Table 2.
Treatment-emergent adverse events occurring in ≥10% of patients overall
| Event, n (%) patients | Enadenotucirev IP monotherapy (n=10) | Enadenotucirev IP plus paclitaxel (n=8) | Enadenotucirev IV plus paclitaxel (n=20) | Overall (N=38) | ||||
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Gastrointestinal disorders | 10 (100) | 4 (40) | 8 (100) | 2 (25) | 12 (60) | 2 (10) | 30 (79) | 8 (21) |
| Diarrhea | 7 (70) | 3 (30) | 4 (50) | 0 | 5 (25) | 0 | 16 (42) | 3 (8) |
| Nausea | 7 (70) | 0 | 2 (25) | 0 | 7 (35) | 1 (5) | 16 (42) | 1 (3) |
| Abdominal pain | 5 (50) | 0 | 4 (50) | 1 (13) | 3 (15) | 0 | 12 (32) | 1 (3) |
| Vomiting | 5 (50) | 1 (10) | 2 (25) | 0 | 3 (15) | 1 (5) | 10 (26) | 2 (5) |
| Constipation | 0 | 0 | 2 (25) | 0 | 4 (20) | 0 | 6 (16) | 0 |
| Ascites | 1 (10) | 0 | 2 (25) | 1 (13) | 1 (5) | 0 | 4 (11) | 1 (3) |
| General disorders and administration site conditions | 8 (80) | 0 | 6 (75) | 0 | 13 (65) | 1 (5) | 27 (71) | 1 (3) |
| Fever | 3 (30) | 0 | 4 (50) | 0 | 4 (20) | 0 | 11 (29) | 0 |
| Fatigue | 2 (20) | 0 | 2 (25) | 0 | 4 (20) | 0 | 8 (21) | 0 |
| Asthenia | 1 (10) | 0 | 0 | 0 | 6 (30) | 0 | 7 (18) | 0 |
| Chills | 2 (20) | 0 | 2 (25) | 0 | 3 (15) | 0 | 7 (18) | 0 |
| Edema peripheral | 2 (20) | 0 | 3 (38) | 0 | 1 (5) | 0 | 6 (16) | 0 |
| Influenza-like illness | 2 (20) | 0 | 0 | 0 | 2 (10) | 0 | 4 (11) | 0 |
| Blood/lymphatic system disorders | 6 (60) | 0 | 5 (63) | 5 (63) | 13 (65) | 6 (30) | 24 (63) | 11 (29) |
| Anemia | 6 (60) | 0 | 3 (38) | 1 (13) | 10 (50) | 2 (10) | 19 (50) | 3 (8) |
| Neutropenia/neutrophil count decreased | 0 | 0 | 4 (50) | 3 (38) | 10 (50) | 5 (25) | 12 (32) | 8 (21) |
| Infections and infestations | 5 (50) | 1 (10) | 5 (63) | 2 (25) | 10 (50) | 1 (5) | 20 (53) | 4 (11) |
| Urinary tract infection | 3 (30) | 1 (10) | 0 | 0 | 2 (10) | 0 | 5 (13) | 1 (10) |
| Nervous system disorders | 6 (60) | 1 (14) | 3 (38) | 0 | 6 (30) | 0 | 15 (39) | 1 (3) |
| Lethargy | 4 (40) | 1 (14) | 2 (25) | 0 | 1 (5) | 0 | 7 (18) | 1 (3) |
| Headache | 3 (30) | 0 | 1 (13) | 0 | 1 (5) | 0 | 5 (13) | 0 |
| Respiratory, thoracic and mediastinal disorders | 3 (30) | 0 | 3 (38) | 2 (25) | 5 (25) | 0 | 11 (29) | 2 (5) |
| Dyspnea | 3 (30) | 0 | 1 (13) | 0 | 2 (10) | 0 | 6 (16) | 0 |
| Cough | 0 | 0 | 2 (25) | 0 | 2 (10) | 0 | 4 (11) | 0 |
| Metabolism and nutrition disorders | 5 (50) | 0 | 2 (25) | 0 | 3 (15) | 0 | 10 (26) | 0 |
| Hypomagnesemia | 1 (10) | 0 | 1 (13) | 0 | 2 (10) | 0 | 4 (11) | 0 |
| Skin and subcutaneous tissue disorders | 1 (10) | 0 | 3 (38) | 0 | 5 (25) | 0 | 9 (24) | 0 |
| Alopecia | 0 | 0 | 2 (25) | 0 | 4 (20) | 0 | 6 (16) | 0 |
IP, intraperitoneal; IV, intravenous.