Summary of TEAEs (safety population)
| n (%) | Lesinurad 200 mg+allopurinol (n=46) | Lesinurad 400 mg+allopurinol (n=42) | Lesinurad 600 mg+allopurinol (n=48) | Pooled lesinurad (n=136) | Placebo+allopurinol (n=72) |
|---|---|---|---|---|---|
| ≥1 TEAE | 21 (45.7) | 20 (47.6) | 26 (54.2) | 67 (49.3) | 33 (45.8) |
| ≥1 treatment-related TEAE | 1 (2.2) | 5 (11.9) | 5 (10.4) | 11 (8.1) | 9 (12.5) |
| ≥1 SAE | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 |
| Discontinuation due to TEAE | 0 | 1 (2.4) | 2 (4.2) | 3 (2.2) | 1 (1.4) |
| Specific TEAEs* | |||||
| Gout flare | 10 (21.7) | 13 (31) | 15 (31.3) | 38 (27.9) | 15 (20.8) |
| Arthralgia | 3 (6.5) | 1 (2.4) | 2 (4.2) | 6 (4.4) | 4 (5.6) |
| Headache | 3 (6.5) | 2 (4.8) | 1 (2.1) | 6 (4.4) | 1 (1.4) |
| Nasopharyngitis | 4 (8.7) | 0 | 1 (2.1) | 5 (3.7) | 1 (1.4) |
| Tendonitis | 2 (4.3) | 0 | 1 (2.1) | 3 (2.2) | 0 |
| Lipase increased | 0 | 2 (4.8) | 0 | 2 (1.5) | 1 (1.4) |
| URI | 0 | 0 | 2 (4.2) | 2 (1.5) | 0 |
| Urticaria | 0 | 0 | 2 (4.2) | 2 (1.5) | 0 |
| Diarrhoea | 1 (2.2) | 1 (2.4) | 0 | 2 (1.5) | 3 (4.2) |
| Haematuria | 0 | 1 (2.4) | 0 | 1 (0.7) | 3 (4.2) |
| Back pain | 0 | 1 (2.4) | 0 | 1 (0.7) | 2 (2.8) |
| Dizziness | 1 (2.2) | 0 | 0 | 1 (0.7) | 2 (2.8) |
| Fatigue | 0 | 1 (2.4) | 0 | 1 (0.7) | 2 (2.8) |
| Myalgia | 0 | 1 (2.4) | 0 | 1 (0.7) | 0 |
| Nausea | 0 | 0 | 0 | 0 | 2 (2.8) |
*Reported in ≥1 patient in any group.
SAE, serious adverse event; TEAE, treatment-emergent adverse event; URI, upper respiratory tract infection.