Table 3.
Treatment‐emergent adverse events (TEAEs) in the escalation phase
| Everolimus dose (mg/d) TEAEs | 2.5 mg | 5 mg | 7.5 mg | 10 mg | All doses | ||||
|---|---|---|---|---|---|---|---|---|---|
| Gr1/2 (n) | Gr 3/4 (n) | Gr1/2 (n) | Gr3/4 (n) | Gr1/2 (n) | Gr3/4 (n) | Gr1/2 (n) | Gr3/4 (n) | All grades (n) | |
| Hand‐foot‐skin‐reaction | 1 | 1 | 2 | 1 | 3 | 2 | 10 | ||
| Infection | 1 | 1 | 1 | 1 | 4 | 1 | 1 | 10 | |
| Rash | 4 | 7 | 1 | 8 | |||||
| Mucositis | 1 | 1 | 4 | 1 | 1 | 8 | |||
| Diarrhea | 3 | 1 | 6 | 7 | |||||
| Skin hypersensitivity | 1 | 2 | 3 | 6 | |||||
| Lack of appetite | 1 | 1 | 3 | 5 | |||||
| Cough | 5 | 5 | |||||||
| Fatigue | 1 | 2 | 3 | ||||||
| Thombocytopenia | 3 | 3 | |||||||
| Rhinorrhea | 1 | 1 | 1 | 3 | |||||
| Increased GOT | 2 | 1 | 3 | ||||||
| Abdominal pain | 1 | 2 | 3 | ||||||
| Nausea | 1 | 1 | 2 | ||||||
| Hypertension | 1 | 1 | 2 | ||||||
| Nail changes | 2 | 2 | |||||||
| Heartburn | 2 | 2 | |||||||
| Leucocytopenia | 1 | 1 | 2 | ||||||
| Gastrointestinal ulceration | 1 | 1 |
2 |
||||||
| Sleeplessness | 2 | 2 | |||||||
| Dyspnea | 1 | 1 | 2 | ||||||
| Anemia | 2 | 2 | |||||||
| Headache | 1 | 2 | |||||||
| Muscle pain | 2 | 2 | |||||||
| Mouth hypersensitivity | 1 | 1 | |||||||
| Epistaxis | 1 | 1 | 1 | ||||||
| Increased GPT | 1 | 1 | |||||||
| Increased GGT | 1 | 1 | |||||||
| Increased AP | 1 | 1 | |||||||
| Neutropenia | 1 | 1 | |||||||
| Gastrointestinal bleeding | 1 | 1 | |||||||
| Hyperthyreosis | 1 | 1 | |||||||
| Constipation | 1 | 1 | |||||||
| Pruritus | 1 | 1 | |||||||
| Hemorrhoids | 1 | 1 | |||||||
| Hematoma | 1 | 1 | |||||||
| Alopecia | 1 | 1 | |||||||
| Edema | 1 | 1 | |||||||
| Dysphagia | 1 | 1 | |||||||
| Hoarseness | 1 | 1 | |||||||
| Flu like syndrome | 1 | 1 | |||||||
| Cardiac ischemia | 1 | 1 | |||||||