Page 152 - 2018_11-Haematologica-web

V. Leblond et al.
Table 2. Summary of adverse events according to line of therapy and fitness of patients (safety population).
N (%) First-line fit First-line unfit First-line all
R/R (n=341)
334 (97.9) 198 (58.1) 101 (29.6) 115 (33.7) 94 (27.6) 83 (24.3) 57 (16.7) 44 (12.9) 42 (12.3) 46 (13.5) 55 (16.1) 42 (12.3) 55 (16.1) 46 (13.5) 42 (12.3) 46 (13.5)
281 (82.4) 179 (52.5) 67 (19.6) 40 (11.7) 46 (13.5) 27 (7.9) 29 (8.5) 16 (4.7) 20 (5.9)
40 (11.7) 7 (2.1) 2 (0.6) 2 (0.6) 3 (0.9) 0
0
2 (0.6) 0
197 (57.8) 43 (12.6) 48 (14.1) 25 (7.3) 8 (2.3) 11 (3.2) 12 (3.5)
189 (55.4) 90 (26.4) 68 (19.9)
Total (n=971)
950 (97.8) 567 (58.4) 311 (32.0) 303 (31.2) 270 (27.8) 230 (23.7) 157 (16.2) 135 (13.9) 135 (13.9) 118 (12.2) 116 (11.9) 115 (11.8) 114 (11.7) 109 (11.2) 104 (10.7) 99 (10.2)
780 (80.3) 485 (49.9) 159 (16.4) 93 (9.6) 87 (9.0) 74 (7.6) 66 (6.8) 62 (6.4) 49 (5.0)
71 (7.3) 12 (1.2) 5 (0.5) 4 (0.4) 3 (0.3) 2(0.2) 2 (0.2) 2 (0.2) 2 (0.2)
516 (53.1) 105 (10.8) 92 (9.5) 68 (7.0) 36 (3.7) 36 (3.7) 31 (3.2)
521 (53.7) 195 (20.1) 193 (19.9)
(n=339) (n=291)
AEs of any grade (in ≥10% of patients in the safety population by preferred term)
(n=630)
Any
Neutropenia Pyrexia Thrombocytopenia Nausea
Anemia
Chills
Diarrhea
Vomiting
Fatigue Pneumonia Constipation Cough Leukopenia Hypotension Dyspnea
328 (96.8) 216 (63.7) 112 (33.0) 99 (29.2) 99 (29.2) 68 (20.1) 47 (13.9) 47 (13.9) 57 (16.8) 31 (9.1) 28 (8.3) 35 (10.3) 27 (8.0) 43 (12.7) 26 (7.7) 28 (8.3)
288 (99.0) 153 (52.6) 98 (33.7) 89 (30.6) 77 (26.5) 79 (27.1) 53 (18.2) 44 (15.1) 36 (12.4) 41 (14.1) 33 (11.3) 38 (13.1) 32 (11.0) 20 (6.9) 36 (12.4) 25 (8.6)
616 (97.8) 369 (58.6) 210 (33.3) 188 (29.8) 176 (27.9) 147 (23.3) 100 (15.9) 91 (14.4) 93 (14.8) 72 (11.4) 61 (9.7) 73 (11.6) 59 (9.4) 63 (10.0) 62 (9.8) 53 (8.4)
499 (79.2) 306 (48.6) 92 (14.6) 53 (8.4) 41 (6.5) 47 (7.5) 37 (5.9) 46 (7.3) 29 (4.6)
31 (4.9) 5 (0.8) 3 (0.5) 2 (0.3) 0 1(0.2) 2 (0.3) 0
2 (0.3)
319 (50.6) 62 (9.8) 44 (7.0) 43 (6.8) 28 (4.4) 25 (4.0) 19 (3.0)
332 (52.7) 105 (16.7) 125 (19.8)
Grade ≥3 AEs (in ≥5% of patients in the safety population by preferred term)
Any
Neutropenia Thrombocytopenia Anemia
Pneumonia
Febrile neutropenia Leukopenia
TLS
Lymphopenia
266 (78.5) 177 (52.2) 46 (13.6) 23 (6.8) 17 (5.0) 29 (8.6) 26 (7.7) 14 (4.1) 20 (5.9)
233 (80.1) 129 (44.3) 46 (15.8) 30 (10.3) 24 (8.2) 18 (6.2) 11 (3.8) 32 (11.0) 9 (3.1)
Grade 5 (fatal) AEs (in ≥2 patients in the safety population by preferred term)
Any
Pneumonia
Sepsis
Death
Richter syndrome AML
Febrile neutropenia Septic shock
TLS
13 (3.8) 1 (0.3) 1 (0.3) 1 (0.3) 0 1(0.3) 0
0
1 (0.3)
18 (6.2) 4 (1.4) 2 (0.7) 1 (0.3) 0
0
2 (0.7) 0
1 (0.3)
SAEs (in ≥2% of patients in the safety population by preferred term)
Any
Neutropenia Pneumonia
Febrile neutropenia Pyrexia
TLS Thrombocytopenia
148 (43.7) 39 (11.5) 20 (5.9) 25 (7.4) 15 (4.4) 4 (1.2) 8 (2.4)
171 (58.8) 23 (7.9) 24 (8.2) 18 (6.2) 13 (4.5) 21 (7.2) 11 (3.8)
138 (47.4) 57 (19.6) 65 (22.3)
Grade ≥3 AESIs/AEPIs (basket terms)*
Neutropenia Infections IRRs
194 (57.2) 48 (14.2) 60 (17.7)
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haematologica | 2018; 103(11)