Unadjusted and adjusted hazard ratios for treatment effect: effect of baseline characteristics on comparison of OS between patients treated with zosuquidar or placebo
| Factor . | Unadjusted model . | Adjusted model . | ||
|---|---|---|---|---|
| HR (95% CI) . | P . | HR (95% CI) . | P . | |
| Treatment (zosuquidar vs placebo) | 1.12 (0.91, 1.37) | .282 | 1.20 (0.89, 1.40) | .338 |
| Sex (male vs female) | — | — | 1.12 (0.90, 1.40) | .320 |
| ECOG PS (1 vs 0) | — | — | 1.11 (0.85, 1.44) | .454 |
| ECOG PS (2 vs 0) | — | — | 1.85 (1.29, 2.65) | .001 |
| ECOG PS (3 vs 0) | — | — | 2.20 (1.28, 3.79) | .004 |
| P-gp ratio (> 1.3 vs ≤ 1.3) | — | — | 1.43 (1.10, 1.85) | .007 |
| Cytogenetics (intermediate risk vs unfavorable) | — | — | 2.04 (1.54, 2.69) | < .001 |
| Cytogenetics (intermediate risk vs unknown) | — | — | 1.13 (0.85, 1.51) | .399 |
| Cytogenetics (intermediate risk vs favorable) | — | — | 0.61 (0.26, 1.40) | .240 |
| Factor . | Unadjusted model . | Adjusted model . | ||
|---|---|---|---|---|
| HR (95% CI) . | P . | HR (95% CI) . | P . | |
| Treatment (zosuquidar vs placebo) | 1.12 (0.91, 1.37) | .282 | 1.20 (0.89, 1.40) | .338 |
| Sex (male vs female) | — | — | 1.12 (0.90, 1.40) | .320 |
| ECOG PS (1 vs 0) | — | — | 1.11 (0.85, 1.44) | .454 |
| ECOG PS (2 vs 0) | — | — | 1.85 (1.29, 2.65) | .001 |
| ECOG PS (3 vs 0) | — | — | 2.20 (1.28, 3.79) | .004 |
| P-gp ratio (> 1.3 vs ≤ 1.3) | — | — | 1.43 (1.10, 1.85) | .007 |
| Cytogenetics (intermediate risk vs unfavorable) | — | — | 2.04 (1.54, 2.69) | < .001 |
| Cytogenetics (intermediate risk vs unknown) | — | — | 1.13 (0.85, 1.51) | .399 |
| Cytogenetics (intermediate risk vs favorable) | — | — | 0.61 (0.26, 1.40) | .240 |
Stratified Cox regression models were used for both adjusted and unadjusted models. The stratification factors used for randomization (age < 70 vs ≥ 70 years, disease type [de novo AML or RAEB-t, RAEB, secondary AML]) were included as strata in the models. The HRs were expressed as zosuquidar/placebo. A ratio < 1 would indicate an improved outcome with zosuquidar.
— indicates not applicable.