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. 2021 Sep 3;68(3):133–137. doi: 10.4103/jpgm.JPGM_78_21

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