Table 2.
Dose-Limiting Toxicities (DLTs) in the DLT-Evaluable Populationa
| Treatment Group | Patients, N |
DLT | Patients with DLTs, n | DLT by Maximum Gradeb | |||
|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | |||||
| MK-8353 50 mg + selumetinib 25 mg | 3 | Any DLT | 0 | ||||
| MK-8353 100 mg + selumetinib 50 mg | 11 | Any DLT | 1 | ||||
| Urticaria | 1 | 0 | 0 | 1 | |||
| MK-8353 150 mg + selumetinib 75 mg | 14 | Any DLT | 7 | ||||
| Diarrhea | 1 | 0 | 0 | 1 | |||
| Macular edema | 1 | 0 | 1 | 0 | |||
| Nausea | 1 | 0 | 1 | 0 | |||
| Retinal detachment | 2 | 0 | 2 | 0 | |||
| Retinopathy | 1 | 0 | 1 | 0 | |||
| Vision blurred | 2 | 0 | 2 | 0 | |||
| Vomiting | 2 | 0 | 2 | 0 | |||
aDLT-evaluable population consists of patients that received ≥1 dose of study medication and satisfy 1 of the following criteria: (a) were observed for safety for 21 days after the first dose of assigned treatment, or (b) experienced a DLT prior to 21 days after the first dose of assigned treatment
bOnly the highest reported grade for a given DLT is counted for the individual patient. There were no grade 4/5 DLTs.