Table 2.
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.