Table 2 ICON8 serious adverse events mapped to already-reported adverse events
Event classification | Total SAEs | Not matched to AE | Matched to AE |
|---|---|---|---|
Vomiting | 143 | 68 (48%) | 75 (52%) |
Diarrhoea | 77 | 35 (46%) | 42 (55%) |
Nausea | 68 | 25 (37%) | 43 (63%) |
Febrile neutropenia | 65 | 31 (48%) | 34 (52%) |
Thromboembolic event | 52 | 24 (46%) | 28 (54%) |
Fatigue | 41 | 8 (20%) | 33 (81%) |
Constipation | 41 | 8 (20%) | 33 (81%) |
Neutrophil count decreased | 33 | 10 (30%) | 23 (70%) |
Anaemia | 32 | 4 (13%) | 28 (88%) |
Pain | 29 | 13 (45%) | 16 (55%) |
Rash | 15 | 7 (47%) | 8 (53%) |
Dehydration | 15 | 10 (67%) | 5 (33%) |
Allergic reaction | 14 | 5 (36%) | 9 (64%) |
Anorexia | 11 | 2 (18%) | 9 (82%) |
Platelet count decreased | 10 | 2 (20%) | 8 (80%) |
Peripheral sensory neuropathy | 5 | 1 (20%) | 4 (80%) |
ALT or AST elevation | 4 | 2 (50%) | 2 (50%) |
Creatinine increased | 2 | 0 (0%) | 2 (100%) |
Myalgia | 2 | 1 (50%) | 1 (50%) |
Weight loss | 2 | 0 (0%) | 2 (100%) |
White blood cell decreased | 2 | 0 (0%) | 2 (100%) |
Myocardial infarction | 1 | 1 (100%) | 0 (0%) |
Peripheral motor neuropathy | 1 | 1 (100%) | 0 (0%) |
Hypokalaemia | 1 | 1 (100%) | 0 (0%) |
Arrhythmia | 1 | 1 (100%) | 0 (0%) |
Muscle weakness | 1 | 0 (0%) | 1 (100%) |
Total | 668 | 260 (39%) | 408 (61%) |