Table 1.

Patient demographics and baseline characteristics

Copanlisib + R-B (n = 262)Placebo + R-B (n = 262)
Sex, n (%)   
Male 159 (60.7) 134 (51.1) 
Female 103 (39.3) 128 (48.9) 
Median age, y (range) 61.0 (29-96) 61.0 (26-85) 
ECOG performance status, n (%)   
155 (59.2) 156 (59.5) 
105 (40.1) 96 (36.6) 
2 (0.8) 10 (3.8) 
Histology of lymphoma, n (%)   
FL 175 (66.8) 178 (67.9) 
MZL 43 (16.4) 49 (18.7) 
SLL 19 (7.3) 20 (7.6) 
LPL/WM 25 (9.5) 14 (5.3) 
Other 1 (0.4) 
Previous systemic anticancer therapy lines, median (range) 1.0 (1-3) 1.0 (1-7) 
Previous systemic anticancer therapy lines, n (%) 262 (100) 262 (100) 
170 (64.9) 164 (62.6) 
73 (27.9) 73 (27.9) 
≥3 19 (7.3) 25 (9.5) 
Median time since last systemic anticancer therapy, mo (range) 28.3 (0.5-155.5) 24.8 (0.3-171.9) 
Previous systemic anticancer therapy , n (%)   
Rituximab 260 (99.2) 262 (100) 
Bendamustine 12 (4.6) 15 (5.7) 
Cyclophosphamide 254 (96.9) 256 (97.7) 
Doxorubicin 131 (50.0) 146 (55.7) 
Vincristine 206 (78.6) 225 (85.9) 
Copanlisib + R-B (n = 262)Placebo + R-B (n = 262)
Sex, n (%)   
Male 159 (60.7) 134 (51.1) 
Female 103 (39.3) 128 (48.9) 
Median age, y (range) 61.0 (29-96) 61.0 (26-85) 
ECOG performance status, n (%)   
155 (59.2) 156 (59.5) 
105 (40.1) 96 (36.6) 
2 (0.8) 10 (3.8) 
Histology of lymphoma, n (%)   
FL 175 (66.8) 178 (67.9) 
MZL 43 (16.4) 49 (18.7) 
SLL 19 (7.3) 20 (7.6) 
LPL/WM 25 (9.5) 14 (5.3) 
Other 1 (0.4) 
Previous systemic anticancer therapy lines, median (range) 1.0 (1-3) 1.0 (1-7) 
Previous systemic anticancer therapy lines, n (%) 262 (100) 262 (100) 
170 (64.9) 164 (62.6) 
73 (27.9) 73 (27.9) 
≥3 19 (7.3) 25 (9.5) 
Median time since last systemic anticancer therapy, mo (range) 28.3 (0.5-155.5) 24.8 (0.3-171.9) 
Previous systemic anticancer therapy , n (%)   
Rituximab 260 (99.2) 262 (100) 
Bendamustine 12 (4.6) 15 (5.7) 
Cyclophosphamide 254 (96.9) 256 (97.7) 
Doxorubicin 131 (50.0) 146 (55.7) 
Vincristine 206 (78.6) 225 (85.9) 

ECOG, Eastern Cooperative Oncology Group; LPL, lymphoplasmacytic lymphoma; MZL, marginal zone lymphoma; SLL, small lymphocytic lymphoma; WM, Waldenström macroglobulinemia.

Patients may have had >1 entry.

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