Table 5.
Complications of the three dose levels of recombinant human adenovirus type 5 (H101) in groups A and C.
| Complications | Group A at various doses (vp/day) (n = 30) | Group C at various doses (vp/day) (n = 32) | ||||||
|---|---|---|---|---|---|---|---|---|
| 0.5 × 1012 (n = 5) | 1.0 × 1012 (n = 13) | 1.5 × 1012 (n = 12) | p-value | 0.5 × 1012 (n = 3) | 1.0 × 1012 (n = 15) | 1.5 × 1012 (n = 14) | p-value | |
| Nausea and vomiting | 1 (20.0) | 4 (30.1) | 3 (25.0) | 0.503 | 2 (66.7) | 12 (80.0) | 10 (71.4) | 0.107 |
| Diarrhea | 2 (40.0) | 6 (46.2) | 5 (41.7) | 0.683 | 1 (33.3) | 6 (40.0) | 6 (42.3) | 0.389 |
| Constipation | 0 (0.0) | 2 (15.4) | 2 (16.7) | 0.000 | 1 (33.3) | 7 (46.7) | 4 (33.3) | 0.062 |
| Granulocytopenia | 0 (0.0) | 1 (7.7) | 0 (0.0) | 0.000 | 2 (66.7) | 8 (53.3) | 9 (64.2) | 0.101 |
| Anemia | 0 (0.0) | 1 (7.7) | 1 (8.3) | 0.015 | 1 (33.3) | 8 (53.3) | 7 (50.0) | 0.009 |
| Hair loss | 0 (0.0) | 0 (0.0) | 0 (0.0) | – | 1 (33.3) | 8 (53.3) | 8 (57.1) | 0.001 |
| Fever | 4 (80.0) | 11 (84.6) | 10 (83.3) | 0.643 | 3 (100.0) | 12 (80.0) | 12 (85.7) | 0.000 |
| Overall | 4 (80.0) | 11 (84.6) | 11 (91.7) | 0.052 | 3 (100.0) | 13 (86.7) | 13 (92.9) | 0.048 |
Data were expressed as number (percentage). Group A, H101; Group C, H101 combined with chemotherapy.