Table 5. Summary of treatment-emergent adverse eventsa.
| Number of Patients with (%) | Lomitapide MTD at Day 1 |
FAS (N= 5) |
||
|---|---|---|---|---|
| 10 mg (n = 1) | 20 mg (n = 3) | 40 mg (n = 1) | ||
| Adverse events (AEs) | 1 (100.0) | 3 (100.0) | 1 (100.0) | 5 (100.0) |
| Drug-related AEsb | 1 (100.0) | 2 (66.7) | 0 | 3 (60.0) |
| Severe AEs | 0 | 0 | 0 | 0 |
| Serious AEs | 0 | 1 (33.3) | 0 | 1 (20.0) |
| AEs leading to study discontinuation | 0 | 0 | 0 | 0 |
| Dose held or reduced due to an AE | 0 | 0 | 0 | 0 |
| Deaths due to an AE | 0 | 0 | 0 | 0 |
FAS, full analysis set; MTD, maximum tolerated dose
a
Events with onset date that occurred during this study phase are included. The FAS column includes all adverse events reported, including events where a dose was not indicated or study drug was interrupted/stopped. A subject's AE was counted according to the MTD at Day 1. Only 1 occurrence of that event was counted within each dose. Subjects may have been counted more than once for AEs occurring during multiple dose values.
b
Related is defined as definite by the investigator on the CRF