Table 2.
Only AEs occurring 5% overall are included in this table.
| Adverse Events (AEs) | Adverse Events % (N) participants | ||
|---|---|---|---|
| Regular (n = 30) | Flexible (n = 5) | Total (n = 35) | |
| [A] ALL ADVERSE EVENTS | 100% (30) | 100%(5) | 100%(35) |
| [B] SERIOUS ADVERSE EVENTS (SAE) | |||
| Serious Adverse Events- Total | 20%(6) | 0%(0) | 17%(6) |
| SAEs at least “Possibly Related” to study drug | 0% (0) | 0% (0) | 0%(0) |
| [C] AEs leading to permanent study drug discontinuation | 37%(11) | 20%(1) | 34%(12) |
| GI disorders- other | 13% (4) | 0% (0) | 11%(4) |
| Nausea | 10%(3) | 0%(0) | 9%(3) |
| Diarrhea | 3% (1) | 0% (0) | 6% (2) |
| Dysphagia | 10% (3) | 0% (0) | 9% (3) |
| Dehydration | 7% (2) | 0% (0) | 6% (2) |
| [E]AEs AT LEAST “POSSIBLY RELATED” TO STUDY DRUG | 83%(25) | 100%(5) | 86%(30) |
| Nausea | 37% (11) | 60% (3) | 40%(14) |
| Fatigue | 23% (7) | 40% (2) | 26%(9) |
| Diarrhea | 17% (5) | 40%(2) | 20%(7) |
| Other GI | 20% (6) | 20%(1) | 20%(7) |
| Insomnia | 17% (5) | 40% (2) | 20%(7) |
| Hot flashes | 20% (6) | 0% (0) | 17%(6) |
| Headache | 13% (4) | 20% (1) | 14%(5) |
| Abdominal/Stomach/GI pain | 13% (4) | 20% (1) | 14%(5) |
| Dizziness | 13% (4) | 0% (0) | 11%(4) |
| Other skin and subcutaneous tissue disorders | 10%(3) | 20%(1) | 11%(4) |
| Vomiting | 7%(2) | 20%(1) | 9%(3) |
| Flatulence | 10%(3) | 0%(0) | 9%(3) |
| Abdominal distension | 7%(2) | 0%(0) | 6%(2) |
| Weight loss | 3% (1) | 20%(1) | 6% (2) |
| Anorexia | 3% (1) | 20% (1) | 6% (2) |