Table 3. Percentage of subjects with significant differences in incidence of unsolicited AEs within the 31-d (days 0–30) post-vaccination period (total vaccinated cohort).

	Human RV vaccine n = 11856		Placebo n = 4778		Relative risk (vaccine over placebo)
Symptom	n	% [95% CI]	n	% [95% CI]	RR [95% CI]‡	P value§
At least 1 symptom	5662	47.76 [46.85–48.66]	2362	49.43 [48.01–50.86]	0.99 [0.94–1.04]	0.72
Irritability*	730	6.16 [5.73, 6.60]	312	6.53 [5.85, 7.27]	1.15 [1.00, 1.31]	0.05
Rhinorrhea†	164	1.38 [1.18, 1.61]	112	2.34 [1.93, 2.81]	0.58 [0.45, 0.75]	<0.0001
Flatulence*	157	1.32 [1.13, 1.55]	50	1.05 [0.78, 1.38]	1.48 [1.07, 2.08]	0.02
Pharyngitis†	140	1.18 [0.99, 1.39]	63	1.32 [1.01, 1.68]	0.66 [0.48, 0.91]	0.01
Heat rash*	40	0.34 [0.24, 0.46]	3	0.06 [0.01, 0.18]	5.04 [1.60, 25.59]	0.002

*Significantly higher incidence in vaccine group. ^†Significantly higher incidence in placebo group. ^‡RR calculations were performed based on the Poisson method on stratified studies (incidence rate was not directly dependent on the RR value generated). ^§P value: 2-sided Exact Stratified Test conditional to number of cases. AEs listed by decreasing order of frequency in the vaccine group. Note: studies 023, 024, 028, 029, 030, and 037 are not included in this part of the analysis since collection of unsolicited AEs in these studies was different from the others.