10.6. Analysis.

Comparison 10: Live attenuated CVD 103‐HgR vaccine versus placebo ‐ Subgroup analysis, Outcome 6: Additional adverse event data

Additional adverse event data
Study	Adverse event monitoring	Adverse events reporting	Results
Kotloff 1992	Monitored daily for 7 days	Data presented in an unusable form	'Among volunteers who experienced symptoms, the complaints were mild'. 'All episodes of fever were low grade. No subject exceeded the minimum definition of diarrhea (four stools within 24 h) or vomiting (one episode of emesis) or met these criteria for more than 1 day'.
Migasena 1989a	Seen daily for 5 days	Text summary only	'No significant adverse reactions, including fever, diarrhea, vomiting, anorexia, or abdominal cramps were observed in any participant during the 7‐day period of observation'.
Perry 1998	Seen daily for 6 days after each inoculation of vaccine or placebo	Data presented is from a crossover trial where all participants took vaccine and placebo 12 days apart	'No significant difference was seen in reported diarrhoea, fever or vomiting following vaccine or placebo'.
Su‐Arehawaratana 1992a	Monitored daily for 7 days	Numerical data is only provided for diarrhoea	'No increased rate of diarrhoeal episodes or other gastrointestinal adverse reactions was observed among vaccine than among placebo recipients'.
Su‐Arehawaratana 1992b	Monitored daily for seven days after each dose	Numerical data is only provided for diarrhoea	'No increased rate of diarrhoeal episodes or other gastrointestinal adverse reactions was observed among vaccine than among placebo recipients'.