Serious AEs for trial (DFCI/WUSTL) patients
. | DFCI . | WUSTL . | Combined . | ||||||
---|---|---|---|---|---|---|---|---|---|
. | Grade 3-4 (n = 23 [56%]) . | Grade 3 . | Grade 4 . | Grade 3-4 (n = 18 [44%]) . | Grade 3 . | Grade 4 . | Grade 3-4 (n = 41) . | Grade 3 . | Grade 4 . |
Lymphopenia | 21 (91) | — | 21 (91) | 15 (83) | 1 (6) | 14 (78) | 36 (88) | 1 (2) | 35 (85) |
Thrombocytopenia | 19 (83) | — | 19 (83) | 16 (89) | 2 (11) | 14 (78) | 35 (85) | 2 (5) | 33 (80) |
Neutropenia | 20 (87) | 2 (9) | 18 (78) | 14 (78) | 4 (22) | 10 (56) | 34 (83) | 6 (15) | 28 (68) |
Leukopenia | 18 (78) | — | 18 (78) | 13 (72) | 1 (6) | 12 (67) | 31 (76) | 1 (2) | 30 (73) |
Anemia | 11 (48) | 11 (48) | — | 7 (39) | 6 (33) | 1 (6) | 18 (44) | 17 (41) | 1 (2) |
Febrile neutropenia | 4 (17) | 3 (13) | 1 (4) | 2 (11) | 1 (6) | 1 (6) | 6 (15) | 4 (10) | 2 (5) |
Fever | 2 (9) | 2 (9) | — | — | — | — | 2 (5) | 2 (5) | — |
Enterocolitis | — | — | — | 1 (6) | 1 (6) | — | 1 (2) | 1 (2) | — |
Pneumonia | 1 (4) | 1 (4) | — | — | — | — | 1 (2) | 1 (2) | — |
Sepsis | 1 (4) | 1 (4) | — | — | — | — | 1 (2) | 1 (2) | — |
Hyperglycemia | — | — | — | 1 (6) | 1 (6) | — | 1 (2) | 1 (2) | — |
Hyperuricemia | — | — | — | 1 (6) | — | 1 (6) | 1 (2) | — | 1 (2) |
Infusion related reaction | — | — | — | 1 (6) | 1 (6) | — | 1 (2) | 1 (2) | — |
Thrombotic thrombocytopenic purpura | 1 (4) | — | 1 (4) | — | — | — | 1 (2) | — | 1 (2) |
. | DFCI . | WUSTL . | Combined . | ||||||
---|---|---|---|---|---|---|---|---|---|
. | Grade 3-4 (n = 23 [56%]) . | Grade 3 . | Grade 4 . | Grade 3-4 (n = 18 [44%]) . | Grade 3 . | Grade 4 . | Grade 3-4 (n = 41) . | Grade 3 . | Grade 4 . |
Lymphopenia | 21 (91) | — | 21 (91) | 15 (83) | 1 (6) | 14 (78) | 36 (88) | 1 (2) | 35 (85) |
Thrombocytopenia | 19 (83) | — | 19 (83) | 16 (89) | 2 (11) | 14 (78) | 35 (85) | 2 (5) | 33 (80) |
Neutropenia | 20 (87) | 2 (9) | 18 (78) | 14 (78) | 4 (22) | 10 (56) | 34 (83) | 6 (15) | 28 (68) |
Leukopenia | 18 (78) | — | 18 (78) | 13 (72) | 1 (6) | 12 (67) | 31 (76) | 1 (2) | 30 (73) |
Anemia | 11 (48) | 11 (48) | — | 7 (39) | 6 (33) | 1 (6) | 18 (44) | 17 (41) | 1 (2) |
Febrile neutropenia | 4 (17) | 3 (13) | 1 (4) | 2 (11) | 1 (6) | 1 (6) | 6 (15) | 4 (10) | 2 (5) |
Fever | 2 (9) | 2 (9) | — | — | — | — | 2 (5) | 2 (5) | — |
Enterocolitis | — | — | — | 1 (6) | 1 (6) | — | 1 (2) | 1 (2) | — |
Pneumonia | 1 (4) | 1 (4) | — | — | — | — | 1 (2) | 1 (2) | — |
Sepsis | 1 (4) | 1 (4) | — | — | — | — | 1 (2) | 1 (2) | — |
Hyperglycemia | — | — | — | 1 (6) | 1 (6) | — | 1 (2) | 1 (2) | — |
Hyperuricemia | — | — | — | 1 (6) | — | 1 (6) | 1 (2) | — | 1 (2) |
Infusion related reaction | — | — | — | 1 (6) | 1 (6) | — | 1 (2) | 1 (2) | — |
Thrombotic thrombocytopenic purpura | 1 (4) | — | 1 (4) | — | — | — | 1 (2) | — | 1 (2) |
Data are presented as n (%) of patients.