Table 2:
Total adverse events (intention-to-treat population)
| 100 mg/day | 300 mg/day | 1000 mg/day | 2000 mg/day | All groups | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Patients (n=8) | Events (n=7) | Patients (n=8) | Events (n=6) | Patients (n=10) | Events (n=20) | Patients (n=8) | Events (n=12) | Patients (n=34) | Events (n=45) | ||
| Any serious adverse events | 6 (75·0%) | 7 (100%) | 4 (50.0%) | 6 (100%) | 8 (80·0%) | 20 (100%) | 7 (87·5%) | 12 (100%) | 25 (73 5%) | 45 (100%) | |
| Gastrointestinal disorders | 0 | 0 | 0 | 0 | 4 (40·0%) | 6 (30·0%) | 4 (50·0%) | 4 (333%) | 8 (23 5%) | 10 (22·2%) | |
| Constipation | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12.5%) | 1 (8·3%) | 1 (2·9%) | 1 (2·2%) | |
| Diarrhoea | 0 | 0 | 0 | 0 | 3 (30·0%) | 3 (15·0%) | 0 | 0 | 3 (8·8%) | 3 (67%) | |
| Flatulence | 0 | 0 | 0 | 0 | 2 (20·0%) | 2 (10·0%) | 1 (12·5%) | 1 (8·3%) | 3 (8·8%) | 3 (6·7%) | |
| Abnormal gastrointestinal sounds | 0 | 0 | 0 | 0 | 0 | 0 | 2 (25·0%) | 2 (16·7%) | 2 (5·9%) | 2 (4·4%) | |
| Nausea | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Infections and infestations | 0 | 0 | 1 (12·5%) | 1 (16·7%) | 2 (20·0%) | 2 (10·0%) | 1 (12·5%) | 1 (8·3%) | 4 (11·8%) | 4 (8·9%) | |
| Bronchitis | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Influenza | 0 | 0 | 1 (12·5%) | 1 (16·7%) | 0 | 0 | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Myringitis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12·5%) | 1 (8·3%) | 1 (2·9%) | 1 (2·2%) | |
| Nasopharyngitis | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Injury, poisoning, and procedural complications | 1 (12·5%) | 1 (14·3%) | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 2 (5·9%) | 2 (4·4%) | |
| Joint injury | 1 (12·5%) | 1 (14·3%) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Post-procedural myocardial Infarction | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Investigations | 0 | 0 | 1 (12·5%) | 2 (33·3%) | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 2 (5·9%) | 3 (6·7%) | |
| Increased C-reactive protein | 0 | 0 | 1 (12·5%) | 1 (16·7%) | 0 | 0 | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Increased serum amyloid A | 0 | 0 | 1 (12·5%) | 1 (16·7%) | 0 | 0 | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| protein | |||||||||||
| Weight decreased | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Metabolism and nutrition disorders | 5 (62·5%) | 6 (85·7%) | 3 (37·5%) | 3 (50·0%) | 5 (50·0%) | 6 (30·0%) | 2 (25·0%) | 2 (16·7%) | 15 (44·1%) | 17 (37·8%) | |
| Decreased appetite | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Gout | 5 (62·5%) | 6 (85·7%) | 3 (37·5%) | 3 (50·0%) | 4 (40·0%) | 4 (20·0%) | 2 (25·0%) | 2 (16·7%) | 14 (41·2%) | 15 (33·3%) | |
| Hyponatraemia | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Musculoskeletal and connective | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12·5%) | 1 (8·3%) | 1 (2·9%) | 1 (2·2%) | |
| tissue disorders | |||||||||||
| Arthritis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12·5%) | 1 (8·3%) | 1 (2·9%) | 1 (2·2%) | |
| Nervous system disorders | 0 | 0 | 0 | 0 | 3 (30·0%) | 3 (15·0%) | 1 (12·5%) | 2 (16·7%) | 4 (11·8%) | 5 (11·4%) | |
| Dizziness | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Dysgeusia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12·5%) | 1 (8·3%) | 1 (2·9%) | 1 (2·2%) | |
| Headache | 0 | 0 | 0 | 0 | 2 (20·0%) | 2 (10·0%) | 1 (12·5%) | 1 (8·3%) | 3 (8·8%) | 3 (6·7%) | |
| Respiratory, thoracic, and mediastinal disorders | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 1 (12·5%) | 1 (8·3%) | 2 (5·9%) | 2 (4·4%) | |
| Dyspnoea | 0 | 0 | 0 | 0 | 1 (10·0%) | 1 (5·0%) | 0 | 0 | 1 (2·9%) | 1 (2·2%) | |
| Rhinorrhoea | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12·5%) | 1 (8·3%) | 1 (2·9%) | 1 (2·2%) | |
| Skin and subcutaneous tissue disorders | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12·5%) | 1 (8·3%) | 1 (2·9%) | 1 (2·2%) | |
| Hyperhidrosis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (12·5%) | 1 (8·3%) | 1 (2·9%) | 1 (2·2%) | |
| Adverse events are listed according to MedDRA System Organ Class preferred terms. | |||||||||||
Adverse events are listed according to MedDRA System Organ Class preferred terms.