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V. Leblond et al.
Table 3. Summary of adverse events according to treatment (safety population). N (%) G-mono G-FC
(n=126) (n=193)
AEs of any grade (in ≥10% of patients in the safety population by preferred term)
G-Clb (n=114)
113 (99.1) 60 (52.6) 28 (24.6) 36 (31.6) 26 (22.8) 26 (22.8) 17 (14.9) 10 (8.8) 14 (12.3) 22 (19.3) 19 (16.7) 14 (12.3) 15 (13.2) 8 (7.0) 17 (14.9) 11 (9.6)
87 (76.3) 51 (44.7) 22 (19.3) 15 (13.2) 2 (1.8) 10 (8.8) 7 (6.1)
3 (2.6) 5 (4.4) 0
Any
Pneumonia
Sepsis
Death
Richter syndrome
AML 0
Febrile neutropenia 1 (0.8)
Septic shock 1 (0.8)
TLS 0 0 0
G-benda (n=538)
523 (97.2) 314 (58.4) 185 (34.4) 170 (31.6) 146 (27.1) 132 (24.5) 93 (17.3) 80 (14.9) 69 (12.8) 70 (13.0) 66 (12.3) 71 (13.2) 56 (10.4) 71 (13.2) 56 (10.4) 54 (10.0)
429 (79.7) 263 (48.9) 84 (15.6) 49 (9.1) 43 (8.0) 55 (10.2) 7 (1.3) 40 (7.4) 50 (9.3) 39 (7.2)
42 (7.8) 6 (1.1) 2 (0.4) 1 (0.2) 1 (0.2) 0
1 (0.2) 1 (0.2) 2(0.4)
305 (56.7) 52 (9.7) 62 (11.5) 40 (7.4) 21 (3.9) 29 (5.4)
283 (52.6) 103 (19.1) 115 (21.4) 84 (15.6)
Any
Neutropenia Pyrexia Thrombocytopenia Nausea
Anemia
Chills
Diarrhea
Vomiting
Fatigue Pneumonia Constipation Cough Leukopenia Hypotension Dyspnea
123 (97.6) 50 (39.7) 29 (23.0) 28 (22.2) 22 (17.5) 20 (15.9) 17 (13.5) 6 (4.8)
8 (6.3)
7 (5.6) 14 (11.1) 6 (4.8) 15 (11.9) 5 (4.0) 14 (11.1) 10 (7.9)
191 (99.0) 143 (74.1) 69 (35.8) 69 (35.8) 76 (39.4) 52 (26.9) 30 (15.5) 39 (20.2) 44 (22.8) 19 (9.8) 17 (8.8) 24 (12.4) 28 (14.5) 25 (13.0) 17 (8.8) 24 (12.4)
Grade ≥3 AEs (in ≥5% of patients in the safety population by preferred term)
169 (87.6) 129 (66.8) 38 (19.7) 12 (6.2) 21 (10.9) 21 (10.9) 3 (1.6) 20 (10.4) 5 (2.6) 10 (5.2) Grade 5 (fatal) AEs (in ≥2 patients in the safety population by preferred term)
Any
Neutropenia Thrombocytopenia Pneumonia
Febrile neutropenia Anemia Hypotension Leukopenia
TLS
Lymphopenia
95 (75.4) 42 (33.3) 15 (11.9) 11 (8.7) 8 (6.3)
7 (5.6) 6 (4.8) 3 (2.4) 2 (1.6) 0
SAEs (in ≥5% of patients in the safety population by preferred term)
11 (8.7) 1 (0.8) 1 (0.8) 1 (0.8) 1 (0.8)
9 (4.7) 2 (1.0) 2 (1.0) 1 (0.5) 1 (0.5) 1(0.5) 0
9 (7.9) 3 (2.6) 0
1 (0.9) 0 1(0.9) 0
0
0
87 (45.1) 13 (6.7) 28 (14.5) 20 (10.4) 11 (5.7) 3 (1.6)
136 (70.5) 35 (18.1) 30 (15.5) 39 (20.2)
Any
Pneumonia Neutropenia Febrile neutropenia Pyrexia
TLS
67 (53.2) 11 (8.7) 9 (7.1) 6 (4.8) 3 (2.4) 1 (0.8)
49 (38.9) 31 (24.6) 27 (21.4) 16 (12.7)
57 (50.0) 16 (14.0) 6 (5.3) 2 (1.8) 1 (0.9) 3 (2.6)
53 (46.5) 24 (21.1) 23 (20.2) 24 (21.1)
Grade ≥3 AESIs/AEPIs (basket terms)* Neutropenia
IRRs
Infections
Thrombocytopenia
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haematologica | 2018; 103(11)