Table 2. Treatment-related adverse events.
| Toxicity-no. | Total | Arm A (N = 11) | Arm B (N = 11) | ||
|---|---|---|---|---|---|
| Any Grade | G3–4 | Any Grade | G3–4 | ||
| Any event | 17 | 6 | - | 11 | 3 |
| Laboratory | |||||
| platelet count decreased | 6 | — | — | 6 | 1 |
| anemia | 2 | — | — | 2 | 1 |
| neutrophil count decreased | 2 | — | — | 2 | — |
| elevated rapamycin level | 2 | — | — | 2 | — |
| alkaline phosphatase increased | 1 | — | — | 1 | — |
| hypokalemia | 1 | — | — | 1 | 1 |
| hyponatremia | 1 | — | — | 1 | 1 |
| Gastrointestinal | |||||
| nausea/vomiting | 6 | 3 | — | 3 | — |
| diarrhea, loose stools | 6 | 2 | — | 4 | — |
| abdominal pain | 3 | — | — | 3 | — |
| bloating | 3 | 2 | — | 1 | — |
| anorexia | 2 | — | — | 2 | — |
| abdominal distension | 1 | — | — | 1 | — |
| early satiety | 1 | — | — | 1 | — |
| mucositis | 1 | — | — | 1 | — |
| Generalized | |||||
| diaphoresis | 4 | 2 | — | 2 | — |
| chills | 2 | 1 | — | 1 | — |
| edema | 2 | — | — | 2 | — |
| fatigue | 2 | — | — | 2 | — |
| weight loss | 2 | — | — | 2 | — |
| fever | 1 | — | — | 1 | — |
| dehydration | 1 | — | — | 1 | — |
| Dermatologic | |||||
| rash | 4 | — | — | 4 | — |
| dry skin | 1 | — | — | 1 | — |
| pruritis | 1 | — | — | 1 | — |
| Respiratory | |||||
| cough | 1 | — | — | 1 | — |
| dyspnea | 1 | — | — | 1 | — |
| sore throat | 1 | — | — | 1 | — |
| upper respiratory infection | 1 | — | — | 1 | — |
| Other | |||||
| arthralgia | 2 | — | — | 2 | — |
| paresthesia | 1 | — | — | 1 | — |
*Events were counted once for each patient using the highest grading.