Table 2.
Study related adverse events (AE’s) that occurred on or after treatment began.
| Adverse Event | Number of Unique Patients | |||||
|---|---|---|---|---|---|---|
| Mild (Grade1) | Moderate (Grade 2) | Sub-Total | Mild (Grade1) | Moderate (Grade 2) | Sub-Total | |
| ABDOMINAL PAIN | 2 | 0 | 2 | 2 | 0 | 2 |
| ANOREXIA | 6 | 0 | 6 | 6 | 0 | 6 |
| BLOATING | 1 | 0 | 1 | 1 | 0 | 1 |
| CONSTIPATION | 1 | 0 | 1 | 1 | 0 | 1 |
| DIARRHEA | 16 | 1 | 17 | 15 | 1 | 16 |
| DIZZINESS | 3 | 0 | 3 | 3 | 0 | 3 |
| DRY MOUTH | 1 | 0 | 1 | 1 | 0 | 1 |
| DYSPEPSIA | 5 | 1 | 6 | 3 | 1 | 4 |
| FATIGUE | 3 | 0 | 3 | 3 | 0 | 3 |
| FEVER | 1 | 0 | 1 | 1 | 0 | 1 |
| FLATULENCE | 9 | 0 | 9 | 9 | 0 | 9 |
| HYPERHIDROSIS | 1 | 0 | 1 | 1 | 0 | 1 |
| HYPOGLYCEMIA | 1 | 1 | 2 | 1 | 1 | 2 |
| INSOMNIA | 2 | 0 | 2 | 2 | 0 | 2 |
| METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY | 1 | 0 | 1 | 1 | 0 | 1 |
| MYALGIA | 2 | 0 | 2 | 2 | 0 | 2 |
| NAUSEA | 6 | 0 | 6 | 6 | 0 | 6 |
| STOMACH PAIN | 15 | 4 | 19 | 8 | 2 | 10 |
| TREMOR | 2 | 0 | 2 | 1 | 0 | 1 |
| VOMITING | 1 | 1 | 2 | 1 | 1 | 2 |
| Total | 79 | 8 | 87 | |||
Note: Study related was defined as Possible, Probable, and Definite related to the study regimen. For the number of participants, column percent was calculated. Rows are not mutually exclusive. Of note, no Grade 3 or Grade 4 AE’s were observed. Shaded cells indicate the data is not applicable.