Table 2.
Frequent all-causality adverse events (≥10% patients in either treatment group; safety population)
| Preferred term n (%) |
ONCOS-102 plus chemotherapy (N=20) | Chemotherapy alone (N=11) | ||||
| All grade | Grade 3 | Grade 4 | All grade | Grade 3 | Grade 4 | |
| Hematological events | ||||||
| Anemia | 15 (75.0) | 3 (15.0) | 0 | 10 (90.9) | 3 (27.3) | 0 |
| Lymphopenia | 4 (20.0) | 1 (5.0) | 0 | 1 (9.1) | 0 | 0 |
| Neutropenia | 14 (70.0) | 5 (25.0) | 3 (15.0) | 8 (72.7) | 4 (36.4) | 1 (9.1)* |
| Thrombocytopenia | 6 (30.0) | 3 (15.0) | 2 (10.0)† | 5 (45.5) | 1 (9.1) | 0 |
| Non-hematological events | ||||||
| Abdominal pain | 3 (15.0) | 0 | 0 | 0 | 0 | 0 |
| Acute kidney injury | 3 (15.0) | 0 | 0 | 1 (9.1) | 0 | 0 |
| ALT increased | 1 (5.0) | 0 | 0 | 2 (18.2) | 0 | 0 |
| Asthenia | 17 (85.0) | 2 (10.0) | 0 | 7 (63.6) | 1 (9.1) | 0 |
| Chest pain | 6 (30.0) | 1 (5.0) | 0 | 3 (27.3) | 0 | 0 |
| Constipation | 5 (25.0) | 0 | 0 | 4 (36.4) | 0 | 0 |
| Cough | 6 (30.0) | 0 | 0 | 1 (9.1) | 0 | 0 |
| C-reactive protein increased | 7 (35.0) | 0 | 0 | 4 (36.4) | 0 | 0 |
| Decreased appetite | 7 (35.0) | 1 (5.0) | 0 | 6 (54.5) | 0 | 0 |
| Depressed mood | 1 (5.0) | 0 | 0 | 2 (18.2) | 0 | 0 |
| Diarrhea | 5 (25.0) | 0 | 0 | 3 (27.3) | 0 | 0 |
| Dyspnea | 3 (15.0) | 2 (10.0) | 0 | 2 (18.2) | 0 | 0 |
| Fever | 15 (75.0) | 1 (5.0) | 0 | 2 (18.2) | 0 | 0 |
| Injection site pain | 4 (20.0) | 0 | 0 | 0 | 0 | 0 |
| Musculoskeletal chest pain | 5 (25.0) | 0 | 0 | 0 | 0 | 0 |
| Nausea | 15 (75.0) | 1 (5.0) | 0 | 5 (45.5) | 0 | 0 |
| Non-cardiac chest pain | 0 | 0 | 0 | 2 (18.2) | 0 | 0 |
| Pain | 4 (20.0) | 0 | 0 | 0 | 0 | 0 |
| Rash | 1 (5.0) | 0 | 0 | 2 (18.2) | 0 | 0 |
| Respiratory tract infection | 3 (15.0) | 2 (10.0) | 0 | 0 | 0 | 0 |
| Tinnitus | 1 (5.0) | 0 | 0 | 2 (18.2) | 0 | 0 |
| Vomiting | 10 (50.0) | 0 | 0 | 2 (18.2) | 1 (9.1) | 0 |
*One patient experienced two events of grade 4 neutropenia that were considered related to chemotherapy only.
†An event of grade 4 sepsis was also experienced by a patient with grade 4 thrombocytopenia.
ALT, alanine transaminase.