Table 5 Comparison of 15 harms criteria (CONSORT-harms extension used as a benchmark)
| Â | Â | Trial ID | |||||
|---|---|---|---|---|---|---|---|
Criteria | Description of item | NM16189 | M37013 | M37002 | M37047 | BM15421 | |
Methods criteria | 1 | List addressed adverse events (AEs) with definitions. | CSR | CSR | CSR | CSR | CSR |
2 | Mode of collecting harms data. | BOTH b | BOTH b | BOTH b | CSR | BOTH a | |
3 | Timing and time frame of surveillance for adverse events. | BOTH b | Pub | CSR | NR | BOTH a | |
4 | Attribution methods. | CSR | NR | CSR | NR | NR | |
5 | Intensity of ascertainment. | CSR | BOTH b | CSR | CSR | CSR | |
6 | Harms related monitoring. | CSR | BOTH b | CSR | CSR | CSR | |
7 | Coding of AEs. | CSR | CSR | BOTH a | CSR | CSR | |
8 | Handling of recurrent events. | NR | CSR | NR | CSR | NR | |
9 | Timing issues. | CSR | CSR | CSR | NR | CSR | |
10 | Plans to perform any statistical analyses and inferences. | CSR | BOTH a | BOTH a | BOTH a | BOTH a | |
Total items satisfied for methods criteria in clinical study report (CSR) (% of total 10 items assessed) | 9 (90) | 8 (80) | 9 (90) | 7 (70) | 8 (80) | ||
Total items satisfied for methods criteria in publication (% of total ten items assessed) | 2 (20) | 5 (50) | 3 (30) | 1 (10) | 3 (30) | ||
Results criteria | 11 | Withdrawals and discontinuations. | BOTH a | BOTH a | BOTH a | BOTH a | CSR |
12 | Denominators for analyses on harms. | BOTH b | BOTH b | BOTH a | CSR | BOTH b | |
13 | Specifying AE type. | BOTH a | BOTH a | BOTH a | BOTH a | BOTH a | |
14 | Grading or scaling used. | NR | BOTH a | BOTH a | BOTH a | BOTH a | |
15 | Seriousness per arm. | BOTH a | BOTH a | BOTH a | BOTH a | BOTH a | |
Total items satisfied for results criteria in the CSR (% of total five items assessed) | 4 (80) | 5 (100) | 5 (100) | 5 (100) | 5 (100) | ||
Total items satisfied for results criteria in the publication (% of total five items assessed) | 4 (80) | 5 (100) | 5 (100) | 4 (80) | 4 (80) | ||
Total items satisfied in CSR (% of total 15 items assessed) | 13 (87) | 13 (87) | 14 (93) | 12 (80) | 13 (87) | ||
Total items satisfied in publication (% of total 15 items assessed) | 6 (40) | 10 (67) | 8 (53) | 5 (33) | 7 (47) | ||