TEAEs occurring in 10% or more of patients in any treatment group eligible for nonintensive therapy
TEAE, n (%) . | Magro/Aza (n = 96) . | Ven/Aza (n = 98) . | ||
---|---|---|---|---|
Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
Total | 96 (100.0) | 93 (96.9) | 97 (99.0) | 94 (95.9) |
Related to any study drug | 78 (81.3) | 62 (64.6) | 80 (81.6) | 58 (59.2) |
Febrile neutropenia | 46 (47.9) | 44 (45.8) | 48 (49.0) | 46 (46.9) |
Pyrexia | 43 (44.8) | 4 (4.2) | 26 (26.5) | 5 (5.1) |
Constipation | 33 (34.4) | 0 | 37 (37.8) | 0 |
Anemia | 31 (32.3) | 26 (27.1) | 28 (28.6) | 23 (23.5) |
Nausea | 28 (29.2) | 4 (4.2) | 32 (32.7) | 2 (2.0) |
Diarrhea | 27 (28.1) | 1 (1.0) | 38 (38.8) | 0 |
Thrombocytopenia∗ | 26 (27.1) | 23 (24.0) | 41 (41.8) | 35 (35.7) |
Fatigue | 25 (26.0) | 4 (4.2) | 21 (21.4) | 6 (6.1) |
IRR | 22 (22.9) | 7 (7.3) | 3 (3.1) | 1 (1.0) |
Hypokalemia | 21 (21.9) | 4 (4.2) | 22 (22.4) | 9 (9.2) |
Pneumonia | 21 (21.9) | 16 (16.7) | 18 (18.4) | 17 (17.3) |
Decreased appetite | 20 (20.8) | 8 (8.3) | 21 (21.4) | 4 (4.1) |
Dyspnea | 20 (20.8) | 4 (4.2) | 16 (16.3) | 3 (3.1) |
Increased blood bilirubin | 19 (19.8) | 2 (2.1) | 11 (11.2) | 0 |
Neutropenia† | 17 (17.7) | 17 (17.7) | 48 (49.0) | 47 (48.0) |
Peripheral edema | 17 (17.7) | 1 (1.0) | 19 (19.4) | 0 |
Vomiting | 15 (15.6) | 1 (1.0) | 22 (22.4) | 2 (2.0) |
Asthenia | 15 (15.6) | 3 (3.1) | 13 (13.3) | 1 (1.0) |
Headache | 13 (13.5) | 2 (2.1) | 11 (11.2) | 0 |
Increased AST | 13 (13.5) | 2 (2.1) | 9 (9.2) | 1 (1.0) |
Hypotension | 13 (13.5) | 3 (3.1) | 6 (6.1) | 2 (2.0) |
Increased ALT | 13 (13.5) | 2 (2.1) | 6 (6.1) | 1 (1.0) |
Hypophosphatemia | 12 (12.5) | 1 (1.0) | 8 (8.2) | 0 |
Abdominal pain | 11 (11.5) | 2 (2.1) | 11 (11.2) | 2 (2.0) |
Arthralgia | 11 (11.5) | 2 (2.1) | 10 (10.2) | 1 (1.0) |
Hypomagnesemia | 11 (11.5) | 0 | 8 (8.2) | 0 |
Pleural effusion | 11 (11.5) | 4 (4.2) | 6 (6.1) | 3 (3.1) |
Hypoalbuminemia | 10 (10.4) | 1 (1.0) | 12 (12.2) | 1 (1.0) |
Fall | 10 (10.4) | 1 (1.0) | 11 (11.2) | 1 (1.0) |
Cough | 9 (9.4) | 0 | 10 (10.2) | 0 |
Epistaxis | 8 (8.3) | 1 (1.0) | 15 (15.3) | 0 |
Hyponatremia | 8 (8.3) | 1 (1.0) | 14 (14.3) | 3 (3.1) |
Increase blood creatinine | 8 (8.3) | 1 (1.0) | 14 (14.3) | 1 (1.0) |
Decreased WBC count | 6 (6.3) | 5 (5.2) | 14 (14.3) | 14 (14.3) |
Increased blood ALP | 6 (6.3) | 1 (1.0) | 10 (10.2) | 0 |
Injection site reaction | 5 (5.2) | 0 | 15 (15.3) | 0 |
Stomatitis | 5 (5.2) | 0 | 15 (15.3) | 1 (1.0) |
Decreased lymphocyte count | 4 (4.2) | 4 (4.2) | 11 (11.2) | 10 (10.2) |
TEAE, n (%) . | Magro/Aza (n = 96) . | Ven/Aza (n = 98) . | ||
---|---|---|---|---|
Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
Total | 96 (100.0) | 93 (96.9) | 97 (99.0) | 94 (95.9) |
Related to any study drug | 78 (81.3) | 62 (64.6) | 80 (81.6) | 58 (59.2) |
Febrile neutropenia | 46 (47.9) | 44 (45.8) | 48 (49.0) | 46 (46.9) |
Pyrexia | 43 (44.8) | 4 (4.2) | 26 (26.5) | 5 (5.1) |
Constipation | 33 (34.4) | 0 | 37 (37.8) | 0 |
Anemia | 31 (32.3) | 26 (27.1) | 28 (28.6) | 23 (23.5) |
Nausea | 28 (29.2) | 4 (4.2) | 32 (32.7) | 2 (2.0) |
Diarrhea | 27 (28.1) | 1 (1.0) | 38 (38.8) | 0 |
Thrombocytopenia∗ | 26 (27.1) | 23 (24.0) | 41 (41.8) | 35 (35.7) |
Fatigue | 25 (26.0) | 4 (4.2) | 21 (21.4) | 6 (6.1) |
IRR | 22 (22.9) | 7 (7.3) | 3 (3.1) | 1 (1.0) |
Hypokalemia | 21 (21.9) | 4 (4.2) | 22 (22.4) | 9 (9.2) |
Pneumonia | 21 (21.9) | 16 (16.7) | 18 (18.4) | 17 (17.3) |
Decreased appetite | 20 (20.8) | 8 (8.3) | 21 (21.4) | 4 (4.1) |
Dyspnea | 20 (20.8) | 4 (4.2) | 16 (16.3) | 3 (3.1) |
Increased blood bilirubin | 19 (19.8) | 2 (2.1) | 11 (11.2) | 0 |
Neutropenia† | 17 (17.7) | 17 (17.7) | 48 (49.0) | 47 (48.0) |
Peripheral edema | 17 (17.7) | 1 (1.0) | 19 (19.4) | 0 |
Vomiting | 15 (15.6) | 1 (1.0) | 22 (22.4) | 2 (2.0) |
Asthenia | 15 (15.6) | 3 (3.1) | 13 (13.3) | 1 (1.0) |
Headache | 13 (13.5) | 2 (2.1) | 11 (11.2) | 0 |
Increased AST | 13 (13.5) | 2 (2.1) | 9 (9.2) | 1 (1.0) |
Hypotension | 13 (13.5) | 3 (3.1) | 6 (6.1) | 2 (2.0) |
Increased ALT | 13 (13.5) | 2 (2.1) | 6 (6.1) | 1 (1.0) |
Hypophosphatemia | 12 (12.5) | 1 (1.0) | 8 (8.2) | 0 |
Abdominal pain | 11 (11.5) | 2 (2.1) | 11 (11.2) | 2 (2.0) |
Arthralgia | 11 (11.5) | 2 (2.1) | 10 (10.2) | 1 (1.0) |
Hypomagnesemia | 11 (11.5) | 0 | 8 (8.2) | 0 |
Pleural effusion | 11 (11.5) | 4 (4.2) | 6 (6.1) | 3 (3.1) |
Hypoalbuminemia | 10 (10.4) | 1 (1.0) | 12 (12.2) | 1 (1.0) |
Fall | 10 (10.4) | 1 (1.0) | 11 (11.2) | 1 (1.0) |
Cough | 9 (9.4) | 0 | 10 (10.2) | 0 |
Epistaxis | 8 (8.3) | 1 (1.0) | 15 (15.3) | 0 |
Hyponatremia | 8 (8.3) | 1 (1.0) | 14 (14.3) | 3 (3.1) |
Increase blood creatinine | 8 (8.3) | 1 (1.0) | 14 (14.3) | 1 (1.0) |
Decreased WBC count | 6 (6.3) | 5 (5.2) | 14 (14.3) | 14 (14.3) |
Increased blood ALP | 6 (6.3) | 1 (1.0) | 10 (10.2) | 0 |
Injection site reaction | 5 (5.2) | 0 | 15 (15.3) | 0 |
Stomatitis | 5 (5.2) | 0 | 15 (15.3) | 1 (1.0) |
Decreased lymphocyte count | 4 (4.2) | 4 (4.2) | 11 (11.2) | 10 (10.2) |