Number (%) of participants with treatment emergent serious and non-adverse events in each category during year 1 and year 2
| Serious adverse events months 0–12 | Serious adverse events months 12–24 | Non-laboratory treatment emergent adverse event months 0–12 | Non-laboratory treatment emergent adverse event months 12–24 | |||||
| Control/DE (n=93) | DE/DE (n=90) | Control/DE (n=93) | DE/DE (n=90) | Control/DE (n=93) | DE/DE (n=90) | Control/DE (n=93) | DE/DE (n=90) | |
| Number of participants with at least one adverse event | 25 (27%) | 22 (24%) | 14 (15.1%) | 22 (24.4%) | 80 (86%) | 73 (81%) | 65 (70%) | 62 (69%) |
| Cardiac disorders | 8 (9%) | 11 (12%) | 7 (7.5%) | 7 (7.8%) | 9 (10%) | 5 (6%) | 3 (3%) | 3 (3%) |
| Gastrointestinal disorders | 6 (7%) | 3 (3%) | 5 (5.4%) | 4 (4.4%) | 21 (23%) | 18 (20%) | 14 (15%) | 14 (16%) |
| General disorders | 1 (1%) | 1 (1%) | 2 (2%) | 1 (1%) | 47 (51%) | 48 (53%) | 31 (33%) | 30 (33%) |
| Hepatobiliary disorders | 0 | 1 (1%) | 0 | 0 | 0 | 2 (2%) | 0 | 2 (2%) |
| Infections and infestations | 8 (9%) | 3 (3%) | 6 (6.5%) | 7 (7.8%) | 18 (19%) | 14 (16%) | 17 (18%) | 11 (12%) |
| Injury, poisoning and procedural complications | 2 (2%) | 1 (1%) | 4 (4.3%) | 1 (1%) | 15 (16%) | 24 (27%) | 12 (13%) | 10 (11%) |
| Metabolism and nutrition | 0 | 0 | 0 | 0 | 4 (4%) | 1 (1%) | 2 (2%) | 4 (4%) |
| Musculoskeletal | 1 (1%) | 1 (1%) | 1 (1%) | 1 (1%) | 27 (29%) | 24 (27%) | 24 (26%) | 30 (33%) |
| Nervous system disorders | 3 (3%) | 1 (1%) | 2 (2%) | 4 (4.4%) | 10 (11%) | 11 (12%) | 13 (14%) | 4 (4%) |
| Renal and urinary disorders | 5 (5%) | 2 (2%) | 0 | 3 (3.3%) | 0 | 2 (2%) | 1 (1%) | 0 |
| Respiratory, thoracic and mediastinal disorders | 2 (2%) | 2 (2%) | 0 | 0 | 16 (17%) | 15 (17%) | 11 (12%) | 11 (12%) |
| Skin and subcutaneous tissue disorders | 1 (1%) | 1 (1%) | 0 | 0 | 20 (22%) | 23 (26%) | 18 (19%) | 14 (16%) |
| Ear and labyrinth | 0 | 0 | 0 | 0 | 3 (3%) | 3 (3%) | 1 (1%) | 3 (3%) |
| Endocrine | 0 | 0 | 0 | 0 | 0 | 1 (1%) | 0 | 1 (1%) |
| Eye | 0 | 0 | 0 | 0 | 4 (4%) | 3 (3%) | 1 (1%) | 1 (1%) |
| Immune system | 0 | 0 | 0 | 0 | 1 (1%) | 1 (1%) | 0 | 1 (1%) |
| Neoplasms benign, malignant and unspecified | 0 | 0 | 0 | 0 | 4 (4%) | 4 (4%) | 11 (12%) | 3 (3%) |
| Psychiatric disorders | 0 | 0 | 1 (1%) | 1 (1%) | 5 (5%) | 4 (4%) | 3 (3%) | 4 (4%) |
| Reproductive and breast disorders | 0 | 0 | 0 | 0 | 2 (2%) | 0 | 1 (1%) | 2 (2%) |
| Surgical and medical procedures | 0 | 0 | 0 | 0 | 2 (2%) | 2 (2%) | 1 (1%) | 2 (2%) |
| Vascular disorders | 0 | 0 | 0 | 1 (1%) | 8 (9%) | 10 (11%) | 4 (4%) | 12 (13%) |
| Venous disorders | 0 | 0 | 0 | 0 | 1 (1%) | 0 | 1 (1%) | 0 |
| Allopurinol specific adverse events | ||||||||
| Allopurinol hypersensitivity syndrome | 0 | 0 | 0 | 0 | ||||
| Rash | 11 (12%) | 8 (9%) | 7 (7%) | 4 (4%) | ||||
| Pruritus | 5 (5%) | 10 (11%) | 7 (7%) | 4 (4%) | ||||
| Nausea/vomiting | 9 (10%) | 6 (7%) | 6 (6%) | 5 (6%) | ||||
| Abdominal pain | 5 (5%) | 6 (7%) | 2 (2%) | 3 (3%) | ||||
DE, dose escalation.