Erythroid response, as assessed by RBC-TI for ≥ 26 weeks or ≥ 8 weeks (double-blind phase; mITT and ITT populations)
. | RBC-TI, n (%) [95% CI] . | ||
---|---|---|---|
Placebo . | Lenalidomide 5 mg . | Lenalidomide 10 mg . | |
mITT population | n = 51 | n = 47 | n = 41 |
Protocol defined (≥ 26 wk) | 3 (5.9) [1.2-16.2] | 20 (42.6) [28.3-57.8]* | 23 (56.1) [39.7-71.5]* |
IWG 200013 (≥ 8 wk) | 4 (7.8) [2.2-18.9] | 24 (51.1) [36.1-65.9]* | 25 (61.0) [44.5-75.8]* |
IWG 200614 (≥ 8 wk) | 3 (5.9) [1.2-16.2] | 24 (51.1) [36.1-65.9]* | 25 (61.0) [44.5-75.8]* |
ITT population | n = 67 | n = 69 | n = 69 |
Protocol defined (≥ 26 wk) | 4 (6.0) [1.7-14.6] | 24 (34.8) [23.7-47.2]* | 38 (55.1) [42.6-67.1]* |
IWG 200013 (≥ 8 wk) | 5 (7.5) [2.5-16.6] | 33 (47.8) [35.6-60.2]* | 42 (60.9) [48.4-72.4]* |
IWG 200614 (≥ 8 wk) | 4 (6.0) [1.7-14.6] | 33 (47.8) [35.6-60.2]* | 42 (60.9) [48.4-72.4]* |
. | RBC-TI, n (%) [95% CI] . | ||
---|---|---|---|
Placebo . | Lenalidomide 5 mg . | Lenalidomide 10 mg . | |
mITT population | n = 51 | n = 47 | n = 41 |
Protocol defined (≥ 26 wk) | 3 (5.9) [1.2-16.2] | 20 (42.6) [28.3-57.8]* | 23 (56.1) [39.7-71.5]* |
IWG 200013 (≥ 8 wk) | 4 (7.8) [2.2-18.9] | 24 (51.1) [36.1-65.9]* | 25 (61.0) [44.5-75.8]* |
IWG 200614 (≥ 8 wk) | 3 (5.9) [1.2-16.2] | 24 (51.1) [36.1-65.9]* | 25 (61.0) [44.5-75.8]* |
ITT population | n = 67 | n = 69 | n = 69 |
Protocol defined (≥ 26 wk) | 4 (6.0) [1.7-14.6] | 24 (34.8) [23.7-47.2]* | 38 (55.1) [42.6-67.1]* |
IWG 200013 (≥ 8 wk) | 5 (7.5) [2.5-16.6] | 33 (47.8) [35.6-60.2]* | 42 (60.9) [48.4-72.4]* |
IWG 200614 (≥ 8 wk) | 4 (6.0) [1.7-14.6] | 33 (47.8) [35.6-60.2]* | 42 (60.9) [48.4-72.4]* |
P < .001 versus placebo.