> ![](media/image1.png){width="1.1in" height="1.1in"}**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**:

1.  SAS data base in EDR

**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/Dr. Hung

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    |          | Death |          | Death |          |
|             | hosp  |          | only  |          | after |          |
|             | only  |          |       |          | hosp  |          |
+-------------+-------+----------+-------+----------+-------+----------+
|             | Pl    | # Ca     | Pl    | # Ca     | Pl    | # Ca     |
|             | acebo | rvedilol | acebo | rvedilol | acebo | rvedilol |
|             |       |          |       |          |       |          |
|             | N=216 | #  N=224 | N=78  | #  N=65  | N=73  | #  N=51  |
+-------------+-------+----------+-------+----------+-------+----------+
| # R         | 163   | 145      | \     | \_\_\_   | 133   | 95       |
| and to hosp |       |          | _\_\_ |          |       |          |
|             | 98    | 81       |       |          | 68    | 51       |
| Mean        |       |          |       |          |       |          |
|             |       |          |       |          |       |          |
| Median      |       |          |       |          |       |          |
+-------------+-------+----------+-------+----------+-------+----------+
| Rand to     | \     | \_\_\_   | 187   | 195      | 276   | 223      |
| death       | _\_\_ |          |       |          |       |          |
|             |       |          | 148   | 93       | 233   | 185      |
| Mean        |       |          |       |          |       |          |
|             |       |          |       |          |       |          |
| Median      |       |          |       |          |       |          |
+-------------+-------+----------+-------+----------+-------+----------+
| Hosp to     | \     | \_\_\_   | \     | \_\_\_   | 142   | 128      |
| death       | _\_\_ |          | _\_\_ |          |       |          |
|             |       |          |       |          | 66    | 48       |
| Mean        |       |          |       |          |       |          |
|             |       |          |       |          |       |          |
| Median      |       |          |       |          |       |          |
+-------------+-------+----------+-------+----------+-------+----------+