Table 7.
Patients who discontinued the study drug because of adverse events (safety population).
| Patient identifier | TEAEs (preferred term) | Serious | Relationship/Severity | Outcome |
|---|---|---|---|---|
| ISC 17536 (250 mg BID group) | ||||
| A | Aspartate aminotransferase increased | No | Related/Moderate | Resolved |
| B | Dyspepsia | No | Related/Moderate | Resolved |
| C* | Vomiting | No | Related/Moderate | Resolved |
| Abdominal distension | No | Related/Moderate | Resolved | |
| D | Hypertension | No | Not related/Moderate | Resolved |
| Hyperchlorhydria | No | Related/Moderate | Resolved | |
| Pyrexia | Yes | Not related/Severe | Resolved | |
| E | Blood creatine phosphokinase abnormal | No | Not related/Severe | Resolved |
| Placebo group | ||||
| F | Skin hypopigmentation | No | Not related/Moderate | Resolved |
| Hemorrhage | No | Not related/Moderate | Resolved |
MedDRA (version 14.1) preferred term.
*
This patient discontinued the study drug on day 1 because of events that started during the placebo run-in period (ie, not treatment emergent).
BID, twice daily; TEAE, treatment-emergent adverse event.