taneous
n (%) Heparin
5000 U
twice daily
subcutaneous
n (%) FRAGMIN
5000 IU
once
daily subcutaneous
n (%) Heparin
5000 U
twice daily
subcutaneous
n (%)
Postoperative
Transfusions 26/459
(5.7) 36/454
(7.9) 81/508
(15.9) 63/498
(12.7)
Wound
Hematoma 16/467
(3.4) 18/467
(3.9) 12/508
(2.4) 6/498
(1.2)
Reoperation
Due to Bleeding 2/392
(0.5) 3/392
(0.8) 4/508
(0.8) 2/498
(0.4)
Injection Site
Hematoma 1/466
(0.2) 5/464
(1.1) 36/506
(7.1) 47/493
(9.5)
In a trial comparing FRAGMIN 5000 IU once daily to FRAGMIN 2500 IU once daily in patients undergoing surgery for malignancy, the incidence of bleeding reactions was 4.6% and 3.6%, respectively (n.s.). In a trial comparing FRAGMIN 5000 IU once daily to heparin 5000 U twice daily, in the malignancy subgroup the incidence of bleeding reactions was 3.2% and 2.7%, respectively for FRAGMIN and Heparin (n.s.).
Medical Patients with Severely Restricted Mobility During Acute Illness
Table 8 summarizes major bleeding reactions that occurred in a clinical trial of medical patients with severely restricted mobility during acute illness.
Table 8
Bleeding Reactions in Medical Patients with Severely Restricted Mobility During Acute Illness
Indication Dosing Regimen
Medical Patients with Severely
Restricted Mobility FRAGMIN
5000 IU once daily subcutaneous
n (%) Placebo
once daily subcutaneous
n (%)
Major Bleeding Reactions1 at Day 14 8/1848 (0.4) 0/1833 (0)
Major Bleeding Reactions1 at Day 21 9/1848 (0.5) 3/1833 (0.2)
1 A bleeding event was considered major if: 1) it was accompanied by a decrease in hemoglobin of ≥2 g/dL in connection with clinical symptoms; 2) intraocular, spinal/epidural, intracranial, or retroperitoneal bleeding; 3) required transfusion of ≥ 2 units of blood products; 4) required significant medical or surgical intervention; or 5) led to death.
Three of the major bleeding reactions that occurred by Day 21 were fatal, all due to gastrointestinal hemorrhage (two patients in the group treated with FRAGMIN and one in the group receiving placebo).
Patients with Cancer and Acute Symptomatic Venous Thromboembolism
Table 9 summarizes the number of patients with bleeding reactions that occurred in the clinical trial of patients with cancer and acute symptomatic venous thromboembolism. A bleeding event was considered major if it: 1) was accompanied by a decrease in hemoglobin of ≥ 2 g/dL in connection with clinical symptoms; 2) occurred at a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial bleeding); 3) required transfusion of ≥ 2 units of blood products; or 4) led to death. Minor bleedi |
