Table 2.
Overall safety summary and TEAEs occurring in >15% of patients (safety analysis set)
| Patients with at least one: | Overall (N=51) |
Cohort 1 (n=3) |
Cohort 2 (n=3) |
Cohort 3 (n=3) |
Cohort 4 (n=9) |
Cohort 5 (n=10) |
Cohort 6 (n=9) |
Cohort 7A (n=14) |
| Serious TEAE | 13 (25.5) | 2 (66.7) | 1 (33.3) | 0 | 1 (11.1) | 2 (20.0) | 1 (11.1) | 6 (42.9) |
| Serious TEAE related to enadenotucirev | 7 (13.7) | 2 (66.7) | 1 (33.3) | 0 | 0 | 1 (10.0) | 1 (11.1) | 2 (14.3) |
| TEAE with toxicity grade 3–4 | 31 (61.0) | 2 (66.7) | 2 (66.7) | 0 | 4 (44.4) | 6 (60.0) | 7 (77.8) | 10 (71.4) |
| TEAE classified as a dose limiting toxicity | 7 (13.7) | 2 (66.7) | 0 | 0 | 1 (11.1) | 2 (20.0) | 1 (11.1) | 1 (11.1) |
| TEAE leading to discontinuation of enadenotucirev | 12 (23.5) | 2 (66.7) | 0 | 0 | 3 (33.3) | 4 (40.0) | 1 (11.1) | 2 (14.3) |
| General disorders and administration site conditions | 46 (90.2) | 3 (100) | 3 (100) | 2 (66.7) | 8 (88.9) | 10 (100) | 8 (88.9) | 12 (85.7) |
| Fever | 25 (49.0) | 1 (33.3) | 1 (33.3) | 0 | 4 (44.4) | 6 (60.0) | 5 (55.6) | 8 (57.1) |
| Chills | 22 (43.1) | 0 | 0 | 0 | 5 (55.6) | 5 (50.0) | 4 (44.4) | 8 (57.1) |
| Fatigue | 21 (41.2) | 2 (66.7) | 3 (100) | 1 (33.3) | 1 (11.1) | 6 (60.0) | 5 (55.6) | 3 (21.4) |
| Influenza like illness | 11 (21.6) | 3 (100) | 2 (66.7) | 1 (33.3) | 2 (22.2) | 1 (10.0) | 0 | 2 (14.3) |
| Edema peripheral | 10 (19.6) | 0 | 0 | 1 (33.3) | 2 (22.2) | 2 (20.0) | 1 (11.1) | 4 (28.6) |
| Gastrointestinal disorders | 40 (78.4) | 3 (100) | 3 (100) | 1 (33.3) | 8 (88.9) | 10 (100) | 5 (55.6) | 10 (71.4) |
| Nausea | 18 (35.3) | 1 (33.3) | 3 (100) | 0 | 4 (44.4) | 4 (40.0) | 1 (11.1) | 5 (35.7) |
| Diarrhea | 16 (31.4) | 2 (66.7) | 1 (33.3) | 0 | 5 (55.6) | 3 (30.0) | 1 (11.1) | 4 (28.6) |
| Vomiting | 13 (25.5) | 1 (33.3) | 0 | 0 | 2 (22.2) | 3 (30.0) | 1 (11.1) | 6 (42.9) |
| Abdominal pain | 9 (17.6) | 1 (33.3) | 1 (33.3) | 0 | 3 (33.3) | 1 (10.0) | 1 (11.1) | 2 (14.3) |
| Constipation | 9 (17.6) | 0 | 1 (33.3) | 1 (33.3) | 1 (11.1) | 3 (30.0) | 2 (22.2) | 1 (7.1) |
| Abdominal pain upper | 8 (15.7) | 1 (33.3) | 0 | 0 | 1 (11.1) | 2 (20.0) | 1 (11.1) | 3 (21.4) |
| Respiratory, thoracic, and mediastinal disorders | 31 (60.8) | 2 (66.7) | 0 | 2 (66.7) | 5 (55.6) | 7 (70.0) | 6 (66.7) | 9 (64.3) |
| Dyspnea | 13 (25.5) | 1 (33.3) | 0 | 1 (33.3) | 2 (22.2) | 2 (20.0) | 4 (44.4) | 3 (21.4) |
| Cough | 12 (23.5) | 1 (33.3) | 0 | 1 (33.3) | 0 | 2 (20.0) | 3 (33.3) | 5 (35.7) |
| Metabolism and nutrition disorders | 30 (58.8) | 2 (66.7) | 2 (66.7) | 1 (33.3) | 4 (44.4) | 7 (70.0) | 4 (44.4) | 10 (71.4) |
| Decreased appetite | 17 (33.3) | 0 | 2 (66.7) | 0 | 2 (22.2) | 4 (40.0) | 3 (33.3) | 6 (42.9) |
| Hypokalemia | 8 (15.7) | 0 | 0 | 1 (33.3) | 1 (11.1) | 2 (20.0) | 1 (11.1) | 3 (21.4) |
| Musculoskeletal and connective tissue disorders | 24 (47.1) | 2 (66.7) | 2 (66.7) | 1 (33.3) | 6 (66.7) | 6 (60.0) | 3 (33.3) | 4 (28.6) |
| Myalgia | 13 (25.5) | 1 (33.3) | 1 (33.3) | 0 | 3 (33.3) | 4 (40.0) | 1 (11.1) | 3 (21.4) |
| Back pain | 8 (15.7) | 1 (33.3) | 2 (66.7) | 0 | 2 (22.2) | 1 (10.0) | 0 | 2 (14.3) |
| Nervous system disorders | 21 (41.2) | 3 (100) | 1 (33.3) | 1 (33.3) | 5 (55.6) | 5 (50.0) | 3 (33.3) | 3 (21.4) |
| Headache | 13 (25.5) | 1 (33.3) | 1 (33.3) | 0 | 3 (33.3) | 4 (40.0) | 2 (22.2) | 2 (14.3) |
| Blood and lymphatic system disorders | 15 (29.4) | 2 (66.7) | 0 | 1 (33.3) | 3 (33.3) | 3 (30.0) | 2 (22.2) | 4 (28.6) |
| Anemia | 10 (19.6) | 2 (66.7) | 0 | 1 (33.3) | 1 (11.1) | 1 (10.0) | 2 (22.2) | 3 (21.4) |
TEAE, treatment-emergent adverse event.