |||
  Intervention used | 35 (100%) | 30 (88%) | 33 (100%) |
  Dose and delivery | 35 (100%) | 10 (29%) | 27 (82%) |
  Placebo pill explained (i.e. visual detail) | 27 (77%) | 1 (3%) | 9 (27%) |
Outcomes | |||
 Primary outcome specified | 35 (100%) | 30 (88%) | 25 (76%) |
 Secondary outcomes specified | 35 (100%) | 29 (85%) | 20 (61%) |
 HRQoL measured (i.e. SQLS or sleep quality) | 26 (74%) | 3 (9%) | 9 (27%) |
 Symptoms (depression or suicidality) | 34 (97%) | 1 (3%) | 5 (15%) |
Safety | |||
 AEs | 35 (100%) | 10 (29%) | 29 (88%) |
 SAEs | 35 (100%) | 17 (49%) | 20 (61%) |
 Discontinuation due to AEs | 33 (94%) | 9 (26%) | 20 (61%) |
 Reason for withdrawal | 31 (89%) | 1 (3%) | 11 (33%) |
 Death | 35 (100%) | 9 (26%) | 29 (88%) |
 Reason for death | 35 (100%) | 33 (97%) | 30 (91%) |