Table III.
Treatment emergent adverse events occurring in ≥10% of patients by preferred term and maximum severity.
| AE, n (%) | Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 |
|---|---|---|---|---|---|---|
| Any | 123 (100) | 1 (0·8) | 32 (26·0) | 62 (50·4) | 24 (19·5) | 4 (3·3) |
| Contusion | 64 (52·0) | 58 (47·2) | 6 (4·9) | 0 | 0 | 0 |
| URTI | 60 (48·8) | 3 (2·4) | 56 (45·5) | 1 (0·8) | 0 | 0 |
| Cough | 44 (35·8) | 30 (24·4) | 14 (11·4) | 0 | 0 | 0 |
| Diarrhoea | 44 (35·8) | 29 (23·6) | 14 (11·4) | 1 (0·8) | 0 | 0 |
| Headache | 33 (26·8) | 24 (19·5) | 9 (7·3) | 0 | 0 | 0 |
| Constipation | 31 (25·2) | 23 (18·7) | 6 (4·9) | 2 (1·6) | 0 | 0 |
| UTI | 29 (23·6) | 1 (0·8) | 22 (17·9) | 6 (4·9) | 0 | 0 |
| Rash | 29 (23·6) | 19 (15·4) | 9 (7·3) | 1 (0·8) | 0 | 0 |
| Fatigue | 28 (22·8) | 20 (16·3) | 7 (5·7) | 1 (0·8) | 0 | 0 |
| Arthralgia | 27 (22·0) | 13 (10·6) | 11 (8·9) | 3 (2·4) | 0 | 0 |
| Nausea | 26 (21·1) | 15 (12·2) | 11 (8·9) | 0 | 0 | 0 |
| Back pain | 25 (20·3) | 15 (12·2) | 9 (7·3) | 1 (0·8) | 0 | 0 |
| Pneumonia | 24 (19·5) | 0 | 12 (9·8) | 12 (9·8) | 0 | 0 |
| Hypertension | 24 (19·5) | 1 (0·8) | 12 (9·8) | 11 (8·9) | 0 | 0 |
| Sinusitis | 24 (19·5) | 0 | 23 (18·7) | 1 (0·8) | 0 | 0 |
| Neutropenia | 22 (17·9) | 1 (0·8) | 2 (1·6) | 6 (4·9) | 13 (10·6) | 0 |
| LRTI | 21 (17·1) | 2 (1·6) | 16 (13·0) | 2 (1·6) | 1 (0·8) | 0 |
| Haematuria | 20 (16·3) | 18 (14·6) | 2 (1·6) | 0 | 0 | 0 |
| Fall | 17 (13·8) | 6 (4·9) | 7 (5·7) | 4 (3·3) | 0 | 0 |
| Muscle spasms | 16 (13·0) | 11 (8·9) | 5 (4·1) | 0 | 0 | 0 |
| Dizziness | 16 (13·0) | 15 (12·2) | 1 (0·8) | 0 | 0 | 0 |
| Cellulitis | 14 (11·4) | 0 | 8 (6·5) | 6 (4·9) | 0 | 0 |
| GERD | 14 (11·4) | 8 (6·5) | 6 (4·9) | 0 | 0 | 0 |
| Anaemia | 14 (11·4) | 2 (1·6) | 4 (3·3) | 7 (5·7) | 1 (0·8) | 0 |
| Vomiting | 14 (11·4) | 10 (8·1) | 4 (3·3) | 0 | 0 | 0 |
AE, adverse event; GERD, gastro‐oesophageal reflux disease; LRTI, lower respiratory tract infection; URTI, upper respiratory tract infection; UTI, urinary tract infection.