PROs by best response on treatment with gilteritinib in study 2215-CL-0301
PRO outcome . | Observed outcome by best response on treatment . | Risk difference in comparison to patients with best response of NR . | |||||
|---|---|---|---|---|---|---|---|
| CR (n = 32) . | CRh (n = 19) . | CRL (n = 66) . | NR (n = 124) . | CR vs NR . | CRh vs NR . | CRL vs NR . | |
| BFI-GF score <1, % (95% CI) | 87.5%∗ (71.0-96.5) | 52.6% (28.9-75.6) | 51.5% (38.9-64.0) | 39.5% (30.9-48.7) | 48.0 (33.7-62.3) | 13.1 (–10.9 to 37.2) | 12.0 (–2.8 to 26.8) |
| EQ-VAS score ≥80, % (95% CI) | 84.4%∗ (67.2-94.7) | 52.6% (28.9-75.6) | 51.5% (38.9-64.0) | 41.9% (33.1-51.1) | 42.4 (27.2-57.7) | 10.7 (–13.4 to 34.8) | 9.6 (–5.3 to 24.4) |
| FACT-FWB score >21, % (95% CI) | 62.5%∗ (43.7-78.9) | 47.4%† (24.4-71.1) | 27.3% (17.0-39.6) | 25.8% (18.4-34.4) | 36.7 (18.2-55.2) | 21.6 (–2.2 to 45.3) | 1.5 (–11.8 to 14.7) |
| FACT-PWB score >21, % (95% CI) | 96.9%∗ (83.8-99.9) | 78.9% (54.4-93.9) | 77.3% (65.3-86.7) | 62.9% (53.8-71.4) | 34.0 (23.6-44.4) | 16.0 (–4.2 to 36.3) | 14.4 (1.2-27.6) |
| FACT-LEUS score >51, % (95% CI) | 90.6%∗ (75.0-98.0) | 78.9%∗ (54.4-93.9) | 54.5% (41.8-66.9) | 49.2% (40.1-58.3) | 41.4 (28.0-54.8) | 29.8 (9.4-50.1) | 5.4 (–9.5 to 20.2) |
PRO outcome . | Observed outcome by best response on treatment . | Risk difference in comparison to patients with best response of NR . | |||||
|---|---|---|---|---|---|---|---|
| CR (n = 32) . | CRh (n = 19) . | CRL (n = 66) . | NR (n = 124) . | CR vs NR . | CRh vs NR . | CRL vs NR . | |
| BFI-GF score <1, % (95% CI) | 87.5%∗ (71.0-96.5) | 52.6% (28.9-75.6) | 51.5% (38.9-64.0) | 39.5% (30.9-48.7) | 48.0 (33.7-62.3) | 13.1 (–10.9 to 37.2) | 12.0 (–2.8 to 26.8) |
| EQ-VAS score ≥80, % (95% CI) | 84.4%∗ (67.2-94.7) | 52.6% (28.9-75.6) | 51.5% (38.9-64.0) | 41.9% (33.1-51.1) | 42.4 (27.2-57.7) | 10.7 (–13.4 to 34.8) | 9.6 (–5.3 to 24.4) |
| FACT-FWB score >21, % (95% CI) | 62.5%∗ (43.7-78.9) | 47.4%† (24.4-71.1) | 27.3% (17.0-39.6) | 25.8% (18.4-34.4) | 36.7 (18.2-55.2) | 21.6 (–2.2 to 45.3) | 1.5 (–11.8 to 14.7) |
| FACT-PWB score >21, % (95% CI) | 96.9%∗ (83.8-99.9) | 78.9% (54.4-93.9) | 77.3% (65.3-86.7) | 62.9% (53.8-71.4) | 34.0 (23.6-44.4) | 16.0 (–4.2 to 36.3) | 14.4 (1.2-27.6) |
| FACT-LEUS score >51, % (95% CI) | 90.6%∗ (75.0-98.0) | 78.9%∗ (54.4-93.9) | 54.5% (41.8-66.9) | 49.2% (40.1-58.3) | 41.4 (28.0-54.8) | 29.8 (9.4-50.1) | 5.4 (–9.5 to 20.2) |
%, percentage of patients with the listed PRO outcome on treatment.
P < .01 for comparison to NR by logistic regression adjusting for drug and baseline PRO category.
P < .05 for comparison to NR by logistic regression adjusting for drug and baseline PRO category. See supplemental Table 2 for details.