Table 4.
Incidence of adverse events and serious adverse events among different groups.
| Treatment group | P valuea | |||
|---|---|---|---|---|
| Placebo (n = 253) | CVT-E002-400 (n = 249) | CVT-E002-800 (n = 246) | ||
| Adverse events | ||||
| Total number of adverse events | 215 | 220 | 216 | |
| Any adverse event | 117 (46.3%) | 122 (49.0%) | 119 (48.4%) | 0.811 |
| Adverse event by category | ||||
| Allergy | 2 (0.8%) | 0 (0.0%) | 2 (0.8%) | 0.478 |
| Blood | 1 (0.4%) | 0 (0.0%) | 0 (0.0%) | >0.999 |
| Cardiovascular | 17 (6.7%) | 6 (2.4%) | 9 (3.7%) | 0.049 |
| Constitutional | 7 (2.8%) | 8 (3.2%) | 10 (4.1%) | 0.715 |
| Dermatology | 12 (4.7%) | 17 (6.8%) | 10 (4.1%) | 0.353 |
| Endocrine | 0 (0.0%) | 2 (0.8%) | 1 (0.4%) | 0.328 |
| Gastrointestinal | 42 (16.6%) | 30 (12.1%) | 40 (16.3%) | 0.284 |
| Hemorrhage | 1 (0.4%) | 4 (1.6%) | 3 (1.2%) | 0.375 |
| Infection | 5 (2.0%) | 5 (2.0%) | 3 (1.2%) | 0.828 |
| Metabolic | 0 (0.0%) | 2 (0.8%) | 0 (0.0%) | 0.218 |
| Musculoskeletal | 8 (3.2%) | 14 (5.6%) | 6 (2.4%) | 0.147 |
| Neurology | 10 (4.0%) | 11 (4.4%) | 15 (6.1%) | 0.502 |
| Ocular | 1 (0.4%) | 2 (0.8%) | 2 (0.8%) | 0.750 |
| Oncology | 1 (0.4%) | 0 (0.0%) | 2 (0.8%) | 0.437 |
| Otic | 1 (0.4%) | 1 (0.4%) | 3 (1.2%) | 0.461 |
| Pain | 28 (11.1%) | 27 (10.8%) | 24 (9.8%) | 0.879 |
| Pulmonary | 32 (12.7%) | 34 (13.7%) | 34 (13.8%) | 0.917 |
| Renal/genitourinary | 5 (2.0%) | 8 (3.2%) | 4 (1.6%) | 0.460 |
|
| ||||
| Serious adverse events | ||||
| Total number of serious adverse events | 13 | 14 | 10 | |
| Any serious adverse event | 12 (4.7%) | 14 (5.6.0%) | 10 (4.1%) | 0.719 |
| Serious adverse event by category | ||||
| Cardiovascular | 4 (1.6%) | 4 (1.6%) | 2 (0.8%) | 0.784 |
| Dermatology | 0 (0.0%) | 0 (0.0%) | 1 (0.4%) | 0.329 |
| Gastrointestinal | 5 (2.0%) | 3 (1.2%) | 2 (0.8%) | 0.623 |
| Hemorrhage | 0 (0.0%) | 0 (0.0%) | 1 (0.4%) | 0.329 |
| Infection | 0 (0.0%) | 1 (0.4%) | 0 (0.0%) | 0.662 |
| Musculoskeletal | 1 (0.4%) | 2 (0.8%) | 1 (0.4%) | 0.849 |
| Neurology | 1 (0.4%) | 2 (0.8%) | 0 (0.0%) | 0.550 |
| Oncology | 1 (0.4%) | 0 (0.0%) | 0 (0.0%) | >0.999 |
| Pain | 1 (0.4%) | 0 (0.0%) | 1 (0.4%) | 0.775 |
| Pulmonary | 0 (0.0%) | 1 (0.4%) | 0 (0.0%) | 0.662 |
| Renal/genitourinary | 0 (0.0%) | 1 (0.4%) | 2 (0.8%) | 0.218 |
aWhen 50% of the cells have expected cell counts less than 5 Fisher's exact two tailed test was used. Otherwise, comparisons made using chi-square test for comparing proportions.