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) |