Table 3

Best objective clinical responses from screening to week 26

300 mg500 mg700 mg1000 mgTotal
No. of patients (all/previously treated with rituximab) 8*/4* 10/2 10/3 10/5 38/14 
CR 4/3 1/0   5/3 
Cru 1/1   1/0 2/1 
PR  2/0 2/1 5/4 9/5 
SD 3/0 6/2 6/1 3/1 18/4 
PD   2/1 1/0 3/1 
Clinical response (all/previously treated with rituximab) 5/4 3/0 2/1 6/4 16/9 
Evaluable patients 63% 33% 20% 60% 43% 
95% CI (25%-92%) (8%-70%) (3%-56%) (26%-88%) (27%-61%) 
Intention to treat (ITT) 63% 30% 20% 60% 42% 
95% CI (25%-92%) (7%-65%) (3%-56%) (26%-88%) (26%-59%) 
Patients previously treated with rituximab 100% 0% 33% 80% 64% 
95% CI (40%-100%)  (1%-91%) (28%-100%) (43%-95%) 
300 mg500 mg700 mg1000 mgTotal
No. of patients (all/previously treated with rituximab) 8*/4* 10/2 10/3 10/5 38/14 
CR 4/3 1/0   5/3 
Cru 1/1   1/0 2/1 
PR  2/0 2/1 5/4 9/5 
SD 3/0 6/2 6/1 3/1 18/4 
PD   2/1 1/0 3/1 
Clinical response (all/previously treated with rituximab) 5/4 3/0 2/1 6/4 16/9 
Evaluable patients 63% 33% 20% 60% 43% 
95% CI (25%-92%) (8%-70%) (3%-56%) (26%-88%) (27%-61%) 
Intention to treat (ITT) 63% 30% 20% 60% 42% 
95% CI (25%-92%) (7%-65%) (3%-56%) (26%-88%) (26%-59%) 
Patients previously treated with rituximab 100% 0% 33% 80% 64% 
95% CI (40%-100%)  (1%-91%) (28%-100%) (43%-95%) 

CR indicates complete response; Cru, complete response unconfirmed; PR, partial response; SD, stable disease; PD, progressive disease; and CI, confidence interval.

*

Two patients had no indicator lesions.

One patient was withdrawn before assessment (considered as a nonresponder in ITT).

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