Table 3.
Summary of Instances of DLT During Radiation and Vorinostat and Subsequent Maintenance Vorinostat that are Considered in the Analysis of Time to First DLT Event
| Reporting Period | DLTs Observed in at Least One Patient | Number of Patients With DLT Types |
|---|---|---|
| Radiation Therapy and Vorinostat | Grade 2 creatinine elevation | 1 |
| Grade 3 agitation; Grade 3 confusion; Grade 3 hyperglycemia | 1 | |
| Grade 3 anorexia | 1 | |
| Grade 3 hypertension | 1 | |
| Grade 3 hyponatremia | 1 | |
| Grade 3 mucositis; Grade 3 thrombocytopenia | 1 | |
| Grade 3 thrombocytopenia | 1 | |
| Grade 3 maculopapular rash | 1 | |
| Grade 4 hyperglycemia | 1 | |
| Grade 4 neutropenia; Grade 3 thrombocytopenia | 1 | |
| Maintenance Vorinostat Cycles 1 and 2 | Grade 2 anorexia; Grade 2 weight loss | 1 |
| Grade 2 creatinine elevation | 1 | |
| Grade 3 creatinine elevation | 1 | |
| Grade 3 hypermagnesemia | 1a | |
| Grade 3 thrombocytopenia | 3 | |
| Grade 3 thrombocytopenia; Grade 4 neutropenia | 2 | |
| Grade 4 thrombocytopenia | 1 | |
| Grade 4 thrombocytopenia; Grade 3 hypermagnesemia | 1 | |
| Grade 4 thrombocytopenia; Grade 4 neutropenia | 1 | |
| Maintenance Vorinostat Cycles 3 and 4 | Grade 3 alkaline phosphatase elevation | 1 |
| Grade 3 dehydration | 1 | |
| Grade 3 thrombocytopenia | 1 | |
| Grade 4 neutropenia | 2 | |
| Maintenance Vorinostat Cycles 5 and 6 | Grade 3 depressed level of consciousness | 1 |
| Grade 4 intracranial hemorrhage | 1 | |
| Maintenance Vorinostat Cycles 7 and 8 | Grade 3 weight loss; Grade 2 creatinine elevation | 1 |
| Maintenance Vorinostat Cycles 9 and 10 | Grade 3 weight loss | 1 |
| Total | 31 |
For patients experiencing more than 1 DLTs, only the first DLT and associated reporting period are included in this table.
aThis patient also developed grade 3 thromboembolism during cycle 5 and 6 reporting period.