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Table 7 Safety data for patients with or without cancer (safety population)

From: Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY

All patients

Pts with cancer at admission

Pts without cancer at admission

 

Certoparin

(n = 133)

UFH

(n = 141)

OR (95%CI)

Total

(n = 274)

Total

(n = 2965)

OR (95%CI) vs. pts. with cancer

Patients with AEs; n (%)

79 (59.4)

95 (67.4)

0.71 (0.43-1.16)

174 (63.5)

1815 (61.2)

1.10 (0.85-1.43)

   Suspected drug relation

5 (3.8)

6 (4.3)

0.88 (0.26-2.95)

11 (4.0)

82 (2.8)

1.47 (0.77-2.79)

   Dose adjustment or study drug interruption

1 (0.8)

2 (1.4)

0.53 (0.05-5.88)

3 (1.1)

17 (0.6)

1.92 (0.56-6.59)

   Study drug discontinuation

6 (4.5)

7 (5.0)

0.90 (0.30-2.76)

13 (4.7)

115 (3.9)

1.23 (0.69-2.22)

   Concomitant medication/non- drug therapy

56 (42.1)

76 (53.9)

0.62 (0.39-1.00)

132 (48.2)

1265 (42.7)

1.25 (0.98-1.60)

Patients with SAEs (n, %)

10 (7.5)

18 (12.8)

0.56 (0.25-1.25)

28 (10.2)

172 (5.8)

1.85 (1.21-2.81)

   Deaths from any cause

2 (1.5)

6 (4.3)

0.34 (0.07-1.73)

8 (2.9)

33 (1.1)

2.67 (1.22-5.84)

   Suspected drug relation

0 (0)

1 (0.7)

-

1 (0.4)

10 (0.3)

1.08 (0.14-8.49)

   Study drug discontinuation

1 (0.8)

3 (2.1)

0.35 (0.04-3.39)

4 (1.5)

62 (2.1)

0.69 (0.25-1.92)

  1. Legend: HIT II, Heparin induced thrombocytopenia; UFH, unfractionated heparin; AE, adverse event; SAE, serious adverse event.