Summary of AEs
| Toxicity grade . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . |
|---|---|---|---|---|---|
| All-cause AEs, n (%) | 34 (100) | 22 (64) | 15 (44) | 4 (12) | 1 (3) |
| Treatment related, n (%) | 20 (59) | 14 (41) | 10 (29) | 3 (9) | 0 (0) |
| Toxicity grade . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | Grade 5 . |
|---|---|---|---|---|---|
| All-cause AEs, n (%) | 34 (100) | 22 (64) | 15 (44) | 4 (12) | 1 (3) |
| Treatment related, n (%) | 20 (59) | 14 (41) | 10 (29) | 3 (9) | 0 (0) |
| Treatment-related adverse events . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | . |
|---|---|---|---|---|---|
| Hematological | |||||
| Neutrophil count decreased | 1 | 1 | 1 | 3 | |
| Platelet count decreased | 3 | 1 | |||
| Anemia | 1 | 3 | |||
| Gastrointestinal | |||||
| Nausea/vomiting | 3 | 2 | |||
| Diarrhea | 3 | 1 | |||
| Mucositis oral | 1 | ||||
| Liver enzyme derangement | 1 | 1 | 2 | ||
| Anorexia | 1 | 2 | |||
| Odynophagia | 3∗ | ||||
| Laryngeal inflammation | 1 | ||||
| Constipation | 1 | ||||
| Dysgeusia | 1 | ||||
| Abdominal pain | 1 | ||||
| Other | |||||
| Fatigue/lethargy | 6 | 3 | 1 | ||
| Infection | 5 | 1 | |||
| Pruritus | 4 | 1 | |||
| Squamous cell carcinoma | 3 | ||||
| Hyperthyroidism | 2 | ||||
| Hypothyroidism | 1 | ||||
| Fever | 2 | ||||
| Rash (undefined) | 2 | ||||
| Pleural effusion | 1∗ | ||||
| Hypercalcemia | 1 | ||||
| Hypocalcemia | 1 | ||||
| Hypomagnesemia | 1 | ||||
| Hypokalemia | 1 | ||||
| Hypophosphatemia | 1 | ||||
| Arthralgia | 1 | ||||
| Myalgia | 1 | ||||
| Itchy eyes | 1 | ||||
| Pain | 1 | ||||
| Paresthesia | 1 | ||||
| Thromboembolic event | 1∗ | ||||
| Headache | 1 |
| Treatment-related adverse events . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . | . |
|---|---|---|---|---|---|
| Hematological | |||||
| Neutrophil count decreased | 1 | 1 | 1 | 3 | |
| Platelet count decreased | 3 | 1 | |||
| Anemia | 1 | 3 | |||
| Gastrointestinal | |||||
| Nausea/vomiting | 3 | 2 | |||
| Diarrhea | 3 | 1 | |||
| Mucositis oral | 1 | ||||
| Liver enzyme derangement | 1 | 1 | 2 | ||
| Anorexia | 1 | 2 | |||
| Odynophagia | 3∗ | ||||
| Laryngeal inflammation | 1 | ||||
| Constipation | 1 | ||||
| Dysgeusia | 1 | ||||
| Abdominal pain | 1 | ||||
| Other | |||||
| Fatigue/lethargy | 6 | 3 | 1 | ||
| Infection | 5 | 1 | |||
| Pruritus | 4 | 1 | |||
| Squamous cell carcinoma | 3 | ||||
| Hyperthyroidism | 2 | ||||
| Hypothyroidism | 1 | ||||
| Fever | 2 | ||||
| Rash (undefined) | 2 | ||||
| Pleural effusion | 1∗ | ||||
| Hypercalcemia | 1 | ||||
| Hypocalcemia | 1 | ||||
| Hypomagnesemia | 1 | ||||
| Hypokalemia | 1 | ||||
| Hypophosphatemia | 1 | ||||
| Arthralgia | 1 | ||||
| Myalgia | 1 | ||||
| Itchy eyes | 1 | ||||
| Pain | 1 | ||||
| Paresthesia | 1 | ||||
| Thromboembolic event | 1∗ | ||||
| Headache | 1 |
There were no treatment-related deaths on the study.
Events meeting serious AE criteria defined by the protocol.