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Table 4 Adverse events, adverse drug reactions, and abnormal changes in hepatic function

From: Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V

 

Edoxaban 30 mg QD (n = 303)

Enoxaparin 2000 IU BID (n = 301)

Adverse events

  

 Patients with events

197 (65.0)

232 (77.1)

 95 % CI

59.5, 70.2

72.0, 81.5

 Number of events

448

676

Adverse events reported by ≥5 % of patients in either treatment group a

  

 ALT increased

36 (11.9)

126 (41.9)

 AST increased

17 (5.6)

97 (32.2)

 γ-glutamyltransferase increased

44 (14.5)

79 (26.2)

 Blood urine present

38 (12.5)

34 (11.3)

 Blood alkaline phosphatase increased

14 (4.6)

40 (13.3)

 Hemorrhage subcutaneous

12 (4.0)

21 (7.0)

Adverse drug reactions

  

 Patients with events

121 (39.9)

177 (58.8)

 95 % CI

34.6, 45.5

53.2, 64.2

 Number of events

198

439

Hepatic function test parameter

  

 ALT or AST

  

 ≥1.5 x ULN

43 (14.2)

135 (44.9)

 ≥3 x ULN

8 (2.6)

30 (10.0)

 ≥5 x ULN

2 (0.7)

11 (3.7)

  1. Data are presented as n (%) unless otherwise indicated. ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; CI, confidence interval; IU, international unit; QD, once daily; ULN, upper limit of normal
  2. aClassified by MedDRA/J V.12.0 Preferred Term