Table 2.

Durability of platelet counts during 24-week double-blind period

No. of weeks with platelet count (in the absence of rescue therapy)All patientsResponders 
RilzabrutinibPlaceboP valueRilzabrutinibPlaceboP value
50 × 109/L or between ≥30 × 109/L and <50 × 109/L and at least doubled from baseline n = 133 n = 69  n = 85 n = 23  
LS mean (SE) 7.18 (0.75) 0.72 (0.35) <.0001 11.40 (0.99) 2.57 (0.86) <.0001 
LS mean difference (SE) vs placebo
95% CI 
6.46 (0.78)
4.92-7.99 
 8.83 (1.08)
6.72-10.93 
 
≥30 × 109/L and at least doubled from baseline n = 133 n = 69  n = 84 n = 23  
LS mean (SE) 6.95 (0.75) 0.64 (0.34) <.0001 11.20 (1.01) 2.38 (0.86) <.0001 
LS mean difference (SE) vs placebo
95% CI 
6.31 (0.78)
4.79-7.83 
 8.81 (1.08)
6.71-10.92 
 
No. of weeks with platelet count (in the absence of rescue therapy)All patientsResponders 
RilzabrutinibPlaceboP valueRilzabrutinibPlaceboP value
50 × 109/L or between ≥30 × 109/L and <50 × 109/L and at least doubled from baseline n = 133 n = 69  n = 85 n = 23  
LS mean (SE) 7.18 (0.75) 0.72 (0.35) <.0001 11.40 (0.99) 2.57 (0.86) <.0001 
LS mean difference (SE) vs placebo
95% CI 
6.46 (0.78)
4.92-7.99 
 8.83 (1.08)
6.72-10.93 
 
≥30 × 109/L and at least doubled from baseline n = 133 n = 69  n = 84 n = 23  
LS mean (SE) 6.95 (0.75) 0.64 (0.34) <.0001 11.20 (1.01) 2.38 (0.86) <.0001 
LS mean difference (SE) vs placebo
95% CI 
6.31 (0.78)
4.79-7.83 
 8.81 (1.08)
6.71-10.92 
 

Responders included patients who achieved the platelet count threshold being measured.

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