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. Author manuscript; available in PMC: 2024 Nov 28.
Published in final edited form as: Lancet Oncol. 2023 May 1;24(5):443–456. doi: 10.1016/S1470-2045(23)00148-1

Table 2. Summary of adverse events.

Standard of care in the abiraterone and enzalutamide trial (n=454) Standard of care plus abiraterone and enzalutamide in the abiraterone and enzalutamide trial (n=445)
Grade 1-2 Grade 3 Grade 4 Grade 5 Grade 1-2 Grade 3 Grade 4 Grade 5
Blood and lymphatic 193 (43%)   21 (5%)     5 (1%)     0 217 (49%)     9 (2%)     4 (1%)     0
Cardiac   25 (6%)   10 (2%)     5 (1%)     0   45 (10%)   19 (4%)     7 (2%)     5 (1%)*
Eye   54 (12%)     5 (1%)     0     0   73 (16%)     6 (1%)     0     0
Gastrointestinal and hepatobiliary 242 (53%)   19 (4%)     4 (1%)     1 (<1%) 305 (69%)   30 (7%)     6 (1%)     0
General disorders and administration site conditions 329 (72%)   29 (6%)     1 (<1%)     0 348 (78%)   54 (12%)     2 (<1%)     2 (<1%)
    Fatigue 296 (65%)   13 (3%)     0     0 348 (78%)   34 (8%)     0     0
Infections   89 (20%)   17 (4%)     1 (<1%)     1 (<1%) 101 (23%)   22 (5%)     3 (1%)     3 (1%)
Injury     8 (2%)     6 (1%)     0     0   23 (5%)   11 (2%)     0     0
Investigations 216 (48%)   25 (6%)   10 (2%)     0 246 (55%)   66 (15%)   10 (2%)     0
    Alanine aminotransferase increased   75 (17%)     3 (1%)     0     0 112 (25%)   44 (10%)     1 (<1%)     0
    Aspartate aminotransferase increased   17 (4%)     0     0     0   43 (10%)     9 (2%)     0     0
Metabolism and nutrition 143 (31%)     6 (1%)     0     0 190 (43%)   17 (4%)     3 (1%)     0
    Glucose intolerance   31 (7%)     1 (<1%)     0     0   23 (5%)     7 (2%)     0     0
    Hypokalaemia   21 (5%)     0     0     0   66 (15%)     7 (2%)     2 (<1%)     0
Musculoskeletal 288 (63%)   45 (10%)     0     0 292 (66%)   54 (12%)     0     0
Nervous system 144 (32%)   15 (3%)     1 (<1%)     0 232 (52%)   20 (4%)     6 (1%)     0
    Seizure     1 (<1%)     0     0     0     0     4 (1%)     0     0
    Cognitive disturbance   22 (5%)     2 (<1%)     0     0   83 (19%)     2 (<1%)     1 (<1%)     0
Psychiatric 187(41%)     6 (1%)     0     0 230 (52%)     3 (1%)     1 (<1%)     0
Renal and urinary 292 (64%)   17 (4%)     5 (1%)     0 306 (69%)   18 (4%)     5 (1%)     2 (<1%)
Reproductive 179 (39%)   58 (13%)     0     0 194 (44%)   78 (18%)     0     0
Respiratory 161 (35%)     9 (2%)     2 (<1%)     0 196 (44%)   12 (3%)     1 (<1%)     1 (<1%)
Skin 121 (27%)     4 (1%)     1 (<1%)     0 167 (38%)     3 (1%)     1 (<1%)     0
Vascular 365 (80%)   24 (5%)     1 (<1%)     0 324 (73%)   93 (21%)     1 (<1%)     0
    Hypertension   60 (13%)   12 (3%)     0     0 187 (42%)   69 (16%)     0     0
    Hot flushes 365 (80%)   12 (3%)     0     0 374 (84%)   24 (5%)     0     0

Grade 1–2 adverse events occurring in 10% or more of patients in any treatment group or any grade 3, 4, or 5 adverse events stratified by body system, including adverse events of special interest. Abiraterone refers to abiraterone acetate and prednisolone. All adverse events in the abiraterone trial are shown in the appendix (p 7). *Events on old form categorised as “Cardiovascular—other” have been included in the cardiac body system.