Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study
Table 1
Disposition of patients.
All patients (N = 159)
DLBCL (N = 73)
FL (N = 86)
Enrolled patients
159 (100.0%)
73 (100.0%)
86 (100.0%)
Analysed population
158 (99.4%)
72 (98.6%)
86 (100.0%)
Number of patients who completed final staging
67 (42.1%)
67 (91.8%)
NA
Prematurely discontinued on or before the final staging
8 (5.0%)
8 (11.0%)
NA
Reason for discontinuation:
Progression of disease
2 (25.0%)
2 (25.0%)
Adverse event
2 (25.0%)
2 (25.0%)
Investigator decision
1 (12.5%)
1 (12.5%)
Lost to follow-up
1 (12.5%)
1 (12.5%)
Death
2 (25.0%)
2 (25.0%)
Patients who discontinued the study
38 (24.1%)
13 (18.1%)
25 (29.1%)
Reason for discontinuation:
Progression of disease
14 (36.8%)
7 (53.8%)
7 (28.0%)
Adverse event
12 (31.6%)
2 (15.4%)
10 (40.0%)
Consent withdrawn
2 (5.3%)
-
2 (8.0%)
Investigator decision
2 (5.3%)
1 (7.7%)
1 (4.0%)
Lost to follow-up
1 (2.6%)
1 (7.7%)
-
Death
2 (5.3%)
2 (15.4%)
-
Other reasons
5 (13.2%)
-
5 (20.0%)
Number of patients who continued to maintenance phase
77 (48.4%)
NA
77 (89.5%)
Percentages for the reasons for discontinuation are based on the number of patients who discontinued. Other percentages are calculated based on number of patients in the analysed population. N: number of patients; DLBCL: diffuse large B-cell lymphoma; FL: follicular lymphoma; NA: not applicable.
