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Table 3 Serious adverse events during months 0–12 and months13–24 by kidney function group

From: The effect of kidney function on the urate lowering effect and safety of increasing allopurinol above doses based on creatinine clearance: a post hoc analysis of a randomized controlled trial

CTCAE category Time period Control (n = 93) Dose escalation (n = 90)
CrCL <30 ml/min (n = 14) CrCL ≥30 to <60 ml/min (n = 31) CrCL ≥60 ml/min (n = 48) CrCL <30 ml/min (n = 10) CrCL ≥30 to <60 ml/min (n = 40) CrCL ≥60 ml/min (n = 40)
Cardiac disorders Month 0–12 6 (3) 7 (4) 1 (1) 1 (1) 9 (7) 4 (3)
Month 13–24 3 (2) 8 (5) 0 0 6 (5) 2 (2)
Gastrointestinal disorders Month 0–12 1 (1) 3 (3) 2 (2) 0 3 (3) 0
Month 13–24 0 5 (4) 1 (1) 0 3 (3) 0
General disorders Month 0–12 1 (1) 0 0 0 0 1 (1)
Month 13–24 1 (1) 0 1 (1) 0 0 1 (1)
Hepatobiliary disorders Month 0–12 0 0 0 0 1 (1) 0
Month 13–24 0 0 0 0 0 0
Infections and infestations Month 0–12 2 (2) 3 (3) 3 (3) 1 (1) 2 (1) 1 (1)
Month 13–24 0 6 (4) 2 (2) 3 (3) 5 (3) 1 (1)
Injury, poisoning and procedural complications Month 0–12 1 (1) 0 1 (1) 0 1 (1) 0
Month 13–24 1 (1) 3 (2) 1 (1) 0 1 (1) 0
Investigations Month 0–12 0 0 0 0 1 (1) 0
Month 13–24 0 0 0 0 0 0
Metabolism and nutrition Month 0–12 0 0 0 1 (1) 1 (1) 0
Month 13–24 0 0 0 0 0 0
Musculoskeletal Month 0–12 0 0 1 (1) 1 (1) 0 0
Month 13–24 0 0 2 (1) 0 1 (1) 0
Nervous system disorders Month 0–12 1 (1) 1 (1) 1 (1) 0 0 1 (1)
Month 13–24 3 (2) 0 0 1 (1) 3 (3) 0
Renal and urinary disorders Month 0–12 3 (3) 2 (2) 0 1 (1) 1 (1) 0
Month 13–24 0 0 0 2 (2) 1 (1) 0
Respiratory, thoracic and mediastinal disorders Month 0–12 0 1 (1) 1 (1) 1 (1) 1 (1) 0
Month 13–24 0 0 0 0 0 0
Skin and subcutaneous tissue disorders Month 0–12 1 (1) 0 0 0 0 2 (1)
Month 13–24 0 0 0 0 0 0
Psychiatric disorders Month 0–12 0 0 0 0 0 0
Month 13–24 1 (1) 0 0 0 0 1 (1)
Vascular disorders Month 0–12 0 0 0 0 0 0
Month 13–24 0 0 0 0 1 (1) 0
  1. Data reported are number of events (number of individuals)
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