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Table 2 Summary of exposure-adjusted incidence rates of treatment-emergent adverse events during the core study and the core study + extension study (safety population)

From: Efficacy and safety during extended treatment of lesinurad in combination with febuxostat in patients with tophaceous gout: CRYSTAL extension study

System organ class
Preferred term [n (exposure-adjusted rate)]
Core study Core + extension study
200CONT
(n = 64)
(PY = 59.4)
200CROSS
(n = 33)
(PY = 30.6)a
400CONT
(n = 65)
(PY = 60.2)
400CROSS
(n = 34)
(PY = 31.5)a
200CONT
(n = 64)
(PY = 173.6)
200CROSS
(n = 33)
(PY = 61.9)
400CONT
(n = 65)
(PY = 180.6)
400CROSS
(n = 34)
(PY = 61.7)
Any TEAE 54 (90.9) 20 (65.4) 56 (93.0) 29 (92.1) 59 (34.0) 28 (45.2) 62 (34.3) 33 (53.5)
Any serious TEAE 3 (5.1) 1 (3.3) 4 (6.6) 1 (3.2) 11 (6.3) 3 (4.8) 12 (6.6) 5 (8.1)
Any fatal TEAE 0 0 0 0 1 (0.6) 0 0 0
Any renal-related TEAE 4 (6.7) 3 (9.8) 6 (10.0) 0 17 (9.8) 2 (3.2) 17 (9.4) 8 (13.0)
Any serious renal-related TEAE 0 0 0 0 1 (0.6) 0 1 (0.6) 1 (1.6)
Any kidney stone AE 0 0 1 (1.7) 1 (3.2) 3 (1.7) 1 (1.6) 5 (2.8) 2 (3.2)
Any serious kidney stone AE 0 0 0 1 (3.2) 0 0 2 (1.1) 1 (1.6)
sCr elevation 1.5× baseline 3 (5.1) 0 7 (11.6) 2 (6.3) 10 (5.8) 6 (9.7) 18 (10.0) 7 (11.3)
sCr elevation 2.0× baseline 2 (3.4) 0 3 (5.0) 0 6 (3.5) 0 4 (2.2) 4 (6.5)
MACE 0 0 1 (1.7) 0 1 (0.6) 0 2 (1.1) 0
Adjudicated cardiovascular events 3 (5.1) 0 3 (5.0) 0 4 (2.3) 1 (1.6) 4 (2.2) 2 (3.2)
  1. Abbreviations: CONT Continuation of lesinurad treatment, CROSS Crossover from core study placebo to lesinurad treatment, MACE Major adverse cardiovascular event (nonfatal myocardial infraction, nonfatal stroke, cardiovascular death), PY Person-years of lesinurad exposure, sCr Serum creatinine, TEAE Treatment-emergent adverse event
  2. aPY are person-years of placebo (febuxostat) exposure