Table 2.
Indirect comparisons of adverse events.
| ADVERSE EVENTS | AFFIRM15 | COU-AA-30117 | INDIRECT COMPARISON | |||||
|---|---|---|---|---|---|---|---|---|
| N (%) | OR§ (95% CI) | N (%) | OR§ (95% CI) | OR§ (95% CI) | P | |||
| ENZALUTAMIDE (N = 800) | PLACEBO (N = 399) | ABIRATERONE ACETATE (N = 791) | PLACEBO (N = 394) | |||||
| Fatigue | 269 (34%) | 116 (29%) | 1.24 (0.95–1.60) | 372 (47%) | 174 (44%) | 1.12 (0.88–1.43) | 1.10 (0.77–1.57) | 0.60 |
| Diarrhea | 171 (21%) | 70 (18%) | 1.28 (0.94–1.74) | 156 (20%) | 58 (15%) | 1.42 (1.02–1.98) | 0.90 (0.57–1.41) | 0.64 |
| Cardiac disorders† | 49 (6%) | 30 (8%) | 0.80 (0.50–1.29) | 126 (16%) | 46 (12%) | 1.43 (1.00–2.06) | 0.56 (0.31–1.01) | 0.06 |
| Liver function test abnormalities | 8 (1%) | 6 (2%) | 0.66 (0.23–1.92) | 89 (11%) | 35 (9%) | 1.30 (0.86–1.96) | 0.51 (0.16–1.59) | 0.25 |
| Fluid retention | – | – | – | 261 (33%) | 94 (24%) | 1.57 (1.19–2.07) | – | – |
| Hypokalemia | – | – | – | 143 (18%) | 36 (9%) | 2.19 (1.49–3.23) | – | – |
| Hypertension | – | – | – | 88 (11%) | 32 (8%) | 1.42 (0.93–2.16) | – | – |
| Seizure | 5 (<1%) | 0 | Inf. (0.46–Inf.)‡ | – | – | – | – | – |
Notes:
†
Cardiac disorders were defined in COU-AA-301 to include any of the following: cardiac ischemia, myocardial infarction, supraventricular or ventricular tachyarrhythmias, cardiac failure, or other arrhythmia-related problems. In the AFFIRM study, cardiac disorder was defined more broadly as either any disorder or myocardial infarction.
‡
Abbreviations: Inf., infinity;
§
OR, odds ratio.