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Table 5 Comparison of PP and MITT Analyses for RVGE Healthcare Encounters by Type of Encounter and Region

From: Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5)

Region

PP Analysis

MITT Analysis

 

RV5

Placebo

% Rate Reduction

(95% CI)

RV5

Placebo

% Rate Reduction

(95% CI)

Europe

Infants contributing to the analysis of hospitalizations and ED visits a

n = 14018

n = 13984

 

n = 14831

n = 14734

 

   Hospitalizations & ED visitsb

16

(1.7)

301

(32.0)

94.7

(90.9, 96.9)

31

(2.3)

387

(29.4)

92.0

(88.4, 94.6)

   Hospitalizationsb

5

(0.5)

126

(13.4)

96.0

(90.3, 98.4)

14

(1.1)

172

(13.1)

91.9

(85.9, 95.6)

   ED visitsb

11

(1.2)

175

(18.6)

93.7

(87.8, 96.8)

17

(1.3)

215

(16.3)

92.1

(87.0, 95.4)

Infants contributing to the analysis of office visits in the efficacy substudy from Finland

n = 1100

n = 1171

 

n = 1222

n = 1233

 

   Office visitsc

7

(4.7)

58

(37.0)

87.2

(67.5, 94.7)

10

(5.3)

59

(30.9)

82.9

(67.0, 92.4)

United States (including the Navajo and White Mountain Apache Nations)

Infants contributing to the analysis of hospitalizations and ED visits a

n = 12284

n = 12179

 

n = 15587

n = 15561

 

   Hospitalizations & ED visitsb

3

(0.4)

58

(8.0)

94.9

(84.0, 98.9)

24

(1.8)

120

(9.2)

80.0

(68.7, 87.6)

   Hospitalizationsb

0

(0.0)

16

(2.2)

100

(73.8, 100.0)

1

(0.1)

39

(3.0)

97.4

(84.8, 99.9)

   ED visitsb

3

(0.4)

42

(5.8)

92.9

(77.4, 98.6)

23

(1.8)

81

(6.2)

71.6

(54.3, 82.9)

Infants contributing to the analysis of office visits

n = 890

n = 925

 

n = 994

n = 1018

 

   Office visitsc

6

(0.8)

40

(53.5)

84.2

(66.2, 95.1)

11

(10.3)

64

(57.4)

82.0

(68.5, 92.2)

Latin America and the Caribbean (including Puerto Rico)

Infants contributing to the analysis of hospitalizations and ED visits a

n = 2252

n = 2237

 

n = 2630

n = 2651

 

   Hospitalizations & ED visitsb

1

(0.8)

10

(8.0)

90.0

(29.4, 99.8)

3

(1.4)

15

(7.2)

80.2

(28.5, 96.2)

   Hospitalizationsb

1

(0.8)

2

(1.6)

50.2

(<0.0, 99.1)

1

(0.5)

4

(1.9)

75.3

(0, 99.5)

   ED visitsb

0

(0.0)

8

(6.4)

100

(41.2, 100.0)

2

(0.9)

11

(5.3)

82.0

(15.8, 98.0)

  1. a There were 189 infants enrolled in Taiwan who were not included in the regional analyses
  2. b The numbers in the RV5 and Placebo columns represent the number (rate) of events; the rates reflect the incidence density expressed as the annual number of events per 1000 person-years
  3. c Office visits were only documented for a subset of infants from Finland and the US; there were no office visits documented in Latin America and the Caribbean
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