Table 2.
Subgroup analysis of randomized controlled trials
| Nature of RCTS | Subgroups | Total RCTs | Safety Statistics |
Type of Study |
||
|---|---|---|---|---|---|---|
| Present | Absent | IIS | PISS | |||
| IIS/PISS | IIS | 299 | 183 | 116 | ||
| PISS | 324 | 92 | 232 | |||
| Phase of trial | Phase 1 | 8 | 0 | 8 | 0 | 8 |
| Phase 1/2 | 4 | 0 | 4 | 1 | 3 | |
| Phase 2 | 60 | 20 | 40 | 30 | 30 | |
| Phase 2/3 | 14 | 5 | 9 | 10 | 4 | |
| Phase 3 | 368 | 148 | 220 | 138 | 230 | |
| Phase 4 | 48 | 33 | 15 | 30 | 18 | |
| Not mentioned | 121 | 69 | 52 | 90 | 31 | |
| Intervention | Surgery | 63 | 38 | 25 | 44 | 19 |
| Pharma | 403 | 150 | 253 | 153 | 250 | |
| Vaccine | 22 | 8 | 14 | 7 | 15 | |
| Device | 23 | 14 | 9 | 13 | 10 | |
| Radiotherapy | 2 | 1 | 1 | 1 | 1 | |
| Others | 93 | 53 | 40 | 6 | 87 | |
| Combination therapy | 17 | 11 | 6 | 8 | 9 | |
| Therapeutic Area | Cardiovascular | 172 | 120 | 52 | 83 | 89 |
| Oncology | 101 | 20 | 81 | 34 | 68 | |
| Infectious Disease | 94 | 35 | 59 | 51 | 43 | |
| Respiratory | 52 | 21 | 31 | 27 | 25 | |
| Metabolic | 37 | 13 | 24 | 19 | 18 | |
| Neurology | 34 | 15 | 19 | 18 | 16 | |
| Immunology | 32 | 5 | 27 | 7 | 25 | |
| Haematology | 23 | 7 | 16 | 8 | 15 | |
| Nephrology | 15 | 9 | 6 | 10 | 5 | |
| Musculoskeletal | 14 | 3 | 11 | 9 | 5 | |
| Gastrointestinal | 10 | 4 | 6 | 4 | 6 | |
| Others | 39 | 23 | 16 | 28 | 10 | |