Table 3.

Rate of the most common (> 1/10.000 person years) SAEs by gender.

	Rate per 10.000 [95% CI]
Preferred term	All	Girls	Boys
Gastroenteritis	22.0 [20.9;23.5]	18.7 [17.1;20.5]	25.5 [23.6;27.5]
Pneumonia	17.9 [16.8;19.2]	16.6 [15;18.3]	19.2 [17.6;21]
Bronchiolitis	11.6 [10.7;12.6]	8.5 [7.4;9.8]	14.6 [13.2;16.2]
Bronchopneumonia	4.5 [3.9;5.1]	4.1 [3.4;5]	4.9 [4.1;5.8]
Bronchitis	2.8 [2.3;3.3]	2 [1.5;2.7]	3.5 [2.8;4.3]
Bronchospasm	2.8 [2.4;3.3]	2.5 [1.9;3.2]	3.1 [2.4;3.9]
Dehydration	2.8 [2.3;3.2]	2.5 [1.9;3.2]	3 [2.4;3.8]
Urinary tract infection	2.6 [2.1;3]	3.3 [2.6;4.1]	1.9 [1.4;2.5]
Head injury	1.9 [1.6;2.3]	2.1 [1.6;2.8]	1.7 [1.3;2.3]
Asthma	1.8 [1.5;2.3]	1.7 [1.2;2.2]	2 [1.5;2.6]
Febrile convulsion	1.8 [1.4;2.2]	1.5 [1.1;2.1]	2.1 [1.5;2.7]
Pertussis	1.6 [1.3;2]	1.5 [1.1;2.1]	1.6 [1.2;2.2]
Diarrhea	1.3 [1;1.7]	1.1[0.7;1.5]	1.6 [1.1;2.2]
Convulsion	1.1 [0.8;1.4]	0.9 [0.6;1.4]	1.3 [0.9;1.8]
Any SAE*	104.9[102;107.7]	90 [86.3;93.8]	119.2 [115;123.4]

95%CI = 95% Poisson exact confidence interval.

^*including both common and uncommon SAEs.