Table 6.
Adverse Events in the As-Treated Population*
| Events | Curcumin | Placebo | p-value |
|---|---|---|---|
| number of patient (percent) |
number of patient (percent) |
||
| Treatment-related event | |||
| Event leading to dose interruption |
5 (29.4) | 5 (31.2) | 1 |
| Event leading to dose reduction of treatment | 0 | 1 (6.25) | 0.485 |
| Event leading to discontinuation of treatment |
1 (5.9) | 2 (12.5) | 0.601 |
| Event occurring in patients in either group | |||
| Nausea and vomit | 1 (5.9) | 1 (6.2) | 1 |
| Asthenia | 1 (5.9) | 2 (12.5) | 0.601 |
| Diarrhea | 0 | 0 | NA |
| Rash or allergic | 0 | 0 | NA |
| Event of interest | |||
| Skin reaction | 0 | 0 | NA |
| Gall bladder problem | 0 | 0 | NA |
| Bile duct obstruction | 0 | 0 | NA |
| Bleeding disorder | 0 | 0 | NA |
* The as-treated population included all the patients who received at least one dose of study treatment