Table 3

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]
PlaceboLenalidomide 5 mgLenalidomide 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]
PlaceboLenalidomide 5 mgLenalidomide 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.

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