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    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind, Active Comparator-controlled, Multicenter Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Recipients of Allogeneic Hematopoietic Stem Cell Transplant (PNEU-STEM)

    Summary
    EudraCT number
    2018-000066-11
    Trial protocol
    DE   FR   BE   SE  
    Global end of trial date
    04 Nov 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    05 May 2022
    First version publication date
    05 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V114-022
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03565900
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study is designed 1) to describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adult and pediatric recipients of allogeneic hematopoietic stem cell transplant (HSCT), and 2) to describe the safety and tolerability of PNEUMOVAX™23 when administered 12 months after HSCT.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 18
    Country: Number of subjects enrolled
    Belgium: 72
    Country: Number of subjects enrolled
    Brazil: 10
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Colombia: 27
    Country: Number of subjects enrolled
    France: 39
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Mexico: 17
    Country: Number of subjects enrolled
    Sweden: 26
    Country: Number of subjects enrolled
    United States: 37
    Worldwide total number of subjects
    277
    EEA total number of subjects
    163
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    9
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    215
    From 65 to 84 years
    48
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study recruited male and female participants at least 3 years of age who have received allogeneic HSCT.

    Pre-assignment
    Screening details
    263 adult participants and 14 pediatric participants (3 to 18 years of age) were randomized 1:1 to receive either V114 or Prevnar 13™ on Day 1.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject
    Blinding implementation details
    Study was double-blinded with in-house blinding procedures.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    V114
    Arm description
    Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.
    Arm type
    Experimental

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose

    Investigational medicinal product name
    PNEUMOVAX™23
    Investigational medicinal product code
    Other name
    23-valent pneumococcal polysaccharide vaccine (PPV23)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose

    Arm title
    Prevnar 13™
    Arm description
    Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.
    Arm type
    Active comparator

    Investigational medicinal product name
    PNEUMOVAX™23
    Investigational medicinal product code
    Other name
    23-valent pneumococcal polysaccharide vaccine (PPV23)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose

    Investigational medicinal product name
    Prevnar 13™
    Investigational medicinal product code
    Other name
    13-valent pneumococcal conjugate vaccine (PCV13)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 mL dose

    Number of subjects in period 1
    V114 Prevnar 13™
    Started
    139
    138
    Dose 1 - (Day 1)
    139
    135
    Dose 2 - (Day 30)
    135
    128
    Dose 3 - (Day 60)
    130
    124
    Completed
    115
    111
    Not completed
    24
    27
         Physician decision
    7
    11
         Withdrawal By Parent/Guardian
    -
    1
         Adverse event, serious fatal
    9
    7
         unknown
    4
    1
         Randomized By Mistake
    -
    2
         Consent withdrawn by subject
    4
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V114
    Reporting group description
    Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.

    Reporting group title
    Prevnar 13™
    Reporting group description
    Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.

    Reporting group values
    V114 Prevnar 13™ Total
    Number of subjects
    139 138 277
    Age Categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    5 4 9
        Adolescents (12-17 years)
    3 2 5
        Adults (18-64 years)
    108 107 215
        From 65-84 years
    23 25 48
        85 years and over
    0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    47.9 ± 16.0 46.3 ± 18.3 -
    Gender Categorical
    Units: Subjects
        Female
    57 62 119
        Male
    82 76 158
    Race
    Units: Subjects
        American Indian or Alaska Native
    4 3 7
        Asian
    2 4 6
        Black or African American
    6 1 7
        Multiple
    5 15 20
        White
    122 115 237
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    30 29 59
        Not Hispanic or Latino
    104 104 208
        Not Reported
    3 4 7
        Unknown
    2 1 3

    End points

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    End points reporting groups
    Reporting group title
    V114
    Reporting group description
    Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose.

    Reporting group title
    Prevnar 13™
    Reporting group description
    Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose.

    Subject analysis set title
    V114 (Adult)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All randomized adult participants who received at least 1 dose of V114

    Subject analysis set title
    Prevnar 13™ (Adult)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All randomized adult participants who received at least 1 dose of Prevnar 13™

    Subject analysis set title
    V114 (Pediatric)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All randomized pediatric participants who received at least 1 dose of V114

    Subject analysis set title
    Prevnar 13™ (Pediatric)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All randomized pediatric participants who received at least 1 dose of Prevnar 13™

    Primary: Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™

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    End point title
    Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling. All randomized participants who received at least 1 dose of study vaccination were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 5 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    V114 (Adult) Prevnar 13™ (Adult)
    Number of subjects analysed
    131
    129
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site erythema
    20.6 (14.0 to 28.6)
    14.0 (8.5 to 21.2)
        Injection site pain
    88.5 (81.8 to 93.4)
    74.4 (66.0 to 81.7)
        Injection site swelling
    32.1 (24.2 to 40.8)
    17.8 (11.7 to 25.5)
    No statistical analyses for this end point

    Primary: Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™

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    End point title
    Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ [2]
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling. All randomized participants who received at least 1 dose of study vaccination were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    V114 (Pediatric) Prevnar 13™ (Pediatric)
    Number of subjects analysed
    8
    6
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site erythema
    0.0 (0.0 to 36.9)
    33.3 (4.3 to 77.7)
        Injection site induration
    12.5 (0.3 to 52.7)
    33.3 (4.3 to 77.0)
        Injection site pain
    75.0 (34.9 to 96.8)
    83.3 (35.9 to 99.6)
        Injection site swelling
    25.0 (3.2 to 65.1)
    50.0 (11.8 to 88.2)
    No statistical analyses for this end point

    Primary: Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™

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    End point title
    Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ [3]
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, and myalgia. All randomized participants who received at least 1 dose of study vaccination were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    V114 (Adult) Prevnar 13™ (Adult)
    Number of subjects analysed
    131
    129
    Units: Percentage of Participants
    number (confidence interval 95%)
        Arthralgia
    16.0 (10.2 to 23.5)
    18.6 (12.3 to 26.4)
        Fatigue
    45.0 (36.3 to 54.0)
    40.3 (31.8 to 49.3)
        Headache
    29.0 (21.4 to 37.6)
    31.0 (23.2 to 39.7)
        Myalgia
    48.9 (40.0 to 57.7)
    34.9 (26.7 to 43.8)
    No statistical analyses for this end point

    Primary: Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™

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    End point title
    Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ [4]
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, and myalgia. All randomized participants who received at least 1 dose of study vaccination were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    V114 (Pediatric) Prevnar 13™ (Pediatric)
    Number of subjects analysed
    8
    6
    Units: Percentage of Participants
    number (confidence interval 95%)
        Arthralgia
    12.5 (0.3 to 52.7)
    0.0 (0.0 to 45.9)
        Fatigue
    25.0 (3.2 to 65.1)
    16.7 (0.4 to 64.1)
        Headache
    12.5 (0.3 to 52.7)
    16.7 (0.4 to 64.1)
        Myalgia
    50.0 (15.7 to 84.3)
    16.7 (0.4 to 64.1)
    No statistical analyses for this end point

    Primary: Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT

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    End point title
    Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT [5]
    End point description
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or Prevnar 13™) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 up to 12 months post-HSCT, which could be up to 9 months post-vaccine dose 1. All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 9 months
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    V114 (Adult) Prevnar 13™ (Adult) V114 (Pediatric) Prevnar 13™ (Pediatric)
    Number of subjects analysed
    131
    129
    8
    6
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.8 (0.0 to 4.2)
    0.0 (0.0 to 2.8)
    0.0 (0.0 to 36.9)
    0.0 (0.0 to 45.9)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)

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    End point title
    Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) [6]
    End point description
    The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Primary
    End point timeframe
    Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    V114 Prevnar 13™
    Number of subjects analysed
    139
    135
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=105, 88)
    2.97 (2.22 to 3.99)
    1.90 (1.34 to 2.69)
        Serotype 3 (Shared) (n=105, 88)
    0.80 (0.63 to 1.02)
    0.52 (0.38 to 0.71)
        Serotype 4 (Shared) (n=105, 88)
    1.61 (1.23 to 2.11)
    1.52 (1.04 to 2.20)
        Serotype 5 (Shared) (n=105, 88)
    2.85 (2.13 to 3.81)
    1.91 (1.32 to 2.77)
        Serotype 6A (Shared) (n=105, 88)
    3.40 (2.42 to 4.76)
    2.79 (1.78 to 4.38)
        Serotype 6B (Shared) (n=105, 88)
    3.49 (2.45 to 4.98)
    2.86 (1.82 to 4.49)
        Serotype 7F (Shared) (n=105, 88)
    3.20 (2.38 to 4.30)
    3.01 (2.07 to 4.36)
        Serotype 9V (Shared) (n=105, 88)
    2.56 (1.94 to 3.38)
    1.83 (1.26 to 2.65)
        Serotype 14 (Shared) (n=105, 87)
    6.50 (4.94 to 8.57)
    4.61 (3.17 to 6.69)
        Serotype 18C (Shared) (n=105, 88)
    3.84 (2.83 to 5.22)
    2.58 (1.76 to 3.79)
        Serotype 19A (Shared) (n=105, 88)
    5.03 (3.88 to 6.53)
    4.31 (3.00 to 6.20)
        Serotype 19F (Shared) (n=105, 88)
    5.03 (3.72 to 6.79)
    3.67 (2.53 to 5.33)
        Serotype 23F (Shared) (n=105, 88)
    3.59 (2.64 to 4.88)
    2.62 (1.66 to 4.15)
        Serotype 22F (Unique to V114) (n=105, 86)
    4.09 (3.02 to 5.54)
    0.15 (0.11 to 0.20)
        Serotype 33F (Unique to V114) (n=105, 88)
    3.40 (2.58 to 4.48)
    0.39 (0.29 to 0.53)
    No statistical analyses for this end point

    Secondary: Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23

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    End point title
    Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling. All randomized participants who received at least 1 dose of study vaccination were analyzed. Forty-seven participants in the V114 group and 58 participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 5 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
    End point values
    V114 (Adult) Prevnar 13™ (Adult)
    Number of subjects analysed
    84
    71
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site erythema
    17.9 (10.4 to 27.7)
    22.5 (13.5 to 34.0)
        Injection site pain
    67.9 (56.8 to 77.6)
    57.7 (45.4 to 69.4)
        Injection site swelling
    21.4 (13.2 to 31.7)
    23.9 (14.6 to 35.5)
    No statistical analyses for this end point

    Secondary: Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23

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    End point title
    Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were induration, pain, and swelling. All randomized participants who received at least 1 dose of study vaccination were analyzed. Three participants in the V114 group and two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
    End point values
    V114 (Pediatric) Prevnar 13™ (Pediatric)
    Number of subjects analysed
    5
    4
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site induration
    0.0 (0.0 to 52.2)
    25.0 (0.6 to 80.6)
        Injection site pain
    60.0 (14.7 to 94.7)
    50.0 (6.8 to 93.2)
        Injection site swelling
    20.0 (0.5 to 71.6)
    25.0 (0.6 to 80.6)
    No statistical analyses for this end point

    Secondary: Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23

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    End point title
    Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia. All randomized participants who received at least 1 dose of study vaccination were analyzed. Forty-seven participants in the V114 group and 58 participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
    End point values
    V114 (Adult) Prevnar 13™ (Adult)
    Number of subjects analysed
    84
    71
    Units: Percentage of Participants
    number (confidence interval 95%)
        Arthralgia
    7.1 (2.7 to 14.9)
    8.5 (3.2 to 17.5)
        Fatigue
    22.6 (14.2 to 33.0)
    16.9 (9.0 to 27.7)
        Headache
    21.4 (13.2 to 31.7)
    19.7 (11.2 to 30.9)
        Myalgia
    32.1 (22.4 to 43.2)
    26.8 (16.9 to 38.6)
    No statistical analyses for this end point

    Secondary: Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23

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    End point title
    Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following a single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs were fatigue, headache, and myalgia. All randomized participants who received at least 1 dose of study vaccination were analyzed. Three participants in the V114 group and two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
    End point values
    V114 (Pediatric) Prevnar 13™ (Pediatric)
    Number of subjects analysed
    5
    4
    Units: Percentage of Participants
    number (confidence interval 95%)
        Fatigue
    20.0 (0.5 to 71.6)
    0.0 (0.0 to 60.2)
        Headache
    20.0 (0.5 to 71.6)
    0.0 (0.0 to 60.2)
        Myalgia
    40.0 (5.3 to 85.3)
    0.0 (0.0 to 60.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23

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    End point title
    Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23
    End point description
    A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following a single dose vaccination with PNEUMOVAX™23 was reported. All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Forty-seven adult participants in the V114 group, 58 adult participants in the Prevnar 13™ group, 3 pediatric participants in the V114 group, and 2 pediatric participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 1 month after PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 10 months after Day 1)
    End point values
    V114 (Adult) Prevnar 13™ (Adult) V114 (Pediatric) Prevnar 13™ (Pediatric)
    Number of subjects analysed
    84
    71
    5
    4
    Units: Percentage of Participants
        number (confidence interval 95%)
    1.2 (0.0 to 6.5)
    0.0 (0.0 to 5.1)
    0.0 (0.0 to 52.2)
    0.0 (0.0 to 60.2)
    No statistical analyses for this end point

    Secondary: Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™

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    End point title
    Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
    End point description
    This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling. All randomized participants who received at least 1 dose of study vaccination were analyzed. One hundred four participants in the V114 group and 93 participants in the Prevnar 13™ group did not receive a fourth dose of V114 or Prevnar 13™ and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 5 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
    End point values
    V114 (Adult) Prevnar 13™ (Adult)
    Number of subjects analysed
    27
    36
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site erythema
    3.7 (0.1 to 19.0)
    8.3 (1.8 to 22.5)
        Injection site pain
    77.8 (57.7 to 91.4)
    61.1 (43.5 to 76.9)
        Injection site swelling
    22.2 (8.6 to 42.3)
    13.9 (4.7 to 29.5)
    No statistical analyses for this end point

    Secondary: Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™

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    End point title
    Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
    End point description
    This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AE was pain. All randomized participants who received at least 1 dose of study vaccination were analyzed. Six participants in the V114 group and 5 participants in the Prevnar 13™ group did not receive a fourth dose of V114 or Prevnar 13™ and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
    End point values
    V114 (Pediatric) Prevnar 13™ (Pediatric)
    Number of subjects analysed
    2
    1
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site pain
    50.0 (1.3 to 98.7)
    0.0 (0.0 to 97.5)
    No statistical analyses for this end point

    Secondary: Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™

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    End point title
    Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
    End point description
    This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia. All randomized participants who received at least 1 dose of study vaccination were analyzed. One hundred four participants in the V114 group and 93 participants in the Prevnar 13™ group did not receive a fourth dose of V114 or Prevnar 13™ and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
    End point values
    V114 (Adult) Prevnar 13™ (Adult)
    Number of subjects analysed
    27
    36
    Units: Percentage of Participants
    number (confidence interval 95%)
        Arthralgia
    11.1 (2.4 to 29.2)
    8.3 (1.8 to 22.5)
        Fatigue
    29.6 (13.8 to 50.2)
    16.7 (6.4 to 32.8)
        Headache
    22.2 (8.6 to 42.3)
    11.1 (3.1 to 26.1)
        Myalgia
    29.6 (13.8 to 50.2)
    22.2 (10.1 to 39.2)
    No statistical analyses for this end point

    Secondary: Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™

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    End point title
    Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
    End point description
    This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited systemic AEs was assessed. There were no solicited systemic AEs. All randomized participants who received at least 1 dose of study vaccination were analyzed. Six participants in the V114 group and 5 participants in the Prevnar 13™ group did not receive a fourth dose of V114 or Prevnar 13™ and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
    End point values
    V114 (Pediatric) Prevnar 13™ (Pediatric)
    Number of subjects analysed
    2
    1
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™

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    End point title
    Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™
    End point description
    This end point applies to participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as vaccine dose 4. An SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 4 with V114 or Prevnar 13™ through completion of study was reported. All randomized participants who received at least 1 dose of relevant study vaccination for the timepoint of interest were analyzed. 104 adult participants in the V114 group, 93 adult participants in the Prevnar 13™ group, 6 pediatric participants in the V114 group, and 5 pediatric participants in the Prevnar 13™ group did not receive a fourth dose of V114 or Prevnar 13™ and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Up to 6 months after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 15 months after Day 1)
    End point values
    V114 (Adult) Prevnar 13™ (Adult) V114 (Pediatric) Prevnar 13™ (Pediatric)
    Number of subjects analysed
    27
    36
    2
    1
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.0 to 12.8)
    0.0 (0.0 to 9.7)
    0.0 (0.0 to 84.2)
    0.0 (0.0 to 97.5)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)

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    End point title
    Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
    End point description
    The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
    End point values
    V114 Prevnar 13™
    Number of subjects analysed
    139
    135
    Units: Titers
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=92, 68)
    90.9 (60.8 to 135.9)
    59.3 (37.8 to 93.1)
        Serotype 3 (Shared) (n=92, 67)
    152.1 (114.6 to 201.7)
    128.5 (89.6 to 184.4)
        Serotype 4 (Shared) (n=92, 68)
    1008.4 (684.3 to 1486.2)
    1357.7 (786.7 to 2343.1)
        Serotype 5 (Shared) (n=92, 68)
    317.6 (206.7 to 487.9)
    169.1 (106.1 to 269.6)
        Serotype 6A (Shared) (n=91, 68)
    2494.5 (1731.4 to 3593.8)
    2295.0 (1463.8 to 3598.4)
        Serotype 6B (Shared) (n=90, 68)
    2280.2 (1500.8 to 3464.3)
    3000.4 (1800.0 to 5001.3)
        Serotype 7F (Shared) (n=92, 68)
    1945.3 (1278.5 to 2960.0)
    3076.9 (1958.1 to 4834.7)
        Serotype 9V (Shared) (n=92, 66)
    1059.4 (743.0 to 1510.5)
    1050.0 (659.5 to 1671.6)
        Serotype 14 (Shared) (n=91, 68)
    1953.6 (1296.9 to 2942.9)
    1689.2 (995.0 to 2867.6)
        Serotype 18C (Shared) (n=92, 67)
    1146.6 (833.6 to 1577.2)
    714.6 (439.3 to 1162.3)
        Serotype 19A (Shared) (n=92, 68)
    1365.6 (960.4 to 1941.8)
    1201.6 (724.0 to 1994.2)
        Serotype 19F (Shared) (n=92, 67)
    965.6 (675.3 to 1380.8)
    1065.6 (707.8 to 1604.3)
        Serotype 23F (Shared) (n=91, 65)
    1158.3 (784.1 to 1711.1)
    2065.2 (1144.3 to 3727.4)
        Serotype 22F (Unique to V114) (n=89, 67)
    1127.5 (717.9 to 1770.7)
    19.0 (11.9 to 30.2)
        Serotype 33F (Unique to V114) (n=91, 68)
    4441.7 (2966.6 to 6650.2)
    173.6 (97.0 to 310.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)

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    End point title
    Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
    End point description
    The GMFR of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
    End point values
    V114 Prevnar 13™
    Number of subjects analysed
    139
    135
    Units: Percentage of Participants
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=103, 84)
    69.9 (60.1 to 78.5)
    64.3 (53.1 to 74.4)
        Serotype 3 (Shared) (n=103, 84)
    62.1 (52.0 to 71.5)
    48.8 (37.7 to 60.0)
        Serotype 4 (Shared) (n=103, 84)
    73.8 (64.2 to 82.0)
    70.2 (59.3 to 79.7)
        Serotype 5 (Shared) (n=103, 84)
    60.2 (50.1 to 69.7)
    60.7 (49.5 to 71.2)
        Serotype 6A (Shared) (n=103, 84)
    73.8 (64.2 to 82.0)
    69.0 (58.0 to 78.7)
        Serotype 6B (Shared) (n=103, 84)
    71.8 (62.1 to 80.3)
    69.0 (58.0 to 78.7)
        Serotype 7F (Shared) (n=103, 84)
    69.9 (60.1 to 78.5)
    70.2 (59.3 to 79.7)
        Serotype 9V (Shared) (n=103, 84)
    65.0 (55.0 to 74.2)
    63.1 (51.9 to 73.4)
        Serotype 14 (Shared) (n=103, 83)
    51.5 (41.4 to 61.4)
    50.6 (39.4 to 61.8)
        Serotype 18C (Shared) (n=103, 84)
    67.0 (57.0 to 75.9)
    61.9 (50.7 to 72.3)
        Serotype 19A (Shared) (n=103, 84)
    55.3 (45.2 to 65.1)
    48.8 (37.7 to 60.0)
        Serotype 19F (Shared) (n=103, 84)
    63.1 (53.0 to 72.4)
    61.9 (50.7 to 72.3)
        Serotype 23F (Shared) (n=103, 84)
    61.2 (51.1 to 70.6)
    61.9 (50.7 to 72.3)
        Serotype 22F (Unique to V114) (n=103, 83)
    74.8 (65.2 to 82.8)
    1.2 (0.0 to 6.5)
        Serotype 33F (Unique to V114) (n=103, 84)
    54.4 (44.3 to 64.2)
    4.8 (1.3 to 11.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)

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    End point title
    Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
    End point description
    Activity for the 15 serotypes contained in V114 vaccine were determined using a Multiplex Opsonophagocytic Assay. The GMFR of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using multiplexed opsonophagocytic assay. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Secondary
    End point timeframe
    Time Frame: Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
    End point values
    V114 Prevnar 13™
    Number of subjects analysed
    139
    135
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 1 (Shared) (n=88, 61)
    65.9 (55.0 to 75.7)
    54.1 (40.8 to 66.9)
        Serotype 3 (Shared) (n=88, 61)
    58.0 (47.0 to 68.4)
    55.7 (42.4 to 68.5)
        Serotype 4 (Shared) (n=87, 59)
    71.3 (60.6 to 80.5)
    78.0 (65.3 to 87.7)
        Serotype 5 (Shared) (n=88, 62)
    70.5 (59.8 to 79.7)
    53.2 (40.1 to 66.0)
        Serotype 6A (Shared) (n=87, 61)
    64.4 (53.4 to 74.4)
    68.9 (55.7 to 80.1)
        Serotype 6B (Shared) (n=85, 60)
    69.4 (58.5 to 79.0)
    73.3 (60.3 to 83.9)
        Serotype 7F (Shared) (n=86, 60)
    68.6 (57.7 to 78.2)
    71.7 (58.6 to 82.5)
        Serotype 9V (Shared) (n=88, 60)
    54.5 (43.6 to 65.2)
    53.3 (40.0 to 66.3)
        Serotype 14 (Shared) (n=86, 62)
    54.7 (43.5 to 65.4)
    58.1 (44.8 to 70.5)
        Serotype 18C (Shared) (n=88, 60)
    69.3 (58.6 to 78.7)
    46.7 (33.7 to 60.0)
        Serotype 19A (Shared) (n=86, 61)
    64.0 (52.9 to 74.0)
    59.0 (45.7 to 71.7)
        Serotype 19F (Shared) (n=88, 61)
    61.4 (50.4 to 71.6)
    68.9 (55.7 to 80.1)
        Serotype 23F (Shared) (n=85, 55)
    63.5 (52.4 to 73.7)
    69.1 (55.2 to 80.9)
        Serotype 22F (Unique to V114) (n=84, 58)
    70.2 (59.3 to 79.7)
    3.4 (0.4 to 11.9)
        Serotype 33F (Unique to V114) (n=86, 62)
    61.6 (50.5 to 71.9)
    11.3 (4.7 to 21.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious AEs: Up to 14 days after each vaccination; SAEs and deaths (all-causes): Through 6 months after dose 4 with V114 or Prevnar13™ (up to 15 months total) or through 1 month after single dose vaccination with PNEUMOVAX™23 (up to 10 months total).
    Adverse event reporting additional description
    The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    V114 (Following Any of First 3 Doses of PCV) Adults
    Reporting group description
    -

    Reporting group title
    Prevnar 13™ (Following Any of First 3 Doses of PCV) Adults
    Reporting group description
    -

    Reporting group title
    V114 (Following PPV23) Adults
    Reporting group description
    -

    Reporting group title
    Prevnar 13™ (Following PPV23) Adults
    Reporting group description
    -

    Reporting group title
    V114 (Following Dose 4 of PCV) Adults
    Reporting group description
    -

    Reporting group title
    Prevnar 13™ (Following Dose 4 of PCV) Adults
    Reporting group description
    -

    Reporting group title
    Prevnar 13™ (Following Any of First 3 Doses of PCV) Pediatric
    Reporting group description
    -

    Reporting group title
    V114 (Following Any of First 3 Doses of PCV) Pediatric
    Reporting group description
    -

    Reporting group title
    V114 (Following PPV23) Pediatric
    Reporting group description
    -

    Reporting group title
    V114 (Following Dose 4 of PCV) Pediatric
    Reporting group description
    -

    Reporting group title
    Prevnar 13™ (Following PPV23) Pediatric
    Reporting group description
    -

    Reporting group title
    Prevnar 13™ (Following Dose 4 of PCV) Pediatric
    Reporting group description
    -

    Serious adverse events
    V114 (Following Any of First 3 Doses of PCV) Adults Prevnar 13™ (Following Any of First 3 Doses of PCV) Adults V114 (Following PPV23) Adults Prevnar 13™ (Following PPV23) Adults V114 (Following Dose 4 of PCV) Adults Prevnar 13™ (Following Dose 4 of PCV) Adults Prevnar 13™ (Following Any of First 3 Doses of PCV) Pediatric V114 (Following Any of First 3 Doses of PCV) Pediatric V114 (Following PPV23) Pediatric V114 (Following Dose 4 of PCV) Pediatric Prevnar 13™ (Following PPV23) Pediatric Prevnar 13™ (Following Dose 4 of PCV) Pediatric
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 131 (29.01%)
    48 / 129 (37.21%)
    2 / 84 (2.38%)
    4 / 71 (5.63%)
    6 / 27 (22.22%)
    7 / 36 (19.44%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    6
    9
    1
    0
    2
    1
    0
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute lymphocytic leukaemia recurrent
         subjects affected / exposed
    2 / 131 (1.53%)
    7 / 129 (5.43%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    2 / 27 (7.41%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    2 / 131 (1.53%)
    3 / 129 (2.33%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system leukaemia
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia recurrent
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    1 / 36 (2.78%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia recurrent
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphocytic leukaemia
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to meninges
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Acute graft versus host disease
         subjects affected / exposed
    1 / 131 (0.76%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic graft versus host disease
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    4 / 131 (3.05%)
    5 / 129 (3.88%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    1 / 27 (3.70%)
    2 / 36 (5.56%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in gastrointestinal tract
         subjects affected / exposed
    2 / 131 (1.53%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in liver
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    1 / 71 (1.41%)
    0 / 27 (0.00%)
    1 / 36 (2.78%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in lung
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    1 / 36 (2.78%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyserositis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 131 (0.00%)
    3 / 129 (2.33%)
    1 / 84 (1.19%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transfusion microchimerism
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    1 / 36 (2.78%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiglottic cyst
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    1 / 71 (1.41%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    1 / 36 (2.78%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 131 (0.76%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    1 / 36 (2.78%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 131 (1.53%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    1 / 71 (1.41%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Methaemoglobinaemia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    1 / 27 (3.70%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 131 (2.29%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    1 / 84 (1.19%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder obstruction
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myositis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperammonaemia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    1 / 27 (3.70%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    1 / 27 (3.70%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterobacter bacteraemia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    1 / 36 (2.78%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nocardia sepsis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    1 / 27 (3.70%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    2 / 131 (1.53%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 131 (2.29%)
    6 / 129 (4.65%)
    0 / 84 (0.00%)
    1 / 71 (1.41%)
    1 / 27 (3.70%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    1 / 36 (2.78%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    1 / 71 (1.41%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    1 / 36 (2.78%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis fungal
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    1 / 27 (3.70%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    V114 (Following Any of First 3 Doses of PCV) Adults Prevnar 13™ (Following Any of First 3 Doses of PCV) Adults V114 (Following PPV23) Adults Prevnar 13™ (Following PPV23) Adults V114 (Following Dose 4 of PCV) Adults Prevnar 13™ (Following Dose 4 of PCV) Adults Prevnar 13™ (Following Any of First 3 Doses of PCV) Pediatric V114 (Following Any of First 3 Doses of PCV) Pediatric V114 (Following PPV23) Pediatric V114 (Following Dose 4 of PCV) Pediatric Prevnar 13™ (Following PPV23) Pediatric Prevnar 13™ (Following Dose 4 of PCV) Pediatric
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    125 / 131 (95.42%)
    108 / 129 (83.72%)
    65 / 84 (77.38%)
    53 / 71 (74.65%)
    22 / 27 (81.48%)
    26 / 36 (72.22%)
    6 / 6 (100.00%)
    7 / 8 (87.50%)
    3 / 5 (60.00%)
    1 / 2 (50.00%)
    3 / 4 (75.00%)
    0 / 1 (0.00%)
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    1 / 131 (0.76%)
    1 / 129 (0.78%)
    0 / 84 (0.00%)
    1 / 71 (1.41%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    Immune system disorders
    Chronic graft versus host disease in skin
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Graft versus host disease in eye
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    1 / 71 (1.41%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Graft versus host disease in gastrointestinal tract
         subjects affected / exposed
    0 / 131 (0.00%)
    4 / 129 (3.10%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Graft versus host disease in skin
         subjects affected / exposed
    0 / 131 (0.00%)
    3 / 129 (2.33%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    38 / 131 (29.01%)
    40 / 129 (31.01%)
    18 / 84 (21.43%)
    14 / 71 (19.72%)
    6 / 27 (22.22%)
    4 / 36 (11.11%)
    1 / 6 (16.67%)
    1 / 8 (12.50%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    73
    67
    20
    16
    7
    4
    2
    1
    2
    0
    0
    0
    Eye disorders
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    59 / 131 (45.04%)
    52 / 129 (40.31%)
    19 / 84 (22.62%)
    12 / 71 (16.90%)
    8 / 27 (29.63%)
    6 / 36 (16.67%)
    1 / 6 (16.67%)
    2 / 8 (25.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    105
    111
    21
    16
    9
    6
    1
    5
    2
    0
    0
    0
    Injection site erythema
         subjects affected / exposed
    27 / 131 (20.61%)
    18 / 129 (13.95%)
    15 / 84 (17.86%)
    16 / 71 (22.54%)
    1 / 27 (3.70%)
    3 / 36 (8.33%)
    2 / 6 (33.33%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    37
    22
    15
    16
    1
    3
    5
    0
    0
    0
    0
    0
    Injection site hypersensitivity
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Injection site induration
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    2 / 6 (33.33%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    1
    0
    0
    1
    0
    Injection site pain
         subjects affected / exposed
    116 / 131 (88.55%)
    97 / 129 (75.19%)
    57 / 84 (67.86%)
    41 / 71 (57.75%)
    21 / 27 (77.78%)
    22 / 36 (61.11%)
    5 / 6 (83.33%)
    6 / 8 (75.00%)
    3 / 5 (60.00%)
    1 / 2 (50.00%)
    2 / 4 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    284
    237
    57
    42
    21
    23
    8
    13
    3
    1
    2
    0
    Injection site swelling
         subjects affected / exposed
    42 / 131 (32.06%)
    23 / 129 (17.83%)
    18 / 84 (21.43%)
    17 / 71 (23.94%)
    6 / 27 (22.22%)
    5 / 36 (13.89%)
    3 / 6 (50.00%)
    2 / 8 (25.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    64
    35
    18
    17
    7
    5
    5
    3
    1
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    1 / 131 (0.76%)
    2 / 129 (1.55%)
    5 / 84 (5.95%)
    1 / 71 (1.41%)
    1 / 27 (3.70%)
    2 / 36 (5.56%)
    0 / 6 (0.00%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    2
    5
    1
    1
    2
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 131 (1.53%)
    6 / 129 (4.65%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    6
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    1 / 71 (1.41%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    12 / 131 (9.16%)
    5 / 129 (3.88%)
    2 / 84 (2.38%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    15
    6
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    4 / 131 (3.05%)
    3 / 129 (2.33%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    3
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Prurigo
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    21 / 131 (16.03%)
    24 / 129 (18.60%)
    6 / 84 (7.14%)
    6 / 71 (8.45%)
    3 / 27 (11.11%)
    3 / 36 (8.33%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    33
    38
    6
    6
    3
    3
    0
    2
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    64 / 131 (48.85%)
    45 / 129 (34.88%)
    27 / 84 (32.14%)
    19 / 71 (26.76%)
    8 / 27 (29.63%)
    8 / 36 (22.22%)
    1 / 6 (16.67%)
    4 / 8 (50.00%)
    2 / 5 (40.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    111
    77
    30
    20
    8
    8
    1
    8
    2
    0
    0
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 131 (0.00%)
    0 / 129 (0.00%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    1 / 6 (16.67%)
    0 / 8 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    2 / 8 (25.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 129 (1.55%)
    0 / 84 (0.00%)
    0 / 71 (0.00%)
    0 / 27 (0.00%)
    0 / 36 (0.00%)
    0 / 6 (0.00%)
    1 / 8 (12.50%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Jun 2018
    Amendment 01: Primary reason for amendment was to incorporate revisions to the collection of medical device incidents from the protocol.
    16 Nov 2018
    Amendment 03: Primary reason for amendment was to incorporate revisions to add a pediatric cohort (≥3 years of age) to the existing study.
    05 Apr 2019
    Amendment 04: Primary reason for amendment was to adjust the stratification factor for steroid use and clarify the definition and reporting time frame for specific events of interest.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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