Table 3.
Summary of adverse events reported during the vaccination phase of the study.
| Maximum CBER/NCI CTC grade by patient | |||||
|---|---|---|---|---|---|
| Total (related) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Local injection reactions | 109 (96) | 57 | 36 | 12 | 4 |
| Systemic symptoms | 140 (85) | 61 | 71 | 8 | 0 |
| Infections | 11 (0) | 2 | 9 | 0 | 0 |
| Musculoskeletal | 127 (81) | 58 | 62 | 7 | 0 |
| Gastrointestinal | 42 (14) | 30 | 11 | 1 | 0 |
| Neurologic | 7 (2) | 1 | 4 | 2 | 0 |
| Other | 7 (0) | 2 | 5 | 0 | 0 |
| Total | 443 (278) | 211 | 198 | 30 (20) | 4 (1) |
Total number of adverse events (AE) by category reported throughout the study regardless of attribution. Numbers in parenthesis indicate AE that were possibly, probably, or definitely related to vaccination. Study safety objectives are defined by the frequency of vaccination-related grade 3–5 AE. No grade 5 AE occurred.