Table 3.
Summary of treatment-emergent adverse events with LESU
| Adverse event | CLEAR 113
|
CRYSTAL15
|
||||
|---|---|---|---|---|---|---|
| APL monotherapy N=201 |
LESU200 + APL N=201 |
LESU400 + APL N=201 |
PBO + FBX N=109 |
LESU200 + FBX N=106 |
LESU400 + FBX N=109 |
|
| Any TEAE, % | 69 | 73 | 78 | 74 | 82 | 83 |
| Any TEAE with RCTC toxicity grade 3 or 4, % | 6 | 11 | 14 | 12 | 10 | 10 |
| Any serious TEAE, % | 6 | 5 | 8 | 9 | 6 | 8 |
| Any renal-related TEAE, % | 4 | 4 | 10 | 6 | 9 | 10 |
| Any TEAE leading to discontinuation, % | 4 | 8 | 7 | 8 | 9 | 14 |
Abbreviations: APL, allopurinol; FBX, feboxustat; LESU, lesinurad; LESU200, lesinurad 200 mg; LESU400, lesinurad 400; PBO, placebo; RCTC, Rheumatology Common Toxicity Criteria; TEAE, treatment-emergent adverse event.