Table 4. Safety endpoints.
Figures are numbers of participants (percentage) unless stated otherwise.
| All (n = 154) | Low dose (n = 76) | High dose (n = 78) | p-value | |
|---|---|---|---|---|
| Patients reporting Adverse Events | 137 (89%) | 64 (84%) | 73 (94%) | 0·075 |
| Patients reporting Serious Adverse Events | 18 (12%) | 7 (9%) | 11 (14%) | 0·45 |
| Type of events reported | ||||
| Skin and subcutaneous tissue disorders | 101 (65·6%) | 49 (64·5%) | 52 (66·7%) | 0·866 |
| Infected bite | 62 (61·4%) | 34 (44·7%) | 28 (35·9%) | 0·324 |
| Pruritus, rash or angioedema | 59 (58·4%) | 29 (38·2%) | 30 (38·5%) | 1 |
| General disorders | 75 (48·7%) | 35 (46·1%) | 40 (51·3%) | 0·524 |
| Fever and chills | 73 (47·4%) | 35 (46·1%) | 38 (48·7%) | 0·750 |
| Gastrointestinal disorders | 51 (33·1%) | 28 (36·8%) | 23 (29·5%) | 0·393 |
| Epigastric discomfort | 28 (18·2%) | 16 (21·1%) | 12 (15·4%) | 0·408 |
| Vomiting | 23 (14·9%) | 11 (14·5%) | 12 (15·4%) | 1 |
| Abdominal pain | 6 (3·9%) | 4 (5·3%) | 2 (2·6%) | 0·439 |
| Respiratory, thoracic and mediastinal disorders | 39 (25·3%) | 18 (23·7%) | 21 (26·9%) | 0·712 |
| Tachypnoea | 24 (15·6%) | 10 (13·2%) | 14 (17·9%) | 0·507 |
| Wheezing/laryngeal edema | 13 (8·4%) | 7 (9·2%) | 6 (7·7%) | 0·779 |
| Respiratory failure | 6 (3·9%) | 0 (0%) | 6 (7·7%) | 0·028 |
| Nervous system disorders | 22 (14·3%) | 8 (10·5%) | 14 (17·9%) | 0·250 |
| Paraesthesia | 11 (7·1%) | 6 (7·9%) | 5 (6·4%) | 0·764 |
| Headache | 7 (4·5%) | 1 (1·3%) | 6 (7·7%) | 0·117 |
| Musculoskeletal and connective tissue disorders | 22 (14·3%) | 9 (11·8%) | 13 (16·7%) | 0·491 |
| Myalgia | 9 (5·8%) | 3 (3·9%) | 4 (5·1%) | 1 |
| Arthralgia1 | 7 (4·5%) | 3 (3·9%) | 4 (5·1%) | 1 |
1 Late arthralgia: defined as occurring later than 7 days after treatment initiation