Table 4. Percentage of subjects reporting SAEs of frequency ≥0.1% in either group or for which differences between groups were statistically significant during the 31-d (days 0–30) period after any dose (total vaccinated cohort).

	Human RV vaccine n = 56562		Placebo n = 45512		Relative risk (vaccine over placebo)
SAE	n	% [95% CI]	n	% [95% CI]	RR [95% CI]‡	P value§
At least 1 SAE†	1181	2.09 [1.97–2.21]	1026	2.25 [2.12–2.39]	0.90 [0.82–0.98]	0.01
At least 1 SAE excluding gastroenteritis and diarrhea	1064	1.88 [1.77–2.00]	906	1.99 [1.86–2.12]	0.92 [0.84–1.01]	0.07
Bronchiolitis	244	0.43 [0.38–0.49]	192	0.42 [0.36–0.49]	0.97 [0.80–1.19]	0.83
Gastroenteritis†	155	0.27 [0.23–0.32]	176	0.39 [0.33–0.45]	0.65 [0.52–0.82]	0.0002
Pneumonia	185	0.33 [0.28–0.38]	161	0.35 [0.30–0.41]	0.92 [0.73–1.14]	0.45
Bronchopneumonia	63	0.11 [0.09–0.14]	49	0.11 [0.08–0.14]	1.00 [0.67–1.50]	1.00
Bronchitis	54	0.10 [0.07–0.12]	32	0.07 [0.05–0.10]	1.29 [0.81–2.08]	0.31
Urinary tract infection	44	0.08 [0.06–0.10]	44	0.10 [0.07–0.13]	0.75 [0.48–1.18]	0.23
Diarrhea†	17	0.03 [0.02–0.05]	27	0.06 [0.04–0.09]	0.48 [0.24–0.94]	0.03
Intussusception	11	0.02 [0.01–0.03]	7	0.02 [0.01–0.03]	1.39 [0.49–4.27]	0.66
Decreased appetite*	8	0.01 [0.01–0.03]	1	0.0 [0.00–0.01]	7.98 [1.07–354.23]	0.04

^*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.