Table 3.
Serious adverse events of incidence ≥1% higher in either peretinoin group than in the placebo group, and rates of hepatic neoplasm malignant recurrent.
| SOC (MedDRA ver.12.0) PT (MedDRA ver.12.0) |
Adverse Events | Adverse Drug Reactions | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo Group | 300 mg/day Peretinoin Group |
600 mg/day Peretinoin Group |
Placebo Group | 300 mg/day Peretinoin Group |
600 mg/day Peretinoin Group |
|||||||
| N = 129 | N = 131 | N = 132 | N = 129 | N = 131 | N = 132 | |||||||
| n | % | n | % | n | % | n | % | n | % | n | % | |
| Gastrointestinal disorders | ||||||||||||
| Ascites | 1 | 0.8 | 1 | 0.8 | 8 | 6.1 | 0 | 0.0 | 1 | 0.8 | 5 | 3.8 |
| Varices esophageal | 4 | 3.1 | 7 | 5.3 | 5 | 3.8 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
| Gastric ulcer hemorrhage | 0 | 0.0 | 0 | 0.0 | 3 | 2.3 | 0 | 0.0 | 0 | 0.0 | 1 | 0.8 |
| Gastric varices | 0 | 0.0 | 2 | 1.5 | 1 | 0.8 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
| Infections and infestations | ||||||||||||
| Urinary tract infection | 0 | 0.0 | 3 | 2.3 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
| Hepatobiliary disorders | ||||||||||||
| Hepatic failure | 0 | 0.0 | 2 | 1.5 | 1 | 0.8 | 0 | 0.0 | 1 | 0.8 | 1 | 0.8 |
| Cardiac disorders | ||||||||||||
| Cardio-respiratory arrest | 0 | 0.0 | 0 | 0.0 | 2 | 1.5 | 0 | 0.0 | 0 | 0.0 | 2 | 1.5 |
| Nervous system disorders | ||||||||||||
| Hepatic encephalopathy | 0 | 0.0 | 2 | 1.5 | 2 | 1.5 | 0 | 0.0 | 1 | 0.8 | 0 | 0.0 |
| General disorders and administration site conditions | ||||||||||||
| Pyrexia | 0 | 0.0 | 1 | 0.8 | 2 | 1.5 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
| Neoplasms benign, malignant and unspecified (incl. cysts and polyps) | ||||||||||||
| Gastric cancer stage 0 | 0 | 0.0 | 1 | 0.8 | 3 | 2.3 | 0 | 0.0 | 1 | 0.8 | 0 | 0.0 |
n = Number of relevant subjects, N = Total number of subjects.