Table 3

Adverse events experienced by participants during follow-up

MTX+PBO n=55MTX+ETN n=55
Number of patients who experienced an AE55 (100.0%)53 (96.4%)
Maximum severity of AE experienced
 Mild231/338 (68.3%)236/358 (65.9%)
 Moderate104/338 (30.8%)107/358 (29.9%)
 Severe (including SAEs)3/338 (0.9%)15/358 (4.2%)
Total number of AEs338358
Total patient-years of follow-up80.9979.27
Number of AEs per 100 patient-years417.3451.6
Patient expectation of event
 Expected (listed in PIS)256/338 (75.7%)263/358 (73.5%)
Severity*
 Mild231/338 (68.3%)236/358 (65.9%)
 Moderate104/338 (30.8%)107/358 (29.9%)
 Severe (including SAEs)3/338 (0.9%)15/358 (4.2%)
Number of patients who experienced an SAE3/55 (5.5%)9/55 (16.4%)
Total number of SAEs313
SAEs by category—relation to study drug
 Dermatology/skin1—probably not
 Gastrointestinal1—probably not
 Infection—pulmonary/upper respiratory2–1 probably not, 1 possibly
 Malignancy—haematological1—probably not
 Malignancy—metastatic1—possibly
 Musculoskeletal/soft tissue1—not related
 Neurology1—probably not
 Pain—cardiovascular1—probably not
 Pain—musculoskeletal1—not related
 Surgical and medical procedures1—not related5—not related

  • AE, adverse event; SAE, serious adverse event.