Table 2:
Adverse events occurring in at least 10% of patients in any treatment group
| Acalabrutinib-obinutuzumab (n=178) | Acalabrutinib monotherapy (n=179) | Obinutuzumab-chlorambucil (n=169) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Any grade | Grade 1–2 | Grade ≥3 | Any grade | Grade 1–2 | Grade ≥3 | Any grade | Grade 1–2 | Grade ≥3 | |
| Summary of adverse events | |||||||||
| Any | 171 (96·1%) | 46 (25·8%) | 125 (70·2%) | 170 (95·0%) | 81 (45·3%) | 89 (49·7%) | 167 (98·8%) | 49 (29·0%) | 118 (69·8%) |
| Serious | 69 (38·8%) | 11 (6·2%) | 58 (32·6%) | 57 (31·8%) | 4 (2·2%) | 53 (29·6%) | 37 (21·9%) | 4 (2·4%) | 33 (19·5%) |
| Led to drug discontinuation (any grade) | 20 (11·2%) | ‥ | ‥ | 16 (8·9%) | ‥ | ‥ | 25 (14·1%) | ‥ | ‥ |
| Most common adverse events | |||||||||
| Headache | 71 (39·9%) | 69 (38·8%) | 2 (1·1%) | 66 (36·9%) | 64 (35·8%) | 2 (1·1%) | 20 (11·8%) | 20 (11·8%) | 0 |
| Diarrhoea | 69 (38·8%) | 61 (34·3%) | 8 (4·5%) | 62 (34·6%) | 61 (34·1%) | 1 (0·6%) | 36 (21·3%) | 33 (19·5%) | 3 (1·8%) |
| Neutropenia | 56 (31·5%) | 3 (1·7%) | 53 (29·8%) | 19 (10·6%) | 2 (1·1%) | 17 (9·5%) | 76 (45·0%) | 6 (3·6%) | 70 (41·4%) |
| Fatigue | 50 (28·4%) | 47 (26·4%) | 3 (1·7%) | 33 (18·4%) | 31 (17·3%) | 2 (1·1%) | 29 (17·2%) | 28 (16·6%) | 1 (0·6%) |
| Contusion | 42 (23·6%) | 42 (23·6%) | 0 | 27 (15·1%) | 27 (15·1%) | 0 | 7 (4·1%) | 7 (4·1%) | 0 |
| Arthralgia | 39 (21·9%) | 37 (20·8%) | 2 (1·1%) | 28 (15·6%) | 27 (15·1%) | 1 (0·6%) | 8 (4·7%) | 6 (3·6%) | 2 (1·7%) |
| Cough | 39 (21·9%) | 39 (21·9%) | 0 | 33 (18·4%) | 32 (17·9%) | 1 (0·6%) | 15 (8·9%) | 15 (8·9%) | 0 |
| Upper respiratory tract infection | 38 (21·3%) | 34 (19·1%) | 4 (2·2%) | 33 (18·4%) | 33 (18·4%) | 0 | 14 (8·3%) | 13 (7·7%) | 1 (0·6%) |
| Nausea | 36 (20·2%) | 36 (20·2%) | 0 | 40 (22·3%) | 40 (22·3%) | 0 | 53 (31·4%) | 53 (31·4%) | 0 |
| Dizziness | 32 (18·0%) | 32 (18·0%) | 0 | 21 (11·7%) | 21 (11·7%) | 0 | 10 (5·9%) | 10 (5·9%) | 0 |
| Back pain | 25 (14·0%) | 24 (13·5%) | 1 (0·6%) | 25 (14·0%) | 23 (12·8%) | 2 (1·1%) | 14 (8·3%) | 13 (7·7%) | 1 (0·6%) |
| Constipation | 25 (14·0%) | 25 (14·0%) | 0 | 20 (11·2%) | 20 (11·2%) | 0 | 17 (10·1%) | 16 (9·5%) | 1 (0·6%) |
| Infusion-related reaction | 24 (13·5%) | 20 (11·2%) | 4 (2·2%) | 0 | 0 | 0 | 67 (39·6%) | 58 (34·3%) | 9 (5·3%) |
| Vomiting | 24 (13·5%) | 23 (12·9%) | 1 (0·6%) | 22 (12·3%) | 21 (11·7%) | 1 (0·6%) | 19 (11·2%) | 18 (10·7%) | 1 (0·6%) |
| Pyrexia | 23 (12·9%) | 23 (12·9%) | 0 | 12 (6·7%) | 11 (6·1%) | 1 (0·6%) | 35 (20·7%) | 34 (20·4%) | 1 (0·6%) |
| Thrombocytopenia | 23 (12·9%) | 8 (4·5%) | 15 (8·4%) | 13 (7·3%) | 8 (4·5%) | 5 (2·8%) | 24 (14·2%) | 4 (2·4%) | 20 (11·8%) |
| Oedema peripheral | 22 (12·4%) | 21 (11·8%) | 1 (0·6%) | 16 (8·9%) | 15 (8·4%) | 1 (0·6%) | 12 (7·1%) | 12 (7·1%) | 0 |
| Pain in extremity | 22 (12·4%) | 21 (11·8%) | 1 (0·6%) | 11 (6·1%) | 11 (6·1%) | 0 | 7 (4·1%) | 7 (4·1%) | 0 |
| Urinary tract infection | 22 (12·4%) | 21 (11·8%) | 1 (0·6%) | 22 (12·3%) | 19 (10·6%) | 3 (1·7%) | 8 (4·7%) | 8 (4·7%) | 0 |
| Anaemia | 21 (11·8%) | 11 (6·2%) | 10 (5·6%) | 25 (14·0%) | 13 (7·3%) | 12 (6·7%) | 20 (11·8%) | 8 (4·7%) | 12 (7·1%) |
| Rash | 21 (11·8%) | 20 (11·2%) | 1 (0·6%) | 25 (14·0%) | 24 (13·4%) | 1 (0·6%) | 8 (4·7%) | 8 (4·7%) | 0 |
| Chills | 20 (11·2%) | 20 (11·2%) | 0 | 8 (4·5%) | 8 (4·5%) | 0 | 14 (8·3%) | 13 (7·7%) | 1 (0·6%) |
| Nasopharyngitis | 20 (11·2%) | 19 (10·7%) | 1 (0·6%) | 17 (9·5%) | 17 (9·5%) | 0 | 7 (4·1%) | 7 (4·1%) | 0 |
| Pneumonia | 19 (10·7%) | 9 (5·1%) | 10 (5·6%) | 13 (7·3%) | 9 (5·0%) | 4 (2·2%) | 5 (3·0%) | 2 (1·7%) | 3 (1·8%) |
| Decreased appetite | 18 (10·1%) | 18 (10·1%) | 0 | 10 (5·6%) | 10 (5·6%) | 0 | 13 (7·7%) | 12 (7·1%) | 1 (0·6%) |
| Dyspnoea | 15 (8·4%) | 15 (8·4%) | 0 | 12 (6·7%) | 9 (5·0%) | 3 (1·7%) | 17 (10·1%) | 14 (8·3%) | 3 (1·8%) |
Data are n (%).