Table 2

Numbers of subjects with treatment-related AEs before challenge by group

MedDRA System Organ Class preferred termVaccine group (n = 36)Placebo group (n = 34)
Any treatment-emergent AE related to vaccinea1747.21647.1
Gastrointestinal symptoms
    Gastrointestinal sounds abnormal822.2823.5
    Abdominal pain1027.8514.7
    Defecation urgency822.2514.7
    Loose stools (<3 per 24 h)822.2411.8
    Diarrhea (>2 per 24 h)616.712.9
General symptoms
  • a AEs occurring in more than one subject.

  • b P < 0.05.