Table 2.
Overall summary of TEAEs (safety population)
| Adverse event category, n (%) | ALLO alone (n=206) |
Lesinurad 200 mg+ALLO (n=204) | Lesinurad 400 mg+ALLO (n=200) |
|---|---|---|---|
| Any TEAE | 146 (70.9) | 152 (74.5) | 161 (80.5) |
| Any TEAE with RCTC toxicity grade 3 or 4 | 23 (11.2) | 19 (9.3) | 27 (13.5) |
| Any TEAE possibly related to randomised study medication | 39 (18.9) | 40 (19.6) | 50 (25.0) |
| Any serious TEAE | 8 (3.9) | 9 (4.4) | 19 (9.5) |
| Any fatal TEAE | 0 | 0 | 2 (1.0) |
| Any TEAE leading to randomised study medication discontinuation | 11 (5.3) | 7 (3.4) | 19 (9.5) |
| Any TEAE leading to study withdrawal | 7 (3.4) | 4 (2.0) | 12 (6.0) |
| Individual serious TEAEs, n (%) | |||
| Infections and infestations | |||
| Pneumonia | 0 | 2 (1.0) | 0 |
| Bronchopneumonia | 0 | 0 | 1 (0.5) |
| Cellulitis | 0 | 0 | 1 (0.5) |
| Empyema | 0 | 1 (0.5) | 0 |
| Pyelonephritis chronic | 0 | 0 | 1 (0.5) |
| Sinobronchitis | 0 | 1 (0.5) | 0 |
| Abscess limb | 1 (0.5) | 0 | 0 |
| Appendicitis | 1 (0.5) | 0 | 0 |
| Diverticulitis | 1 (0.5) | 0 | 0 |
| Neoplasms benign, malignant and unspecified | |||
| Basal cell carcinoma | 0 | 0 | 1 (0.5) |
| Gastric cancer | 0 | 0 | 1 (0.5)* |
| Ovarian adenoma | 0 | 1 (0.5) | 0 |
| Parathyroid tumour benign | 0 | 1 (0.5) | 0 |
| Prostate cancer | 0 | 0 | 1 (0.5) |
| Pancreatic neuroendocrine tumour | 1 (0.5) | 0 | 0 |
| Metabolism and nutrition disorders | |||
| Gout flare | 0 | 0 | 2 (1.0) |
| Psychiatric disorders | |||
| Depression | 0 | 1 (0.5) | 0 |
| Dissociative disorder | 0 | 0 | 1 (0.5) |
| Nervous system disorders | |||
| Subarachnoid haemorrhage | 1 (0.5) | 0 | 0 |
| Cardiac disorders | |||
| Myocardial infarction | 0 | 0 | 3 (1.5%) |
| Atrial fibrillation | 0 | 1 (0.5) | 0 |
| Coronary artery disease | 0 | 0 | 1 (0.5) |
| Intracardiac thrombus | 0 | 0 | 1 (0.5) |
| Vascular disorders | |||
| Hypertensive crisis | 0 | 0 | 1 (0.5) |
| Respiratory, thoracic and mediastinal disorders | |||
| Pulmonary oedema | 0 | 0 | 1 (0.5)* |
| Gastrointestinal disorders | |||
| Duodenal ulcer haemorrhage | 1 (0.5) | 0 | 1 (0.5) |
| Gastrointestinal haemorrhage | 0 | 1 (0.5) | 0 |
| Musculoskeletal and connective tissue disorders | |||
| Osteoarthritis | 0 | 0 | 2 (1.0) |
| Arthralgia | 0 | 1 (0.5) | 0 |
| Back pain | 0 | 1 (0.5) | 0 |
| Flank pain | 0 | 1 (0.5) | 0 |
| Intervertebral disc degeneration | 0 | 0 | 1 (0.5) |
| Renal and urinary disorders | |||
| Nephrolithiasis | 0 | 0 | 2 (1.0) |
| Renal failure acute | 1 (0.5) | 0 | 1 (0.5) |
| Renal impairment | 0 | 0 | 1 (0.5) |
| General disorders and administration site conditions | |||
| Adverse drug reaction | 0 | 1 (0.5) | 0 |
| Non-cardiac chest pain | 0 | 1 (0.5) | 0 |
| Injury, poisoning and procedural complications | |||
| Multiple drug overdose | 0 | 1 (0.5) | 0 |
| Multiple injuries | 0 | 1 (0.5) | 0 |
| Femur fracture | 1 (0.5) | 0 | 0 |
*Fatal serious TEAE.
ALLO, allopurinol; RCTC, Rheumatology Common Toxicity Criteria; TEAE, treatment-emergent adverse event.