At least grade 3 AEs in patients with R/R TCL exposed to GBV induction phase and maintenance phase
| AE . | Induction phase (N = 71) . | Maintenance phase (N = 28) . | ||||
|---|---|---|---|---|---|---|
| No. of patients . | % of patients . | No. of events . | No. of patients . | % of patients . | No. of events . | |
| Total | 58 | 81.7 | 189 | 11 | 39.3 | |
| Neutropenia | 39 | 54.9 | 74 | 6 | 21.4 | 6 |
| Thrombocytopenia | 10 | 14.1 | 15 | 0 | 0.0 | 0 |
| Anemia | 15 | 21.1 | 24 | 0 | 0.0 | 0 |
| Febrile neutropenia | 2 | 3.1 | 2 | 0 | 0.0 | 0 |
| Infection | 10∗ | 14.1 | 13 | 2† | 7.1 | 2 |
| Peripheral neuropathy | 3 | 4.2 | 3 | 4 | 14.3 | 4 |
| Cardiovascular | 5 | 7.0 | 5 | 0 | 0.0 | 0 |
| Gastrointestinal | 4 | 5.6 | 4 | 0 | 0.0 | 0 |
| Liver | 4 | 5.6 | 4 | 0 | 0.0 | |
| Skin | 3 | 4.2 | 3 | 1 | 3.6 | 1 |
| Ionogram abnormalities | 2 | 2.8 | 2 | 0 | 0.0 | 0 |
| Respiratory | 2 | 2.8 | 1 | 1 | 3.6 | 1 |
| Tumor lysis syndrome | 1 | 1.7 | 1 | 0 | 0.0 | 0 |
| Lipase increased | 1 | 1.7 | 1 | 0 | 0.0 | 0 |
| Arthritis | 1 | 1.7 | 1 | 0 | 0.0 | 0 |
| Sudden death | 1 | 1.7 | 1 | 0 | 0.0 | 0 |
| AE . | Induction phase (N = 71) . | Maintenance phase (N = 28) . | ||||
|---|---|---|---|---|---|---|
| No. of patients . | % of patients . | No. of events . | No. of patients . | % of patients . | No. of events . | |
| Total | 58 | 81.7 | 189 | 11 | 39.3 | |
| Neutropenia | 39 | 54.9 | 74 | 6 | 21.4 | 6 |
| Thrombocytopenia | 10 | 14.1 | 15 | 0 | 0.0 | 0 |
| Anemia | 15 | 21.1 | 24 | 0 | 0.0 | 0 |
| Febrile neutropenia | 2 | 3.1 | 2 | 0 | 0.0 | 0 |
| Infection | 10∗ | 14.1 | 13 | 2† | 7.1 | 2 |
| Peripheral neuropathy | 3 | 4.2 | 3 | 4 | 14.3 | 4 |
| Cardiovascular | 5 | 7.0 | 5 | 0 | 0.0 | 0 |
| Gastrointestinal | 4 | 5.6 | 4 | 0 | 0.0 | 0 |
| Liver | 4 | 5.6 | 4 | 0 | 0.0 | |
| Skin | 3 | 4.2 | 3 | 1 | 3.6 | 1 |
| Ionogram abnormalities | 2 | 2.8 | 2 | 0 | 0.0 | 0 |
| Respiratory | 2 | 2.8 | 1 | 1 | 3.6 | 1 |
| Tumor lysis syndrome | 1 | 1.7 | 1 | 0 | 0.0 | 0 |
| Lipase increased | 1 | 1.7 | 1 | 0 | 0.0 | 0 |
| Arthritis | 1 | 1.7 | 1 | 0 | 0.0 | 0 |
| Sudden death | 1 | 1.7 | 1 | 0 | 0.0 | 0 |
Including Pneumonia (n = 3), sepsis or septic shock (n = 3), Campylobacter infection (n = 1), Clostridium difficile colitis (n = 1), device-related infection (n = 1), Pneumocystis jirovecii pneumonia (n = 1), and Pseudomonas infection (n = 1).
Including bronchitis (n = 1) and cytomegalovirus chorioretinitis (n = 1).