Table 2.
Variable | No. of Patients |
---|---|
Adverse event | |
Patients who could be evaluated for adverse events | 28 |
GVHD — dose-limiting toxicity | |
Chronic GVHD of liver | 3 |
Acute GVHD of gut | 1 |
Immune-related adverse events | |
Death | 1 |
Pneumonitis | |
Grade 4 | 1 |
Grade 2 | 2 |
Colitis, grade 3 | 1 |
Immune thrombocytopenic purpura, grade 2 | 1 |
Diarrhea, grade 2 | 1 |
Other adverse events of grade 3 or higher regardless of attribution, or grade 1 or 2 events at least possibly related to ipilimumab |
|
Acute kidney injury, grade 3 | 1 |
Corneal ulcer, grade 3 | 1 |
Thrombocytopenia, grade 3 or 4 | 9 |
Neutropenia, grade 3 or 4 | 3 |
Anemia, grade 3 or 4 | 2 |
Pleural effusion, grade 3 | 1 |
Limb edema, grade 1 or 2 | 6 |
Outcome of treatment | |
Patients who received maximum administered dose (10 mg/kg) | 22 |
Complete response | 5 |
Partial response | 2 |
Stable disease | 6 |
Progression of disease | 9 |
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.