Table 3

Summary of adverse events (AEs) and protocol discontinuation

Grade 3 AEs12%9%11%
Grade 4–5 AEs0%0%0%
Treatment-related AEs (TRAEs)70%73%71%
Treatment-related serious AEs0%0%0%
AEs leading to d/c study drug*0.9%0.9%0.9%
TRAEs leading to d/c study drug0.4%0%0.3%
Completed 24 months of treatment61.3%63.2%62.0%
D/C early for progressive disease31.7%31.6%31.7%
D/C early for withdrawal of consent3.9%1.7%3.2%
D/C early for TRAE0.4%0%0.3%
Lost to follow-up, pregnancy, other cancer2.6%3.4%2.9%
  • *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.