Table 3.
Serious treatment emergent adverse events by treatment, system organ class and preferred term – safety population (in at least 2 patients in any treatment group)
| Event | Pexa-vec + sorafenib (n = 218), n (%) | Sorafenib (n = 217), n (%) |
|---|---|---|
| Any | 33 (15.14) | 25 (11.52) |
| Leading to death | 33 (15.14) | 25 (11.52) |
| Leading to death, attributed to treatment | 3 (1.38) | 0 (0.00) |
| Occurring in ≥0.5% (≥1) of patients in either group | ||
| Hepatic failure | 11 (5.05) | 8 (3.69) |
| Ascites | 8 (3.67) | 4 (1.84) |
| Pyrexia | 8 (3.67) | 1 (0.46) |
| Abdominal pain, upper | 7 (3.21) | 3 (1.38) |
| Hepatic encephalopathy | 5 (2.29) | 4 (1.84) |
| Abdominal pain | 4 (1.83) | 5 (2.30) |
| Anemia | 4 (1.83) | 1 (0.46) |
| Esophageal varices | 4 (1.83) | 3 (1.38) |
| Gastrointestinal hemorrhage | 4 (1.83) | 1 (0.46) |
| Neoplasm progression | 4 (1.83) | 4 (1.84) |
| Peritonitis bacterial | 4 (1.83) | 0 (0.00) |
| Upper gastrointestinal hemorrhage | 4 (1.83) | 1 (0.46) |
| Asthenia | 3 (1.38) | 5 (2.30) |
| Diarrhea | 3 (1.38) | 3 (1.38) |
| Hemoptysis | 3 (1.38) | 0 (0.00) |
| Hepatic function abnormal | 3 (1.38) | 0 (0.00) |
| Hepatic rupture | 3 (1.38) | 0 (0.00) |
| Liver carcinoma rupture | 3 (1.38) | 2 (0.92) |
| Musculoskeletal chest pain | 3 (1.38) | 0 (0.00) |
| Pneumonia | 3 (1.38) | 4 (1.84) |
| Portal vein thrombosis | 3 (1.38) | 0 (0.00) |
| Angina pectoris | 2 (0.92) | 0 (0.00) |
| Aspartate aminotransferase elevation | 2 (0.92) | 0 (0.00) |
| Bile duct stenosis | 2 (0.92) | 0 (0.00) |
| Blood bilirubin elevation | 1 (0.46) | 4 (1.84) |
| Cholecystitis | 2 (0.92) | 0 (0.00) |
| Constipation | 2 (0.92) | 2 (0.92) |
| Gastric hemorrhage | 2 (0.92) | 1 (0.46) |
| General physical health deterioration | 2 (0.92) | 1 (0.46) |
| Hematemesis | 2 (0.92) | 0 (0.00) |
| HCC | 2 (0.92) | 0 (0.00) |
| Hepatic hemorrhage | 2 (0.92) | 0 (0.00) |
| Hepatorenal syndrome | 2 (0.92) | 0 (0.00) |
| Hypotension | 2 (0.92) | 0 (0.00) |
| Ischemic stroke | 0 (0.00) | 2 (0.92) |
| Jaundice cholestatic | 2 (0.92) | 0 (0.00) |
| Liver abscess | 2 (0.92) | 0 (0.00) |
| Multiple organ dysfunction syndrome | 2 (0.92) | 1 (0.46) |
| Myocardial infarction | 2 (0.92) | 0 (0.00) |
| Pulmonary embolism | 2 (0.92) | 1 (0.46) |
| Rash, maculo-papular | 0 (0.00) | 2 (0.92) |
| Respiratory failure | 2 (0.92) | 1 (0.46) |
| Sepsis | 1 (0.46) | 4 (1.84) |
| Tumor pain | 2 (0.92) | 1 (0.46) |
| Tumor rupture | 2 (0.92) | 0 (0.00) |
HHC, hepatocellular carcinoma.
SAEs were coded using Medical Dictionary for Regulatory Activities (MedDRA), version 22.0.
The total number of SAEs counted all SAEs for patients. At each level of patient summarization, a patient was counted once for the most severe event if the patient reported 1 or more events. “n” represents the number of patients at each level of summarization.
Data are sorted in decreasing frequency for the pexa-vec plus sorafenib treatment arm.