Table 4.

FACIT-Fatigue scores

ParameterStudy 201, mean (SD)Study 103, mean (SD)
Cohort 1:Cohort 2:Cohort 3:Cohort 4:Cohort 1:Cohort 2:
1000 mg q4w,1600 mg q6w,2400 mg q8w,5400 mg q12w,900 mg q4w,1800 mg q4w,
n = 6n = 6n = 7n = 7n = 6n = 7
Baseline 32.0 (11.02)* 29.7 (17.32) 28.7 (15.20) 34.4 (10.08) 35.5 (10.03) 25.4 (14.35) 
End point† 42.0 (6.45) 39.4 (13.48)* 40.8 (10.19)‡ 43.3 (5.57)‡ 41.8 (8.77) 39.3 (10.48) 
Absolute change from baseline 9.8 (8.70)* 13.6 (11.01)* 12.3 (16.87)‡ 11.2 (8.64)‡ 6.3 (11.38) 13.9 (10.42) 
ParameterStudy 201, mean (SD)Study 103, mean (SD)
Cohort 1:Cohort 2:Cohort 3:Cohort 4:Cohort 1:Cohort 2:
1000 mg q4w,1600 mg q6w,2400 mg q8w,5400 mg q12w,900 mg q4w,1800 mg q4w,
n = 6n = 6n = 7n = 7n = 6n = 7
Baseline 32.0 (11.02)* 29.7 (17.32) 28.7 (15.20) 34.4 (10.08) 35.5 (10.03) 25.4 (14.35) 
End point† 42.0 (6.45) 39.4 (13.48)* 40.8 (10.19)‡ 43.3 (5.57)‡ 41.8 (8.77) 39.3 (10.48) 
Absolute change from baseline 9.8 (8.70)* 13.6 (11.01)* 12.3 (16.87)‡ 11.2 (8.64)‡ 6.3 (11.38) 13.9 (10.42) 

Total scores range from 0 to 52, with higher score indicating less fatigue.

*

n = 5.

†

Study 103, day 169. Study 201: cohorts 1-3, day 253; cohort 4, day 281.

‡

n = 6.

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