Frequency in each population, n (%) | ||||
---|---|---|---|---|
TEAE, n (%) | All | 0–3 cycles | 4–7 cycles | ≥8 cycles |
N = 914 | n = 632 | n = 219 | n = 63 | |
Any TEAE | 883 (96.6) | 611 (96.7) | 209 (95.4) | 63 (100.0) |
Severe TEAE (grade ≥ 3) | 683 (74.7) | 466 (73.7) | 160 (73.1) | 57 (90.5) |
Most frequent severe TEAE (grade ≥ 3) | ||||
Neutropeniaa | 355 (38.8) | 180 (28.5) | 127 (58.0) | 48 (76.2) |
Anaemiaa | 103 (11.3) | 65 (10.3) | 30 (13.7) | 8 (12.7) |
Astheniaa | 49 (5.4) | 36 (5.7) | 10 (4.6) | 3 (4.8) |
Diarrhoea | 39 (4.3) | 27 (4.3) | 8 (3.7) | 4 (6.3) |
Severe TEAE (grade ≥ 3) of interest | ||||
Febrile neutropeniaa | 11 (1.2) | 8 (1.3) | 2 (0.9) | 1 (1.6) |
Cardiac disordersa | 6 (0.7) | 5 (0.8) | 1 (0.5) | – |
TEAE related to study drug | 721 (78.9) | 461 (72.9) | 199 (90.9) | 61 (96.8) |
Severe TEAE (grade ≥ 3) related to study drug | 459 (50.2) | 262 (41.5) | 144 (65.8) | 53 (84.1) |
Most frequent severe TEAE (grade ≥ 3) related to study drug | ||||
Neutropeniaa | 348 (38.1) | 175 (27.7) | 126 (57.5) | 47 (74.6) |
Anaemiaa | 66 (7.2) | 37 (5.9) | 23 (10.5) | 6 (9.5) |
Astheniaa | 31 (3.4) | 21 (3.3) | 8 (3.7) | 2 (3.2) |
Diarrhoea | 28 (3.1) | 21 (3.3) | 5 (2.3) | 2 (3.2) |
Severe TEAE (grade ≥ 3) of interest related to study drug | ||||
Febrile neutropeniaa | 11 (1.2) | 8 (1.3) | 2 (0.9) | 1 (1.6) |
Cardiac disordersa | 1 (0.1) | 1 (0.2) | – | – |
TEAE leading to study drug withdrawal | 195 (21.3) | 169 (26.7) | 20 (9.1) | 6 (9.5) |
TEAE leading to study drug dose reduction | 106 (11.6) | 57 (9.0) | 36 (16.4) | 13 (20.6) |
Study drug-related | 93 (10.2) | 48 (7.6) | 32 (14.6) | 13 (20.6) |
TEAE leading to study drug delay or temporary interruption | 481 (52.5) | 285 (44.9) | 145 (66.2) | 51 (81.0) |
Study drug-related | 384 (42.0) | 206 (32.6) | 131 (59.8) | 47 (74.6) |