The efficacy endpoint of the study was recurrence free survival (RFS) defined as the time from date of randomization to the date of recurrence or death from any cause. At a median follow up of 14.0 months, there were 30 RFS events in the Gleevec arm compared to 70 RFS events in the placebo arm (hazard ratio=0.398 [95% CI: 0.259, 0.610], p<0.0001). Based on aninterim analysis, patients still receiving placebo were allowed to cross over to Gleevec. The current follow-up is too short to eva luate survival.

Figure 3 Recurrence Free Survival

15 REFERENCES
Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.

OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.

Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society
16 HOW SUPPLIED/STORAGE AND HANDLING
Each film-coated tablet contains 100 mg or 400 mg of imatinib free base.

100mg Tablets

Very dark yellow to brownish orange, film-coated tablets, round, biconvex with bevelled edges, debossed with “NVR” on one side, and “SA” with score on the other side.

Bottles of 10 tablets………………………………….NDC 54868-5289-1

Bottles of 30 tablets………………………………….NDC 54868-5289-0

Bottles of 60 tablets………………………………….NDC 54868-5289-4

Bottles of 90 tablets………………………………….NDC 54868-5289-2

Bottles of 100 tablets…..…………………………….NDC 54868-5289-3

 
400mg Tablets

Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with “400” on one side with score on the other side, and “SL” on each side of the score.

Bottles of 15 tablets…………………………………...NDC 54868-5427-1

Bottles of 30 tablets…………………………………...NDC 54868-5427-0

Bottles of 45 tablets…………………………………...NDC 54868-5427-2

Bottles of 60 tablets…………………………………...NDC 54868-5427-3

 
Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].