Table 2.
Treatment emergent adverse events in the safety population
| Pexa-vec + sorafenib (n = 218), n (%) | Sorafenib (n = 217), n (%) | |
|---|---|---|
| Any | 218 (100.00) | 214 (98.62) |
| Leading to treatment discontinuationa | 65 (29.8) | 41 (18.9) |
| Leading to study discontinuation | 45 (20.6) | 40 (18.4) |
| Leading to sorafenib dose modification | 66 (30.3) | 70 (32.3) |
| Pyrexia | 184 (84.40) | 28 (12.90) |
| Diarrhea | 107 (49.08) | 116 (53.46) |
| Decreased appetite | 85 (38.99) | 64 (29.49) |
| Nausea | 74 (33.94) | 63 (29.03) |
| Palmar-plantar erythrodysesthesia syndrome | 73 (33.49) | 99 (45.62) |
| Chills | 71 (32.57) | 4 (1.84) |
| Fatigue | 65 (29.82) | 64 (29.49) |
| Abdominal pain | 62 (28.44) | 60 (27.65) |
| Weight decrease | 12 (26.61) | 49 (22.58) |
| Vomiting | 56 (25.69) | 27 (16.59) |
| Constipation | 52 (23.85) | 51 (23.50) |
| Ascites | 46 (21.10) | 36 (16.59) |
| Hypertension | 44 (20.18) | 39 (17.97) |
| Abdominal pain, upper | 43 (19.72) | 30 (13.82) |
| Rash, pustular | 39 (17.89) | 2 (0.92) |
| Influenza-like illness | 37 (16.97) | 5 (2.30) |
| Hypotension | 35 (16.06) | 2 (0.92) |
| Anemia | 33 (15.14) | 23 (10.60) |
| Headache | 33 (15.14) | 23 (10.60) |
| Alopecia | 32 (14.68) | 46 (21.20) |
| Cough | 31 (14.22) | 25 (11.52) |
| Aspartate aminotransferase elevation | 30 (13.76) | 39 (17.97) |
| Back pain | 29 (13.30) | 17 (7.83) |
| Edema, peripheral | 27 (12.39) | 21 (9.68) |
| Injection site pain | 27 (12.39) | 0 (0.00) |
| Abdominal distension | 26 (11.93) | 26 (11.98) |
| Rash | 23 (10.55) | 28 (12.90) |
| Asthenia | 22 (10.09) | 21 (9.68) |
| Arthralgia | 20 (9.17) | 15 (6.91) |
| Dizziness | 20 (9.17) | 13 (5.99) |
| Pain in extremity | 19 (8.72) | 12 (5.53) |
| Hypokalemia | 18 (8.26) | 19 (8.76) |
| Dyspnea | 18 (8.26) | 11 (5.07) |
| Blood bilirubin elevation | 17 (7.80) | 29 (13.36) |
| Stomatitis | 12 (7.80) | 24 (11.06) |
| Upper respiratory tract infection | 17 (7.80) | 23 (10.60) |
| Hyponatremia | 16 (7.34) | 10 (4.61) |
| Insomnia | 16 (7.34) | 20 (9.22) |
| Oropharyngeal pain | 16 (7.34) | 10 (4.61) |
| Pruritus | 16 (7.34) | 17 (7.83) |
| Tachycardia | 16 (7.34) | 0 (0.00) |
| Dyspepsia | 15 (6.88) | 13 (5.99) |
| Hypoalbuminemia | 15 (6.88) | 11 (5.07) |
| Platelet count reduction | 15 (6.88) | 15 (6.91) |
| Hyperkalemia | 14 (6.42) | 4 (1.84) |
| Musculoskeletal pain | 14 (6.42) | 12 (5.53) |
| Epistaxis | 13 (5.96) | 9 (4.15) |
| Sinus tachycardia | 13 (5.96) | 3 (1.38) |
| Procedural pain | 12 (5.50) | 2 (0.92) |
| Myalgia | 11 (5.05) | 8 (3.69) |
| Dysphonia | 10 (4.59) | 12 (5.53) |
| Muscle spasms | 10 (4.59) | 12 (5.53) |
Data are sorted in decreasing frequency for the pexa-vec plus sorafenib treatment arm.
The frequency threshold used for this table was 5% in either treatment group. All events were collected by systematic assessment.
aEither or both study treatments in the pexa-vec + sorafenib treatment group or sorafenib in the sorafenib only treatment group.