Study Evaluating The Safety, Tolerability And Immunogenic... | NCT00546572 | Trialant
NCT00546572
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Jul 14, 2011Estimated
Enrollment
938Actual
Phase
Phase 3
Conditions
Pneumococcal Infections
Interventions
13 valent Pneumococcal Conjugate Vaccine
23vPS
Countries
United States
Sweden
Protocol Section
Identification Module
NCT ID
NCT00546572
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6115A1-3005
Secondary IDs
ID
Type
Description
Link
B1851024
Brief Title
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Official Title
A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Compared To A 23-Valent Pneumococcal Polysaccharide (23vPS) Vaccine in Ambulatory Elderly Individuals Aged 70 Years And Older Who Received One Dose of 23vPS At Least 5 Years Prior To Study Enrollment
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Jul 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2007
Primary Completion Date
Jul 2010Actual
Completion Date
Jul 2010Actual
First Submitted Date
Oct 18, 2007
First Submission Date that Met QC Criteria
Oct 18, 2007
First Posted Date
Oct 19, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 29, 2011
Results First Submitted that Met QC Criteria
Apr 29, 2011
Results First Posted Date
May 30, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 12, 2011
Last Update Posted Date
Jul 14, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.
0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
1 month after Vax 1 / Year 0
Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.
Baseline, 1 month after Vax 1 / Year 0
Secondary Outcomes
Measure
Description
Time Frame
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.
1 month after Vax 1 / Year 0
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or Female aged 70 years or older.
Documented vaccination with 1 dose of 23vPS at least 5 years previous.
Healthy.
Exclusion Criteria:
Receipt of more than one dose of 23vPS prior to enrollment.
History of severe adverse reaction to a vaccine.
Immunodeficiency.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
70 Years
Maximum Age
Not provided
Standard Ages
Older Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pfizer Investigational Site
Mobile
Alabama
36608
United States
Pfizer Investigational Site
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliters (mL) dose intramuscularly (IM) at Year 0 (vaccination 1 [Vax 1]) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
FG001
23vPS / 13vPnC
Periods
Title
Milestones
Reasons Not Completed
Vax 1 / Year 0
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
23vPS
Biological
0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
2
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.
1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
Days 1 through 14 / Year 0
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 )
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Days 1 through 14 / Year 0
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Days 1 through 14 / Year 1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
Mesa
Arizona
85203
United States
Pfizer Investigational Site
Mesa
Arizona
85213
United States
Pfizer Investigational Site
Fountain Valley
California
92708
United States
Pfizer Investigational Site
Denver
Colorado
80262
United States
Pfizer Investigational Site
Waterbury
Connecticut
06708
United States
Pfizer Investigational Site
Clearwater
Florida
33761
United States
Pfizer Investigational Site
Coral Gables
Florida
33134
United States
Pfizer Investigational Site
Jacksonville
Florida
32216
United States
Pfizer Investigational Site
Pinellas Park
Florida
33781
United States
Pfizer Investigational Site
Tampa
Florida
33614
United States
Pfizer Investigational Site
Atlanta
Georgia
30305
United States
Pfizer Investigational Site
Atlanta
Georgia
30328
United States
Pfizer Investigational Site
Stockbridge
Georgia
30328
United States
Pfizer Investigational Site
Shawnee Mission
Kansas
66128
United States
Pfizer Investigational Site
Lexington
Kentucky
40536
United States
Pfizer Investigational Site
Baltimore
Maryland
21209
United States
Pfizer Investigational Site
Minneapolis
Minnesota
55417
United States
Pfizer Investigational Site
Rochester
Minnesota
55905
United States
Pfizer Investigational Site
St Louis
Missouri
63104
United States
Pfizer Investigational Site
St Louis
Missouri
63141
United States
Pfizer Investigational Site
Butte
Montana
59701
United States
Pfizer Investigational Site
Las Vegas
Nevada
89146
United States
Pfizer Investigational Site
Rochester
New York
14642
United States
Pfizer Investigational Site
Cary
North Carolina
27511
United States
Pfizer Investigational Site
Charlotte
North Carolina
28209
United States
Pfizer Investigational Site
Durham
North Carolina
27705
United States
Pfizer Investigational Site
Durham
North Carolina
27710
United States
Pfizer Investigational Site
Hickory
North Carolina
28601
United States
Pfizer Investigational Site
Raleigh
North Carolina
27612
United States
Pfizer Investigational Site
Salisbury
North Carolina
28144
United States
Pfizer Investigational Site
Winston-Salem
North Carolina
27103
United States
Pfizer Investigational Site
Fargo
North Dakota
58103
United States
Pfizer Investigational Site
Cincinnati
Ohio
45229
United States
Pfizer Investigational Site
Cincinnati
Ohio
45236
United States
Pfizer Investigational Site
Cleveland
Ohio
44195
United States
Pfizer Investigational Site
Corvallis
Oregon
97330
United States
Pfizer Investigational Site
Eugene
Oregon
97401
United States
Pfizer Investigational Site
Carnegie
Pennsylvania
15106
United States
Pfizer Investigational Site
Downington
Pennsylvania
19335
United States
Pfizer Investigational Site
Grove City
Pennsylvania
16127
United States
Pfizer Investigational Site
Penndel
Pennsylvania
19047
United States
Pfizer Investigational Site
Pittsburgh
Pennsylvania
15241
United States
Pfizer Investigational Site
Upper Saint Clair
Pennsylvania
15241
United States
Pfizer Investigational Site
Greer
South Carolina
29651
United States
Pfizer Investigational Site
Mt. Pleasant
South Carolina
29464
United States
Pfizer Investigational Site
Bristol
Tennessee
37620
United States
Pfizer Investigational Site
Nashville
Tennessee
37232
United States
Pfizer Investigational Site
Austin
Texas
78705
United States
Pfizer Investigational Site
Norfolk
Virginia
23507
United States
Pfizer Investigational Site
Seattle
Washington
998101
United States
Pfizer Investigational Site
Arlöv
23234
Sweden
Pfizer Investigational Site
Boden
96131
Sweden
Pfizer Investigational Site
Degeberga
29731
Sweden
Pfizer Investigational Site
Gothenburg
40014
Sweden
Pfizer Investigational Site
Malmö
21120
Sweden
Pfizer Investigational Site
Umeå
90736
Sweden
Pfizer Investigational Site
Uppsala
75185
Sweden
23-valent pneumococcal polysaccharide conjugate vaccine (23vPS) 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
FG000464 subjects
FG001474 subjects
Received Vax 1
FG000463 subjects
FG001473 subjects
COMPLETED
FG000391 subjects
FG001404 subjects
NOT COMPLETED
FG00073 subjects
FG00170 subjects
Type
Comment
Reasons
Randomized, not treated
FG0001 subjects
FG0011 subjects
Withdrawal by Subject
FG0003 subjects
FG0012 subjects
Protocol Violation
FG0003 subjects
FG0014 subjects
Death
FG0002 subjects
FG0012 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
6-Month Contact; withdraw before Vax 2
FG00064 subjects
FG00159 subjects
Vax 2 / Year 1
Type
Comment
Milestone Data
STARTED
FG000391 subjects
FG001404 subjects
Received Vax 2
FG000391 subjects
FG001404 subjects
COMPLETED
FG000387 subjects
FG001402 subjects
NOT COMPLETED
FG0004 subjects
FG0012 subjects
Type
Comment
Reasons
Other
FG0001 subjects
FG0011 subjects
Adverse Event
FG0001 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
BG001
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000463
BG001473
BG002936
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00076.7± 4.6
BG00176.7± 4.5
BG00276.7± 4.6
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000221
BG001235
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable Immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate OPA antibody titer to the given serotype.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
1 month after Vax 1 / Year 0
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Units
Counts
Participants
OG000426
OG001445
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG00081(68.4 to 95.9)
OG00155(46.2 to 64.8)
Serotype 3
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.5
2-Sided
95
1.17
1.88
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
Primary
Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
OPA titer for the 6A serotype measured for at least a 4-fold increase from the prevaccination to postvaccination blood sample collection. Exact 2-sided CI (Clopper and Pearson) based upon the observed percentage of participants.
Evaluable Immunogenicity population. N=number of participants with a determinate antibody titer to the given serotype.
Posted
Number
95% Confidence Interval
observed percentage of participants
Baseline, 1 month after Vax 1 / Year 0
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Units
Counts
Participants
OG000
Secondary
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A pneumococcal serotype. Confidence intervals for the GMT are back transformation of a CI based on the Student t distribution for the mean logarithm of the titer.
Evaluable Immunogenicity population. N=number of participants with a determinate OPA antibody titer to the given serotype.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
1 month after Vax 1 / Year 0
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Units
Counts
Participants
OG000
Secondary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0)
Antibody geometric mean titers as measured by OPA assays for the 13 serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype at both the postvaccination 1 and postvaccination 2 blood draws.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
13vPnC / 13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Units
Counts
Participants
Secondary
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titers as measured by OPA assays for the 12 common serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titers
1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
ID
Title
Description
OG000
13vPnC / 13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
OG001
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Units
Counts
Participants
OG000
Secondary
Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0)
Antibody geometric mean titer as measured by OPA assay for the 6A serotype. Confidence intervals (CI) for the GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titer.
Evaluable Immunogenicity population; N=number of participants with a determinate OPA antibody titer to the given serotype.
Posted
Geometric Mean
95% Confidence Interval
geometric mean titer
1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1
ID
Title
Description
OG000
13vPnC / 13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
OG001
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Units
Counts
Participants
OG000
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Safety population is all participants who receive at least 1 dose of study vaccine. N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Vax 1). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 0
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
13vPnC / 13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
ID
Title
Description
OG000
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
OG001
13vPnC / 13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 )
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 1
ID
Title
Description
OG000
13vPnC / 13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
OG001
23vPS / 13vPnC
23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Pre-specified
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)
Local reactions reported in electronic diary. Redness and swelling scaled as Any (redness or swelling present); Mild (2.5 centimeters [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (awareness of symptom, easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating, inability to do usual activity). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move above head, able to move above shoulder); Severe (unable to move above shoulder)
Safety population; N=number of participants who reported any local reaction reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
23vPS / 13vPnC
23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC and 23vPS (Year 0). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 0
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Units
Counts
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
13vPnC / 13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 23vPS (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
ID
Title
Description
OG000
23vPS
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
OG001
13vPnC / 13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC / 13vPnC and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 1
ID
Title
Description
OG000
13vPnC / 13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
OG001
23vPS / 13vPnC
23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax )
Other Pre-specified
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1)
Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1). Participants may be represented in more than 1 category.
Posted
Number
percentage of participants
Days 1 through 14 / Year 0, Days 1 through 14 / Year 1
ID
Title
Description
OG000
13vPnC
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
OG001
23vPS / 13vPnC
23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Time Frame
Events assessed until approximately 1 month after each vaccination. AEs collected up to 43 days after Vax 2 / Year 1; SAEs collected up to 194 days after Vax 2 / Year 1. Local Reactions and Systemic Events assessed within 14 days of each vaccination.
Description
Same event may appear as both an AE and SAE; however, are distinct events. Event may be categorized as serious in 1 subject and nonserious in another, or 1 subject may have experienced both a serious and nonserious event during study. Zero in denominator (0 participants at risk) indicates Reporting Group was not systematically assessed for AE term.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
13vPnC (Vax 1 / Year 0) 1 Month After Vaccination
13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=66; systematic (solicited) Local Reactions N=209; systematic (solicited) Systemic Events N=234.
3
463
234
463
EG001
23vPS (Vax 1 / Year 0) 1 Month After Vaccination
23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=83; systematic (solicited) Local Reactions N=248; systematic (solicited) Systemic Events N=275.
8
473
275
473
EG002
13vPnC 6-M FU (Vax 1 / Year 0)
13vPnC 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-Month Follow-up visit (6-M FU) (Vax 1 / Year 0) telephone visit to report new events.
27
463
60
463
EG003
23vPS 6-M FU (Vax 1 / Year 0)
23vPS 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-M FU (Vax 1 / Year 0) telephone visit to report new events.
26
473
59
473
EG004
13vPnC / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=191; systematic (solicited) Systemic Events N=161.
4
391
191
391
EG005
23vPS / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination
23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=62; systematic (solicited) Local Reactions N=189; systematic (solicited) Systemic Events N=174.
7
404
189
404
EG006
13vPnC / 13vPnC 6-M FU (Vax 2 / Year 1)
13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2) ; events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
17
391
29
391
EG007
23vPS / 13vPnC 6-M FU (Vax 2 / Year 1)
23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose at Year 1 (Vax 2); events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
21
404
30
404
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Idiopathic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG0030 affected473 at risk
EG004
Angina pectoris
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0023 affected463 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Sinus arrest
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Abdominal mass
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Colonic stenosis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Asthenia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Device related infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Gangrene
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Pneumonia primary atypical
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Post procedural pulmonary embolism
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Monarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0012 affected473 at risk
EG0023 affected463 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
B-cell lymphoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Neuroendocrine carcinoma of the skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Breast cancer in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Gastrointestinal tract adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Non-small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Uterovaginal prolapse
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Obstructive airways disorder
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG0031 affected473 at risk
EG0040 affected391 at risk
EG0050 affected404 at risk
EG0060 affected391 at risk
EG0070 affected404 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Goitre
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Hyperparathyroidism
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Eye discharge
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Eye pain
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Vision blurred
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Cataract
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Macular degeneration
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Hypermetropia
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Astigmatism
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Keratitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Presbyopia
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Open angle glaucoma
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0004 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Colonic polyp
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Gastroesophageal reflux disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Coeliac disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Gastric mucosal lesion
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Gastric polyps
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Faecal incontinence
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Injection site pruritus
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0013 affected473 at risk
EG0020 affected463 at risk
EG003
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0013 affected473 at risk
EG0020 affected463 at risk
EG003
Injection site induration
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0012 affected473 at risk
EG0020 affected463 at risk
EG003
Injection site movement impairment
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0012 affected473 at risk
EG0020 affected463 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Chest discomfort
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Injection site erythema
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Injection site haematoma
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Injection site mass
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Injection site pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Vaccination site haematoma
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Vaccination site pain
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Cyst
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Gait disturbance
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Inflammation
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Influenza like illness
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Injection site reaction
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Local swelling
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG00010 affected463 at risk
EG0016 affected473 at risk
EG0020 affected463 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0013 affected473 at risk
EG0020 affected463 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0013 affected473 at risk
EG0020 affected463 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0012 affected473 at risk
EG0020 affected463 at risk
EG003
Eye infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0012 affected473 at risk
EG0020 affected463 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0012 affected473 at risk
EG0020 affected463 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0012 affected473 at risk
EG0020 affected463 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Borrelia infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Folliculitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Wound infecton
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Genital herpes
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Cystitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Otitis externa
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Skin infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0012 affected473 at risk
EG0020 affected463 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Foreign body in eye
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Factured sacrum
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Skin injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Open wound
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Biopsy skin
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Blood parathyroid hormone increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Heart rate irregular
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Blood glucose increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Occult blood positive
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Red blood cell sedimentation rate increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Blood pressure increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0023 affected463 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Diabetic foot
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Type I diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected463 at risk
EG0012 affected473 at risk
EG0023 affected463 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0012 affected473 at risk
EG0020 affected463 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0012 affected473 at risk
EG0022 affected463 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Joint range of motion decreased
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Monarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Pelvic deformity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Dupuytren's contracture
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Sacroiliitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Benign breast neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Benign neoplasm of thyroid gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Sciatica
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Amnesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Anosmia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Dementia alzheimer's type
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Senile dementia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Hemianopia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Narcolepsy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hypertonia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Renal artery occlusion
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Renal failure chronic
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Renal artery arteriosclerosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Bladder neck obstruction
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Breast calcification
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0022 affected463 at risk
EG003
Diaphragmatic hernia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Nasal septum perforation
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0016 affected473 at risk
EG0022 affected463 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0021 affected463 at risk
EG003
Campbell de Morgan spots
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Cutis laxa
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Eczema nummular
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Lichenoid keratosis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Skin wrinkling
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Pruritus generalising
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0011 affected473 at risk
EG0023 affected463 at risk
EG003
Flushing
Vascular disorders
MedDRA
Non-systematic Assessment
EG0001 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Hypotension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0011 affected473 at risk
EG0020 affected463 at risk
EG003
Aortic disorder
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0021 affected463 at risk
EG003
Vasoconstriction
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Venous insufficiency
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Haematoma
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected463 at risk
EG0010 affected473 at risk
EG0020 affected463 at risk
EG003
Redness (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00033 affected306 at risk
EG00172 affected324 at risk
EG0020 affected0 at risk
EG003
Redness (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00029 affected304 at risk
EG00142 affected311 at risk
EG0020 affected0 at risk
EG003
Redness (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00014 affected301 at risk
EG00136 affected314 at risk
EG0020 affected0 at risk
EG003
Redness (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0005 affected299 at risk
EG00115 affected310 at risk
EG0020 affected0 at risk
EG003
Swelling (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00032 affected307 at risk
EG00177 affected333 at risk
EG0020 affected0 at risk
EG003
Swelling (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00027 affected305 at risk
EG00144 affected315 at risk
EG0020 affected0 at risk
EG003
Swelling (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00012 affected299 at risk
EG00144 affected323 at risk
EG0020 affected0 at risk
EG003
Swelling (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0000 affected297 at risk
EG00115 affected310 at risk
EG0020 affected0 at risk
EG003
Pain (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG000187 affected362 at risk
EG001224 affected383 at risk
EG0020 affected0 at risk
EG003
Pain (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG000180 affected359 at risk
EG001204 affected377 at risk
EG0020 affected0 at risk
EG003
Pain (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00023 affected306 at risk
EG00178 affected330 at risk
EG0020 affected0 at risk
EG003
Pain (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0004 affected299 at risk
EG0017 affected306 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00033 affected313 at risk
EG00190 affected326 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00032 affected312 at risk
EG00181 affected322 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0001 affected297 at risk
EG0018 affected303 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0002 affected298 at risk
EG0019 affected305 at risk
EG0020 affected0 at risk
EG003
Redness (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00018 affected185 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Redness (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00015 affected182 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Redness (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0008 affected182 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Redness (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0002 affected179 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Swelling (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00017 affected185 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Swelling (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00012 affected182 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Swelling (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0006 affected179 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Swelling (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0000 affected177 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Pain (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG000142 affected258 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Pain (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG000133 affected251 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Pain (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00016 affected187 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Pain (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0003 affected179 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00019 affected195 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (Mild)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00018 affected194 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (Moderate)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0001 affected178 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Limitation of arm movement (Severe)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0001 affected178 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Fever (Any) ≥ 38 degrees Celsius (C)
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0003 affected299 at risk
EG00113 affected309 at risk
EG0020 affected0 at risk
EG003
Fever (Mild) ≥ 38 degrees but < 38.5 degrees C
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0003 affected299 at risk
EG0016 affected303 at risk
EG0020 affected0 at risk
EG003
Fever (Moderate) ≥ 38.5 degrees but < 39 degrees C
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0000 affected297 at risk
EG0010 affected301 at risk
EG0020 affected0 at risk
EG003
Fever (Severe) ≥ 39 degrees but ≤ 40 degrees C
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0000 affected297 at risk
EG0011 affected301 at risk
EG0020 affected0 at risk
EG003
Fever (Potentially life threatening) > 40 degrees C
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0000 affected297 at risk
EG0016 affected307 at risk
EG0020 affected0 at risk
EG003
Fatigue
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG000119 affected350 at risk
EG001159 affected367 at risk
EG0020 affected0 at risk
EG003
Headache
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00078 affected329 at risk
EG00186 affected331 at risk
EG0020 affected0 at risk
EG003
Chills
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00024 affected305 at risk
EG00135 affected312 at risk
EG0020 affected0 at risk
EG003
Rash
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00022 affected303 at risk
EG00153 affected323 at risk
EG0020 affected0 at risk
EG003
Vomiting
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG0005 affected300 at risk
EG0014 affected304 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00033 affected317 at risk
EG00136 affected313 at risk
EG0020 affected0 at risk
EG003
New generalized muscle pain
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG000127 affected345 at risk
EG001160 affected358 at risk
EG0020 affected0 at risk
EG003
Aggravated generalized muscle pain
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00066 affected320 at risk
EG00192 affected334 at risk
EG0020 affected0 at risk
EG003
New generalized joint pain
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00039 affected310 at risk
EG00148 affected323 at risk
EG0020 affected0 at risk
EG003
Aggravated generalized joint pain
General disorders
Systemic events
Systematic Assessment
13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
EG00036 affected310 at risk
EG00153 affected322 at risk
EG0020 affected0 at risk
EG003
Fever (Any) ≥ 38 degrees C
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0003 affected179 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Fever (Mild) ≥ 38 degrees but < 38.5 degrees C
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0003 affected179 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Fever (Moderate) ≥ 38.5 degrees but < 39 degrees C
General disorders
MedDRA
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0000 affected177 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Fever (Severe) ≥ 39 degrees but ≤ 40 degrees C
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0000 affected177 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Fever (Potentially life threatening) > 40 degrees C
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0000 affected177 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Fatigue
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00072 affected215 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Headache
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00046 affected200 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Chills
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00017 affected182 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Rash
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00015 affected183 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Vomiting
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG0002 affected178 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00016 affected190 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
New generalized muscle pain
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00083 affected219 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Aggravated generalized muscle pain
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00041 affected198 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
New generalized joint pain
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00021 affected187 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Aggravated generalized joint pain
General disorders
Systemic events
Systematic Assessment
13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
EG00021 affected188 at risk
EG0010 affected473 at risk
EG0020 affected0 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D011008
Pneumococcal Infections
Ancestor Terms
ID
Term
D013290
Streptococcal Infections
D016908
Gram-Positive Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
Vax 2; withdraw before 6-Month Contact
FG0002 subjects
FG0011 subjects
456
Male
BG000242
BG001238
BG002480
55
(47.7 to 62.9)
OG00149(42.9 to 56.9)
Serotype 4
Title
Measurements
OG000545(441.9 to 672.3)
OG001203(157.1 to 262.2)
Serotype 5
Title
Measurements
OG00072(59.7 to 86.6)
OG00136(29.5 to 43.1)
Serotype 6B
Title
Measurements
OG0001261(1024.7 to 1552.6)
OG001417(330.5 to 526.7)
Serotype 7F
Title
Measurements
OG000245(191.9 to 312.4)
OG001160(123.5 to 207.9)
Serotype 9V
Title
Measurements
OG000181(138.0 to 237.0)
OG00190(67.8 to 119.7)
Serotype 14
Title
Measurements
OG000280(227.5 to 345.5)
OG001285(228.9 to 354.3)
Serotype 18C
Title
Measurements
OG000907(761.9 to 1080.1)
OG001481(385.1 to 600.7)
Serotype 19A
Title
Measurements
OG000354(307.7 to 408.4)
OG001200(170.0 to 234.4)
Serotype 19F
Title
Measurements
OG000333(273.2 to 404.8)
OG001214(174.3 to 262.8)
Serotype 23F
Title
Measurements
OG000158(126.0 to 198.6)
OG00143(34.2 to 53.5)
OG000
OG001
Serotype 3: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.1
2-Sided
95
0.91
1.35
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
OG000
OG001
Serotype 4: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.7
2-Sided
95
1.93
3.74
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
OG000
OG001
Serotype 5: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.0
2-Sided
95
1.55
2.63
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
OG000
OG001
Serotype 6B: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
3.0
2-Sided
95
2.21
4.13
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
OG000
OG001
Serotype 7F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.5
2-Sided
95
1.07
2.18
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
OG000
OG001
Serotype 9V: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
ratio of geometric mean titer
2.0
2-Sided
95
1.36
2.97
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 14: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.0
2-Sided
95
0.73
1.33
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
OG000
OG001
Serotype 18C: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.9
2-Sided
95
1.42
2.50
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
OG000
OG001
Serotype 19A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.8
2-Sided
95
1.43
2.20
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
OG000
OG001
Serotype 19F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.6
2-Sided
95
1.17
2.06
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
OG000
OG001
Serotype 23F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
3.7
2-Sided
95
2.69
5.09
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.
408
OG001411
Title
Denominators
Categories
Title
Measurements
OG00071.1(66.4 to 75.4)
OG00127.3(23.0 to 31.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 6A: difference in proportions, 13vPnC - 23vPS, expressed as a percentage.
Statistical significance was shown if the lower limit of the 95% CI for the difference in proportions (13vPnC - 23vPS) was > 0.
difference in proportions
43.8
2-Sided
95
37.4
49.9
Exact 2-sided CI (based on Chan and Zhang) for the difference in proportions, 13vPnC - 23vPS expressed as a percentage.
No
Superiority or Other
421
OG001433
Title
Denominators
Categories
Title
Measurements
OG000903(726.7 to 1121.3)
OG00194(74.1 to 118.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 6A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was >2.
ratio of geometric mean titer
9.6
2-Sided
95
7.00
13.26
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).
No
Superiority or Other
OG000361
OG001361
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG00079(65.3 to 94.6)
OG00176(64.8 to 89.7)
Serotype 3
Title
Measurements
OG00055(47.2 to 64.0)
OG00155(48.4 to 63.1)
Serotype 4
Title
Measurements
OG000614(489.8 to 768.8)
OG001487(393.9 to 603.3)
Serotype 5
Title
Measurements
OG00069(56.2 to 84.2)
OG00157(46.9 to 68.5)
Serotype 6A
Title
Measurements
OG000971(771.0 to 1222.1)
OG0011169(974.0 to 1403.0)
Serotype 6B
Title
Measurements
OG0001358(1085.4 to 1700.2)
OG0011590(1316.9 to 1919.8)
Serotype 7F
Title
Measurements
OG000222(170.2 to 290.2)
OG001180(138.1 to 233.8)
Serotype 9V
Title
Measurements
OG000187(139.3 to 250.4)
OG001166(124.2 to 220.8)
Serotype 14
Title
Measurements
OG000265(209.9 to 333.6)
OG001241(194.4 to 299.1)
Serotype 18C
Title
Measurements
OG000918(763.4 to 1104.3)
OG0011003(850.2 to 1182.1)
Serotype 19A
Title
Measurements
OG000349(299.7 to 405.5)
OG001341(297.2 to 390.5)
Serotype 19F
Title
Measurements
OG000329(265.6 to 408.6)
OG001322(266.3 to 389.6)
Serotype 23F
Title
Measurements
OG000167(130.9 to 213.0)
OG001309(251.6 to 380.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
1.0
2-Sided
95
0.85
1.10
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 3: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
1.0
2-Sided
95
0.91
1.11
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 4: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
0.8
2-Sided
95
0.68
0.92
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 5: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
0.8
2-Sided
95
0.73
0.94
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 6A: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
1.2
2-Sided
95
1.03
1.40
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 6B: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
1.2
2-Sided
95
1.02
1.35
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 7F: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
0.8
2-Sided
95
0.65
1.01
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 9V: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
0.9
2-Sided
95
0.69
1.15
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 14: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
0.9
2-Sided
95
0.79
1.05
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 18C: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
1.1
2-Sided
95
0.97
1.23
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 19A: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
1.0
2-Sided
95
0.89
1.07
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 19F: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
1.0
2-Sided
95
0.83
1.15
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 23F: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.
geometric mean fold rise
1.9
2-Sided
95
1.60
2.14
Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).
370
OG001445
Title
Denominators
Categories
Serotype 1
Title
Measurements
OG00076(64.9 to 89.5)
OG00155(46.2 to 64.8)
Serotype 3
Title
Measurements
OG00055(47.9 to 62.0)
OG00149(42.9 to 56.9)
Serotype 4
Title
Measurements
OG000472(383.5 to 580.2)
OG001203(157.1 to 262.2)
Serotype 5
Title
Measurements
OG00056(46.6 to 67.7)
OG00136(29.5 to 43.1)
Serotype 6B
Title
Measurements
OG0001565(1306.1 to 1875.9)
OG001417(330.5 to 526.7)
Serotype 7F
Title
Measurements
OG000185(142.9 to 239.7)
OG001160(123.5 to 207.9)
Serotype 9V
Title
Measurements
OG000158(119.5 to 209.5)
OG00190(67.8 to 119.7)
Serotype 14
Title
Measurements
OG000238(192.3 to 293.8)
OG001285(228.9 to 354.3)
Serotype 18C
Title
Measurements
OG000975(829.0 to 1147.3)
OG001481(385.1 to 600.7)
Serotype 19A
Title
Measurements
OG000339(296.4 to 386.9)
OG001200(170.0 to 234.4)
Serotype 19F
Title
Measurements
OG000311(257.1 to 375.9)
OG001214(174.3 to 262.8)
Serotype 23F
Title
Measurements
OG000310(254.1 to 378.0)
OG00143(34.2 to 53.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 1: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.4
2-Sided
95
1.10
1.76
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 3: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.1
2-Sided
95
0.91
1.34
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 4: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.3
2-Sided
95
1.66
3.25
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 5: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.6
2-Sided
95
1.21
2.06
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 6B: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
3.8
2-Sided
95
2.78
5.07
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 7F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.2
2-Sided
95
0.80
1.67
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 9V: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.8
2-Sided
95
1.18
2.62
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 14: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
0.8
2-Sided
95
0.62
1.13
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 18C: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
2.0
2-Sided
95
1.53
2.69
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 19A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.7
2-Sided
95
1.37
2.10
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 19F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
1.5
2-Sided
95
1.09
1.93
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
OG000
OG001
Serotype 23F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
ratio of geometric mean titer
7.3
2-Sided
95
5.36
9.82
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
Yes
Non-Inferiority or Equivalence
Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).
366
OG001433
Title
Denominators
Categories
Title
Measurements
OG0001134(943.6 to 1363.7)
OG00194(74.1 to 118.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Serotype 6A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.
Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was >2.
ratio of geometric mean titer
12.1
2-Sided
95
8.92
16.44
Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )- (23vPS)].
No
Superiority or Other
Units
Counts
Participants
OG000370
OG001387
Title
Denominators
Categories
Redness: Any (n=306, 324)
Title
Measurements
OG00010.8
OG00122.2
Redness: Mild (n=304, 311)
Title
Measurements
OG0009.5
OG00113.5
Redness: Moderate (n=301, 314)
Title
Measurements
OG0004.7
OG00111.5
Redness: Severe (n=299, 310)
Title
Measurements
OG0001.7
OG0014.8
Swelling: Any (n=307, 333)
Title
Measurements
OG00010.4
OG00123.1
Swelling: Mild (n=305, 315)
Title
Measurements
OG0008.9
OG00114.0
Swelling: Moderate (n=299, 323)
Title
Measurements
OG0004.0
OG00113.6
Swelling: Severe (n=297, 310)
Title
Measurements
OG0000.0
OG0014.8
Pain: Any (n=362, 383)
Title
Measurements
OG00051.7
OG00158.5
Pain: Mild (n=359, 377)
Title
Measurements
OG00050.1
OG00154.1
Pain: Moderate (n=306, 330)
Title
Measurements
OG0007.5
OG00123.6
Pain: Severe (n=299, 306)
Title
Measurements
OG0001.3
OG0012.3
Limitation of arm movement: Any (n=313, 326)
Title
Measurements
OG00010.5
OG00127.6
Limitation of arm movement: Mild (n=312, 322)
Title
Measurements
OG00010.3
OG00125.2
Limitation of arm movement: Moderate (n=297, 303)
Title
Measurements
OG0000.3
OG0012.6
Limitation of arm movement: Severe (n=298, 305)
Title
Measurements
OG0000.7
OG0013.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Redness: any; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
<0.001
difference in proportions
-11.4
2-Sided
95
-17.3
-5.6
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Redness: mild; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.129
difference in proportions
-4.0
2-Sided
95
-9.1
1.1
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Redness: moderate; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.002
difference in proportions
-6.8
2-Sided
95
-11.3
-2.3
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Redness: severe; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.028
difference in proportions
-3.2
2-Sided
95
-6.3
-0.3
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Swelling: any; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
<0.001
difference in proportions
-12.7
2-Sided
95
-18.5
-7.0
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Swelling: mild; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.048
difference in proportions
-5.1
2-Sided
95
-10.2
-0.1
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Swelling: moderate; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
<0.001
difference in proportions
-9.6
2-Sided
95
-14.2
-5.1
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Swelling: severe; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
<0.001
difference in proportions
-4.8
2-Sided
95
-7.9
-2.7
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Pain: any; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.062
Chan & Zhang
-6.8
2-Sided
95
-14.0
0.4
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Pain: mild; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.284
difference in proportions
-4.0
2-Sided
95
-11.3
3.3
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Pain: moderate; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
<0.001
difference in proportions
-16.1
2-Sided
95
-21.7
-10.6
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Pain: severe; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.539
difference in proportions
-0.9
2-Sided
95
-3.5
1.4
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Limitation of arm movement: any; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
<0.001
difference in proportions
-17.1
2-Sided
95
-23.1
-11.1
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Limitation of arm movement: mild; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
<0.001
difference in proportions
-14.9
2-Sided
95
-20.8
-9.0
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Limitation of arm movement: moderate; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.020
difference in proportions
-2.3
2-Sided
95
-4.8
-0.4
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Limitation of arm movement: severe; difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Limitation of arm movement: any; differe
0.042
difference in proportions
-2.3
2-Sided
95
-4.9
-0.1
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
Units
Counts
Participants
OG000265
OG001265
Title
Denominators
Categories
Redness: Any (n=185, 185)
Title
Measurements
OG0009.7
OG00112.4
Redness: Mild (n=182, 182)
Title
Measurements
OG0008.2
OG0016.0
Redness: Moderate (n=182, 182)
Title
Measurements
OG0004.4
OG0017.1
Redness: Severe (n=179, 179)
Title
Measurements
OG0001.1
OG0011.7
Swelling: Any (n=185, 185)
Title
Measurements
OG0009.2
OG00110.8
Swelling: Mild (n=182, 182)
Title
Measurements
OG0006.6
OG0018.8
Swelling: Moderate (n=179, 179)
Title
Measurements
OG0003.4
OG0012.8
Swelling: Severe (n=177, 177)
Title
Measurements
OG0000.0
OG0010.0
Pain: Any (n=258, 258)
Title
Measurements
OG00055.0
OG00157.4
Pain: Mild (n=251, 251)
Title
Measurements
OG00053.0
OG00154.2
Pain: Moderate (n=187, 187)
Title
Measurements
OG0008.6
OG00111.2
Pain: Severe (n=179, 179)
Title
Measurements
OG0001.7
OG0010.6
Limitation of arm movement: Any (n=195, 195)
Title
Measurements
OG0009.7
OG00113.3
Limitation of arm movement: Mild (n=194, 194)
Title
Measurements
OG0009.3
OG00113.4
Limitation of arm movement: Moderate (n=178, 178)
Title
Measurements
OG0000.6
OG0010.6
Limitation of arm movement: Severe (n=178, 178)
Title
Measurements
OG0000.6
OG0010.0
Units
Counts
Participants
OG000387
OG001304
Title
Denominators
Categories
Redness: Any (n=324, 236)
Title
Measurements
OG00022.2
OG00112.7
Redness: Mild (n=311, 233)
Title
Measurements
OG00013.5
OG0016.9
Redness: Moderate (n=314, 231)
Title
Measurements
OG00011.5
OG0016.9
Redness: Severe (n=310, 227)
Title
Measurements
OG0004.8
OG0011.8
Swelling: Any (n=333, 236)
Title
Measurements
OG00023.1
OG00112.3
Swelling: Mild (n=315, 234)
Title
Measurements
OG00014.0
OG00110.3
Swelling: Moderate (n=323, 229)
Title
Measurements
OG00013.6
OG0013.5
Swelling: Severe (n=310, 227)
Title
Measurements
OG0004.8
OG0010.9
Pain: Any (n=383, 297)
Title
Measurements
OG00058.5
OG00158.2
Pain: Mild (n=377, 291)
Title
Measurements
OG00054.1
OG00154.3
Pain: Moderate (n=330, 239)
Title
Measurements
OG00023.6
OG00113.0
Pain: Severe (n=306, 226)
Title
Measurements
OG0002.3
OG0010.4
Limitation of arm movement: Any (n=326, 247)
Title
Measurements
OG00027.6
OG00116.2
Limitation of arm movement: Mild (n=322, 245)
Title
Measurements
OG00025.2
OG00115.5
Limitation of arm movement: Moderate (n=303, 228)
Title
Measurements
OG0002.6
OG0010.9
Limitation of arm movement: Severe (n=305, 228)
Title
Measurements
OG0003.0
OG0010.9
Units
Counts
Participants
OG000304
OG001311
Title
Denominators
Categories
Redness: Any (n=236, 228)
Title
Measurements
OG00012.7
OG00110.1
Redness: Mild (n=233, 226)
Title
Measurements
OG0006.9
OG0018.8
Redness: Moderate (n=231, 223)
Title
Measurements
OG0006.9
OG0013.6
Redness: Severe (n=227, 222)
Title
Measurements
OG0001.8
OG0010.9
Swelling: Any (n=236, 241)
Title
Measurements
OG00012.3
OG00114.1
Swelling: Mild (n=234, 236)
Title
Measurements
OG00010.3
OG00111.9
Swelling: Moderate (n=229, 229)
Title
Measurements
OG0003.5
OG0014.8
Swelling: Severe (n=227, 222)
Title
Measurements
OG0000.9
OG0010.5
Pain: Any (n=297, 302)
Title
Measurements
OG00058.2
OG00156.6
Pain: Mild (n=291, 297)
Title
Measurements
OG00054.3
OG00153.5
Pain: Moderate (n=239, 236)
Title
Measurements
OG00013.0
OG00113.1
Pain: Severe (n=226, 221)
Title
Measurements
OG0000.4
OG0010.9
Limitation of arm movement: Any (n=247, 251)
Title
Measurements
OG00016.2
OG00119.9
Limitation of arm movement: Mild (n=245, 249)
Title
Measurements
OG00015.5
OG00118.9
Limitation of arm movement: Moderate (n=228, 222)
Title
Measurements
OG0000.9
OG0010.9
Limitation of arm movement: Severe (n=228, 222)
Title
Measurements
OG0000.9
OG0011.4
Units
Counts
Participants
OG000370
OG001311
Title
Denominators
Categories
Redness: Any (n=306, 228)
Title
Measurements
OG00010.8
OG00110.1
Redness: Mild (n=304, 226)
Title
Measurements
OG0009.5
OG0018.8
Redness: Moderate (n=301, 223)
Title
Measurements
OG0004.7
OG0013.6
Redness: Severe (n=299, 222)
Title
Measurements
OG0001.7
OG0010.9
Swelling: Any (n=307, 241)
Title
Measurements
OG00010.4
OG00114.1
Swelling: Mild (n=305, 236)
Title
Measurements
OG0008.9
OG00111.9
Swelling: Moderate (n=299, 229)
Title
Measurements
OG0004.0
OG0014.8
Swelling: Severe (n=297, 222)
Title
Measurements
OG0000.0
OG0010.5
Pain: Any (n=362, 302)
Title
Measurements
OG00051.7
OG00156.6
Pain: Mild (n=359, 297)
Title
Measurements
OG00050.1
OG00153.5
Pain: Moderate (n=306, 236)
Title
Measurements
OG0007.5
OG00113.1
Pain: Severe (n=299, 221)
Title
Measurements
OG0001.3
OG0010.9
Limitation of arm movement: Any (n=313, 251)
Title
Measurements
OG00010.5
OG00119.9
Limitation of arm movement: Mild (n=312, 249)
Title
Measurements
OG00010.3
OG00118.9
Limitation of arm movement: Moderate (n=297, 222)
Title
Measurements
OG0000.3
OG0010.9
Limitation of arm movement: Severe (n=298, 222)
Title
Measurements
OG0000.7
OG0011.4
Participants
OG000388
OG001403
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=299, 309)
Title
Measurements
OG0001.0
OG0014.2
Fever: Mild ≥38 but <38.5 degrees C (n=299, 303)
Title
Measurements
OG0001.0
OG0012.0
Fever: Moderate ≥38.5 but <39 degrees C(n=297,301)
Title
Measurements
OG0000.0
OG0010.0
Fever: Severe ≥39 but ≤40 degrees C (n=297, 301)
Title
Measurements
OG0000.0
OG0010.3
Potentially life-threatening >40C (n=297, 307)
Title
Measurements
OG0000.0
OG0012.0
Fatigue (n=350, 367)
Title
Measurements
OG00034.0
OG00143.3
Headache (n=329, 331)
Title
Measurements
OG00023.7
OG00126.0
Chills (n=305, 312)
Title
Measurements
OG0007.9
OG00111.2
Rash (n=303, 323)
Title
Measurements
OG0007.3
OG00116.4
Vomiting (n=300, 304)
Title
Measurements
OG0001.7
OG0011.3
Decreased appetite (n=317, 313)
Title
Measurements
OG00010.4
OG00111.5
New muscle pain (n=345, 358)
Title
Measurements
OG00036.8
OG00144.7
Aggravated muscle pain (n=320, 334)
Title
Measurements
OG00020.6
OG00127.5
New joint pain (n=310, 323)
Title
Measurements
OG00012.6
OG00114.9
Aggravated joint pain (n=310, 322)
Title
Measurements
OG00011.6
OG00116.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
New generalized muscle pain: difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.034
difference in proportions
-7.9
2-Sided
95
-15.2
-0.6
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
OG000
OG001
Aggravated generalized muscle pain: difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
Chan & Zhang
0.039
difference in proportions
-6.9
2-Sided
95
-13.6
-0.3
Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] - [23vPS], expressed as a percentage.
No
Superiority or Other
Units
Counts
Participants
OG000259
OG001259
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=179, 179)
Title
Measurements
OG0001.7
OG0012.2
Fever: Mild ≥38 but <38.5 degrees C (n=179, 179)
Title
Measurements
OG0001.7
OG0010.6
Fever: Moderate ≥38.5 but <39 degrees C(n=177,177)
Title
Measurements
OG0000.0
OG0010.0
Fever: Severe ≥39 but ≤40 degrees C (n=177, 177)
Title
Measurements
OG0000.0
OG0010.6
Potentially life-threatening >40C (n=177, 177)
Title
Measurements
OG0000.0
OG0011.1
Fatigue (n=215, 215)
Title
Measurements
OG00033.5
OG00128.4
Headache (n=200, 200)
Title
Measurements
OG00023.0
OG00119.0
Chills (n=182, 182)
Title
Measurements
OG0009.3
OG0014.4
Rash (n=183, 183)
Title
Measurements
OG0008.2
OG0016.0
Vomiting (n=178, 178)
Title
Measurements
OG0001.1
OG0010.0
Decreased appetite (n=190, 190)
Title
Measurements
OG0008.4
OG0017.9
New muscle pain (n=219, 219)
Title
Measurements
OG00037.9
OG00135.6
Aggravated muscle pain (n=198, 198)
Title
Measurements
OG00020.7
OG00116.2
New joint pain (n=187, 187)
Title
Measurements
OG00011.2
OG0017.5
Aggravated joint pain (n=188, 188)
Title
Measurements
OG00011.2
OG00110.1
Units
Counts
Participants
OG000403
OG001290
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=309, 229)
Title
Measurements
OG0004.2
OG0013.5
Fever: Mild ≥38 but <38.5 degrees C (n=303, 227)
Title
Measurements
OG0002.0
OG0010.9
Fever: Moderate ≥38.5 but <39 degrees C(n=301,227)
Title
Measurements
OG0000.0
OG0010.9
Fever: Severe ≥39 but ≤40 degrees C (n=301, 226)
Title
Measurements
OG0000.3
OG0010.4
Potentially life-threatening >40C (n=307, 227)
Title
Measurements
OG0002.0
OG0011.3
Fatigue (n=367, 255)
Title
Measurements
OG00043.3
OG00128.6
Headache (n=331, 246)
Title
Measurements
OG00026.0
OG00119.1
Chills (n=312, 234)
Title
Measurements
OG00011.2
OG0017.3
Rash (n=323, 232)
Title
Measurements
OG00016.4
OG0016.0
Vomiting (n=304, 226)
Title
Measurements
OG0001.3
OG0010.4
Decreased appetite (n=313, 237)
Title
Measurements
OG00011.5
OG0018.9
New muscle pain (n=358, 260)
Title
Measurements
OG00044.7
OG00134.6
Aggravated muscle pain (n=334, 245)
Title
Measurements
OG00027.5
OG00118.0
New joint pain (n=323, 238)
Title
Measurements
OG00014.9
OG00110.5
Aggravated joint pain (n=322, 239)
Title
Measurements
OG00016.5
OG00112.6
Units
Counts
Participants
OG000290
OG001299
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=229, 224)
Title
Measurements
OG0003.5
OG0012.2
Fever: Mild ≥38 but <38.5 degrees C (n=227, 224)
Title
Measurements
OG0000.9
OG0011.8
Fever: Moderate ≥38.5 but <39 degrees C(n=227,221)
Title
Measurements
OG0000.9
OG0010.0
Fever: Severe ≥39 but ≤40 degrees C (n=226, 222)
Title
Measurements
OG0000.4
OG0010.5
Potentially life-threatening >40C (n=227, 221)
Title
Measurements
OG0001.3
OG0010.5
Fatigue (n=255, 265)
Title
Measurements
OG00028.6
OG00134.3
Headache (n=246, 248)
Title
Measurements
OG00019.1
OG00122.6
Chills (n=234, 233)
Title
Measurements
OG0007.3
OG0019.9
Rash (n=232, 226)
Title
Measurements
OG0006.0
OG0017.1
Vomiting (n=226, 226)
Title
Measurements
OG0000.4
OG0013.1
Decreased appetite (n=237, 230)
Title
Measurements
OG0008.9
OG0017.4
New muscle pain (n=260, 263)
Title
Measurements
OG00034.6
OG00135.0
Aggravated muscle pain (n=245, 248)
Title
Measurements
OG00018.0
OG00121.0
New joint pain (n=238, 234)
Title
Measurements
OG00010.5
OG00112.0
Aggravated joint pain (n=239, 231)
Title
Measurements
OG00012.6
OG00111.7
Units
Counts
Participants
OG000388
OG001299
Title
Denominators
Categories
Fever: Any ≥38 degrees C (n=299, 224)
Title
Measurements
OG0001.0
OG0012.2
Fever: Mild ≥38 but <38.5 degrees C (n=299, 224)
Title
Measurements
OG0001.0
OG0011.8
Fever: Moderate ≥38.5 but <39 degrees C(n=297,221)
Title
Measurements
OG0000.0
OG0010.0
Fever: Severe ≥39 but ≤40 degrees C (n=297, 222)