Table 3.
Non-haematological adverse events occurring in ≥5% of patients for any grade and ≥3% of patients for grade ≥ 3
| Preferred term n (%) | Cabazitaxel (n = 112) | Abiraterone or enzalutamide (n = 105) | ||
|---|---|---|---|---|
| Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
| Asthenia or fatigue | 62 (55.4) | 5 (4.5) | 37 (35.2) | 1 (1.0) |
| Diarrhoea | 45 (40.2) | 4 (3.6) | 6 (5.7) | 0 |
| Infection | 36 (32.1) | 7 (6.3) | 23 (21.9) | 7 (6.7) |
| Musculoskeletal pain or discomfort* | 32 (28.6) | 2 (1.8) | 38 (36.2) | 4 (3.8) |
| Nausea or vomiting | 30 (26.8) | 0 | 21 (20.0) | 1 (1.0) |
| Peripheral neuropathy† | 23 (20.5) | 4 (3.6) | 3 (2.9) | 0 |
| Haematuria | 19 (17.0) | 1 (0.9) | 6 (5.7) | 1 (1.0) |
| Constipation | 16 (14.3) | 0 | 10 (9.5) | 0 |
| Decreased appetite | 16 (14.3) | 1 (0.9) | 15 (14.3) | 3 (2.9) |
| Dysgeusia | 12 (10.7) | 0 | 4 (3.8) | 0 |
| Abdominal pain | 10 (8.9) | 1 (0.9) | 3 (2.9) | 1 (1.0) |
| Bladder or urethral symptom‡ | 10 (8.9) | 0 | 6 (5.7) | 0 |
| Peripheral edema | 10 (8.9) | 0 | 8 (7.6) | 1 (1.0) |
| Cancer pain | 9 (8.0) | 2 (1.8) | 8 (7.6) | 1 (1.0) |
| Stomatitis | 9 (8.0) | 0 | 1 (1.0) | 0 |
| Pain | 8 (7.1) | 0 | 5 (4.8) | 1 (1.0) |
| Renal disorder§ | 7 (6.3) | 3 (2.7) | 12 (11.4) | 9 (8.6) |
| Alopecia | 6 (5.4) | 0 | 0 | 0 |
| Arthralgia | 6 (5.4) | 0 | 14 (13.3) | 1 (1.0) |
| Dyspepsia | 6 (5.4) | 0 | 2 (1.9) | 0 |
| Fall | 6 (5.4) | 0 | 0 | 0 |
| Paraesthesia | 6 (5.4) | 0 | 2 (1.9) | 0 |
| Pyrexia | 6 (5.4) | 0 | 9 (8.6) | 0 |
| Spinal cord or nerve-root disorder|| | 6 (5.4) | 3 (2.7) | 5 (4.8) | 3 (2.9) |
| Hypertensive disorder¶ | 5 (4.5) | 3 (2.7) | 9 (8.6) | 2 (1.9) |
| Psychiatric disorder†† | 5 (4.5) | 0 | 13 (12.4) | 0 |
| Weight decreased | 5 (4.5) | 0 | 7 (6.7) | 0 |
| Cardiac disorder | 4 (3.6) | 1 (0.9) | 8 (7.6) | 5 (4.8) |
| Disease progression | 4 (3.6) | 4 (3.6) | 8 (7.6) | 7 (6.7) |
| Febrile neutropenia | 4 (3.6) | 4 (3.6) | 0 | 0 |
| Bone fracture | 2 (1.8) | 1 (0.9) | 6 (5.7) | 2 (1.9) |
| Dizziness | 1 (0.9) | 0 | 6 (5.7) | 0 |
*Musculoskeletal pain or discomfort included ‘Back pain’, ‘Flank pain’, ‘Musculoskeletal discomfort’, ‘Musculoskeletal pain’, ‘Discomfort’,
‘Neck pain’, ‘Pain in extremity’, ‘Growing pains’, ‘Musculoskeletal chest pain’.
†Peripheral Neuropathy included, ‘Neuropathy peripheral’, ‘Peripheral motor neuropathy’, ‘Peripheral sensorimotor neuropathy’, ‘Peripheral sensory neuropathy’, ‘Polyneuropathy’.
‡Bladder or urethral symptom included ‘Dysuria’, ‘Pollakiuria’, ‘Lower urinary tract symptoms’, ‘Micturition urgency’, ‘Urinary incontinence’, ‘Urinary retention’.
§Renal disorder included, ‘Acute kidney injury’, ‘Renal failure’, ‘Renal impairment’, ‘Hydronephrosis’, ‘Pyelocaliectasis’.
||Spinal cord or nerve-root disorder included ‘Sciatica’, ‘Radiculopathy’, ‘Spinal cord compression’.
¶ Hypertensive disorder included ‘Hypertension’, ‘Hypertensive crisis’.
††Psychiatric disorder included ‘Anxiety’, ‘Depression’, ‘Confusional state’, ‘Disorientation’, ‘Persistent depressive disorder’, ‘Insomnia’.
Note: System organ class was used for infection and cardiac disorders.