ary (21.5%), breast (16%), lung (13.3%), hematological tumors (10.4%) and other tumors (15.1%).
A total of 27 (8.0%) and 53 (15.7%) patients in the FRAGMIN and OAC arms, respectively, experienced at least one episode of an objectively confirmed, symptomatic DVT and/or PE during the 6-month study period. Most of the difference occurred during the first month of treatment (see Table 16). The benefit was maintained over the 6-month study period.
Table 16
Recurrent VTE in Patients with Cancer (Intention to treat population)1
Study Period FRAGMIN arm OAC arm
FRAGMIN 200 IU/kg (max. 18,000 IU) subcutaneous once daily x 1 month, then 150 IU/kg (max. 18,000 IU) subcutaneous once daily x 5 months FRAGMIN 200 IU/kg (max 18,000 IU) subcutaneous once daily x 5-7 days and OAC for 6 months (target INR 2-3)
Number at Risk Patients with VTE % Number at Risk Patients with VTE %
Total 338 27 8.0 338 53 15.7
Week 1 338 5 1.5 338 8 2.4
Weeks 2-4 331 6 1.8 327 25 7.6
Weeks 5-28 307 16 5.2 284 20 7.0
1 Three patients in the FRAGMIN arm and 5 patients in the OAC arm experienced more than 1 VTE over the 6-month study period.
In the intent-to-treat population that included all randomized patients, the primary comparison of the cumulative probability of the first VTE recurrence over the 6-month study period was statistically significant (p < 0.01) in favor of the FRAGMIN arm, with most of the treatment difference evident in the first month.
16 HOW SUPPLIED/STORAGE AND HANDLING
After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks.
Dosage Form Strength Package Size NDC Number
Single-dose prefilled syringe1 2,500 IU / 0.2 mL 10 Syringes 62856-250-10
5,000 IU / 0.2 mL 10 Syringes
62856-500-10
7,500 IU / 0.3 mL 10 Syringes
62856-750-10
10,000 IU / 0.4 mL 10 Syringes
62856-100-10
Single-dose graduated syringe2 10,000 IU / 1 mL 10 Syringes
62856-101-10
Single-dose prefilled syringe1 12,500 IU / 0.5 mL 10 Syringes
62856-125-10
15,000 IU / 0.6 mL 10 Syringes
62856-150-10
18,000 IU / 0.72 mL 10 Syringes
62856-180-10
Multiple dose vial 95,000 IU / 3.8 mL 3.8 mL Vial 62856-251-01
Multiple dose vial 95,000 IU / 9.5 mL &nbs |
