Baseline characteristics for all randomized patients (efficacy analysis set)
| Patient characteristics∗ . | Guadecitabine (n = 408) . | TC (n = 407) . | Total (N = 815) . |
|---|---|---|---|
| Median age, y (range) | 76 (56-93) | 76 (59-94) | 76 (56-94) |
| Age category, n (%) | |||
| <75 y | 155 (38) | 153 (38) | 308 (38) |
| ≥75 y | 253 (62) | 254 (62) | 507 (62) |
| Sex, n (%) | |||
| Men | 231 (57) | 242 (59) | 473 (58) |
| Women | 177 (43) | 165 (41) | 342 (42) |
| Race, n (%) | |||
| White | 311 (76) | 291 (71) | 602 (74) |
| Black or African-American | 9 (2) | 5 (1) | 14 (2) |
| Asian | 71 (17) | 74 (18) | 145 (18) |
| Other or missing | 17 (4) | 37 (9) | 54 (7) |
| ECOG PS, n (%) | |||
| 0 | 54 (13) | 52 (13) | 106 (13) |
| 1 | 148 (36) | 150 (37) | 298 (37) |
| 2 | 162 (40) | 169 (42) | 331 (41) |
| 3 | 44 (11) | 36 (9) | 80 (10) |
| Secondary AML, n (%)† | |||
| Yes | 148 (36) | 150 (37) | 298 (37) |
| No | 260 (64) | 257 (63) | 517 (63) |
| Cytogenetic risk levels, n (%)‡ | |||
| Better risk | 5 (1) | 12 (3) | 17 (2) |
| Intermediate risk | 239 (59) | 236 (58) | 475 (58) |
| Poor risk | 140 (34) | 141 (35) | 281 (34) |
| Not evaluable or missing | 24 (5) | 18 (4) | 42 (4) |
| Median BM blasts, % | 45 | 41 | 43 |
| WBCs | |||
| ≥20 000/μL, n (%) | 62 (15) | 58 (14) | 120 (15) |
| Mutation, n (%) | |||
| NPM1 | 44 (11) | 46 (11) | 90 (11) |
| CEBPA§ | 13 (3) | 18 (4) | 31 (4) |
| FLT3-ITD | 20 (5) | 16 (4) | 36 (4) |
| TP53 | 60 (15) | 56 (14) | 116 (14) |
| Patient characteristics∗ . | Guadecitabine (n = 408) . | TC (n = 407) . | Total (N = 815) . |
|---|---|---|---|
| Median age, y (range) | 76 (56-93) | 76 (59-94) | 76 (56-94) |
| Age category, n (%) | |||
| <75 y | 155 (38) | 153 (38) | 308 (38) |
| ≥75 y | 253 (62) | 254 (62) | 507 (62) |
| Sex, n (%) | |||
| Men | 231 (57) | 242 (59) | 473 (58) |
| Women | 177 (43) | 165 (41) | 342 (42) |
| Race, n (%) | |||
| White | 311 (76) | 291 (71) | 602 (74) |
| Black or African-American | 9 (2) | 5 (1) | 14 (2) |
| Asian | 71 (17) | 74 (18) | 145 (18) |
| Other or missing | 17 (4) | 37 (9) | 54 (7) |
| ECOG PS, n (%) | |||
| 0 | 54 (13) | 52 (13) | 106 (13) |
| 1 | 148 (36) | 150 (37) | 298 (37) |
| 2 | 162 (40) | 169 (42) | 331 (41) |
| 3 | 44 (11) | 36 (9) | 80 (10) |
| Secondary AML, n (%)† | |||
| Yes | 148 (36) | 150 (37) | 298 (37) |
| No | 260 (64) | 257 (63) | 517 (63) |
| Cytogenetic risk levels, n (%)‡ | |||
| Better risk | 5 (1) | 12 (3) | 17 (2) |
| Intermediate risk | 239 (59) | 236 (58) | 475 (58) |
| Poor risk | 140 (34) | 141 (35) | 281 (34) |
| Not evaluable or missing | 24 (5) | 18 (4) | 42 (4) |
| Median BM blasts, % | 45 | 41 | 43 |
| WBCs | |||
| ≥20 000/μL, n (%) | 62 (15) | 58 (14) | 120 (15) |
| Mutation, n (%) | |||
| NPM1 | 44 (11) | 46 (11) | 90 (11) |
| CEBPA§ | 13 (3) | 18 (4) | 31 (4) |
| FLT3-ITD | 20 (5) | 16 (4) | 36 (4) |
| TP53 | 60 (15) | 56 (14) | 116 (14) |
NCCN, National Comprehensive Cancer Network.
Baseline hematologic characteristics based on local pathologic assessment.
Secondary to myelodysplastic syndromes or other antecedent hematologic disorder and central pathologist AML World Health Organization classification.
Based on local treating center data according to NCCN 2014 classification.
Defined irrespective of presence of bi- or monoallelic mutations in CEBPA.