Table 1:
Demographic and disease characteristics of patients included in the primary efficacy analysis and the primary safety population
| ADMIRAL Study: Randomized Population | Gilteritinib-treated Safety population (N=319) |
||
|---|---|---|---|
| Demographic parameter | Gilteritinib (N=247) |
Chemotherapy (N=124) |
|
| Sex | |||
| Male | 116 (47%) | 54 (44%) | 149 (47%) |
| Female | 131 (53%) | 70 (57%) | 170 (53%) |
| Age | |||
| Median (years) | 62 | 62 | 61 |
| Min, max (years) | 20, 84 | 19, 85 | 20, 90 |
| Age group | |||
| <65 | 141 (57%) | 75 (60%) | 183 (58%) |
| ≥65 | 106 (43%) | 49 (40%) | 136 (42%) |
| Race | |||
| White | 145 (59%) | 75 (60%) | 203 (64%) |
| Asian | 69 (28%) | 33 (27%) | 74 (23%) |
| Black/African American | 14 (6%) | 7 (6%) | 17 (5%) |
| Other1 | 19 (8%) | 9 (7%) | 25 (8%) |
| Ethnicity | |||
| Hispanic or Latino | 12 (5%) | 2 (2%) | 16 (5%) |
| Not Hispanic or Latino2 | 235 (95%) | 122 (98%) | 303 (95%) |
| Region | |||
| North America | 114 (46%) | 52 (42%) | 178 (56%) |
| Europe3 | 68 (28%) | 43 (35%) | 72 (23%) |
| Asia | 65 (26%) | 29 (23%) | 69 (22%) |
| Disease status | |||
| Untreated relapse | 151 (61%) | 74 (60%) | NA |
| Primary refractory | 96 (39%) | 49 (40%) | NA |
| Refractory relapse | 0 | 1 (1%) | NA |
| Prior relapses | |||
| 0 | 96 (39%) | 49 (40%) | NA |
| 1 | 149 (60%) | 74 (60%) | NA |
| 2+ | 2 (1%) | 1 (1%) | NA |
| FLT3 mutation | |||
| ITD | 215 (87%) | 113 (91%) | 262 (82%) |
| TKD | 21 (9%) | 10 (8%) | 27 (8%) |
| Both | 7 (3%) | 0 | 10 (3%) |
| Other4 | 4 (2%) | 1 (1%) | 20 (6%) |
1
Includes Native Hawaiian or other Pacific Islander, Native American/Alaskan Native, “other,” unknown race, and no race listed
2
Includes patients listed as not Hispanic or Latino, unknown, or with no ethnicity listed
3
Includes Turkey and Israel
4
Missing, unknown, or negative by central review
NA, not available