Posttreatment treatment-related AEs
. | Clb-Obi (N = 214) . | Ven-Obi (N = 212) . |
---|---|---|
Total no. of patients with at least 1 AE | 10 (4.7%) | 17 (8.0%) |
Neutropenia | 2 (0.9%) | 6 (2.8%) |
Maximum CTC grade 3 | 1 (0.5%) | 3 (1.4%) |
Maximum CTC grade 4 | 1 (0.5%) | 3 (1.4%) |
Febrile neutropenia | 1 (0.5%) | 2 (0.9%) |
Maximum CTC grade 1 | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 1 (0.5%) | 1 (0.5%) |
Pneumonia | 1 (0.5%) | 1 (0.5%) |
Maximum CTC grade 3 | 1 (0.5%) | 1 (0.5%) |
Sepsis | 1 (0.5%) | 1 (0.5%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 5 | 0 (0.0%) | 1 (0.5%) |
Anemia | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Atrial fibrillation | 1 (0.5%) | 1 (0.5%) |
Maximum CTC grade 2 | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Headache | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Basal cell carcinoma | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 2 | 1 (0.5%) | 0 (0.0%) |
Bladder neoplasm | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Calculus bladder | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Candida infection | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
COVID-19 | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Dyspnea | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Hemoptysis | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 2 | 1 (0.5%) | 0 (0.0%) |
Hepatitis viral | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Infected neoplasm | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 0 (0.0%) | 1 (0.5%) |
Infection | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 0 (0.0%) | 1 (0.5%) |
Malignant melanoma | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Ophthalmic herpes zoster | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Penile cancer | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Plasma cell myeloma | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Pneumonia streptococcal | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Pneumonitis | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Prostate cancer | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Sinusitis | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Sinusitis Aspergillus | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Splenomegaly | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 0 (0.0%) | 1 (0.5%) |
Staphylococcal bacteremia | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Streptococcal infection | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
T-cell lymphoma | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 0 (0.0%) | 1 (0.5%) |
Thrombocytopenia | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Toxicity of various agents | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
. | Clb-Obi (N = 214) . | Ven-Obi (N = 212) . |
---|---|---|
Total no. of patients with at least 1 AE | 10 (4.7%) | 17 (8.0%) |
Neutropenia | 2 (0.9%) | 6 (2.8%) |
Maximum CTC grade 3 | 1 (0.5%) | 3 (1.4%) |
Maximum CTC grade 4 | 1 (0.5%) | 3 (1.4%) |
Febrile neutropenia | 1 (0.5%) | 2 (0.9%) |
Maximum CTC grade 1 | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 1 (0.5%) | 1 (0.5%) |
Pneumonia | 1 (0.5%) | 1 (0.5%) |
Maximum CTC grade 3 | 1 (0.5%) | 1 (0.5%) |
Sepsis | 1 (0.5%) | 1 (0.5%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 5 | 0 (0.0%) | 1 (0.5%) |
Anemia | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Atrial fibrillation | 1 (0.5%) | 1 (0.5%) |
Maximum CTC grade 2 | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Headache | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Basal cell carcinoma | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 2 | 1 (0.5%) | 0 (0.0%) |
Bladder neoplasm | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Calculus bladder | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Candida infection | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
COVID-19 | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Dyspnea | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Hemoptysis | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 2 | 1 (0.5%) | 0 (0.0%) |
Hepatitis viral | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Infected neoplasm | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 0 (0.0%) | 1 (0.5%) |
Infection | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 0 (0.0%) | 1 (0.5%) |
Malignant melanoma | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Ophthalmic herpes zoster | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Penile cancer | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Plasma cell myeloma | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Pneumonia streptococcal | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Pneumonitis | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Prostate cancer | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Sinusitis | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Sinusitis Aspergillus | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Splenomegaly | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 0 (0.0%) | 1 (0.5%) |
Staphylococcal bacteremia | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
Streptococcal infection | 1 (0.5%) | 0 (0.0%) |
Maximum CTC grade 3 | 1 (0.5%) | 0 (0.0%) |
T-cell lymphoma | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 4 | 0 (0.0%) | 1 (0.5%) |
Thrombocytopenia | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Toxicity of various agents | 0 (0.0%) | 1 (0.5%) |
Maximum CTC grade 3 | 0 (0.0%) | 1 (0.5%) |
Investigator-assessed relatedness.
CTC, common terminology criteria.