Study-drug exposure and disposition
| . | All Patients (N = 35) . |
|---|---|
| Drug exposure | |
| Median treatment duration, days (range) | 272 (2-589) |
| Actual dose intensity (mg/day) | 394 (87.5-400) |
| Relative dose intensity (%) | 98.5 (22-100) |
| Reason for study-drug discontinuation | |
| AE/SAE | 9 (26%) |
| Sponsor’s decision to terminate the study* | 8 (23%) |
| Disease progression | 7 (20%) |
| Lack of response | 6 (17%) |
| Subject withdrew consent | 4 (11%) |
| Protocol deviation | 1 (3%)† |
| . | All Patients (N = 35) . |
|---|---|
| Drug exposure | |
| Median treatment duration, days (range) | 272 (2-589) |
| Actual dose intensity (mg/day) | 394 (87.5-400) |
| Relative dose intensity (%) | 98.5 (22-100) |
| Reason for study-drug discontinuation | |
| AE/SAE | 9 (26%) |
| Sponsor’s decision to terminate the study* | 8 (23%) |
| Disease progression | 7 (20%) |
| Lack of response | 6 (17%) |
| Subject withdrew consent | 4 (11%) |
| Protocol deviation | 1 (3%)† |