(10%) achieved a complete response and 14 patients (20%) achieved a partial response. The overall median duration of response, measured from first day of response, was 4 months with a median duration for complete response of 9 months and for partial response of 4 months.
Table 3: Efficacy Results in Study 2 Clinical Response 9 mcg/kg/day 18 mcg/kg/day
Complete Response
95% Confidence Interval 9% (3/35)
(2%, 23%) 11% (4/36)
(3%, 26%)
Partial Response
95% Confidence Interval 14% (5/35)
(9%, 30%) 25% (9/36)
(12%, 42%)
Overall Response
95% Confidence Interval 23% (8/35)
(10%, 40%) 36% (13/36)
(21%, 54%)
16 HOW SUPPLIED/STORAGE AND HANDLING
Ontak is supplied as 150 mcg/ml, sterile, frozen solution (300 mcg in 2 mL) in a sterile single-use vial.NDC 62856-603-01, 6 vials in a package.
Store frozen at or below -10°C (14°F).
Manufactured by:Eisai Medical Research Inc.Woodcliff Lake, NJ 07677US License No. 1763
Manufactured at:Hollister-Stier Labs LLCSpokane, WA 99207
Distributed by:Eisai Inc.Woodcliff Lake, NJ 07677
17 PATIENT COUNSELING INFORMATION
Advise patients to report:
PRINCIPAL DISPLAY PANEL
NDC 62856-603-01, 6 vials in a package (300 mcg in 2 mL single-use vials)
Manufacturer
Eisai Inc.
Active Ingredients
Source
U.S. National Library of Medicine
DailyMed
Last Updated: 2nd of March 2011
