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Adverse events reported in healthy volunteers in the test (T, +PRO) and control (C, IPERGAY) treatments.
| Adverse Event | C IPERGAY | T +PRO | ||
|---|---|---|---|---|
| # of Subjects (% of 14 total) | Severity grade | # of Subjects (% of 15 total) | Severity grade | |
| Headache | 2 (14) | 1 | 4 (27) | 1 |
| Nausea | 2 (14) | 1 | 6 (40) | 1 |
| Vomiting | 1 (7) | 2 | ||
| Loss of appetite | 1 (7) | 2 | ||
| Nose bleed | 1 (7) | 1 | ||
| GERD | 1 (7) | 2 | ||
| Total AE | 4 | 14 | ||
- Severity grade based on NCI Common Toxicity Criteria.
- Grade 1 = mild; Grade 2 = moderate
