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| Number of AEs | AE | CTCAE grade | Related? |
|---|---|---|---|
| Tostran | |||
| 1 | Heartburn/indigestion | Grade 3 | No |
| 1 | Chest pain | Grade 3 | No |
| 1 | Fatigue | Grade 3 | No |
| 1 | Insomnia | Grade 3 | No |
| 1 | Anxiety | Grade 3 | No |
| Placebo | |||
| 1 | Appendicitis | Grade 3 | No |
| 1 | Skin rash | Grade 3 | Yes |
| 1 | Indigestion and bowel disturbance | Grade 3 | No |
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events
