Summary of AEs
n (%) . | Patients (n = 40) . |
---|---|
Patients with at least one AE | 40 (100.0) |
Mosunetuzumab-related AE | 40 (100.0) |
SAE, not including grade 5 disease progression | 20 (50.0) |
Mosunetuzumab-related SAE | 12 (30.0) |
Grade 5 AE | 2 (5.0)∗ |
AE leading to mosunetuzumab discontinuation | 4 (10.0) |
Treatment-related AE leading to mosunetuzumab discontinuation | 1 (2.5) |
n (%) . | Patients (n = 40) . |
---|---|
Patients with at least one AE | 40 (100.0) |
Mosunetuzumab-related AE | 40 (100.0) |
SAE, not including grade 5 disease progression | 20 (50.0) |
Mosunetuzumab-related SAE | 12 (30.0) |
Grade 5 AE | 2 (5.0)∗ |
AE leading to mosunetuzumab discontinuation | 4 (10.0) |
Treatment-related AE leading to mosunetuzumab discontinuation | 1 (2.5) |
Any-grade AEs (≥20% of patients) or grade ≥3 AEs (≥5% of patients) based on preferred term . | Any grade . | Grade ≥3 . |
---|---|---|
Neutropenia/neutrophil count decreased | 28 (70.0) | 26 (65.0) |
CRS | 24 (60.0) | 0 |
Nausea | 22 (55.0) | 1 (2.5) |
Fatigue | 19 (47.5) | 4 (10.0) |
Anemia/hemoglobin decreased | 17 (42.5) | 12 (30.0) |
Decreased appetite | 15 (37.5) | 3 (7.5) |
Constipation | 15 (37.5) | 1 (2.5) |
Hypokalemia | 13 (32.5) | 3 (7.5) |
Peripheral neuropathy | 13 (32.5) | 1 (2.5) |
Diarrhea | 13 (32.5) | 1 (2.5) |
Alopecia | 12 (30.0) | 0 |
Vomiting | 12 (30.0) | 1 (2.5) |
Thrombocytopenia/platelet count decreased | 10 (25.0) | 7 (17.5) |
Headache | 10 (25.0) | 1 (2.5) |
Dizziness | 10 (25.0) | 0 |
Hypotension | 9 (22.5) | 1 (2.5) |
Febrile neutropenia | 8 (20.0) | 8 (20.0) |
Abdominal pain | 8 (20.0) | 1 (2.5) |
Peripheral edema | 8 (20.0) | 0 |
Pyrexia | 8 (20.0) | 0 |
Dyspnea | 7 (17.5) | 2 (5.0) |
Hypophosphatemia | 7 (17.5) | 2 (5.0) |
Hypoalbuminemia | 6 (15.0) | 2 (5.0) |
Alanine aminotransferase increased | 6 (15.0) | 2 (5.0) |
Aspartate transaminase increased | 5 (12.5) | 2 (5.0) |
Lymphopenia/lymphocyte count decreased | 5 (12.5) | 4 (10.0) |
Dehydration | 5 (12.5) | 2 (5.0) |
Leukopenia/white blood cell decreased | 4 (10.0) | 3 (7.5) |
Pneumonia | 4 (10.0) | 3 (7.5) |
Colitis | 3 (7.5) | 2 (5.0) |
Syncope | 2 (5.0) | 2 (5.0) |
Any-grade AEs (≥20% of patients) or grade ≥3 AEs (≥5% of patients) based on preferred term . | Any grade . | Grade ≥3 . |
---|---|---|
Neutropenia/neutrophil count decreased | 28 (70.0) | 26 (65.0) |
CRS | 24 (60.0) | 0 |
Nausea | 22 (55.0) | 1 (2.5) |
Fatigue | 19 (47.5) | 4 (10.0) |
Anemia/hemoglobin decreased | 17 (42.5) | 12 (30.0) |
Decreased appetite | 15 (37.5) | 3 (7.5) |
Constipation | 15 (37.5) | 1 (2.5) |
Hypokalemia | 13 (32.5) | 3 (7.5) |
Peripheral neuropathy | 13 (32.5) | 1 (2.5) |
Diarrhea | 13 (32.5) | 1 (2.5) |
Alopecia | 12 (30.0) | 0 |
Vomiting | 12 (30.0) | 1 (2.5) |
Thrombocytopenia/platelet count decreased | 10 (25.0) | 7 (17.5) |
Headache | 10 (25.0) | 1 (2.5) |
Dizziness | 10 (25.0) | 0 |
Hypotension | 9 (22.5) | 1 (2.5) |
Febrile neutropenia | 8 (20.0) | 8 (20.0) |
Abdominal pain | 8 (20.0) | 1 (2.5) |
Peripheral edema | 8 (20.0) | 0 |
Pyrexia | 8 (20.0) | 0 |
Dyspnea | 7 (17.5) | 2 (5.0) |
Hypophosphatemia | 7 (17.5) | 2 (5.0) |
Hypoalbuminemia | 6 (15.0) | 2 (5.0) |
Alanine aminotransferase increased | 6 (15.0) | 2 (5.0) |
Aspartate transaminase increased | 5 (12.5) | 2 (5.0) |
Lymphopenia/lymphocyte count decreased | 5 (12.5) | 4 (10.0) |
Dehydration | 5 (12.5) | 2 (5.0) |
Leukopenia/white blood cell decreased | 4 (10.0) | 3 (7.5) |
Pneumonia | 4 (10.0) | 3 (7.5) |
Colitis | 3 (7.5) | 2 (5.0) |
Syncope | 2 (5.0) | 2 (5.0) |
SAEs (≥5% of patients) based on preferred term . | Any grade . | Grade ≥3 . |
---|---|---|
Febrile neutropenia | 6 (15.0) | 6 (15.0) |
Neutropenia/neutrophil count decreased | 3 (7.5) | 3 (7.5) |
Pneumonia | 3 (7.5) | 3 (7.5) |
Colitis | 2 (5.0) | 2 (5.0) |
Nausea | 2 (5.0) | 1 (2.5) |
SAEs (≥5% of patients) based on preferred term . | Any grade . | Grade ≥3 . |
---|---|---|
Febrile neutropenia | 6 (15.0) | 6 (15.0) |
Neutropenia/neutrophil count decreased | 3 (7.5) | 3 (7.5) |
Pneumonia | 3 (7.5) | 3 (7.5) |
Colitis | 2 (5.0) | 2 (5.0) |
Nausea | 2 (5.0) | 1 (2.5) |
AE, adverse event; SAE, serious adverse event
One case of pneumonia unrelated to mosunetuzumab but related to chemotherapy and 1 case of malignant disease progression.