Table 2

Risk of ADRs from RCTs and prospective cohort studies

ADRsNo. of eventsPooled incidence of ADRs per 100 patients*
Gastrointestinal disorders
 Nausea and vomiting841.7
 Abdominal pain420.8
Subtotal 292
General disorders and administration site conditions
 Pain in injection site741.5
 Localised pain40.1
Subtotal 174
Skin and subcutaneous tissue disorders
 Infusion site erythema2<0.1
Subtotal 63
 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.