The most notable adverse events
| Treatment/infectious adverse events . | FL (n = 14) . | R/R (n = 17) . |
|---|---|---|
| Admission during first cycle, n (%) | 12 (86) | 17 (100) |
| Days in hospital during first cycle, median (range) | 25 (7-60) | 31 (7-64) |
| Neutropenic (ANC <1) before VEN initiation, n (%) | 9 (64) | 14 (82) |
| Infection requiring IV antibiotic before VEN initiation, n (%) | 2 (14) | 13 (76) |
| Pneumonia | 2 (14) | 8 (47) |
| Others* | – | 5 (29) |
| Grade 3 or higher infection during first cycle requiring IV antibiotic, n (%) | 12 (86) | 14 (93) |
| Pneumonia | 6 | 9 |
| Bacteremia† | 3: 2 GN, 1 GP | 3: 1 GN, 2 GP |
| Others‡ | 3 | 2 |
| Grade 3 or higher infection during subsequent cycles, n/N treated (%) | 7/9 (78) | 10/11 (91) |
| Pneumonia | 3 | 7 |
| Bacteremia† | 2: 2 GN | 1: 1 GP |
| Others§ | 2 | 2 |
| New probable/proven IFD while on VEN therapy, n (%) | 3 (21) | 5 (29) |
| Patients with >1 infection/>1 organ involvement, n (%) | 7 (50) | 9 (53) |
| Severe hemorrhage (requiring inpatient intervention), n (%) | ||
| CNS (subdural, intracranial) hemorrhage | 2 (14) | 4 (24) |
| Gastrointestinal | 1 (7) | 2 (12) |
| Lung (diffuse alveolar hemorrhage) | 2 (14) | 3 (18) |
| Non-hematologic grade 3 or higher in >2 patients, n (%) | ||
| Fatigue | 4 (29) | 5 (29) |
| Gastrointestinal symptoms | 3 (21) | 4 (24) |
| Mortality <30 d | 1 (7) | 2 (12) |
| Total mortality <60 d | 3 (21) | 7 (42) |
| Treatment/infectious adverse events . | FL (n = 14) . | R/R (n = 17) . |
|---|---|---|
| Admission during first cycle, n (%) | 12 (86) | 17 (100) |
| Days in hospital during first cycle, median (range) | 25 (7-60) | 31 (7-64) |
| Neutropenic (ANC <1) before VEN initiation, n (%) | 9 (64) | 14 (82) |
| Infection requiring IV antibiotic before VEN initiation, n (%) | 2 (14) | 13 (76) |
| Pneumonia | 2 (14) | 8 (47) |
| Others* | – | 5 (29) |
| Grade 3 or higher infection during first cycle requiring IV antibiotic, n (%) | 12 (86) | 14 (93) |
| Pneumonia | 6 | 9 |
| Bacteremia† | 3: 2 GN, 1 GP | 3: 1 GN, 2 GP |
| Others‡ | 3 | 2 |
| Grade 3 or higher infection during subsequent cycles, n/N treated (%) | 7/9 (78) | 10/11 (91) |
| Pneumonia | 3 | 7 |
| Bacteremia† | 2: 2 GN | 1: 1 GP |
| Others§ | 2 | 2 |
| New probable/proven IFD while on VEN therapy, n (%) | 3 (21) | 5 (29) |
| Patients with >1 infection/>1 organ involvement, n (%) | 7 (50) | 9 (53) |
| Severe hemorrhage (requiring inpatient intervention), n (%) | ||
| CNS (subdural, intracranial) hemorrhage | 2 (14) | 4 (24) |
| Gastrointestinal | 1 (7) | 2 (12) |
| Lung (diffuse alveolar hemorrhage) | 2 (14) | 3 (18) |
| Non-hematologic grade 3 or higher in >2 patients, n (%) | ||
| Fatigue | 4 (29) | 5 (29) |
| Gastrointestinal symptoms | 3 (21) | 4 (24) |
| Mortality <30 d | 1 (7) | 2 (12) |
| Total mortality <60 d | 3 (21) | 7 (42) |
ANC, absolute neutrophil count; CNS, central nervous system; IFD, invasive fungal disease.
Others: 3 colitis or abdominal infection, and 2 cellulitis in R/R.
Gram-negative bacteremia (GN); gram-positive bacteremia (GP).
Others: 1 mastoiditis and 2 cellulitis for FL, and 1 abdominal infection and 1 cellulitis in R/R.
Others: 2 colitis for FL, 1 colitis and 1 cellulitis for R/R.