DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
STATISTICAL REVIEW AND EVALUATION
(amendment of Clinical/Statistical Review of 12/04/02)
NDA #: 20-297
SERIAL #: SE8-009
DRUG NAME: Coreg (carvedilol)
INDICATION: to reduce mortality and the risk of infarction in clinically stable patients
who have survived the acute phase of a myocardial infarction
SPONSOR: Glaxo SmithKline
DOCUMENT REVIEWED:
STATISTICAL REVIEWER: H.M. James Hung, Ph.D. (HFD-710)
MEDICAL REVIEWER: Norman Stockbridge, M.D. (HFD-110)
STATISTICAL KEY WORDS: Change of primary endpoint, alpha allocation
Distribution: NDA 20-297, SE8-009
HFD-110/Dr. Throckmorton
HFD-110/Dr. Stockbridge
HFD-700/Dr. Anello
HFD-710/Dr. Chi
HFD-710/Dr. Mahjoob
HFD-710/chron
JHung/301-594-5436/DB1/capricorn1.doc/12-9-2002
The following table is to replace Table 10 of the clinical/statistical review dated 12/4/02, as a result of some minor changes because a few patients (six in the placebo group and one in the carvedilol group) were hospitalized and died on the same dates. These minor changes did not affect the reviewers’ conclusions in the 12/4/02 review.
Table 10a. Time to event for death or cardiovascular hospitalization
|
Time (days) |
CV hosp only |
Death only |
Death after hosp |
|||
|
Placebo N=216 |
Carvedilol N=224 |
Placebo N=78 |
Carvedilol N=65 |
Placebo N=73 |
Carvedilol N=51 |
|
|
Rand to hosp Mean Median |
163 98 |
145 81 |
___ |
___ |
133 68 |
95 51 |
|
Rand to death Mean Median |
___ |
___ |
187 148 |
195 93 |
276 233 |
223 185 |
|
Hosp to death Mean Median |
___ |
___ |
___ |
___ |
142 66 |
128 48 |