Total adverse events and serious adverse events in the 2 study groups*
| Category . | Total adverse events . | Serious adverse events† . | ||
|---|---|---|---|---|
| SIR + PRE . | SIR . | SIR + PRE . | SIR . | |
| Upper respiratory infection | 20 | 17 | 4 | 3 |
| Mucositis | 15 | 17 | 1 | 2 |
| Nausea/vomiting | 15 | 12 | 0 | 0 |
| Pneumonia‡ | 11 | 8 | 2 | 3 |
| Thrombocytosis | 9 | 10 | 0 | 0 |
| Cough | 6 | 10 | 0 | 0 |
| Eczema | 7 | 8 | 0 | 1 |
| Increased liver enzyme levels | 5 | 5 | 0 | 0 |
| Constipation | 6 | 4 | 0 | 0 |
| Diarrhea | 6 | 3 | 1 | 0 |
| Pain | 4 | 4 | 0 | 0 |
| Gastroenteritis | 2 | 6 | 1 | 1 |
| Rash | 5 | 3 | 0 | 0 |
| Acne | 3 | 4 | 0 | 0 |
| Decreased appetite | 3 | 3 | 0 | 0 |
| Lymphopenia | 4 | 2 | 0 | 0 |
| Lymph gland infection | 2 | 3 | 0 | 0 |
| Hyperlipidemia | 3 | 1 | 0 | 0 |
| Hypercholesterolemia | 2 | 2 | 0 | 0 |
| Urinary tract infection | 2 | 1 | 1 | 0 |
| Neutropenia | 2 | 0 | 0 | 0 |
| Cataract | 1 | 0 | 1 | 0 |
| Total | 133 | 123 | 11 | 10 |
| Category . | Total adverse events . | Serious adverse events† . | ||
|---|---|---|---|---|
| SIR + PRE . | SIR . | SIR + PRE . | SIR . | |
| Upper respiratory infection | 20 | 17 | 4 | 3 |
| Mucositis | 15 | 17 | 1 | 2 |
| Nausea/vomiting | 15 | 12 | 0 | 0 |
| Pneumonia‡ | 11 | 8 | 2 | 3 |
| Thrombocytosis | 9 | 10 | 0 | 0 |
| Cough | 6 | 10 | 0 | 0 |
| Eczema | 7 | 8 | 0 | 1 |
| Increased liver enzyme levels | 5 | 5 | 0 | 0 |
| Constipation | 6 | 4 | 0 | 0 |
| Diarrhea | 6 | 3 | 1 | 0 |
| Pain | 4 | 4 | 0 | 0 |
| Gastroenteritis | 2 | 6 | 1 | 1 |
| Rash | 5 | 3 | 0 | 0 |
| Acne | 3 | 4 | 0 | 0 |
| Decreased appetite | 3 | 3 | 0 | 0 |
| Lymphopenia | 4 | 2 | 0 | 0 |
| Lymph gland infection | 2 | 3 | 0 | 0 |
| Hyperlipidemia | 3 | 1 | 0 | 0 |
| Hypercholesterolemia | 2 | 2 | 0 | 0 |
| Urinary tract infection | 2 | 1 | 1 | 0 |
| Neutropenia | 2 | 0 | 0 | 0 |
| Cataract | 1 | 0 | 1 | 0 |
| Total | 133 | 123 | 11 | 10 |
The safety population included all patients who received at least 1 dose of sirolimus. Adverse events were assessed using the Common Terminology Criteria for Adverse Events, version 4.0. The details of the assessment plan for adverse events are provided in the trial protocol.
A serious adverse event was defined as any of the grade ≥3 toxicities identified during the 12 months of treatment.
Potential causative agents were found in 13 patients. A bacterial agent was found in 9 patients and a respiratory virus was found in 7 patients. In 3 patients, there was evidence of a mixed bacteria/virus infection.