Adverse events by treatment regimen
| Doublet TAG-AZA (n = 19) . | n (%) . | . | . | . | . |
|---|---|---|---|---|---|
| Event term . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total, grade 2+ . |
| ALT increased | 6 (31.6) | 4 (21.1) | 10 (52.6) | ||
| CLS | 7 (36.8) | 2 (10.5) | 9 (47.3) | ||
| Febrile neutropenia | 7 (36.8) | 7 (36.8) | |||
| Neutrophil count decreased | 1 (5.3) | 5 (26.3) | 6 (31.6) | ||
| Platelet count decreased | 1 (5.3) | 2 (10.5) | 3 (15.8) | 6 (31.6) | |
| White blood cell decreased | 1 (5.3) | 2 (10.5) | 3 (15.8) | 6 (31.6) | |
| Hypotension | 4 (21.1) | 2 (10.5) | 6 (31.6) | ||
| Blood bilirubin increased | 4 (21.1) | 4 (21.1) | |||
| Lung infection | 1 (5.3) | 2 (10.5) | 3 (15.8) | ||
| Anemia | 1 (5.3) | 2 (10.5) | 3 (15.8) | ||
| Hypophosphatemia | 1 (5.3) | 2 (10.5) | 3 (15.8) | ||
| Back pain | 1 (5.3) | 2 (10.5) | 3 (15.8) | ||
| Infections and infestations - other | 2 (10.5) | 2 (10.5) | |||
| Lymphocyte count decreased | 2 (10.5) | 2 (10.5) | |||
| Hypocalcemia | 2 (10.5) | 2 (10.5) | |||
| Hypoxia | 2 (10.5) | 2 (10.5) |
| Doublet TAG-AZA (n = 19) . | n (%) . | . | . | . | . |
|---|---|---|---|---|---|
| Event term . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total, grade 2+ . |
| ALT increased | 6 (31.6) | 4 (21.1) | 10 (52.6) | ||
| CLS | 7 (36.8) | 2 (10.5) | 9 (47.3) | ||
| Febrile neutropenia | 7 (36.8) | 7 (36.8) | |||
| Neutrophil count decreased | 1 (5.3) | 5 (26.3) | 6 (31.6) | ||
| Platelet count decreased | 1 (5.3) | 2 (10.5) | 3 (15.8) | 6 (31.6) | |
| White blood cell decreased | 1 (5.3) | 2 (10.5) | 3 (15.8) | 6 (31.6) | |
| Hypotension | 4 (21.1) | 2 (10.5) | 6 (31.6) | ||
| Blood bilirubin increased | 4 (21.1) | 4 (21.1) | |||
| Lung infection | 1 (5.3) | 2 (10.5) | 3 (15.8) | ||
| Anemia | 1 (5.3) | 2 (10.5) | 3 (15.8) | ||
| Hypophosphatemia | 1 (5.3) | 2 (10.5) | 3 (15.8) | ||
| Back pain | 1 (5.3) | 2 (10.5) | 3 (15.8) | ||
| Infections and infestations - other | 2 (10.5) | 2 (10.5) | |||
| Lymphocyte count decreased | 2 (10.5) | 2 (10.5) | |||
| Hypocalcemia | 2 (10.5) | 2 (10.5) | |||
| Hypoxia | 2 (10.5) | 2 (10.5) |
| Triplet TAG-AZA-VEN (n = 37) . | . | . | . | . | . |
|---|---|---|---|---|---|
| Event term . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total, grade 2+ . |
| Platelet count decreased | 2 (5.4) | 2 (5.4) | 17 (45.9) | 21 (56.8) | |
| White blood cell decreased | 1 (2.7) | 17 (45.9) | 18 (48.6) | ||
| Neutrophil count decreased | 14 (37.8) | 14 (37.8) | |||
| Anemia | 1 (2.7) | 10 (27) | 1 (2.7) | 12 (32.4) | |
| Febrile neutropenia | 1 (2.7) | 9 (24.3) | 1 (2.7) | 11 (29.7) | |
| Infections and infestations - other | 2 (5.4) | 6 (16.2) | 8 (21.7) | ||
| CLS | 5 (13.5) | 1 (2.7) | 1 (2.7) | 7 (18.9) | |
| Lymphocyte count decreased | 5 (13.5) | 5 (13.5) | |||
| Tumor lysis syndrome | 1 (2.7) | 4 (10.8) | 5 (13.5) | ||
| Sepsis | 1 (2.7) | 1 (2.7) | 2 (5.4) | 4 (10.8) |
| Triplet TAG-AZA-VEN (n = 37) . | . | . | . | . | . |
|---|---|---|---|---|---|
| Event term . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . | Total, grade 2+ . |
| Platelet count decreased | 2 (5.4) | 2 (5.4) | 17 (45.9) | 21 (56.8) | |
| White blood cell decreased | 1 (2.7) | 17 (45.9) | 18 (48.6) | ||
| Neutrophil count decreased | 14 (37.8) | 14 (37.8) | |||
| Anemia | 1 (2.7) | 10 (27) | 1 (2.7) | 12 (32.4) | |
| Febrile neutropenia | 1 (2.7) | 9 (24.3) | 1 (2.7) | 11 (29.7) | |
| Infections and infestations - other | 2 (5.4) | 6 (16.2) | 8 (21.7) | ||
| CLS | 5 (13.5) | 1 (2.7) | 1 (2.7) | 7 (18.9) | |
| Lymphocyte count decreased | 5 (13.5) | 5 (13.5) | |||
| Tumor lysis syndrome | 1 (2.7) | 4 (10.8) | 5 (13.5) | ||
| Sepsis | 1 (2.7) | 1 (2.7) | 2 (5.4) | 4 (10.8) |
Displayed are any terms that occurred as grade 3 or higher in 10% or more of patients in either the doublet or triplet regimens, with the incidence of grade 2 to 5 events shown for each term. Additionally, all CLS events are shown. CTCAE v4.0 does not define any CLS as grade 1; the lowest possible is grade 2. AEs in this table are listed regardless of attribution as treatment-related or not treatment-related. Grade 5 events of disease progression are not included.
CTCAE, Common Terminology Criteria for Adverse Events.