Table 4.
AE Summary
| System | AE | Grade | Cause | Rate% |
|---|---|---|---|---|
| Cardiovascular | Bradycardia | 1 | Possible | 4% |
| Electrolytes | Hyperkalemia | 3 | Unrelated | 4% |
| General | Blurred vision | 1 | Possible | 4% |
| Chest Pain | 1 | Unrelated | 4% | |
| Cough, productive | 1 | Unrelated | 4% | |
| Fatigue (Fatigue, worsening) | 1–2 | Probable | 9% | |
| Hot flashes | 1 | Unrelated/Possible | 9% | |
| Lower Jaw/Tooth Swelling and Discomfort | 1 | Unrelated | 4% | |
| Phimosis | 2 | Unrelated | 4% | |
| Sore throat | 1 | Unrelated | 4% | |
| Vitiligo | 1 | Possible | 4% | |
| GI | ALT, elevated | 1 | Possible | 4% |
| Bloating, intestinal, intermittent | 1 | Possible | 4% | |
| Constipation | 1 | Unrelated | 4% | |
| Diarrhea (Diarrhea, intermittent) | 1 | Unrelated/Possible | 13% | |
| Diverticulitis | 1 | Unrelated | 4% | |
| Flatulence | 1 | Possible | 9% | |
| Nausea | 1 | Possible/Probable | 4% | |
| Stool, loose (Stools, loose, intermittent) | 1 | Possible | 13% | |
| Hematologic | DVT, bilateral lower extremity | 3 | Unrelated | 4% |
| Hematoma, left gluteal muscle | 1 | Unrelated | 4% | |
| Infection/Infestation | Common cold | 1 | Unrelated | 4% |
| UTI | 2 | Unrelated | 13% | |
| Virus, GI | 1 | Unrelated | 4% | |
| Inflammation/Immunologic | Arthritis, gouty | 2 | Unrelated | 4% |
| Nodule, prurigo, right arm | 1 | Unrelated | 4% | |
| Metabolic | Lactose intolerance | 2 | Unrelated | 4% |
| Urinary | Dysuria | 1 | Unrelated | 4% |
AE adverse event, ALT alanine aminotransferase, DVT Deep Vein Thrombosis, GI gastrointestinal, UTI Urinary Tract Infection