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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)