Table 2:
Demographics and Clinical Characteristics of Patients in the Efficacy Intention-to-Treat population*
| RIPRETINIB (N = 85) |
PLACEBO (N = 44) |
|
|---|---|---|
| SEX [N(%)] | ||
| FEMALE | 38 (45) | 18 (41) |
| MALE | 47 (55) | 26 (59) |
| AGE [YEARS] | ||
| [MEDIAN (RANGE)] | 59 (29-82) | 65 (33-83) |
| AGE GROUP [N (%)] | ||
| 18 – 64 YEARS | 57 (67) | 22 (50) |
| 65 – 74 YEARS | 20 (24) | 12 (27) |
| 75 YEARS OR OLDER | 8 (9) | 10 (23) |
| RACE [N (%)] | ||
| ASIAN | 4 (5) | 5 (11) |
| BLACK | 8 (9) | 2 (5) |
| WHITE | 64 (75) | 33 (75) |
| NOT REPORTED | 8 (9) | 4 (9) |
| OTHER | 1 (1) | 0 |
| REGION [N (%)] | ||
| US | 40 (47) | 20 (46) |
| NON-US | 45 (53) | 24 (54) |
| ECOG PS [N (%)] | ||
| 0 | 37 (44) | 17 (39) |
| 1 | 40 (47) | 24 (55) |
| 2 | 8 (9) | 3 (7) |
Source: FDA Analysis
Abbreviations: US – United States; ECOG PS: Eastern Cooperative Oncology Group Performance Status
*
Percentages may not total 100 due to rounding