ADRs | No. of events | Pooled incidence of ADRs per 100 patients* |
Gastrointestinal disorders | ||
Diarrhoea | 150 | 3.0 |
Nausea and vomiting | 84 | 1.7 |
Abdominal pain | 42 | 0.8 |
Stomachache | 16 | 0.3 |
Subtotal | 292 | |
General disorders and administration site conditions | ||
Fever | 85 | 1.7 |
Pain in injection site | 74 | 1.5 |
Localised pain | 4 | 0.1 |
Thrombophelibitis | 10 | 0.2 |
Arthralgia | 1 | <0.1 |
Subtotal | 174 | |
Skin and subcutaneous tissue disorders | ||
Rash | 57 | 1.2 |
Itching | 4 | 0.1 |
Infusion site erythema | 2 | <0.1 |
Subtotal | 63 | |
Others | ||
Stomatitis | 7 | 0.1 |
Anorexia | 6 | 0.1 |
Persistent hearing deficiencies | 2 | <0.1 |
Otitis media | 1 | <0.1 |
Subtotal | 16 | |
Total | 545 |
*The total number of patients is 4928.
ADRs, adverse drug reactions; RCTs, randomised controlled trials.