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Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01165177
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : May 1, 2017
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Herpes Zoster
Interventions Biological: Herpes Zoster Vaccine GSK1437173A
Biological: Placebo
Enrollment 16165
Recruitment Details  
Pre-assignment Details Out of all the subjects enrolled into this study, only 15405 received vaccination and were hence considered to start the study.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule. Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Period Title: Overall Study
Started 7695 7710
Completed 6773 6808
Not Completed 922 902
Reason Not Completed
Serious Adverse Event             227             235
Withdrawal by Subject             368             354
Protocol Violation             19             21
Non-serious adverse event             30             18
Other unspecified reasons             47             35
Suspected HZ episode             0             2
Lost to Follow-up             183             194
Migrated/ moved from study area             48             43
Arm/Group Title GSK1437173A Group Placebo Group Total
Hide Arm/Group Description Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule. Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 7695 7710 15405
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7695 participants 7710 participants 15405 participants
62.4  (9.0) 62.3  (9.0) 62.35  (9.0)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7695 participants 7710 participants 15405 participants
50 - 59 YOA
3644
  47.4%
3642
  47.2%
7286
  47.3%
60 - 69 YOA
2243
  29.1%
2245
  29.1%
4488
  29.1%
>= 70 YOA
1808
  23.5%
1823
  23.6%
3631
  23.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7695 participants 7710 participants 15405 participants
Female
4709
  61.2%
4711
  61.1%
9420
  61.1%
Male
2986
  38.8%
2999
  38.9%
5985
  38.9%
1.Primary Outcome
Title Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
Hide Description Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 3492 2141 1711 7344 3525 2166 1724 7415
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.1%
2
   0.1%
1
   0.1%
6
   0.1%
87
   2.5%
75
   3.5%
48
   2.8%
210
   2.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1437173A 50-59 YOA Group, Placebo 50-59 YOA Group
Comments Comparison of vaccine efficacy in prevention of HZ between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group
Type of Statistical Test Other
Comments Criteria for the vaccine efficacy (VE) objective of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) disease, in the 50-59 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.
Statistical Test of Hypothesis P-Value <0.0001
Comments Two sided exact P-value conditional to number of cases.
Method Poisson exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 96.6
Confidence Interval (2-Sided) 95%
89.6 to 99.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK1437173A 60-69 YOA Group, Placebo 60-69 YOA Group
Comments Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 60-69 YOA group and placebo over 60-69 YOA group
Type of Statistical Test Other
Comments Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 60-69 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.
Statistical Test of Hypothesis P-Value <0.0001
Comments Two sided exact P-value conditional to number of cases.
Method Poisson exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 97.4
Confidence Interval (2-Sided) 95%
90.1 to 99.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK1437173A Over 70 YOA Group, Placebo Over 70 YOA Group
Comments Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 70 YOA group and placebo over 70 YOA group
Type of Statistical Test Other
Comments Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 70-79 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.
Statistical Test of Hypothesis P-Value 0.0001
Comments Two sided exact P-value conditional to number of cases.
Method Poisson exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 97.9
Confidence Interval (2-Sided) 95%
87.9 to 100
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK1437173A Overall Ages Group, Placebo Overall Ages Group
Comments Comparison of vaccine efficacy in prevention of HZ between GSK1437173A overall ages group and placebo overall ages group
Type of Statistical Test Other
Comments Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the overall age strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.
Statistical Test of Hypothesis P-Value <0.0001
Comments Two sided exact P-value conditional to number of cases.
Method Poisson exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 97.2
Confidence Interval (2-Sided) 95%
93.7 to 99
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)
Hide Description The incidence of PHN was calculated using the modified total vaccinated chort.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 3491 2140 1709 7430 3523 2166 1724 7413
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8
   0.2%
2
   0.1%
8
   0.5%
18
   0.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1437173A 50-59 YOA Group, Placebo 50-59 YOA Group
Comments Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group
Type of Statistical Test Other
Comments Criteria for the VE objective of HZ/su vaccine against PHN in the 50-59 YOA strata: The lower limit of the 95% CI of VE had to be above 0%
Statistical Test of Hypothesis P-Value 0.0081
Comments [Not Specified]
Method Poisson exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 100
Confidence Interval (2-Sided) 95%
40.9 to 100
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK1437173A 60-69 YOA Group, Placebo 60-69 YOA Group
Comments Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 60-69 YOA group and placebo 60-69 YOA group
Type of Statistical Test Other
Comments Criteria for VE objective of HZ/su vaccine against PHN in the 60-69 YOA strata: The lower limit of the 95% CI of VE had to be above 0%
Statistical Test of Hypothesis P-Value 0.5097
Comments [Not Specified]
Method Poisson exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 100
Confidence Interval (2-Sided) 95%
-442.8 to 100
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK1437173A Over 70 YOA Group, Placebo Over 70 YOA Group
Comments Comparison of vaccine efficacy in prevention of PHN between GSK1437173A over 70 YOA group and placebo over 70 YOA group
Type of Statistical Test Other
Comments Criteria for the VE objective of HZ/su vaccine against PHN in the 70-79 YOA strata: The lower limit of the 95% CI of VE had to be above 0%
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method Poisson exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 100
Confidence Interval (2-Sided) 95%
41.4 to 100
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK1437173A Overall Ages Group, Placebo Overall Ages Group
Comments Comparison of vaccine efficacy in prevention of PHN between GSK1437173A overall ages group and placebo overall ages group
Type of Statistical Test Other
Comments Criteria for the VE objective of HZ/su vaccine against PHN in the overall ages strata: The lower limit of the 95% CI of VE had to be above 0%
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine efficacy
Estimated Value 100
Confidence Interval (2-Sided) 95%
77.1 to 100
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain
Hide Description Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) questionnaire. The outcome assessed the duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects with confirmed HZ. This analysis involved any subject reporting clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4 3 2 9 103 90 61 254
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
1
  33.3%
2
 100.0%
7
  77.8%
91
  88.3%
74
  82.2%
56
  91.8%
221
  87.0%
4.Secondary Outcome
Title Number of Subjects With Confirmed HZ Episode Related Mortality
Hide Description The analysis focused on the number of subjects who died due to HZ
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 3491 2140 1709 7340 3523 2166 1724 7413
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Subjects With HZ Related Complications
Hide Description The analysis focused on the incidence of HZ complications in subjects with confirmed HZ
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4 3 2 9 103 90 61 254
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
3
   3.3%
2
   3.3%
6
   2.4%
6.Secondary Outcome
Title Number of Subjects With Confirmed HZ Episode Related Hospitalizations
Hide Description The analysis focused on confirmed HZ episode related hospitalizations.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 3491 2140 1709 7340 3523 2166 1724 7413
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ
Hide Description The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4 3 2 9 103 90 61 254
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
2
  66.7%
1
  50.0%
6
  66.7%
82
  79.6%
63
  70.0%
45
  73.8%
190
  74.8%
8.Secondary Outcome
Title Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ
Hide Description The analysis focused on subjects taking pain medication due to HZ
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4 3 2 9 103 90 61 254
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
2
  66.7%
1
  50.0%
6
  66.7%
82
  79.6%
63
  70.0%
45
  73.8%
190
  74.8%
9.Secondary Outcome
Title Number of Days With Severe 'Worst' HZ-associated Pain.
Hide Description Severe 'worst' pain was defined as HZ-associated pain rated as 3 or above on the 'worst pain' ZBPI questionnaire. This Outcome Measure was only assessed participants with confirmed HZ. This analysis involved any subject reporting ZBPI clinically significant pain (i.e. pain with a score of 3 or more on a 0-10 point scale) at any time during the study.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4 1 2 7 91 74 56 221
Mean (Standard Deviation)
Unit of Measure: Days
12.0  (11.8) 78.0  (0.0) 9.0  (4.2) 20.6  (26.8) 28.7  (48.4) 21.6  (29.3) 44.0  (74.4) 30.2  (51.9)
10.Secondary Outcome
Title Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
Hide Description The analysis focused on confirmed HZ episode related hospitalizations and deaths.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 3491 2140 1709 7340 3523 2166 1724 7413
Measure Type: Count of Participants
Unit of Measure: Participants
Mortality
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hospitalization
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Mortality or hospitalization
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Subjects With HZ Related Complications, by Complication Type
Hide Description Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke. This Outcome Measure was only assessed participants with confirmed HZ.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4 3 2 9 103 90 61 254
Measure Type: Count of Participants
Unit of Measure: Participants
At least one complication
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
3
   3.3%
2
   3.3%
6
   2.4%
HZ vasculitis
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
0
   0.0%
1
   0.4%
Disseminated Disease
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
1
   1.1%
2
   3.3%
4
   1.6%
Ophtalmic Disease
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
0
   0.0%
1
   0.4%
Neurologic Disease
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Visceral Disease
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Stroke
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Distribution of Pain Medication Associated With HZ
Hide Description The distribution of pain medication included 1 to 3 or more separate medications. This Outcome Measure was only assessed on participants with confirmed HZ.
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4 3 2 9 103 90 61 254
Measure Type: Count of Participants
Unit of Measure: Participants
At least one pain medication
3
  75.0%
2
  66.7%
1
  50.0%
6
  66.7%
82
  79.6%
63
  70.0%
45
  73.8%
190
  74.8%
1 pain medication only
1
  25.0%
1
  33.3%
0
   0.0%
2
  22.2%
30
  29.1%
23
  25.6%
14
  23.0%
67
  26.4%
2 pain medications only
1
  25.0%
1
  33.3%
0
   0.0%
2
  22.2%
26
  25.2%
19
  21.1%
9
  14.8%
54
  21.3%
3 pain medications or more
1
  25.0%
0
   0.0%
1
  50.0%
2
  22.2%
26
  25.2%
21
  23.3%
22
  36.1%
69
  27.2%
13.Secondary Outcome
Title Number of Days of Pain Medication Associated With HZ
Hide Description The analysis was performed on subjects with a confirmed HZ episode
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the modified total vaccinated cohort, which included subjects from the total vaccinated cohort, except those who were not administered with the second vaccination or who developed a confirmed case of Herpes Zoster prior to 1 month after the second vaccination.
Arm/Group Title GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
Hide Arm/Group Description:
Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 3 2 1 6 82 63 45 190
Mean (Standard Deviation)
Unit of Measure: Days
17.3  (14.5) 20.5  (16.3) 63.0  (0.0) 26.0  (21.6) 49.2  (121.5) 74.3  (166.3) 127.7  (266.9) 76.1  (181.5)
14.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
Time Frame During the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the total vaccinated cohort - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4379 4375
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 4359 participants 4361 participants
3120
  71.6%
352
   8.1%
Grade 3 Pain, Dose 1 Number Analyzed 4359 participants 4361 participants
159
   3.6%
6
   0.1%
Any Redness, Dose 1 Number Analyzed 4359 participants 4361 participants
1225
  28.1%
40
   0.9%
Grade 3 Redness, Dose 1 Number Analyzed 4359 participants 4361 participants
82
   1.9%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 4359 participants 4361 participants
810
  18.6%
31
   0.7%
Grade 3 Swelling, Dose 1 Number Analyzed 4359 participants 4361 participants
28
   0.6%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 4207 participants 4224 participants
2807
  66.7%
258
   6.1%
Grade 3 Pain, Dose 2 Number Analyzed 4207 participants 4224 participants
185
   4.4%
10
   0.2%
Any Redness, Dose 2 Number Analyzed 4207 participants 4224 participants
1151
  27.4%
24
   0.6%
Grade 3 Redness, Dose 2 Number Analyzed 4207 participants 4224 participants
56
   1.3%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 4207 participants 4224 participants
762
  18.1%
17
   0.4%
Grade 3 Swelling, Dose 2 Number Analyzed 4207 participants 4224 participants
18
   0.4%
0
   0.0%
Any Pain, Overall Number Analyzed 4379 participants 4375 participants
3463
  79.1%
490
  11.2%
Grade 3 Pain, Overall Number Analyzed 4379 participants 4375 participants
293
   6.7%
16
   0.4%
Any Redness, Overall Number Analyzed 4379 participants 4375 participants
1665
  38.0%
59
   1.3%
Grade 3 Redness, Overall Number Analyzed 4379 participants 4375 participants
121
   2.8%
0
   0.0%
Any Swelling, Overall Number Analyzed 4379 participants 4375 participants
1153
  26.3%
46
   1.1%
Grade 3 Swelling, Overall Number Analyzed 4379 participants 4375 participants
43
   1.0%
0
   0.0%
15.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, GI (gastrointestinal) symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), fever [defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = temperature> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame Within the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the TVc - Diary Card, which was a subset of subjects from the TVc, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4372 4376
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 4346 participants 4362 participants
1395
  32.1%
531
  12.2%
Grade 3 Fatigue, Dose 1 Number Analyzed 4346 participants 4362 participants
109
   2.5%
29
   0.7%
Related fatigue, Dose 1 Number Analyzed 4346 participants 4362 participants
1153
  26.5%
355
   8.1%
Any GI symptoms, Dose 1 Number Analyzed 4346 participants 4362 participants
465
  10.7%
263
   6.0%
Grade 3 GI symptoms, Dose 1 Number Analyzed 4346 participants 4362 participants
30
   0.7%
12
   0.3%
Related GI symptoms, Dose 1 Number Analyzed 4346 participants 4362 participants
317
   7.3%
141
   3.2%
Any Headache, Dose 1 Number Analyzed 4346 participants 4362 participants
1112
  25.6%
511
  11.7%
Grade 3 Headache, Dose 1 Number Analyzed 4346 participants 4362 participants
67
   1.5%
20
   0.5%
Related Headache, Dose 1 Number Analyzed 4346 participants 4362 participants
891
  20.5%
341
   7.8%
Any Myalgia, Dose 1 Number Analyzed 4346 participants 4362 participants
1446
  33.3%
377
   8.6%
Grade 3 Myalgia, Dose 1 Number Analyzed 4346 participants 4362 participants
104
   2.4%
21
   0.5%
Related Myalgia, Dose 1 Number Analyzed 4346 participants 4362 participants
1231
  28.3%
265
   6.1%
Any Shivering, Dose 1 Number Analyzed 4346 participants 4362 participants
632
  14.5%
166
   3.8%
Grade 3 Shivering, Dose 1 Number Analyzed 4346 participants 4362 participants
69
   1.6%
3
   0.1%
Related Shivering, Dose 1 Number Analyzed 4346 participants 4362 participants
539
  12.4%
104
   2.4%
Any Temperature, Dose 1 Number Analyzed 4346 participants 4362 participants
500
  11.5%
65
   1.5%
Grade 3 Temperature, Dose 1 Number Analyzed 4346 participants 4362 participants
7
   0.2%
1
   0.0%
Related Temperature, Dose 1 Number Analyzed 4346 participants 4362 participants
420
   9.7%
38
   0.9%
Any Fatigue, Dose 2 Number Analyzed 4205 participants 4222 participants
1456
  34.6%
379
   9.0%
Grade 3 Fatigue, Dose 2 Number Analyzed 4205 participants 4222 participants
157
   3.7%
18
   0.4%
Related fatigue, Dose 2 Number Analyzed 4205 participants 4222 participants
1270
  30.2%
279
   6.6%
Any GI symptoms, Dose 2 Number Analyzed 4205 participants 4222 participants
495
  11.8%
183
   4.3%
Grade 3 GI symptoms, Dose 2 Number Analyzed 4205 participants 4222 participants
33
   0.8%
14
   0.3%
Related GI symptoms, Dose 2 Number Analyzed 4205 participants 4222 participants
392
   9.3%
91
   2.2%
Any Headache, Dose 2 Number Analyzed 4205 participants 4222 participants
1249
  29.7%
340
   8.1%
Grade 3 Headache, Dose 2 Number Analyzed 4205 participants 4222 participants
105
   2.5%
13
   0.3%
Related Headache, Dose 2 Number Analyzed 4205 participants 4222 participants
1107
  26.3%
219
   5.2%
Any Myalgia, Dose 2 Number Analyzed 4205 participants 4222 participants
1474
  35.1%
274
   6.5%
Grade 3 Myalgia, Dose 2 Number Analyzed 4205 participants 4222 participants
160
   3.8%
13
   0.3%
Related Myalgia, Dose 2 Number Analyzed 4205 participants 4222 participants
1314
  31.2%
197
   4.7%
Any Shivering, Dose 2 Number Analyzed 4205 participants 4222 participants
947
  22.5%
128
   3.0%
Grade 3 Shivering, Dose 2 Number Analyzed 4205 participants 4222 participants
139
   3.3%
9
   0.2%
Related Shivering, Dose 2 Number Analyzed 4205 participants 4222 participants
838
  19.9%
88
   2.1%
Any Temperature, Dose 2 Number Analyzed 4205 participants 4222 participants
645
  15.3%
72
   1.7%
Grade 3 Temperature, Dose 2 Number Analyzed 4205 participants 4222 participants
8
   0.2%
5
   0.1%
Related Temperature, Dose 2 Number Analyzed 4205 participants 4222 participants
571
  13.6%
40
   0.9%
Any Fatigue, Overall Number Analyzed 4372 participants 4376 participants
2006
  45.9%
728
  16.6%
Grade 3 Fatigue, Overall Number Analyzed 4372 participants 4376 participants
241
   5.5%
46
   1.1%
Related fatigue, Overall Number Analyzed 4372 participants 4376 participants
1724
  39.4%
522
  11.9%
Any GI symptoms, Overall Number Analyzed 4372 participants 4376 participants
787
  18.0%
386
   8.8%
Grade 3 GI symptoms, Overall Number Analyzed 4372 participants 4376 participants
61
   1.4%
25
   0.6%
Related GI symptoms, Overall Number Analyzed 4372 participants 4376 participants
591
  13.5%
206
   4.7%
Any Headache, Overall Number Analyzed 4372 participants 4376 participants
1714
  39.2%
700
  16.0%
Grade 3 Headache, Overall Number Analyzed 4372 participants 4376 participants
157
   3.6%
30
   0.7%
Related Headache, Overall Number Analyzed 4372 participants 4376 participants
1470
  33.6%
469
  10.7%
Any Myalgia, Overall Number Analyzed 4372 participants 4376 participants
2023
  46.3%
529
  12.1%
Grade 3 Myalgia, Overall Number Analyzed 4372 participants 4376 participants
236
   5.4%
31
   0.7%
Related Myalgia, Overall Number Analyzed 4372 participants 4376 participants
1791
  41.0%
390
   8.9%
Any Shivering, Overall Number Analyzed 4372 participants 4376 participants
1232
  28.2%
259
   5.9%
Grade 3 Shivering, Overall Number Analyzed 4372 participants 4376 participants
192
   4.4%
11
   0.3%
Related Shivering, Overall Number Analyzed 4372 participants 4376 participants
1082
  24.7%
177
   4.0%
Any Temperature, Overall Number Analyzed 4372 participants 4376 participants
940
  21.5%
132
   3.0%
Grade 3 Temperature, Overall Number Analyzed 4372 participants 4376 participants
14
   0.3%
6
   0.1%
Related Temperature, Overall Number Analyzed 4372 participants 4376 participants
813
  18.6%
78
   1.8%
16.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)
Hide Description Number of subjects with any and grade 3 solicited and unsolicited symptoms were tabulated
Time Frame Within the 7-day (Days 0-6) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the total vaccinated cohort - Diary Card, which was a subset of subjects from the total vaccinated cohort, who completed diary cards with any solicited symptoms during the 7 days (Day 0 to Day 6) post vaccination period.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 4457 4464
Measure Type: Count of Participants
Unit of Measure: Participants
Any solicited or unsolicited symptoms
3766
  84.5%
1691
  37.9%
Grade 3 solicited or unsolicited symptoms
759
  17.0%
145
   3.2%
17.Secondary Outcome
Title Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
Hide Description Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 7695 7710
Measure Type: Count of Participants
Unit of Measure: Participants
Any pIMDs
87
   1.1%
105
   1.4%
Related pIMDs
8
   0.1%
12
   0.2%
18.Secondary Outcome
Title Number of Subjects With AEs With Any and Related Medically Attended Visit
Hide Description Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.
Time Frame From Month 0 to Month 8 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 7695 7710
Measure Type: Count of Participants
Unit of Measure: Participants
Any medically attended visits
2952
  38.4%
3072
  39.8%
Related medically attended visits
142
   1.8%
60
   0.8%
19.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame Within 30 days (Days 0 - 29) after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 7695 7710
Measure Type: Count of Participants
Unit of Measure: Participants
Any unsolicited AEs
3534
  45.9%
2426
  31.5%
Grade 3 unsolicited AEs
609
   7.9%
298
   3.9%
Related unsolicited AEs
2199
  28.6%
439
   5.7%
20.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Occurrence and relationship to vaccination of all SAEs in all subjects. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 7695 7710
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs (up to Day 30)
88
   1.1%
97
   1.3%
Related SAEs (up to Day 30)
1
   0.0%
3
   0.0%
Any SAEs (up to Month 14)
594
   7.7%
590
   7.7%
Related SAEs (up to Month 14)
3
   0.0%
6
   0.1%
Any SAEs (up to study end)
727
   9.4%
731
   9.5%
Related SAEs (up to study end)
3
   0.0%
7
   0.1%
21.Secondary Outcome
Title Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
Hide Description The number of subjects with SAEs related to study participation or to a concurrent GSK medication/vaccine were tabulated
Time Frame During the entire study period (3 to 5 year period following Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on TVC, which included all subjects with at least one dose of the study vaccine or place administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 7695 7710
Measure Type: Count of Participants
Unit of Measure: Participants
43
   0.6%
25
   0.3%
22.Secondary Outcome
Title Number of Subjects With Fatal SAEs
Hide Description Number of subjects with fatal SAEs during the entire study period were tabulated
Time Frame During the entire study period (3 to 5 years following day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was based on the the total vaccinated cohort, which included all subjects with at least one dose of study vaccine or placebo administered.
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description:
Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
Overall Number of Participants Analyzed 7695 7710
Measure Type: Count of Participants
Unit of Measure: Participants
208
   2.7%
221
   2.9%
Time Frame Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK1437173A Group Placebo Group
Hide Arm/Group Description Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule. Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
All-Cause Mortality
GSK1437173A Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   11/7695 (0.14%)      15/7710 (0.19%)    
Hide Serious Adverse Events
GSK1437173A Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   727/7695 (9.45%)      731/7710 (9.48%)    
Blood and lymphatic system disorders     
Anaemia  6/7695 (0.08%)  6 4/7710 (0.05%)  4
Anaemia vitamin b12 deficiency  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Disseminated intravascular coagulation  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Haemorrhagic anaemia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Heparin-induced thrombocytopenia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Hypochromic anaemia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Immune thrombocytopenic purpura  3/7695 (0.04%)  3 1/7710 (0.01%)  1
Iron deficiency anaemia  2/7695 (0.03%)  3 1/7710 (0.01%)  1
Lymphadenopathy  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Lymphadenopathy mediastinal  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Splenic haemorrhage  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Splenic infarction  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Thrombocytopenia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Cardiac disorders     
Acute coronary syndrome  4/7695 (0.05%)  4 2/7710 (0.03%)  2
Acute myocardial infarction  8/7695 (0.10%)  8 19/7710 (0.25%)  19
Angina pectoris  3/7695 (0.04%)  4 3/7710 (0.04%)  3
Angina unstable  2/7695 (0.03%)  2 4/7710 (0.05%)  4
Aortic valve disease  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Aortic valve stenosis  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Arrhythmia  6/7695 (0.08%)  6 0/7710 (0.00%)  0
Atrial fibrillation  19/7695 (0.25%)  23 6/7710 (0.08%)  6
Atrial flutter  4/7695 (0.05%)  4 4/7710 (0.05%)  4
Atrial tachycardia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Atrioventricular block  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Atrioventricular block complete  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Atrioventricular block second degree  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Bradyarrhythmia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Bradycardia  2/7695 (0.03%)  2 2/7710 (0.03%)  2
Cardiac arrest  8/7695 (0.10%)  8 8/7710 (0.10%)  8
Cardiac failure  20/7695 (0.26%)  21 24/7710 (0.31%)  27
Cardiac failure acute  0/7695 (0.00%)  0 3/7710 (0.04%)  3
Cardiac failure chronic  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Cardiac failure congestive  14/7695 (0.18%)  15 10/7710 (0.13%)  10
Cardiac valve disease  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Cardio-respiratory arrest  0/7695 (0.00%)  0 2/7710 (0.03%)  2
Cardiogenic shock  3/7695 (0.04%)  3 1/7710 (0.01%)  1
Cardiomyopathy alcoholic  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Cardiopulmonary failure  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Cardiovascular deconditioning  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Cardiovascular insufficiency  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Cor pulmonale  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Coronary artery disease  11/7695 (0.14%)  11 17/7710 (0.22%)  19
Coronary artery insufficiency  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Coronary artery occlusion  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Coronary artery stenosis  4/7695 (0.05%)  4 0/7710 (0.00%)  0
Intracardiac thrombus  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Left ventricular failure  3/7695 (0.04%)  3 0/7710 (0.00%)  0
Mitral valve prolapse  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Mitral valve stenosis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Myocardial infarction  28/7695 (0.36%)  28 27/7710 (0.35%)  27
Myocardial ischaemia  7/7695 (0.09%)  7 11/7710 (0.14%)  11
Palpitations  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Pericardial effusion  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Pericarditis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Right ventricular failure  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Sinus node dysfunction  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Stress cardiomyopathy  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Supraventricular tachycardia  3/7695 (0.04%)  3 0/7710 (0.00%)  0
Tachycardia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Ventricular extrasystoles  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Ventricular fibrillation  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Ventricular tachycardia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hypertrophic cardiomyopathy  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Odontogenic cyst  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Congenital, familial and genetic disorders     
Cystic fibrosis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hernia congenital  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Hydrocele  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Ear and labyrinth disorders     
Deafness neurosensory  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Motion sickness  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Vertigo  4/7695 (0.05%)  4 3/7710 (0.04%)  3
Vertigo positional  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Endocrine disorders     
Basedow's disease  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Goitre  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hypopituitarism  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Thyroiditis subacute  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Eye disorders     
Amaurosis fugax  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Cataract  2/7695 (0.03%)  2 5/7710 (0.06%)  5
Eyelid ptosis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Glaucoma  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Lens dislocation  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Macular cyst  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Macular hole  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Neovascular age-related macular degeneration  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Retinal artery occlusion  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Retinal detachment  1/7695 (0.01%)  1 4/7710 (0.05%)  4
Retinal tear  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Vitreous detachment  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Vitreous haemorrhage  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Gastrointestinal disorders     
Abdominal hernia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Abdominal pain  2/7695 (0.03%)  2 2/7710 (0.03%)  2
Abdominal pain upper  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Abdominal strangulated hernia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Ascites  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Colitis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Colitis ischaemic  1/7695 (0.01%)  1 3/7710 (0.04%)  3
Constipation  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Crohn's disease  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Diarrhoea  4/7695 (0.05%)  4 1/7710 (0.01%)  1
Diverticulum  3/7695 (0.04%)  3 1/7710 (0.01%)  1
Diverticulum intestinal  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Duodenal perforation  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Duodenal ulcer haemorrhage  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Duodenitis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Enteritis  0/7695 (0.00%)  0 2/7710 (0.03%)  2
Enterovesical fistula  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Functional gastrointestinal disorder  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Gastric haemorrhage  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Gastric mucosal lesion  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Gastric polyps  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Gastric ulcer  3/7695 (0.04%)  3 3/7710 (0.04%)  3
Gastric ulcer haemorrhage  0/7695 (0.00%)  0 2/7710 (0.03%)  2
Gastritis  5/7695 (0.06%)  5 4/7710 (0.05%)  4
Gastritis alcoholic  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Gastrointestinal angiodysplasia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Gastrointestinal haemorrhage  3/7695 (0.04%)  3 4/7710 (0.05%)  4
Gastrointestinal polyp haemorrhage  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Gastrooesophageal reflux disease  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Gingival disorder  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Haemorrhoidal haemorrhage  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Haemorrhoids  1/7695 (0.01%)  1 4/7710 (0.05%)  4
Hiatus hernia  0/7695 (0.00%)  0 3/7710 (0.04%)  3
Ileus  1/7695 (0.01%)  1 3/7710 (0.04%)  3
Incarcerated umbilical hernia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Inguinal hernia  3/7695 (0.04%)  3 8/7710 (0.10%)  8
Intestinal congestion  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Intestinal obstruction  3/7695 (0.04%)  3 3/7710 (0.04%)  3
Intestinal polyp  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Irritable bowel syndrome  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Large intestine polyp  1/7695 (0.01%)  1 4/7710 (0.05%)  4
Mallory-weiss syndrome  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Melaena  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Nausea  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Oesophageal ulcer  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Oesophageal varices haemorrhage  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Oesophagitis  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Pancreatic cyst  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Pancreatic fistula  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Pancreatitis  4/7695 (0.05%)  4 0/7710 (0.00%)  0
Pancreatitis acute  5/7695 (0.06%)  5 6/7710 (0.08%)  7
Pancreatitis necrotising  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Peptic ulcer  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Peptic ulcer perforation  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Periodontal disease  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Peritoneal cyst  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Peritoneal haemorrhage  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Pneumoperitoneum  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Portal hypertensive gastropathy  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Rectal haemorrhage  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Rectal polyp  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Retroperitoneal haemorrhage  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Small intestinal obstruction  2/7695 (0.03%)  2 3/7710 (0.04%)  3
Splenic artery aneurysm  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Subileus  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Thrombosis mesenteric vessel  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Upper gastrointestinal haemorrhage  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Volvulus  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Vomiting  1/7695 (0.01%)  1 0/7710 (0.00%)  0
General disorders     
Asthenia  3/7695 (0.04%)  3 0/7710 (0.00%)  0
Chest discomfort  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Chest pain  12/7695 (0.16%)  12 10/7710 (0.13%)  12
Death  11/7695 (0.14%)  11 15/7710 (0.19%)  15
Device dislocation  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Device failure  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Drowning  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Drug withdrawal syndrome  1/7695 (0.01%)  1 0/7710 (0.00%)  0
General physical health deterioration  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Gravitational oedema  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hernia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Impaired healing  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Influenza like illness  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Malaise  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Multi-organ failure  6/7695 (0.08%)  6 2/7710 (0.03%)  2
Non-cardiac chest pain  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Pain  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Peripheral swelling  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Polyp  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Pyrexia  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Strangulated hernia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Sudden cardiac death  0/7695 (0.00%)  0 3/7710 (0.04%)  3
Sudden death  5/7695 (0.06%)  5 7/7710 (0.09%)  7
Systemic inflammatory response syndrome  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hepatobiliary disorders     
Bile duct obstruction  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Bile duct stenosis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Bile duct stone  0/7695 (0.00%)  0 3/7710 (0.04%)  3
Biliary colic  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Cholangitis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Cholangitis acute  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Cholecystitis  5/7695 (0.06%)  5 6/7710 (0.08%)  6
Cholecystitis acute  6/7695 (0.08%)  6 4/7710 (0.05%)  4
Cholelithiasis  7/7695 (0.09%)  7 10/7710 (0.13%)  10
Fatty liver alcoholic  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Gallbladder polyp  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hepatic cirrhosis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hepatic failure  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Hepatotoxicity  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Jaundice cholestatic  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Biliary dyskinesia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Drug hypersensitivity  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Hypersensitivity  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Sarcoidosis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Infections and infestations     
Abdominal infection  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Abdominal sepsis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Abscess  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Abscess neck  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Anal abscess  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Appendiceal abscess  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Appendicitis  3/7695 (0.04%)  3 6/7710 (0.08%)  6
Appendicitis perforated  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Atypical pneumonia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Bacteraemia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Bacterial infection  0/7695 (0.00%)  0 2/7710 (0.03%)  2
Bacteriuria  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Biliary sepsis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Breast abscess  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Bronchitis  3/7695 (0.04%)  3 4/7710 (0.05%)  4
Bronchitis bacterial  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Bronchopneumonia  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Candiduria  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Catheter site infection  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Cellulitis  8/7695 (0.10%)  8 6/7710 (0.08%)  6
Cellulitis orbital  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Cellulitis streptococcal  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Chronic sinusitis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Clostridium difficile colitis  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Clostridium difficile infection  0/7695 (0.00%)  0 3/7710 (0.04%)  3
Cystitis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Cystitis klebsiella  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Dengue fever  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Diabetic gangrene  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Diverticulitis  4/7695 (0.05%)  4 6/7710 (0.08%)  7
Encephalomyelitis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Endocarditis  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Endometritis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Erysipelas  2/7695 (0.03%)  2 3/7710 (0.04%)  3
Fungaemia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Gangrene  3/7695 (0.04%)  3 0/7710 (0.00%)  0
Gastroenteritis  3/7695 (0.04%)  4 4/7710 (0.05%)  4
Gastroenteritis caliciviral  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Gastroenteritis clostridial  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Gastroenteritis salmonella  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Gastroenteritis viral  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Gastrointestinal infection  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Helicobacter gastritis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Hepatitis a  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Herpes zoster  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Infected dermal cyst  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Infected skin ulcer  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Infection  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Infectious colitis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Influenza  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Klebsiella sepsis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Labyrinthitis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Leptospirosis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Liver abscess  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Lobar pneumonia  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Localised infection  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Lower respiratory tract infection  1/7695 (0.01%)  1 6/7710 (0.08%)  6
Lung infection  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Lymph node tuberculosis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Meningitis pneumococcal  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Mycobacterial infection  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Nasal abscess  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Nasopharyngitis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Neuroborreliosis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Osteomyelitis  4/7695 (0.05%)  5 2/7710 (0.03%)  2
Osteomyelitis chronic  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Otitis media chronic  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Periodontitis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Peritonitis  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Peritonsillar abscess  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Pertussis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Pharyngitis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Pharyngotonsillitis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Pneumonia  40/7695 (0.52%)  41 26/7710 (0.34%)  28
Pneumonia bacterial  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Pneumonia mycoplasmal  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Pneumonia pneumococcal  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Post procedural infection  0/7695 (0.00%)  0 3/7710 (0.04%)  3
Pseudomembranous colitis  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Pyelonephritis  6/7695 (0.08%)  6 3/7710 (0.04%)  3
Pyelonephritis acute  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Respiratory tract infection  3/7695 (0.04%)  3 2/7710 (0.03%)  2
Sepsis  7/7695 (0.09%)  7 13/7710 (0.17%)  14
Septic shock  1/7695 (0.01%)  1 4/7710 (0.05%)  4
Serratia infection  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Shigella infection  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Sinusitis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Sinusitis fungal  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Soft tissue infection  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Staphylococcal infection  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Subcutaneous abscess  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Subdiaphragmatic abscess  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Superinfection  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Testicular abscess  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Toxic shock syndrome  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Tracheobronchitis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Tularaemia  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Upper respiratory tract infection  2/7695 (0.03%)  2 2/7710 (0.03%)  2
Upper respiratory tract infection bacterial  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Urethritis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Urinary tract infection  10/7695 (0.13%)  10 10/7710 (0.13%)  10
Urosepsis  2/7695 (0.03%)  2 3/7710 (0.04%)  3
Vestibular neuronitis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Viral sepsis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Viral upper respiratory tract infection  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Visceral leishmaniasis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Wound infection  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Wound infection pseudomonas  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Wound infection staphylococcal  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Injury, poisoning and procedural complications     
Accident  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Acetabulum fracture  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Anastomotic leak  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Aneurysm perforation  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Ankle fracture  7/7695 (0.09%)  7 4/7710 (0.05%)  4
Burns second degree  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Burns third degree  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Cataract operation complication  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Chemical poisoning  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Chest injury  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Clavicle fracture  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Comminuted fracture  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Concussion  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Contusion  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Craniocerebral injury  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Electrical burn  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Eye penetration  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Facial bones fracture  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Fall  2/7695 (0.03%)  2 2/7710 (0.03%)  2
Femoral neck fracture  5/7695 (0.06%)  5 4/7710 (0.05%)  5
Femur fracture  7/7695 (0.09%)  7 3/7710 (0.04%)  3
Fibula fracture  3/7695 (0.04%)  3 0/7710 (0.00%)  0
Flail chest  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Foot fracture  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Forearm fracture  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Fractured sacrum  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Gun shot wound  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hand fracture  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Head injury  3/7695 (0.04%)  3 4/7710 (0.05%)  4
Hip fracture  2/7695 (0.03%)  2 6/7710 (0.08%)  6
Humerus fracture  2/7695 (0.03%)  2 2/7710 (0.03%)  2
Incarcerated incisional hernia  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Incisional hernia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Joint dislocation  3/7695 (0.04%)  3 1/7710 (0.01%)  1
Joint injury  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Laceration  1/7695 (0.01%)  1 4/7710 (0.05%)  4
Ligament rupture  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Ligament sprain  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Limb injury  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Lower limb fracture  1/7695 (0.01%)  1 3/7710 (0.04%)  3
Lumbar vertebral fracture  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Meniscus injury  3/7695 (0.04%)  3 1/7710 (0.01%)  1
Multiple fractures  0/7695 (0.00%)  0 2/7710 (0.03%)  2
Multiple injuries  1/7695 (0.01%)  1 3/7710 (0.04%)  3
Muscle rupture  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Muscle strain  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Nerve root injury cervical  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Open fracture  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Overdose  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Patella fracture  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Pelvic fracture  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Pneumothorax traumatic  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Poisoning  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Post procedural haemorrhage  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Procedural pain  3/7695 (0.04%)  3 1/7710 (0.01%)  1
Pubis fracture  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Radius fracture  7/7695 (0.09%)  7 7/7710 (0.09%)  7
Respiratory fume inhalation disorder  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Rib fracture  3/7695 (0.04%)  3 1/7710 (0.01%)  1
Road traffic accident  1/7695 (0.01%)  1 5/7710 (0.06%)  5
Seroma  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Skin abrasion  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Skull fracture  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Snake bite  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Soft tissue injury  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Spinal compression fracture  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Spinal cord injury  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Spinal fracture  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Splenic rupture  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Sternal fracture  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Subdural haematoma  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Spinal cord injury cervical  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Subdural haemorrhage  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Tendon injury  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Tendon rupture  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Tibia fracture  3/7695 (0.04%)  3 1/7710 (0.01%)  1
Toxicity to various agents  3/7695 (0.04%)  4 1/7710 (0.01%)  1
Traumatic intracranial haemorrhage  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Traumatic shock  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Ulna fracture  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Upper limb fracture  4/7695 (0.05%)  4 1/7710 (0.01%)  1
Vascular pseudoaneurysm ruptured  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Wound  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Wound dehiscence  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Wrist fracture  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Investigations     
Anticoagulation drug level above therapeutic  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Blood heavy metal increased  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Haemoglobin decreased  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Metabolism and nutrition disorders     
Decreased appetite  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Dehydration  4/7695 (0.05%)  4 2/7710 (0.03%)  2
Diabetes mellitus  3/7695 (0.04%)  3 2/7710 (0.03%)  2
Diabetes mellitus inadequate control  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Diabetic ketoacidosis  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Electrolyte imbalance  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Gout  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hyperammonaemia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hyperglycaemia  1/7695 (0.01%)  1 2/7710 (0.03%)  2
Hyperkalaemia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Hyperlipidaemia  3/7695 (0.04%)  3 1/7710 (0.01%)  1
Hypertriglyceridaemia  1/7695 (0.01%)  1 1/7710 (0.01%)  1
Hypoglycaemia  3/7695 (0.04%)  3 0/7710 (0.00%)  0
Hypokalaemia  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Hyponatraemia  2/7695 (0.03%)  2 2/7710 (0.03%)  2
Ketoacidosis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Malnutrition  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Metabolic acidosis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Obesity  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Type 1 diabetes mellitus  0/7695 (0.00%)  0 2/7710 (0.03%)  2
Type 2 diabetes mellitus  2/7695 (0.03%)  2 4/7710 (0.05%)  4
Musculoskeletal and connective tissue disorders     
Arthritis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Arthropathy  2/7695 (0.03%)  2 0/7710 (0.00%)  0
Back pain  2/7695 (0.03%)  2 1/7710 (0.01%)  1
Costochondritis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Fasciitis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Foot deformity  0/7695 (0.00%)  0 2/7710 (0.03%)  2
Intervertebral disc degeneration  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Intervertebral disc disorder  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Intervertebral disc protrusion  1/7695 (0.01%)  1 7/7710 (0.09%)  7
Joint destruction  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Lumbar spinal stenosis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Muscle spasms  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Musculoskeletal chest pain  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Musculoskeletal pain  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Myalgia  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Neck pain  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Osteitis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Osteoarthritis  8/7695 (0.10%)  8 11/7710 (0.14%)  11
Osteochondrosis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Osteolysis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Osteonecrosis  4/7695 (0.05%)  4 0/7710 (0.00%)  0
Periarthritis  0/7695 (0.00%)  0 1/7710 (0.01%)  1
Polyarthritis  1/7695 (0.01%)  1 0/7710 (0.00%)  0
Polymyalgia rheumatica  1/7695 (0.01%)  1