Table 4.
Adverse events occurring in ≥10% of patients in the Japanese safety-evaluable subgroup
Atezolizumab + nab-paclitaxel (n = 34) | Placebo + nab-paclitaxel (n = 30) | |||
---|---|---|---|---|
Any grade in ≥10% of patients | Grade ≥ 3 | Any grade in ≥10% of patients | Grade ≥ 3 | |
Patients with ≥1 event, n (%) | 34 (100) | 13 (28.2) | 30 (100) | 12 (40.0) |
Alopecia | 29 (85.3) | 0 | 26 (86.7) | 0 |
Peripheral sensory neuropathy | 20 (58.8) | 0 | 15 (50.0) | 0 |
Nausea | 16 (47.1) | 0 | 12 (40.0) | 1 (3.3) |
Neutrophil count decreased | 15 (44.1) | 6 (17.6) | 10 (33.3) | 5 (16.7) |
Nasopharyngitis | 11 (32.4) | 0 | 3 (10.0) | 0 |
Rash | 10 (29.4) | 0 | 6 (20.0) | 0 |
White blood cell count decreased | 10 (29.4) | 4 (11.8) | 3 (10.0) | 2 (6.7) |
Stomatitis | 9 (26.5) | 0 | 3 (10.0) | 0 |
Constipation | 8 (23.5) | 0 | 10 (33.3) | 0 |
Dysgeusia | 8 (23.5) | 0 | 9 (30.0) | 0 |
Pyrexia | 8 (23.5) | 0 | 6 (20.0) | 0 |
Fatigue | 8 (23.5) | 0 | 6 (20.0) | 0 |
Peripheral oedema | 8 (23.5) | 0 | 6 (20.0) | 0 |
Nail discoloration | 7 (20.6) | 0 | 9 (30.0) | 0 |
Decreased appetite | 7 (20.6) | 0 | 8 (26.7) | 1 (3.3) |
Vomiting | 7 (20.6) | 1 (2.9) | 3 (10.0) | 0 |
Paronychia | 7 (20.6) | 0 | 0 | 0 |
Myalgia | 6 (17.6) | 0 | 7 (23.3) | 1 (3.3) |
Anaemia | 6 (17.6) | 0 | 7 (23.3) | 0 |
Dry skin | 6 (17.6) | 0 | 6 (20.0) | 0 |
Diarrhoea | 6 (17.6) | 0 | 5 (16.7) | 0 |
Headache | 6 (17.6) | 0 | 4 (13.3) | 0 |
Pruritis | 6 (17.6) | 0 | 2 (6.7) | 0 |
Malaise | 5 (14.7) | 0 | 10 (33.3) | 0 |
Alanine aminotransferase increased | 5 (14.7) | 0 | 8 (26.7) | 1 (3.3) |
Aspartate aminotransferase increased | 4 (11.8) | 0 | 5 (16.7) | 1 (3.3) |
Arthralgia | 4 (11.8) | 0 | 4 (13.3) | 0 |
Urinary tract infection | 4 (11.8) | 0 | 1 (3.3) | 0 |
Insomnia | 4 (11.8) | 0 | 1 (3.3) | 0 |
Neutropenia | 4 (11.8) | 3 (8.8) | 0 | 0 |
Hypothyroidism | 4 (11.8) | 0 | 0 | 0 |
Oedema | 3 (8.8) | 0 | 3 (10.0) | 0 |
Peripheral neuropathy | 2 (5.9) | 0 | 5 (16.7) | 0 |
Cough | 2 (5.9) | 0 | 4 (13.3) | 0 |
Pharyngitis | 2 (5.9) | 0 | 3 (10.0) | 0 |