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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.