Table 2.

DLTs observed in all 3 studies

StudyNature of DLTDose level (mg sirolimus)
Sirolimus alonePneumonia20
Dehydration30
Unable to complete cycle 1 because of toxicity (anorexia and fatigue ≤grade 2)60
Sirolimus/ketoconazolePneumonia5
Hand/foot syndromea6
Diarrheaa6
Hyperglycemia16
Sirolimus/grapefruit juiceHyperglycemia25
Mucositis25
Anorexia30
  • aThese occurred concurrently in the same subject.