Table 6.
Schedule B investigator-identified and sponsor-assessed DLTs
| Patient’s starting dose cohort | Dose when DLT occurred | AE recorded as DLT | Was the AE serious? | Severity | Relationship to MRZ/Dex | Action taken with MRZ /Dex | Outcome |
|---|---|---|---|---|---|---|---|
| RP2D 0.5 mg/m2 | 0.5 mg/m2 | Nausea | Yes | Grade 3 | MRZ probable/Dex not related | None | Resolved |
| RP2D 0.5 mg/m2 | 0.5 mg/m2 | Confusional state | Yes | Grade 4 | MRZ probable/Dex not related | MRZ discontinued | Resolved |
| 0.6 mg/m2 | 0.4 mg/m2 | Gait disturbance | No | Grade 2 | MRZ probable/Dex not related | MRZ dose reduced, dose delayed | Resolved |
| 0.6 mg/m2 | 0.6 mg/m2 | Paranoia | No | Grade 2 | MRZ possible/Dex not related | MRZ discontinued | Resolved |