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. 2023 Sep 3;11(9):e007552. doi: 10.1136/jitc-2023-007552

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.