Characteristics of patients who were evaluated as having progression to AML by treatment
| . | Eltrombopag (n =179) . | Placebo (n =177) . | OR (95% CI) . | Nominal P . |
|---|---|---|---|---|
| Total number of patients who progressed to AML (confirmed by central or investigator assessment), n (%)* | 33/179 (18) | 20/177 (11) | ||
| Confirmed by both central and investigator assessment | 15 (8) | 6 (3) | ||
| Confirmed by central assessment | 21 (12) | 10 (6) | 2.04 (0.90-4.65) | .042 |
| Confirmed by central assessment only | 6 (3) | 4 (2) | ||
| Confirmed by investigator assessment | 27 (15) | 16 (9) | 1.59 (0.81-3.14) | .079 |
| Confirmed by investigator assessment only | 12 (7) | 10 (6) | ||
| Proportion who progressed to AML within 60 d of randomization, n (%) | 16/33 (48) | 1/20 (5) | ||
| Median (range) age of patients who progressed to AML, y | 69 (34-87) | 67.5 (47-79) | ||
| Patients with baseline BM blast counts >20% who progressed to AML (confirmed by central assessment), n (%) | 6/33 (18) | 3/20 (15) | ||
| % BM blasts at baseline in each patient† | 24, 25, 25, 27, 29, 39 | 32, 43, 53 | ||
| Patients with abnormal karyotype at baseline, n (%) | 19/33 (58) | 13/20 (65) | ||
| Median (range) time to AML diagnosis, d | ||||
| By central assessment | 113 (1-260) | 137 (33-387) | ||
| By investigator assessment | 60 (20-307) | 178 (33-389) |
| . | Eltrombopag (n =179) . | Placebo (n =177) . | OR (95% CI) . | Nominal P . |
|---|---|---|---|---|
| Total number of patients who progressed to AML (confirmed by central or investigator assessment), n (%)* | 33/179 (18) | 20/177 (11) | ||
| Confirmed by both central and investigator assessment | 15 (8) | 6 (3) | ||
| Confirmed by central assessment | 21 (12) | 10 (6) | 2.04 (0.90-4.65) | .042 |
| Confirmed by central assessment only | 6 (3) | 4 (2) | ||
| Confirmed by investigator assessment | 27 (15) | 16 (9) | 1.59 (0.81-3.14) | .079 |
| Confirmed by investigator assessment only | 12 (7) | 10 (6) | ||
| Proportion who progressed to AML within 60 d of randomization, n (%) | 16/33 (48) | 1/20 (5) | ||
| Median (range) age of patients who progressed to AML, y | 69 (34-87) | 67.5 (47-79) | ||
| Patients with baseline BM blast counts >20% who progressed to AML (confirmed by central assessment), n (%) | 6/33 (18) | 3/20 (15) | ||
| % BM blasts at baseline in each patient† | 24, 25, 25, 27, 29, 39 | 32, 43, 53 | ||
| Patients with abnormal karyotype at baseline, n (%) | 19/33 (58) | 13/20 (65) | ||
| Median (range) time to AML diagnosis, d | ||||
| By central assessment | 113 (1-260) | 137 (33-387) | ||
| By investigator assessment | 60 (20-307) | 178 (33-389) |