Selected anticipated grade 3 or greater adverse events for VEN patients stratified by dosing schedule
| Adverse event . | Overall (N = 99) . | ≤7 days (n = 42) . | 8-21 days (n = 31) . | 22-28 days (n = 26) . | P value∗ . | ||||
|---|---|---|---|---|---|---|---|---|---|
| n . | % . | n . | % . | n . | % . | n . | % . | ||
| Adverse event within 30 days of start of treatment | |||||||||
| Febrile neutropenia, grade ≥3 | 8 | 8.1 | 3 | 7.1 | 3 | 9.7 | 2 | 7.7 | .933 |
| Sepsis | 2 | 2.0 | 0 | 0.0 | 0 | 0.0 | 2 | 7.7 | — |
| Infection, grade ≥3 | 2 | 2.0 | 0 | 0.0 | 1 | 3.2 | 1 | 3.8 | — |
| Pneumonia, grade ≥3 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| Neutropenia, grade ≥3 | 7 | 7.1 | 1 | 2.4 | 6 | 19.4 | 0 | 0.0 | — |
| Thrombocytopenia, grade ≥3 | 7 | 7.1 | 1 | 2.4 | 5 | 16.1 | 1 | 3.8 | .728 |
| Leukocytosis, grade ≥3 | 1 | 1.0 | 0 | 0.0 | 0 | 0.0 | 1 | 3.8 | — |
| Differentiation syndrome | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| None of the above | 86 | 86.9 | 39 | 92.9 | 24 | 77.4 | 23 | 88.5 | .535 |
| Cardiac events | |||||||||
| Ejection fraction decrease | 2 | 2.0 | 0 | 0.0 | 2 | 6.5 | 0 | 0.0 | — |
| Troponin elevation | 1 | 1.0 | 0 | 0.0 | 1 | 3.2 | 0 | 0.0 | — |
| Type I NSTEMI | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| Worsening HFpEF by echo | 2 | 2.0 | 0 | 0.0 | 1 | 3.2 | 1 | 3.8 | .200 |
| Cardiogenic pulmonary edema | 2 | 2.0 | 1 | 2.4 | 0 | 0.0 | 1 | 3.8 | .728 |
| Atrial fibrillation with RVR | 3 | 3.0 | 0 | 0.0 | 1 | 3.2 | 2 | 7.7 | .068 |
| Other symptomatic arrhythmia | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| Worsening CAD | 2 | 2.0 | 0 | 0.0 | 2 | 6.5 | 0 | 0.0 | — |
| Pericardial effusion/pericarditis | 1 | 1.0 | 0 | 0.0 | 0 | 0.0 | 1 | 3.8 | — |
| Cardiopulmonary arrest | 1 | 1.0 | 0 | 0.0 | 1 | 3.2 | 0 | 0.0 | — |
| Worsening RV dysfunction by echo | 1 | 1.0 | 0 | 0.0 | 0 | 0.0 | 1 | 3.8 | — |
| Initiation of new cardiac treatment | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| Any other significant cardiac event | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| None of the above | 89 | 89.9 | 41 | 97.6 | 25 | 80.6 | 23 | 88.5 | .119 |
| Adverse event . | Overall (N = 99) . | ≤7 days (n = 42) . | 8-21 days (n = 31) . | 22-28 days (n = 26) . | P value∗ . | ||||
|---|---|---|---|---|---|---|---|---|---|
| n . | % . | n . | % . | n . | % . | n . | % . | ||
| Adverse event within 30 days of start of treatment | |||||||||
| Febrile neutropenia, grade ≥3 | 8 | 8.1 | 3 | 7.1 | 3 | 9.7 | 2 | 7.7 | .933 |
| Sepsis | 2 | 2.0 | 0 | 0.0 | 0 | 0.0 | 2 | 7.7 | — |
| Infection, grade ≥3 | 2 | 2.0 | 0 | 0.0 | 1 | 3.2 | 1 | 3.8 | — |
| Pneumonia, grade ≥3 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| Neutropenia, grade ≥3 | 7 | 7.1 | 1 | 2.4 | 6 | 19.4 | 0 | 0.0 | — |
| Thrombocytopenia, grade ≥3 | 7 | 7.1 | 1 | 2.4 | 5 | 16.1 | 1 | 3.8 | .728 |
| Leukocytosis, grade ≥3 | 1 | 1.0 | 0 | 0.0 | 0 | 0.0 | 1 | 3.8 | — |
| Differentiation syndrome | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| None of the above | 86 | 86.9 | 39 | 92.9 | 24 | 77.4 | 23 | 88.5 | .535 |
| Cardiac events | |||||||||
| Ejection fraction decrease | 2 | 2.0 | 0 | 0.0 | 2 | 6.5 | 0 | 0.0 | — |
| Troponin elevation | 1 | 1.0 | 0 | 0.0 | 1 | 3.2 | 0 | 0.0 | — |
| Type I NSTEMI | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| Worsening HFpEF by echo | 2 | 2.0 | 0 | 0.0 | 1 | 3.2 | 1 | 3.8 | .200 |
| Cardiogenic pulmonary edema | 2 | 2.0 | 1 | 2.4 | 0 | 0.0 | 1 | 3.8 | .728 |
| Atrial fibrillation with RVR | 3 | 3.0 | 0 | 0.0 | 1 | 3.2 | 2 | 7.7 | .068 |
| Other symptomatic arrhythmia | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| Worsening CAD | 2 | 2.0 | 0 | 0.0 | 2 | 6.5 | 0 | 0.0 | — |
| Pericardial effusion/pericarditis | 1 | 1.0 | 0 | 0.0 | 0 | 0.0 | 1 | 3.8 | — |
| Cardiopulmonary arrest | 1 | 1.0 | 0 | 0.0 | 1 | 3.2 | 0 | 0.0 | — |
| Worsening RV dysfunction by echo | 1 | 1.0 | 0 | 0.0 | 0 | 0.0 | 1 | 3.8 | — |
| Initiation of new cardiac treatment | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| Any other significant cardiac event | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | — |
| None of the above | 89 | 89.9 | 41 | 97.6 | 25 | 80.6 | 23 | 88.5 | .119 |
CAD, coronary artery disease; HFpEF, heart failure with preserved ejection fraction; NSTEMI, non–ST-elevation myocardial infarction; RV, right ventricular; RVR, rapid ventricular response.
P value is between ≤7 days and 22 to 28 days VEN durations per cycle.