Summary of adverse events (AEs) and protocol discontinuation
Seviprotimut-L | Placebo | Total | |
N | 230 | 117 | 347 |
AEs | 96% | 97% | 96% |
Grade 3 AEs | 12% | 9% | 11% |
Grade 4–5 AEs | 0% | 0% | 0% |
Treatment-related AEs (TRAEs) | 70% | 73% | 71% |
Treatment-related serious AEs | 0% | 0% | 0% |
AEs leading to d/c study drug* | 0.9% | 0.9% | 0.9% |
TRAEs leading to d/c study drug | 0.4% | 0% | 0.3% |
Completed 24 months of treatment | 61.3% | 63.2% | 62.0% |
D/C early for progressive disease | 31.7% | 31.6% | 31.7% |
D/C early for withdrawal of consent | 3.9% | 1.7% | 3.2% |
D/C early for TRAE | 0.4% | 0% | 0.3% |
Lost to follow-up, pregnancy, other cancer | 2.6% | 3.4% | 2.9% |
Total | 100% | 100% | 100% |
*AEs leading to discontinuation (d/c) of study drug included one TRAE (macular rash) on the vaccine arm, and development of adenocarcinoma of the colon on the vaccine arm and squamous cell carcinoma of the larynx on the placebo arm.