Table 2.
Adverse events in the safety population
|
Control group in the abiraterone trial (n=455) |
Control group in the abiraterone and enzalutamide trial (n=533) |
Combination therapy in the abiraterone trial (n=451) |
Combination therapy in the abiraterone and enzalutamide trial (n=513) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | Grade 1–2 | Grade 3 | Grade 4 | |
| Erectile dysfunction | 211 (46%) | 48 (11%) | 0 | 237 (44%) | 55 (10%) | 0 | 209 (46%) | 41 (9%) | 0 | 243 (47%) | 71 (14%) | 0 |
| Hypertension | 65 (14%) | 6 (1%) | 0 | 74 (14%) | 8 (2%) | 0 | 108 (24%) | 23 (5%) | 0 | 189 (37%) | 73 (14%) | 0 |
| ALT increased | 51 (11%) | 0 | 0 | 72 (14%) | 4 (1%) | 0 | 82 (18%) | 23 (5%) | 2 (<1%) | 145 (28%) | 59 (12%) | 5 (1%) |
| Fatigue | 279 (61%) | 4 (1%) | NM | 371 (70%) | 12 (2%) | NM | 299 (66%) | 10 (2%) | NM | 411 (80%) | 49 (10%) | NM |
| AST increased | 14 (3%) | 1 (<1%) | 0 | 17 (3%) | 0 | 0 | 33 (7%) | 2 (<1%) | 0 | 61 (12%) | 17 (3%) | 2 (<1%) |
| Insomnia | 126 (28%) | 1 (<1%) | NM | 162 (30%) | 1 (<1%) | NM | 133 (29%) | 8 (2%) | NM | 200 (39%) | 7 (1%) | NM |
| Hypokalemia | 4 (1%) | 1 (<1%) | 0 | 9 (2%) | 1 (<1%) | 0 | 50 (11%) | 4 (1%) | 1 (<1%) | 56 (11%) | 6 (1%) | 0 |
| Anaemia | 142 (31%) | 3 (1%) | 2 (<1%) | 211 (40%) | 2 (<1%) | 0 | 185 (41%) | 1 (<1%) | 1 (<1%) | 225 (44%) | 2 (<1%) | 0 |
| Dizziness | 53 (12%) | 0 | NM | 70 (13%) | 1 (<1%) | NM | 72 (16%) | 1 (<1%) | NM | 126 (25%) | 4 (1%) | NM |
| Constipation | 104 (23%) | 3 (1%) | 0 | 149 (28%) | 0 | 0 | 128 (28%) | 1 (<1%) | 0 | 181 (35%) | 1 (<1%) | 0 |
| Cough | 72 (16%) | 0 | 0 | 107 (20%) | 0 | 0 | 103 (23%) | 5 (1%) | 0 | 103 (20%) | 0 | 0 |
| Nausea | 43 (9%) | 1 (<1%) | NM | 67 (13%) | 0 | NM | 60 (13%) | 0 | NM | 130 (25%) | 3 (1%) | NM |
| Cognitive disturbance | 21 (5%) | 0 | 0 | 29 (5%) | 0 | 0 | 26 (6%) | 2 (<1%) | 0 | 85 (17%) | 2 (<1%) | 0 |
| Dyspepsia | 47 (10%) | 0 | 0 | 71 (13%) | 0 | 0 | 64 (14%) | 1 (<1%) | 0 | 103 (20%) | 2 (<1%) | 0 |
| Anorexia | 24 (5%) | 0 | 0 | 41 (8%) | 1 (<1%) | 0 | 29 (6%) | 0 | 0 | 94 (18%) | 1 (<1%) | 0 |
| Headache | 57 (13%) | 0 | 0 | 75 (14%) | 0 | 0 | 74 (16%) | 0 | 0 | 138 (27%) | 2 (<1%) | 0 |
| Anxiety | NM | NM | NM | 52 (10%) | 0 | 0 | NM | NM | NM | 88 (17%) | 1 (<1%) | 0 |
| Depression | NM | NM | NM | 48 (9%) | 0 | 0 | NM | NM | NM | 86 (17%) | 1 (<1%) | 0 |
Data are n (%). Anxiety and depression included as options in toxicity forms in the abiraterone and enzalutamide trial, but not abiraterone trial. Grade 5 events reported in the text only. ALT=alanine transminase. AST=aspartate transminase. NM=not measured.