Table 2

Risk of ADRs from RCTs and prospective cohort studies

ADRsNo. of eventsPooled incidence of ADRs per 100 patients*
Gastrointestinal disorders
 Diarrhoea1503.0
 Nausea and vomiting841.7
 Abdominal pain420.8
 Stomachache160.3
Subtotal 292
General disorders and administration site conditions
 Fever851.7
 Pain in injection site741.5
 Localised pain40.1
 Thrombophelibitis100.2
 Arthralgia1<0.1
Subtotal 174
Skin and subcutaneous tissue disorders
 Rash571.2
 Itching40.1
 Infusion site erythema2<0.1
Subtotal 63
Others
 Stomatitis70.1
 Anorexia60.1
 Persistent hearing deficiencies2<0.1
 Otitis media1<0.1
Subtotal 16
Total 545
  • *The total number of patients is 4928.

  • ADRs, adverse drug reactions; RCTs, randomised controlled trials.