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    Clinical Trial Results:
    A Phase 3, Open-label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years and Older

    Summary
    EudraCT number
    		 2009-012087-13
    Trial protocol
    		 BE   DE   SE   FR   NL   ES   CZ   Outside EU/EEA  
    Global end of trial date
    16 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2016
    First version publication date
    02 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B1851022 (6115A1-3003-WW)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00980655
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    15 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the immune responses 1 month after 3 doses of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) as measured by fold rises of serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in subjects aged 2 Years and older.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all  International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Belgium: 81
    Country: Number of subjects enrolled
    France: 46
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Spain: 26
    Country: Number of subjects enrolled
    Sweden: 35
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    United States: 15
    Country: Number of subjects enrolled
    Canada: 6
    Worldwide total number of subjects
    247
    EEA total number of subjects
    226
    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)
    34
    Adolescents (12-17 years)
    25
    Adults (18-64 years)
    168
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total 61 and 190 subjects were enrolled in 13vPnC, 23vPS (Pediatric Subjects) and 13vPnC, 23vPS (Adult Subjects) respectively. Of these, 59 subjects in 13vPnC, 23vPS (Pediatric Subjects) and 188 subjects in 13vPnC, 23vPS (Adult Subjects) were treated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 13vPnC, 23vPS (Pediatric Subjects)
    Arm description
    		 Pediatric subjects aged 2 to 17 years received 4 single doses of 13vPnC followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    23vPS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5 milliliter (mL) dose of 23vPS intramuscular injection administered 1 month after 13vPnC Dose 4.

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 4 single 0.5 mL doses of 13vPnC intramuscular injections. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3

    Arm title
    		 13vPnC, 23vPS (Adult Subjects)
    Arm description
    		 Adult subjects aged 18 years and above received 4 single doses of 13vPnC followed by single dose of 23vPS. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    23vPS
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5 mL dose of 23vPS intramuscular injection administered 1 month after 13vPnC Dose 4.

    Investigational medicinal product name
    13vPnC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    4 single 0.5 mL doses of 13vPnC intramuscular injections. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3.

    Number of subjects in period 1
    		13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects)
    Started
    59
    188
    Vaccinated 13vPnC Dose 1
    59
    188
    Vaccinated 23vPS Dose
    45
    140
    Vaccinated 13vPnC Dose 4
    46
    146
    Vaccinated 13vPnC Dose 2
    55
    176
    Vaccinated 13vPnC Dose 3
    54
    167
    Completed
    45
    139
    Not completed
    14
    49
         Adverse Event
    13
    31
         Death
    -
    7
         Withdrawal by Subject
    -
    3
         Protocol Violation
    1
    6
         Unspecified
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    13vPnC, 23vPS (Pediatric Subjects)
    Reporting group description
    		 Pediatric subjects aged 2 to 17 years received 4 single doses of 13vPnC followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Reporting group title
    13vPnC, 23vPS (Adult Subjects)
    Reporting group description
    		 Adult subjects aged 18 years and above received 4 single doses of 13vPnC followed by single dose of 23vPS. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Reporting group values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) Total
    Number of subjects
    		 59 188 247
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.3 ± 4.41 47.3 ± 12.39 -
    Gender categorical
    Units: Subjects
        Female
    		 26 74 100
        Male
    		 33 114 147

    End points

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    End points reporting groups
    Reporting group title
    13vPnC, 23vPS (Pediatric Subjects)
    Reporting group description
    		 Pediatric subjects aged 2 to 17 years received 4 single doses of 13vPnC followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Reporting group title
    13vPnC, 23vPS (Adult Subjects)
    Reporting group description
    		 Adult subjects aged 18 years and above received 4 single doses of 13vPnC followed by single dose of 23vPS. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Subject analysis set title
    13vPnC, 23vPS (All Subjects)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All subjects aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.

    Primary: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Subjects

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    End point title
    		 Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Subjects [1]
    End point description
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws. Evaluable immunogenicity population: eligible subjects who received vaccination as assigned; had blood drawn within pre-specified time-frames; had at least 1 valid, determinate assay result; had no major protocol violation, n = subjects evaluable for specified serotype.
    End point type
    Primary
    End point timeframe
    Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
    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: Only descriptive data was planned to be reported for this end point.
    End point values
    		 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    247 [2]
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 1 (n=191)
    17.96 (13.63 to 23.66)
        Serotype 3 (n=192)
    5.07 (3.98 to 6.46)
        Serotype 4 (n=193)
    23.85 (17.61 to 32.3)
        Serotype 5 (n=194)
    2.99 (2.46 to 3.63)
        Serotype 6A (n=195)
    5.35 (4.18 to 6.85)
        Serotype 6B (n=192)
    5.18 (3.99 to 6.74)
        Serotype 7F (n=195)
    10.28 (8.15 to 12.96)
        Serotype 9V (n=196)
    5.76 (4.63 to 7.17)
        Serotype 14 (n=197)
    4.95 (3.72 to 6.58)
        Serotype 18C (n=196)
    8.22 (6.36 to 10.62)
        Serotype 19A (n=196)
    3.9 (3.1 to 4.89)
        Serotype 19F (n=195)
    6.73 (5.15 to 8.78)
        Serotype 23F (n=197)
    8.01 (6.11 to 10.51)
    Notes
    [2] - N (number of subjects analyzed)=subjects evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Subjects

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Subjects
    End point description
    Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all subjects are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all subjects with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable immunogenicity population. Here, 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after 13vPnC Dose 3
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    49 [3]
    149 [4]
    198 [5]
    Units: microgram per milliliter (mcg/mL)
    geometric mean (confidence interval 95%)
        Serotype 1 (n=49, 147, 196)
    3.52 (2.38 to 5.19)
    2.05 (1.53 to 2.76)
    2.35 (1.84 to 2.99)
        Serotype 3 (n=49, 147, 196)
    1.6 (1.13 to 2.26)
    0.62 (0.49 to 0.79)
    0.79 (0.64 to 0.97)
        Serotype 4 (n=49, 147, 196)
    4.13 (2.68 to 6.36)
    1.78 (1.35 to 2.34)
    2.2 (1.73 to 2.78)
        Serotype 5 (n=48, 149, 197)
    4.18 (2.95 to 5.91)
    2 (1.6 to 2.51)
    2.39 (1.97 to 2.91)
        Serotype 6A (n=49, 148, 197)
    7.61 (5.16 to 11.23)
    3.31 (2.53 to 4.33)
    4.07 (3.25 to 5.11)
        Serotype 6B (n=48, 147, 195)
    6.29 (3.88 to 10.19)
    3 (2.25 to 3.98)
    3.6 (2.81 to 4.61)
        Serotype 7F (n=48, 149, 197)
    7.34 (5.12 to 10.53)
    3.92 (3.08 to 5)
    4.57 (3.72 to 5.61)
        Serotype 9V (n=49, 149, 198)
    4.17 (3.01 to 5.98)
    2.44 (1.93 to 3.1)
    2.79 (2.29 to 3.4)
        Serotype 14 (n=49, 149, 198)
    6.22 (4.03 to 9.61)
    5.99 (4.35 to 8.26)
    6.05 (4.65 to 7.86)
        Serotype 18C (n=49, 148, 197)
    4.17 (2.9 to 5.98)
    3.04 (2.37 to 3.91)
    3.29 (2.67 to 4.05)
        Serotype 19A (n=49, 148, 197)
    8.26 (5.86 to 11.65)
    4.77 (3.77 to 6.04)
    5.47 (4.49 to 6.67)
        Serotype 19F (n=49, 148, 197)
    5.8 (3.8 to 8.84)
    3.48 (2.69 to 4.5)
    3.95 (3.17 to 4.93)
        Serotype 23F (n=49, 149, 198)
    6.74 (4.12 to 11.05)
    3.87 (2.85 to 5.26)
    4.44 (3.42 to 5.77)
    Notes
    [3] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [4] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [5] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects
    End point description
    Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all subjects are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all subjects with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable immunogenicity population. Here , 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after 13vPnC Dose 4
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    38 [6]
    124 [7]
    162 [8]
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (n=38, 123, 161)
    8.75 (5.64 to 13.59)
    4.67 (0.71 to 1.17)
    5.41 (0.7 to 1.2)
        Serotype 3 (n=38, 123, 161)
    1.23 (0.89 to 1.7)
    0.91 (3.31 to 6.27)
    0.97 (3.99 to 6.86)
        Serotype 4 (n=36, 124, 160)
    8.41 (5.15 to 13.72)
    4.56 (4.28 to 7.26)
    5.23 (4.95 to 7.64)
        Serotype 5 (n=38, 122, 160)
    8.43 (6.07 to 11.7)
    5.57 (8.63 to 17)
    6.15 (9.99 to 17.13)
        Serotype 6A (n=37, 122, 159)
    16.33 (10.59 to 25.16)
    12.23 (8.81 to 16.98)
    13.08 (10.04 to 17.7)
        Serotype 6B (n=38, 124, 162)
    18.13 (11.15 to 29.47)
    12.13 (3.37 to 6.47)
    13.33 (7 to 10.83)
        Serotype 7F (n=38, 124, 162)
    10.37 (7.36 to 14.61)
    8.26 (6.33 to 10.78)
    8.71 (4.13 to 7.1)
        Serotype 9V (n=37, 124, 161)
    7.78 (5.21 to 11.61)
    5.09 (3.93 to 6.59)
    5.61 (4.5 to 6.98)
        Serotype 14 (n=37, 124, 161)
    16.04 (10.04 to 25.63)
    12.24 (9.09 to 16.47)
    13.02 (10.13 to 16.74)
        Serotype 18C (n=38, 122, 160)
    6.54 (4.04 to 10.59)
    6.69 (5.01 to 8.93)
    6.65 (5.2 to 8.51)
        Serotype 19A (n=37, 124, 161)
    16.94 (11.05 to 25.98)
    12.99 (9.78 to 17.26)
    13.81 (10.88 to 17.52)
        Serotype 19F (n=38, 123, 161)
    19.96 (12.19 to 32.68)
    13.69 (9.93 to 18.88)
    14.96 (11.42 to 19.61)
        Serotype 23F (n=38, 123, 161)
    16.65 (10.73 to 25.82)
    12.68 (8.82 to 18.22)
    13.52 (10.07 to 18.15)
    Notes
    [6] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [7] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [8] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Subjects

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    End point title
    		 Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Subjects
    End point description
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all students with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws. Evaluable immunogenicity population. Here , 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects)
    Number of subjects analysed
    49 [9]
    148 [10]
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 1 (n=48, 143)
    27.64 (16.75 to 45.62)
    15.54 (11.2 to 21.56)
        Serotype 3 (n=48, 144)
    7.58 (4.74 to 12.13)
    4.43 (3.35 to 5.88)
        Serotype 4 (n=49, 144)
    40.83 (23.84 to 69.95)
    19.86 (13.83 to 28.52)
        Serotype 5 (n=47, 147)
    4.11 (2.86 to 5.9)
    2.7 (2.15 to 3.39)
        Serotype 6A (n=48, 147)
    7.49 (4.79 to 11.72)
    4.79 (3.57 to 6.44)
        Serotype 6B (n=47, 145)
    6.02 (3.79 to 9.55)
    4.94 (3.6 to 6.77)
        Serotype 7F (n=48, 147)
    14.65 (9.63 to 22.28)
    9.15 (6.95 to 12.05)
        Serotype 9V (n=48, 148)
    7.64 (5.4 to 10.82)
    5.26 (4.02 to 6.87)
        Serotype 14 (n=49, 148)
    5.01 (2.83 to 8.86)
    4.92 (3.53 to 6.87)
        Serotype 18C (n=49, 147)
    12.59 (7.84 to 20.21)
    7.13 (5.27 to 9.65)
        Serotype 19A (n=49, 147)
    5.04 (3.38 to 7.51)
    3.58 (2.72 to 4.7)
        Serotype 19F (n=49, 146)
    7.66 (4.67 to 12.57)
    6.44 (4.69 to 8.85)
        Serotype 23F (n=49, 148)
    9.73 (5.79 to 16.34)
    7.52 (5.46 to 10.35)
    Notes
    [9] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [10] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects

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    End point title
    		 Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects
    End point description
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws. Evaluable immunogenicity population. Here, 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    38 [11]
    123 [12]
    161 [13]
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 1 (n=37, 120, 157)
    70.66 (39.2 to 127.36)
    35.81 (25.06 to 51.18)
    42.03 (30.94 to 57.11)
        Serotype 3 (n=37, 120, 157)
    5.88 (3.25 to 10.61)
    6.41 (4.74 to 8.66)
    6.28 (4.81 to 8.19)
        Serotype 4 (n=36, 121, 157)
    90.31 (48.05 to 169.77)
    47.47 (32.09 to 70.22)
    55.02 (39.39 to 76.85)
        Serotype 5 (n=37, 119, 156)
    7.76 (4.81 to 12.51)
    7.29 (5.32 to 9.99)
    7.4 (5.69 to 9.63)
        Serotype 6A (n=36, 121, 157)
    15.62 (9.63 to 25.34)
    17.02 (11.95 to 24.23)
    16.7 (12.47 to 22.34)
        Serotype 6B (n=37, 122, 159)
    16.9 (9.76 to 29.25)
    20.09 (13.94 to 28.94)
    19.29 (14.22 to 26.18)
        Serotype 7F (n=38, 123, 161)
    19.18 (11.75 to 31.33)
    18.69 (13.7 to 25.5)
    18.81 (14.48 to 24.43)
        Serotype 9V (n=36, 122, 158)
    14.9 (9.55 to 23.25)
    11.13 (8.27 to 14.99)
    11.9 (9.27 to 15.27)
        Serotype 14 (n=37, 123, 160)
    12.61 (6.47 to 24.56)
    9.69 (6.8 to 13.8)
    10.3 (7.55 to 14.03)
        Serotype 18C (n=38, 121, 159)
    21.22 (12.05 to 37.36)
    14.4 (10.17 to 20.41)
    15.8 (11.76 to 21.24)
        Serotype 19A (n=37, 123, 160)
    11.46 (7.22 to 18.2)
    9.52 (6.9 to 13.12)
    9.94 (7.61 to 12.98)
        Serotype 19F (n=38, 120, 158)
    29.31 (16.63 to 51.64)
    25.63 (17.56 to 37.43)
    26.47 (19.31 to 36.29)
        Serotype 23F (n=38, 122, 160)
    25.37 (14.69 to 43.83)
    23.02 (15.63 to 33.92)
    23.56 (17.11 to 32.45)
    Notes
    [11] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [12] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [13] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects

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    End point title
    		 Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Subjects
    End point description
    GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all subjects with available data from both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws. Evaluable immunogenicity population. Here, 'n' signifies all subjects who were evaluable for specified serotype for each treatment arm, respectively.
    End point type
    Secondary
    End point timeframe
    1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    37 [14]
    121 [15]
    157 [16]
    Units: Fold rise
    geometric mean (confidence interval 95%)
        Serotype 1 (n=37, 119, 156)
    2.8 (1.99 to 3.95)
    2.16 (1.65 to 2.82)
    2.3 (1.85 to 2.86)
        Serotype 3 (n=37, 119, 156)
    0.88 (0.64 to 1.22)
    1.32 (1.07 to 1.62)
    1.2 (1.01 to 1.43)
        Serotype 4 (n=35, 121, 156)
    2.19 (1.51 to 3.19)
    2.32 (1.88 to 2.86)
    2.29 (1.91 to 2.74)
        Serotype 5 (n=37, 119, 156)
    2.25 (1.74 to 2.93)
    2.43 (1.94 to 3.06)
    2.39 (1.99 to 2.87)
        Serotype 6A (n=36, 119, 155)
    2.36 (1.87 to 2.99)
    3.06 (2.35 to 3.98)
    2.88 (2.34 to 3.55)
        Serotype 6B (n=37, 120, 157)
    2.96 (2.09 to 4.19)
    3.1 (2.44 to 3.95)
    3.07 (2.51 to 3.75)
        Serotype 7F (n=36, 121, 157)
    1.51 (1.08 to 2.11)
    1.83 (1.47 to 2.29)
    1.75 (1.46 to 2.11)
        Serotype 9V (n=36, 121, 157)
    2.08 (1.43 to 3.03)
    1.82 (1.48 to 2.23)
    1.88 (1.57 to 2.24)
        Serotype 14 (n=36, 121, 157)
    2.5 (1.65 to 3.8)
    1.68 (1.32 to 2.13)
    1.84 (1.5 to 2.26)
        Serotype 18C (n=37, 118, 155)
    1.64 (1.24 to 2.16)
    1.87 (1.54 to 2.28)
    1.81 (1.54 to 2.13)
        Serotype 19A (n=36, 121, 157)
    2.25 (1.6 to 3.17)
    2.33 (1.91 to 2.85)
    2.31 (1.95 to 2.74)
        Serotype 19F (n=37, 120, 157)
    3.5 (2.15 to 5.68)
    3.65 (2.9 to 4.59)
    3.61 (2.94 to 4.44)
        Serotype 23F (n=37, 120, 157)
    2.49 (1.72 to 3.61)
    2.59 (2.04 to 3.3)
    2.57 (2.1 to 3.14)
    Notes
    [14] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [15] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    [16] - N (number of subjects analyzed) signifies all subjects who were evaluable for this measure.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 1

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    End point title
    		 Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 1
    End point description
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for subjects aged 2 to less than [<]12 years and 2.5 to 5.0 cm for subjects aged greater than or equal to [ >=] 12 years); Moderate (2.5 to 7.0 cm for subjects aged 2 to <12 years and 5.5 to 10.0 cm for subjects aged >=12 years); Severe (greater than [>] 7.0 cm for subjects aged 2 to <12 years and >10.0 cm for subjects aged >=12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Population analysed was the safety population. Here, 'n' signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 1
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    52 [17]
    171 [18]
    223 [19]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: any (n = 38, 130, 168)
    21.1 (9.6 to 37.3)
    11.5 (6.6 to 18.3)
    13.7 (8.9 to 19.8)
        Redness: mild (n = 38, 130, 168)
    15.8 (0 to 9.5)
    10.8 (6 to 17.4)
    11.9 (7.4 to 17.8)
        Redness: moderate (n = 37, 128, 165)
    10.8 (12.7 to 41.2)
    1.6 (0.2 to 5.5)
    3.6 (1.3 to 7.7)
        Redness: severe (n = 37, 128, 165)
    0 (2.9 to 24.2)
    0 (0 to 2.8)
    0 (0 to 2.2)
        Swelling: any (n = 40, 130, 170)
    25 (9.3 to 36.5)
    11.5 (6.6 to 18.3)
    14.7 (9.7 to 20.9)
        Swelling: mild (n = 39, 130, 169)
    10.3 (0 to 9.5)
    10.8 (6 to 17.4)
    10.7 (6.4 to 16.3)
        Swelling: moderate (n = 39, 128, 167)
    20.5 (64.7 to 88.7)
    0.8 (0 to 4.3)
    5.4 (2.5 to 10)
        Swelling: severe (n = 37, 128, 165)
    0 (53.7 to 81.3)
    0.8 (0 to 4.3)
    0.6 (0 to 3.3)
        Pain: any (n = 51, 171, 222)
    78.4 (29.8 to 61.3)
    73.1 (65.8 to 79.6)
    74.3 (68.1 to 79.9)
        Pain: mild (n = 48, 169, 217)
    68.8 (0.7 to 18.2)
    69.8 (62.3 to 76.6)
    69.6 (63 to 75.6)
        Pain: moderate (n = 42, 138, 180)
    45.2 (9.6 to 37.3)
    22.5 (15.8 to 30.3)
    27.8 (21.4 to 34.9)
        Pain: severe (n = 37, 129, 166)
    5.4 (0.7 to 18.2)
    2.3 (0.5 to 6.6)
    3 (1 to 6.9)
    Notes
    [17] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [18] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [19] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 2

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    End point title
    		 Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 2
    End point description
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for subjects aged 2 to <12 years and 2.5 to 5.0 cm for subjects aged >=12 years); Moderate (2.5 to 7.0 cm for subjects aged 2 to <12 years and 5.5 to 10.0 cm for subjects aged >=12 years); Severe >7.0 cm for subjects aged 2 to <12 years and >10.0 cm for subjects aged >=12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Population analysed was the safety population. Here, 'n' signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 2
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    41 [20]
    157 [21]
    198 [22]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: any (n = 28, 109, 137)
    42.9 (24.5 to 62.8)
    16.5 (10.1 to 24.8)
    21.9 (15.3 to 29.8)
        Redness: mild (n = 26, 108, 134)
    34.6 (17.2 to 55.7)
    15.7 (9.4 to 24)
    19.4 (13.1 to 27.1)
        Redness: moderate (n = 26, 103, 129)
    26.9 (11.6 to 47.8)
    1.9 (0.2 to 6.8)
    7 (3.2 to 12.8)
        Redness: severe (n = 24, 103, 127)
    4.2 (0.1 to 21.1)
    1 (0 to 5.3)
    1.6 (0.2 to 5.6)
        Swelling: any (n = 28, 105, 133)
    35.7 (18.6 to 55.9)
    14.3 (8.2 to 22.5)
    18.8 (12.5 to 26.5)
        Swelling: mild (n = 26, 105, 131)
    15.4 (4.4 to 34.9)
    14.3 (8.2 to 22.5)
    14.5 (9 to 21.7)
        Swelling: moderate (n = 26, 102, 128)
    26.9 (11.6 to 47.8)
    0 (0 to 3.6)
    5.5 (2.2 to 10.9)
        Swelling: severe (n = 24, 102, 126)
    0 (0 to 14.2)
    0 (0 to 3.6)
    0 (0 to 2.9)
        Pain: any (n = 40, 154, 194)
    77.5 (61.5 to 89.2)
    74.7 (67 to 81.3)
    75.3 (68.6 to 81.2)
        Pain: mild (n = 36, 148, 184)
    66.7 (49 to 81.4)
    70.9 (62.9 to 78.1)
    70.1 (62.9 to 76.6)
        Pain: moderate (n = 32, 116, 148)
    53.1 (34.7 to 70.9)
    27.6 (19.7 to 36.7)
    33.1 (25.6 to 41.3)
        Pain: severe (n = 27, 104, 131)
    14.8 (4.2 to 33.7)
    1.9 (0.2 to 6.8)
    4.6 (1.7 to 9.7)
    Notes
    [20] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [21] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [22] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 3

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    End point title
    		 Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 3
    End point description
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for subjects aged 2 to <12 years and 2.5 to 5.0 cm for subjects aged >=12 years); Moderate (2.5 to 7.0 cm for subjects aged 2 to <12 years and 5.5 to 10.0 cm for subjects aged >=12 years); Severe >7.0 cm for subjects aged 2 to <12 years and >10.0 cm for subjects aged >=12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Population analysed was the safety population. Here, 'n' signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 3
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    37 [23]
    138 [24]
    175 [25]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: any (n = 25, 95, 120)
    32 (45.25 to 80.8)
    9.5 (4.4 to 17.2)
    14.2 (8.5 to 21.7)
        Redness: mild (n = 24, 94, 118)
    20.8 (22.2 to 56.4)
    8.5 (3.7 to 16.1)
    11 (6 to 18.1)
        Redness: moderate (n = 24, 93, 117)
    20.8 (14.9 to 53.5)
    1.1 (0 to 5.8)
    5.1 (1.9 to 10.8)
        Redness: severe (n = 23, 93, 116)
    4.3 (7.1 to 42.2)
    1.1 (0 to 5.8)
    1.7 (0.2 to 6.1)
        Swelling: any (n = 28, 93, 121)
    35.7 (7.1 to 42.2)
    8.6 (3.8 to 16.2)
    14.9 (9.1 to 22.5)
        Swelling: mild (n = 27, 93, 120)
    25.9 (0.1 to 21.9)
    8.6 (3.8 to 16.2)
    12.5 (7.2 to 19.8)
        Swelling: moderate (n = 25, 92, 117)
    20 (18.6 to 55.9)
    0 (0 to 3.9)
    4.3 (1.4 to 9.7)
        Swelling: severe (n = 23, 92, 115)
    4.3 (11.1 to 46.3)
    0 (0 to 3.9)
    0.9 (0 to 4.7)
        Pain: any (n = 37, 138, 175)
    70.3 (6.8 to 40.7)
    73.2 (65 to 80.4)
    72.6 (65.3 to 79)
        Pain: mild (n = 31, 132, 163)
    64.5 (0.1 to 21.9)
    67.4 (58.7 to 75.3)
    66.9 (59.1 to 74)
        Pain: moderate (n = 34, 107, 141)
    38.2 (53 to 84.1)
    27.1 (19 to 36.6)
    29.8 (22.4 to 38.1)
        Pain: severe (n = 24, 93, 117)
    8.3 (1 to 27)
    3.2 (0.7 to 9.1)
    4.3 (1.4 to 9.7)
    Notes
    [23] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [24] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [25] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 4

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    End point title
    		 Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Local Reactions: 13vPnC Dose 4
    End point description
    Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 cm for subjects aged 2 to <12 years and 2.5 to 5.0 cm for subjects aged >=12 years); Moderate (2.5 to 7.0 cm for subjects aged 2 to <12 years and 5.5 to 10.0 cm for subjects aged >=12 years); Severe >7.0 cm for subjects aged 2 to <12 years and >10.0 cm for subjects aged >=12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Population analysed was the safety population. Here, 'n' signifies subjects with known values for specified local reaction. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 4
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    35 [26]
    116 [27]
    151 [28]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: any (n = 21, 79, 100)
    71.4 (47.8 to 88.7)
    22.8 (14.1 to 33.6)
    33 (23.9 to 43.1)
        Redness: mild (n = 20, 77, 97)
    50 (27.2 to 72.8)
    15.6 (8.3 to 25.6)
    22.7 (14.8 to 32.3)
        Redness: moderate (n = 18, 72, 90)
    50 (26 to 74)
    9.7 (4 to 19)
    17.8 (10.5 to 27.3)
        Redness: severe (n = 16, 73, 89)
    12.5 (1.6 to 38.3)
    4.1 (0.9 to 11.5)
    5.6 (1.8 to 12.6)
        Swelling: any (n = 27, 81, 108)
    66.7 (46 to 83.5)
    28.4 (18.9 to 39.5)
    38 (28.8 to 47.8)
        Swelling: mild (n = 21, 79, 100)
    38.1 (18.1 to 61.6)
    21.5 (13.1 to 32.2)
    25 (16.9 to 34.7)
        Swelling: moderate (n = 23, 72, 95)
    52.2 (30.6 to 73.2)
    6.9 (2.3 to 15.5)
    17.9 (10.8 to 27.1)
        Swelling: severe (n = 15, 73, 88)
    6.7 (0.2 to 31.9)
    4.1 (0.9 to 11.5)
    4.5 (1.3 to 11.2)
        Pain: any (n = 30, 113, 143)
    86.7 (69.3 to 96.2)
    77 (68.1 to 84.4)
    79 (71.4 to 85.4)
        Pain: mild (n = 25, 105, 130)
    76 (54.9 to 90.6)
    71.4 (61.8 to 79.8)
    72.3 (63.8 to 79.8)
        Pain: moderate (n = 24, 85, 109)
    62.5 (40.6 to 81.2)
    31.8 (22.1 to 42.8)
    38.5 (29.4 to 48.3)
        Pain: severe (n = 16, 74, 90)
    12.5 (1.6 to 38.3)
    5.4 (1.5 to 13.3)
    6.7 (2.5 to 13.9)
    Notes
    [26] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [27] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    [28] - N (number of subjects analyzed) signifies subjects with known values for any local reaction.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 1

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    End point title
    		 Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 1
    End point description
    Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). Safety population. Here, 'n' signifies subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 1
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    51 [29]
    172 [30]
    223 [31]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38 degrees C (n = 39, 130, 169)
    12.8 (4.3 to 27.4)
    6.2 (2.7 to 11.8)
    7.7 (4.2 to 12.8)
        Fever: >=38, <38.5 degrees C (n = 37, 130, 167)
    5.4 (0.7 to 18.2)
    6.2 (2.7 to 11.8)
    6 (2.9 to 10.7)
        Fever: >=38.5, <39 degrees C (n = 37, 128, 165)
    5.4 (0.7 to 18.2)
    0 (0 to 2.8)
    1.2 (0.1 to 4.3)
        Fever: >=39, =<40 degrees C (n = 39, 128, 167)
    7.7 (1.6 to 20.9)
    0 (0 to 2.8)
    1.8 (0.4 to 5.2)
        Fever: >40 degrees C (n = 37, 128, 165)
    0 (0 to 9.5)
    0 (0 to 2.8)
    0 (0 to 2.2)
        Fatigue: Any (n = 45, 159, 204)
    53.3 (37.9 to 68.3)
    59.7 (51.7 to 67.4)
    58.3 (51.2 to 65.2)
        Fatigue: Mild (n = 41, 149, 190)
    36.6 (22.1 to 53.1)
    49 (40.7 to 57.3)
    46.3 (39.1 to 53.7)
        Fatigue: Moderate (n = 44, 148, 192)
    36.4 (22.4 to 52.2)
    35.8 (28.1 to 44.1)
    35.9 (29.2 to 43.2)
        Fatigue: Severe (n = 37, 136, 173)
    10.8 (3 to 25.4)
    11.8 (6.9 to 18.4)
    11.6 (7.2 to 17.3)
        Headache: Any (n = 42, 147, 189)
    45.2 (29.8 to 61.3)
    44.2 (36 to 52.6)
    44.4 (37.2 to 51.8)
        Headache: Mild (n = 41, 145, 186)
    39 (24.2 to 55.5)
    37.9 (30 to 46.4)
    38.2 (31.2 to 45.6)
        Headache: Moderate (n = 40, 134, 174)
    20 (9.1 to 35.6)
    17.2 (11.2 to 24.6)
    17.8 (12.4 to 24.3)
        Headache: Severe (n = 37, 130, 167)
    2.7 (0.1 to 14.2)
    2.3 (0.5 to 6.6)
    2.4 (0.7 to 6)
        Vomiting: Any (n = 39, 134, 173)
    20.5 (9.3 to 36.5)
    20.9 (14.4 to 28.8)
    20.8 (15 to 27.6)
        Vomiting: Mild (n = 38, 134, 172)
    18.4 (7.7 to 34.3)
    17.9 (11.8 to 25.5)
    18 (12.6 to 24.6)
        Vomiting: Moderate (n = 38, 128, 166)
    2.6 (0.1 to 13.8)
    3.9 (1.3 to 8.9)
    3.6 (1.3 to 7.7)
        Vomiting: Severe (n = 37, 128, 165)
    5.4 (0.7 to 18.2)
    0 (0 to 2.8)
    1.2 (0.1 to 4.3)
        Diarrhea: Any (n = 44, 145, 189)
    31.8 (18.6 to 47.6)
    35.9 (28.1 to 44.2)
    34.9 (28.1 to 42.2)
        Diarrhea: Mild (n = 44, 142, 186)
    31.8 (18.6 to 47.6)
    33.8 (26.1 to 42.2)
    33.3 (26.6 to 40.6)
        Diarrhea: Moderate (n = 38, 133, 171)
    5.3 (0.6 to 17.7)
    9 (4.7 to 15.2)
    8.2 (4.5 to 13.4)
        Diarrhea: Severe (n = 37, 131, 168)
    0 (0 to 9.5)
    3.8 (1.3 to 8.7)
    3 (1 to 6.8)
        Muscle Pain: Any (n = 47, 154, 201)
    55.3 (40.1 to 69.8)
    50 (41.8 to 58.2)
    51.2 (44.1 to 58.3)
        Muscle Pain: Mild (n = 43, 148, 191)
    46.5 (31.2 to 62.3)
    42.6 (34.5 to 51)
    43.5 (36.3 to 50.8)
        Muscle Pain: Moderate (n = 44, 139, 183)
    36.4 (22.4 to 52.2)
    21.6 (15.1 to 29.4)
    25.1 (19 to 32.1)
        Muscle Pain: Severe (n = 37, 131, 168)
    5.4 (0.7 to 18.2)
    5.3 (2.2 to 10.7)
    5.4 (2.5 to 9.9)
        Joint Pain: Any (n = 38, 143, 181)
    26.3 (13.4 to 43.1)
    26.6 (19.5 to 34.6)
    26.5 (20.2 to 33.6)
        Joint Pain: Mild (n = 37, 139, 176)
    18.9 (8 to 35.2)
    19.4 (13.2 to 27)
    19.3 (13.8 to 25.9)
        Joint Pain: Moderate (n = 38, 137, 175)
    15.8 (6 to 31.3)
    14.6 (9.2 to 21.6)
    14.9 (9.9 to 21)
        Joint Pain: Severe (n = 37, 130, 167)
    2.7 (0.1 to 14.2)
    3.1 (0.8 to 7.7)
    3 (1 to 6.8)
        Use of Medication to Treat Pain (n= 40, 136, 176)
    25 (12.7 to 41.2)
    13.2 (8 to 20.1)
    15.9 (10.8 to 22.2)
        Use of Medication to Treat Fever (n= 41, 133, 174)
    24.4 (12.4 to 40.3)
    14.3 (8.8 to 21.4)
    16.7 (11.5 to 23.1)
    Notes
    [29] - N signifies subjects with known values for any systemic event.
    [30] - N signifies subjects with known values for any systemic event.
    [31] - N signifies subjects with known values for any systemic event.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 2

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    End point title
    		 Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 2
    End point description
    Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). Safety population. Here, 'n' signifies subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 2
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    45 [32]
    146 [33]
    191
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38 degrees C (n = 26, 105, 131)
    23.1 (9 to 43.6)
    6.7 (2.7 to 13.3)
    27.5 (5.4 to 16.4)
        Fever: >=38, <38.5 degrees C (n = 26, 105, 131)
    19.2 (6.6 to 39.4)
    5.7 (2.1 to 12)
    9.7 (4.3 to 14.5)
        Fever: >=38.5, <39 degrees C (n = 24, 102, 126)
    8.3 (1 to 27)
    1 (0 to 5.3)
    1.6 (0.5 to 6.8)
        Fever: >=39, =<40 degrees C (n = 24, 102, 126)
    8.3 (1 to 27)
    1 (0 to 5.3)
    45 (0.5 to 6.8)
        Fever: >40 degrees C (n = 24, 102, 126)
    0 (0 to 14.2)
    0 (0 to 3.6)
    36 (0 to 2.9)
        Fatigue: Any (n = 38, 133, 171)
    60.5 (43.4 to 76)
    56.4 (47.5 to 65)
    28 (49.5 to 64.8)
        Fatigue: Mild (n = 31, 125, 156)
    45.2 (27.3 to 64)
    39.2 (30.6 to 48.3)
    6.1 (32.6 to 48.5)
        Fatigue: Moderate (n = 33, 122, 155)
    45.5 (28.1 to 63.6)
    37.7 (29.1 to 46.9)
    25.2 (31.6 to 47.5)
        Fatigue: Severe (n = 24, 107, 131)
    12.5 (2.7 to 32.4)
    9.3 (4.6 to 16.5)
    21.1 (5.4 to 16.4)
        Headache: Any (n = 31, 121,152)
    32.3 (16.7 to 51.4)
    35.5 (27 to 44.8)
    14.7 (27.3 to 43)
        Headache: Mild (n = 30, 117, 147)
    30 (14.7 to 49.4)
    29.9 (21.8 to 39.1)
    2.3 (22.7 to 38)
        Headache: Moderate (n = 26, 110, 136)
    7.7 (0.9 to 25.1)
    16.4 (10 to 24.6)
    11.3 (9.2 to 21.8)
        Headache: Severe (n = 24, 104, 128)
    0 (0 to 14.2)
    1.9 (0.2 to 6.8)
    14.9 (0.2 to 5.5)
        Vomiting: Any (n = 28, 107, 135)
    21.4 (8.3 to 41)
    13.1 (7.3 to 21)
    9.9 (9.3 to 21.9)
        Vomiting: Mild (n = 27, 107, 134)
    18.5 (6.3 to 38.1)
    10.3 (5.2 to 17.7)
    8.4 (7 to 18.7)
        Vomiting: Moderate (n = 28, 103, 131)
    14.3 (4 to 32.7)
    4.9 (1.6 to 11)
    2.4 (3.2 to 12.6)
        Vomiting: Severe (n = 24, 102, 126)
    0 (0 to 14.2)
    1 (0 to 5.3)
    2.4 (0 to 4.3)
        Diarrhea: Any (n = 29, 121, 150)
    31 (15.3 to 50.8)
    28.9 (21 to 37.9)
    0 (22.2 to 37.3)
        Diarrhea: Mild (n = 29, 120, 149)
    31 (15.3 to 50.8)
    26.7 (19 to 35.5)
    57.3 (20.5 to 35.4)
        Diarrhea: Moderate (n = 25, 109, 134)
    8 (1 to 26)
    10.1 (5.1 to 17.3)
    40.4 (5.3 to 16)
        Diarrhea: Severe (n = 24, 103, 127)
    0 (0 to 14.2)
    1.9 (0.2 to 6.8)
    39.4 (0.2 to 5.6)
        Muscle Pain: Any (n = 36, 124, 160)
    44.4 (27.9 to 61.9)
    45.2 (36.2 to 54.3)
    9.9 (37.1 to 53.1)
        Muscle Pain: Mild (n = 32, 118, 150)
    31.3 (16.1 to 50)
    37.3 (28.6 to 46.7)
    34.9 (28.3 to 44.2)
        Muscle Pain: Moderate (n = 32, 111, 143)
    37.5 (21.1 to 56.3)
    25.2 (17.5 to 34.4)
    29.9 (20.8 to 36.1)
        Muscle Pain: Severe (n = 25, 106, 131)
    8 (1 to 26)
    5.7 (2.1 to 11.9)
    14.7 (2.7 to 11.7)
        Joint Pain: Any (n = 31, 116, 147)
    32.3 (16.7 to 51.4)
    23.3 (15.9 to 32)
    1.6 (18.4 to 33)
        Joint Pain: Mild (n = 27, 115, 142)
    18.5 (6.3 to 38.1)
    21.7 (14.6 to 30.4)
    14.8 (14.7 to 28.8)
        Joint Pain: Moderate (n = 30, 106, 136)
    30 (14.7 to 49.4)
    10.4 (5.3 to 17.8)
    11.9 (9.2 to 21.8)
        Joint Pain: Severe (n = 25, 104, 129)
    4 (0.1 to 20.4)
    1.9 (0.2 to 6.8)
    6.9 (0.5 to 6.6)
        Use of Medication to Treat Pain (n= 28, 105, 133)
    25 (10.7 to 44.9)
    7.6 (3.3 to 14.5)
    0.8 (6.5 to 17.9)
        Use of Medication to Treat Fever (n= 27, 107, 134)
    33.3 (16.5 to 54)
    10.3 (5.2 to 17.7)
    29.3 (9.4 to 22.1)
    Notes
    [32] - N signifies subjects with known values for any systemic event.
    [33] - N signifies subjects with known values for any systemic event.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 3

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    End point title
    		 Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 3
    End point description
    Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). Safety population. Here, 'n' signifies subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 3
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    42 [34]
    136 [35]
    178 [36]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38 degrees C (n = 27, 93, 120)
    14.8 (0.1 to 21.1)
    4.3 (1.2 to 10.6)
    6.7 (2.9 to 12.7)
        Fever: >=38, <38.5 degrees C (n = 26, 93, 119)
    11.5 (0.1 to 21.1)
    3.2 (0.7 to 9.1)
    5 (1.9 to 10.7)
        Fever: >=38.5, <39 degrees C (n = 24, 93, 117)
    4.2 (0 to 14.8)
    3.2 (0.7 to 9.1)
    3.4 (0.9 to 8.5)
        Fever: >=39, =<40 degrees C (n = 24, 92, 116)
    4.2 (31.4 to 66)
    1.1 (0 to 5.9)
    1.7 (0.2 to 6.1)
        Fever: >40 degrees C (n = 23, 92, 115)
    0 (23.7 to 59.4)
    0 (0 to 3.9)
    0 (0 to 3.2)
        Fatigue: Any (n = 35, 122, 157)
    48.6 (17.3 to 52.8)
    49.2 (40 to 58.4)
    49 (41 to 57.1)
        Fatigue: Mild (n = 32, 116, 148)
    40.6 (0.1 to 21.1)
    38.8 (29.9 to 48.3)
    39.2 (31.3 to 47.5)
        Fatigue: Moderate (n = 30, 107, 137)
    33.3 (4.2 to 33.7)
    29.9 (21.4 to 39.5)
    30.7 (23.1 to 39.1)
        Fatigue: Severe (n = 24, 96, 120)
    4.2 (2.4 to 30.2)
    7.3 (3 to 14.4)
    6.7 (2.9 to 12.7)
        Headache: Any (n = 32, 110,142)
    37.5 (21.1 to 56.3)
    37.3 (28.2 to 47)
    37.3 (29.4 to 45.8)
        Headache: Mild (n = 30, 108, 138)
    30 (14.7 to 49.4)
    32.4 (23.7 to 42.1)
    31.9 (24.2 to 40.4)
        Headache: Moderate (n = 27, 95, 122)
    22.2 (8.6 to 42.3)
    15.8 (9.1 to 24.7)
    17.2 (11 to 25.1)
        Headache: Severe (n = 25, 94, 119)
    8 (1 to 26)
    2.1 (0.3 to 7.5)
    3.4 (0.9 to 8.4)
        Vomiting: Any (n = 25, 95, 120)
    8 (1 to 26)
    11.6 (5.9 to 19.8)
    10.8 (5.9 to 17.8)
        Vomiting: Mild (n = 24, 95, 119)
    4.2 (0.1 to 21.1)
    5.3 (1.7 to 11.9)
    5 (1.9 to 10.7)
        Vomiting: Moderate (n = 24, 93, 117)
    4.2 (0.1 to 21.1)
    7.5 (3.1 to 14.9)
    6.8 (3 to 13)
        Vomiting: Severe (n = 23, 92, 115)
    0 (0 to 14.8)
    0 (0 to 3.9)
    0 (0 to 3.2)
        Diarrhea: Any (n = 26, 104, 130)
    15.4 (4.4 to 34.9)
    25 (17 to 34.4)
    23.1 (16.1 to 31.3)
        Diarrhea: Mild (n = 26, 102, 128)
    15.4 (4.4 to 34.9)
    21.6 (14 to 30.8)
    20.3 (13.7 to 28.3)
        Diarrhea: Moderate (n = 24, 95, 119)
    4.2 (0.1 to 21.1)
    5.3 (1.7 to 11.9)
    5 (1.9 to 10.7)
        Diarrhea: Severe (n = 23, 94, 117)
    0 (0 to 14.8)
    2.1 (0.3 to 7.5)
    1.7 (0.2 to 6)
        Muscle Pain: Any (n = 35, 117, 152)
    45.7 (28.8 to 63.4)
    38.5 (29.6 to 47.9)
    40.1 (32.3 to 48.4)
        Muscle Pain: Mild (n = 30, 112, 142)
    33.3 (17.3 to 52.8)
    33 (24.4 to 42.6)
    33.1 (25.4 to 41.5)
        Muscle Pain: Moderate (n = 31, 101, 132)
    32.3 (16.7 to 51.4)
    16.8 (10.1 to 25.6)
    20.5 (13.9 to 28.3)
        Muscle Pain: Severe (n = 24, 94, 118)
    4.2 (0.1 to 21.1)
    3.2 (0.7 to 9)
    3.4 (0.9 to 8.5)
        Joint Pain: Any (n = 28, 104, 132)
    25 (10.7 to 44.9)
    20.2 (13 to 29.2)
    21.2 (14.6 to 29.2)
        Joint Pain: Mild (n = 26, 102, 128)
    19.2 (6.6 to 39.4)
    17.6 (10.8 to 26.4)
    18 (11.7 to 25.7)
        Joint Pain: Moderate (n = 27, 95, 122)
    18.5 (6.3 to 38.1)
    8.4 (3.7 to 15.9)
    10.7 (5.8 to 17.5)
        Joint Pain: Severe (n = 25, 94, 119)
    8 (1 to 26)
    2.1 (0.3 to 7.5)
    3.4 (0.9 to 8.4)
        Use of Medication to Treat Pain (n= 28, 97, 125)
    21.4 (8.3 to 41)
    12.4 (6.6 to 20.6)
    14.4 (8.8 to 21.8)
        Use of Medication to Treat Fever (n= 30, 101, 131)
    26.7 (12.3 to 45.9)
    15.8 (9.3 to 24.4)
    18.3 (12.1 to 26)
    Notes
    [34] - N signifies subjects with known values for any systemic event.
    [35] - N signifies subjects with known values for any systemic event.
    [36] - N signifies subjects with known values for any systemic event.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 4

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    End point title
    		 Percentage of Pediatric, Adult and All Subjects Reporting Pre-specified Systemic Events: 13vPnC Dose 4
    End point description
    Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an e-diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours). Safety population. Here, 'n' signifies subjects with known values for specified systemic event. Subjects may be represented in more than 1 category.
    End point type
    Other pre-specified
    End point timeframe
    Within 14 days after 13vPnC Dose 4
    End point values
    		 13vPnC, 23vPS (Pediatric Subjects) 13vPnC, 23vPS (Adult Subjects) 13vPnC, 23vPS (All Subjects)
    Number of subjects analysed
    32 [37]
    116 [38]
    148 [39]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: >=38 degrees C (n= 18, 78, 96)
    27.8 (9.7 to 53.5)
    15.4 (8.2 to 25.3)
    17.7 (10.7 to 26.8)
        Fever: >=38, <38.5 degrees C (n = 16, 76, 92)
    12.5 (1.6 to 38.3)
    13.2 (6.5 to 22.9)
    13 (6.9 to 21.7)
        Fever: >=38.5, <39 degrees C (n = 17, 73, 90)
    17.6 (3.8 to 43.4)
    2.7 (0.3 to 9.5)
    5.6 (1.8 to 12.5)
        Fever: >=39, =<40 degrees C (n = 15, 72, 87)
    0 (0 to 21.8)
    2.8 (0.3 to 9.7)
    2.3 (0.3 to 8.1)
        Fever: >40 degrees C (n = 15, 71, 86)
    0 (0 to 21.8)
    0 (0 to 5.1)
    0 (0 to 4.2)
        Fatigue: Any (n = 28, 100, 128)
    67.9 (47.6 to 84.1)
    67 (56.9 to 76.1)
    67.2 (58.3 to 75.2)
        Fatigue: Mild (n = 26, 95, 121)
    61.5 (40.6 to 79.8)
    54.7 (44.2 to 65)
    56.2 (46.9 to 65.2)
        Fatigue: Moderate (n = 20, 86, 106)
    45 (23.1 to 68.5)
    45.3 (34.6 to 56.5)
    45.3 (35.6 to 55.2)
        Fatigue: Severe (n = 16, 77, 93)
    12.5 (1.6 to 38.3)
    13 (6.4 to 22.6)
    12.9 (6.8 to 21.5)
        Headache: Any (n = 21, 93, 114)
    52.4 (29.8 to 74.3)
    45.2 (34.8 to 55.8)
    46.5 (37.1 to 56.1)
        Headache: Mild (n = 21, 88, 109)
    47.6 (25.7 to 70.2)
    38.6 (28.4 to 49.6)
    40.4 (31.1 to 50.2)
        Headache: Moderate (n = 16, 82, 98)
    18.8 (4 to 45.6)
    28 (18.7 to 39.1)
    26.5 (18.1 to 36.4)
        Headache: Severe (n = 16, 74, 90)
    12.5 (1.6 to 38.3)
    5.4 (1.5 to 13.3)
    6.7 (2.5 to 13.9)
        Vomiting: Any (n = 16, 73, 89)
    6.3 (0.2 to 30.2)
    5.5 (1.5 to 13.4)
    5.6 (1.8 to 12.6)
        Vomiting: Mild (n = 16, 73, 89)
    6.3 (0.2 to 30.2)
    5.5 (1.5 to 13.4)
    5.6 (1.8 to 12.6)
        Vomiting: Moderate (n = 15, 71, 86)
    0 (0 to 21.8)
    0 (0 to 5.1)
    0 (0 to 4.2)
        Vomiting: Severe (n = 15, 71, 86)
    0 (0 to 21.8)
    0 (0 to 5.1)
    0 (0 to 4.2)
        Diarrhea: Any (n = 18, 83, 101)
    22.2 (6.4 to 47.6)
    30.1 (20.5 to 41.2)
    28.7 (20.1 to 38.6)
        Diarrhea: Mild (n = 18, 82, 100)
    22.2 (6.4 to 47.6)
    29.3 (19.7 to 40.4)
    28 (19.5 to 37.9)
        Diarrhea: Moderate (n = 15, 72, 87)
    0 (0 to 21.8)
    4.2 (0.9 to 11.7)
    3.4 (0.7 to 9.7)
        Diarrhea: Severe (n = 15, 72, 87)
    0 (0 to 21.8)
    1.4 (0 to 7.5)
    1.1 (0 to 6.2)
        Muscle Pain: Any (n = 24, 99, 123)
    58.3 (36.6 to 77.9)
    60.6 (50.3 to 70.3)
    60.2 (50.9 to 68.9)
        Muscle Pain: Mild (n = 22, 92, 114)
    50 (28.2 to 71.8)
    50 (39.4 to 60.6)
    50 (40.5 to 59.5)
        Muscle Pain: Moderate (n = 19, 80, 99)
    36.8 (16.3 to 61.6)
    30 (20.3 to 41.3)
    31.3 (22.4 to 41.4)
        Muscle Pain: Severe (n = 16, 75, 91)
    12.5 (1.6 to 38.3)
    6.7 (2.2 to 14.9)
    7.7 (3.1 to 15.2)
        Joint Pain: Any (n = 16, 83, 99)
    25 (7.3 to 52.4)
    32.5 (22.6 to 43.7)
    31.3 (22.4 to 41.4)
        Joint Pain: Mild (n = 15, 78, 93)
    13.3 (1.7 to 40.5)
    24.4 (15.3 to 35.4)
    22.6 (14.6 to 32.4)
        Joint Pain: Moderate (n = 16, 75, 91)
    12.5 (1.6 to 38.3)
    17.3 (9.6 to 27.8)
    16.5 (9.5 to 25.7)
        Joint Pain: Severe (n = 16, 74, 90)
    6.3 (0.2 to 30.2)
    4.1 (0.8 to 11.4)
    4.4 (1.2 to 11)
        Use of Medication to Treat Pain (n= 16, 77, 93)
    18.8 (4 to 45.6)
    16.9 (9.3 to 27.1)
    17.2 (10.2 to 26.4)
        Use of Medication to Treat Fever (n= 17, 77, 94)
    23.5 (6.8 to 49.9)
    15.6 (8.3 to 25.6)
    17 (10.1 to 26.2)
    Notes
    [37] - N signifies subjects with known values for any systemic event.
    [38] - N signifies subjects with known values for any systemic event.
    [39] - N signifies subjects with known values for any systemic event.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs/SAEs: recorded from 13vPnC Dose 1 to completion of study. Subjects recorded pre-specified AEs in electronic diary: local reactions; systemic events (up to 14 days after 13vPnC vaccination)
    Adverse event reporting additional description
    AEs/SAEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions for dose 1, 2, 3, 4 of 13vPnC; systematic assessment), on case report form at each visit (non systematic assessment). Safety population was analysed. Version was not captured, 0.0 is mentioned for dictionary version.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    13vPnC Dose 3 Blood Draw to 13vPnC Dose 4
    Reporting group description
    		 All subjects aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4.

    Reporting group title
    13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw
    Reporting group description
    		 All subjects aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3.

    Reporting group title
    13vPnC Dose 4
    Reporting group description
    		 All subjects aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4.

    Reporting group title
    23vPS Dose
    Reporting group description
    		 All subjects aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose.

    Reporting group title
    Follow-up
    Reporting group description
    		 All subjects aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up.

    Serious adverse events
    		 13vPnC Dose 3 Blood Draw to 13vPnC Dose 4 13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw 13vPnC Dose 4 23vPS Dose Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    42 / 221 (19.00%)
    58 / 247 (23.48%)
    11 / 192 (5.73%)
    11 / 184 (5.98%)
    28 / 247 (11.34%)
         number of deaths (all causes)
    1
    11
    2
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 221 (0.90%)
    6 / 247 (2.43%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia recurrent
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma recurrent
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post transplant lymphoproliferative disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute lymphocytic leukaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Acute lymphocytic leukaemia recurrent
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Ependymoma
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Refractory anaemia with an excess of blasts
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Juvenile chronic myelomonocytic leukaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    4 / 221 (1.81%)
    6 / 247 (2.43%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    3 / 247 (1.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 221 (1.81%)
    6 / 247 (2.43%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    4 / 247 (1.62%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 8
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injection site erythema
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Death
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Graft versus host disease
         subjects affected / exposed
    1 / 221 (0.45%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    2 / 247 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in intestine
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic graft versus host disease
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in liver
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft versus host disease in skin
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Uncoded
    Additional description: Term was not coded because it violated sponsor’s coding conventions.
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Dyspnoea
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Completed suicide
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Cytomegalovirus test positive
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    False positive investigation result
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Spinal fracture
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Nervous system disorders
    VIIth nerve paralysis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemolytic anaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia haemolytic autoimmune
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    2 / 247 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Warm type haemolytic anaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hernial eventration
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Pancreatitis acute
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Escherichia sepsis
         subjects affected / exposed
    2 / 221 (0.90%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    4 / 221 (1.81%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    2 / 247 (0.81%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 221 (0.90%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    4 / 247 (1.62%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    2 / 221 (0.90%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral toxoplasmosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gingivitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Molluscum contagiosum
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Haemophilus sepsis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatic candidiasis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Hepatitis B
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Herpes virus infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Herpes zoster disseminated
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Meningitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Nasopharyngitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Oral herpes
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Pneumonia pseudomonas aeruginosa
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Urinary tract infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    H1N1 influenza
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis septic
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    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
    Hyperglycaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 13vPnC Dose 3 Blood Draw to 13vPnC Dose 4 13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw 13vPnC Dose 4 23vPS Dose Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    89 / 221 (40.27%)
    203 / 247 (82.19%)
    127 / 192 (66.15%)
    93 / 184 (50.54%)
    19 / 247 (7.69%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Plasmacytoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Precursor B-lymphoblastic lymphoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Acute leukaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Acute myeloid leukaemia recurrent
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Kaposi's sarcoma
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Anogenital warts
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 221 (0.45%)
    7 / 247 (2.83%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    7
    0
    0
    0
    Hypotension
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    1
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Thrombophlebitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Flushing
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vasodilatation
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Venous insufficiency
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Venous thrombosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hot flush
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vena cava thrombosis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 221 (1.36%)
    15 / 247 (6.07%)
    3 / 192 (1.56%)
    5 / 184 (2.72%)
    0 / 247 (0.00%)
         occurrences all number
    4
    17
    3
    6
    0
    Pyrexia
         subjects affected / exposed
    5 / 221 (2.26%)
    16 / 247 (6.48%)
    3 / 192 (1.56%)
    8 / 184 (4.35%)
    1 / 247 (0.40%)
         occurrences all number
    5
    17
    3
    8
    2
    Oedema peripheral
         subjects affected / exposed
    6 / 221 (2.71%)
    12 / 247 (4.86%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    6
    12
    0
    2
    0
    Asthenia
         subjects affected / exposed
    2 / 221 (0.90%)
    10 / 247 (4.05%)
    1 / 192 (0.52%)
    3 / 184 (1.63%)
    1 / 247 (0.40%)
         occurrences all number
    2
    10
    1
    3
    1
    Injection site swelling
         subjects affected / exposed
    0 / 221 (0.00%)
    4 / 247 (1.62%)
    3 / 192 (1.56%)
    8 / 184 (4.35%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    4
    9
    0
    Injection site erythema
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    4 / 192 (2.08%)
    5 / 184 (2.72%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    5
    5
    0
    Oedema
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    2
    1
    0
    1
    Catheter site rash
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Complication of device removal
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Feeling cold
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Feeling hot
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Injection site movement impairment
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    5 / 192 (2.60%)
    8 / 184 (4.35%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    5
    8
    0
    Medical device complication
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pain
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Vaccination site haematoma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Vaccination site pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    6 / 184 (3.26%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    6
    0
    Vaccination site reaction
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    4 / 184 (2.17%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    4
    0
    Inflammation
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Spinal pain
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Vaccination site erythema
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    5 / 184 (2.72%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    5
    0
    Vaccination site swelling
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    4 / 184 (2.17%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    Injection site induration
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection site inflammation
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vaccination site oedema
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vaccination site rash
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hernia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    0
    0
    0
    1
    Fever >=38 degrees C: 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    0 / 221 (0.00%)
    13 / 169 (7.69%)
    17 / 96 (17.71%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    17
    0
    0
    Fever >=38, <38.5 degrees C: 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    0 / 221 (0.00%)
    10 / 167 (5.99%)
    12 / 92 (13.04%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    10
    12
    0
    0
    Fever >=38.5, <39 degrees C: 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    0 / 221 (0.00%)
    2 / 165 (1.21%)
    5 / 90 (5.56%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    5
    0
    0
    Fever >=39, =<40 degrees C: 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    0 / 221 (0.00%)
    3 / 167 (1.80%)
    2 / 87 (2.30%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    Fatigue (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    0 / 221 (0.00%)
    77 / 157 (49.04%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    77
    0
    0
    0
    Fatigue (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    0 / 221 (0.00%)
    42 / 137 (30.66%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    42
    0
    0
    0
    Fatigue (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    0 / 221 (0.00%)
    8 / 120 (6.67%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    8
    0
    0
    0
    Headache (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    0 / 221 (0.00%)
    53 / 142 (37.32%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    53
    0
    0
    0
    Headache (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    0 / 221 (0.00%)
    44 / 138 (31.88%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    44
    0
    0
    0
    Headache (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    0 / 221 (0.00%)
    21 / 122 (17.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    21
    0
    0
    0
    Headache (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    0 / 221 (0.00%)
    4 / 119 (3.36%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Vomiting (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    0 / 221 (0.00%)
    13 / 120 (10.83%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Vomiting (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [13]
    0 / 221 (0.00%)
    6 / 119 (5.04%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Vomiting (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    0 / 221 (0.00%)
    8 / 117 (6.84%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    8
    0
    0
    0
    Diarrhea (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [15]
    0 / 221 (0.00%)
    30 / 130 (23.08%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    30
    0
    0
    0
    Diarrhea (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [16]
    0 / 221 (0.00%)
    26 / 128 (20.31%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    26
    0
    0
    0
    Diarrhea (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [17]
    0 / 221 (0.00%)
    6 / 119 (5.04%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Diarrhea (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [18]
    0 / 221 (0.00%)
    2 / 117 (1.71%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Muscle pain (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [19]
    0 / 221 (0.00%)
    61 / 152 (40.13%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    61
    0
    0
    0
    Muscle pain (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [20]
    0 / 221 (0.00%)
    47 / 142 (33.10%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    47
    0
    0
    0
    Muscle pain (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [21]
    0 / 221 (0.00%)
    27 / 132 (20.45%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    27
    0
    0
    0
    Muscle pain (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [22]
    0 / 221 (0.00%)
    4 / 118 (3.39%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Joint pain (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [23]
    0 / 221 (0.00%)
    28 / 132 (21.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    28
    0
    0
    0
    Joint pain (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [24]
    0 / 221 (0.00%)
    23 / 128 (17.97%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    23
    0
    0
    0
    Joint pain (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [25]
    0 / 221 (0.00%)
    13 / 122 (10.66%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Joint pain (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [26]
    0 / 221 (0.00%)
    4 / 119 (3.36%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Fever >=38 degrees C: 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [27]
    0 / 221 (0.00%)
    13 / 131 (9.92%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Fever >=38, <38.5 degrees C: 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [28]
    0 / 221 (0.00%)
    11 / 131 (8.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    11
    0
    0
    0
    Fever >=38.5, <39 degrees C: 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [29]
    0 / 221 (0.00%)
    3 / 126 (2.38%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Fever >=39, =<40 degrees C: 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [30]
    0 / 221 (0.00%)
    3 / 126 (2.38%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Fever >=38 degrees C: 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [31]
    0 / 221 (0.00%)
    8 / 120 (6.67%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    8
    0
    0
    0
    Fever >=38, <38.5 degrees C: 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [32]
    0 / 221 (0.00%)
    6 / 119 (5.04%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Fever >=38.5, <39 degrees C: 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [33]
    0 / 221 (0.00%)
    4 / 117 (3.42%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Fever >=39, =<40 degrees C: 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [34]
    0 / 221 (0.00%)
    2 / 116 (1.72%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Fatigue (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [35]
    0 / 221 (0.00%)
    119 / 204 (58.33%)
    86 / 128 (67.19%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    119
    86
    0
    0
    Fatigue (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    0 / 221 (0.00%)
    88 / 190 (46.32%)
    68 / 121 (56.20%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    88
    68
    0
    0
    Fatigue (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    0 / 221 (0.00%)
    69 / 192 (35.94%)
    48 / 106 (45.28%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    69
    48
    0
    0
    Fatigue (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    0 / 221 (0.00%)
    20 / 173 (11.56%)
    12 / 93 (12.90%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    20
    12
    0
    0
    Fatigue (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    0 / 221 (0.00%)
    91 / 171 (53.22%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    91
    0
    0
    0
    Fatigue (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    0 / 221 (0.00%)
    63 / 156 (40.38%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    63
    0
    0
    0
    Fatigue (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    0 / 221 (0.00%)
    61 / 155 (39.35%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    61
    0
    0
    0
    Fatigue (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    0 / 221 (0.00%)
    13 / 131 (9.92%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Headache (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [43]
    0 / 221 (0.00%)
    84 / 189 (44.44%)
    53 / 114 (46.49%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    84
    53
    0
    0
    Headache (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [44]
    0 / 221 (0.00%)
    71 / 186 (38.17%)
    44 / 109 (40.37%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    71
    44
    0
    0
    Headache (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [45]
    0 / 221 (0.00%)
    31 / 174 (17.82%)
    26 / 98 (26.53%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    31
    26
    0
    0
    Headache (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [46]
    0 / 221 (0.00%)
    6 / 167 (3.59%)
    6 / 90 (6.67%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    6
    0
    0
    Headache (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [47]
    0 / 221 (0.00%)
    53 / 152 (34.87%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    53
    0
    0
    0
    Headache (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [48]
    0 / 221 (0.00%)
    44 / 147 (29.93%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    44
    0
    0
    0
    Headache (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [49]
    0 / 221 (0.00%)
    20 / 136 (14.71%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    Headache (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [50]
    0 / 221 (0.00%)
    2 / 128 (1.56%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Vomiting (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [51]
    0 / 221 (0.00%)
    36 / 173 (20.81%)
    5 / 89 (5.62%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    36
    5
    0
    0
    Vomiting (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [52]
    0 / 221 (0.00%)
    31 / 172 (18.02%)
    5 / 89 (5.62%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    31
    5
    0
    0
    Vomiting (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [53]
    0 / 221 (0.00%)
    6 / 166 (3.61%)
    0 / 86 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Vomiting (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [54]
    0 / 221 (0.00%)
    2 / 165 (1.21%)
    0 / 86 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Vomiting (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [55]
    0 / 221 (0.00%)
    20 / 135 (14.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    20
    0
    0
    0
    Vomiting (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [56]
    0 / 221 (0.00%)
    16 / 134 (11.94%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    16
    0
    0
    0
    Vomiting (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [57]
    0 / 221 (0.00%)
    9 / 131 (6.87%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    9
    0
    0
    0
    Vomiting (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [58]
    0 / 221 (0.00%)
    1 / 126 (0.79%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Diarrhea (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [59]
    0 / 221 (0.00%)
    66 / 189 (34.92%)
    29 / 101 (28.71%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    66
    29
    0
    0
    Diarrhea (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [60]
    0 / 221 (0.00%)
    62 / 186 (33.33%)
    28 / 100 (28.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    62
    28
    0
    0
    Diarrhea (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [61]
    0 / 221 (0.00%)
    14 / 171 (8.19%)
    3 / 87 (3.45%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    14
    3
    0
    0
    Diarrhea (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [62]
    0 / 221 (0.00%)
    5 / 168 (2.98%)
    1 / 87 (1.15%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    5
    1
    0
    0
    Diarrhea (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [63]
    0 / 221 (0.00%)
    44 / 150 (29.33%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    44
    0
    0
    0
    Diarrhea (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [64]
    0 / 221 (0.00%)
    41 / 149 (27.52%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    41
    0
    0
    0
    Diarrhea (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [65]
    0 / 221 (0.00%)
    13 / 134 (9.70%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Diarrhea (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [66]
    0 / 221 (0.00%)
    2 / 127 (1.57%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Muscle pain (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [67]
    0 / 221 (0.00%)
    103 / 201 (51.24%)
    74 / 123 (60.16%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    103
    74
    0
    0
    Muscle pain (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [68]
    0 / 221 (0.00%)
    83 / 191 (43.46%)
    57 / 114 (50.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    83
    57
    0
    0
    Muscle pain (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [69]
    0 / 221 (0.00%)
    46 / 183 (25.14%)
    31 / 99 (31.31%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    46
    31
    0
    0
    Muscle pain (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [70]
    0 / 221 (0.00%)
    9 / 168 (5.36%)
    7 / 91 (7.69%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    9
    7
    0
    0
    Muscle pain (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [71]
    0 / 221 (0.00%)
    72 / 160 (45.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    72
    0
    0
    0
    Muscle pain (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [72]
    0 / 221 (0.00%)
    54 / 150 (36.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    54
    0
    0
    0
    Muscle pain (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [73]
    0 / 221 (0.00%)
    40 / 143 (27.97%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    40
    0
    0
    0
    Muscle pain (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [74]
    0 / 221 (0.00%)
    8 / 131 (6.11%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    8
    0
    0
    0
    Joint pain (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [75]
    0 / 221 (0.00%)
    34 / 176 (19.32%)
    21 / 93 (22.58%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    34
    21
    0
    0
    Joint pain (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [76]
    0 / 221 (0.00%)
    34 / 176 (19.32%)
    21 / 93 (22.58%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    34
    21
    0
    0
    Joint pain (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [77]
    0 / 221 (0.00%)
    24 / 175 (13.71%)
    15 / 91 (16.48%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    24
    15
    0
    0
    Joint pain (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [78]
    0 / 221 (0.00%)
    5 / 167 (2.99%)
    4 / 90 (4.44%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    5
    4
    0
    0
    Joint pain (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [79]
    0 / 221 (0.00%)
    37 / 147 (25.17%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    37
    0
    0
    0
    Joint pain (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [80]
    0 / 221 (0.00%)
    30 / 142 (21.13%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    30
    0
    0
    0
    Joint pain (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [81]
    0 / 221 (0.00%)
    20 / 136 (14.71%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    20
    0
    0
    0
    Joint pain (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-­diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [82]
    0 / 221 (0.00%)
    3 / 129 (2.33%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Immune system disorders
    Graft versus host disease
         subjects affected / exposed
    8 / 221 (3.62%)
    21 / 247 (8.50%)
    2 / 192 (1.04%)
    4 / 184 (2.17%)
    0 / 247 (0.00%)
         occurrences all number
    9
    24
    2
    4
    0
    Chronic graft versus host disease
         subjects affected / exposed
    3 / 221 (1.36%)
    12 / 247 (4.86%)
    0 / 192 (0.00%)
    3 / 184 (1.63%)
    0 / 247 (0.00%)
         occurrences all number
    3
    14
    0
    3
    0
    Graft versus host disease in liver
         subjects affected / exposed
    1 / 221 (0.45%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    1
    7
    0
    1
    0
    Graft versus host disease in skin
         subjects affected / exposed
    6 / 221 (2.71%)
    4 / 247 (1.62%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    7
    4
    0
    0
    0
    Food allergy
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Acute graft versus host disease
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Chronic graft versus host disease in liver
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Graft versus host disease in intestine
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypersensitivity
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Gynaecomastia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vulvovaginal discomfort
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Prostatitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Genital discharge
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Amenorrhoea
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 221 (0.90%)
    24 / 247 (9.72%)
    4 / 192 (2.08%)
    7 / 184 (3.80%)
    2 / 247 (0.81%)
         occurrences all number
    2
    24
    4
    7
    2
    Dyspnoea exertional
         subjects affected / exposed
    1 / 221 (0.45%)
    4 / 247 (1.62%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    4
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 221 (0.45%)
    4 / 247 (1.62%)
    2 / 192 (1.04%)
    3 / 184 (1.63%)
    0 / 247 (0.00%)
         occurrences all number
    1
    4
    2
    3
    0
    Lung disorder
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Lung infiltration
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Oropharyngeal plaque
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pulmonary mass
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    2
    0
    0
    0
    1
    Hyperventilation
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Organising pneumonia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 221 (0.45%)
    8 / 247 (3.24%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    8
    0
    0
    0
    Pneumonitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Rhonchi
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sputum discoloured
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    0
    0
    0
    2
    Pleural effusion
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    2 / 247 (0.81%)
         occurrences all number
    0
    0
    0
    0
    2
    Laryngeal oedema
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    0
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 221 (0.45%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    6
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 221 (0.45%)
    4 / 247 (1.62%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    5
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervousness
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Stress
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Depression
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Investigations
    Blood testosterone decreased
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    3 / 184 (1.63%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    1
    3
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Human herpes virus 6 serology positive
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Intraocular pressure increased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Thyroxine decreased
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    1
    0
    0
    1
    Serum ferritin increased
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    Cystogram
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Ejection fraction abnormal
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Body temperature increased
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Transaminases increased
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Transfusion reaction
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Laceration
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Eye injury
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Febrile nonhaemolytic transfusion reaction
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Conjunctival scar
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Drug administration error
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Post-traumatic pain
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Arthropod bite
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Anaemia postoperative
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    0
    0
    0
    1
    Congenital, familial and genetic disorders
    Myotonic dystrophy
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ichthyosis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Arrhythmia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Atrial thrombosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dilatation ventricular
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Myocardial infarction
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cardiomyopathy
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Polyneuropathy
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Sinus headache
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Amnesia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Migraine with aura
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Syncope
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Disturbance in attention
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Cranial nerve palsies multiple
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Epilepsy
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Restless legs syndrome
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Headache
         subjects affected / exposed
    3 / 221 (1.36%)
    13 / 247 (5.26%)
    4 / 192 (2.08%)
    3 / 184 (1.63%)
    0 / 247 (0.00%)
         occurrences all number
    3
    13
    5
    3
    0
    Balance disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    2 / 221 (0.90%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    2
    0
    0
    0
    Coordination abnormal
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperaesthesia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Myoclonus
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervous system disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    2 / 221 (0.90%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    2
    6
    0
    1
    0
    Eosinophilia
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    3
    0
    0
    1
    Anaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Aplasia pure red cell
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Anaemia macrocytic
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Aplastic anaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Febrile neutropenia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Histiocytosis haematophagic
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pancytopenia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Splenomegaly
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Haemolytic uraemic syndrome
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hypergammaglobulinaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 221 (0.90%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    2
    3
    0
    2
    0
    Vertigo
         subjects affected / exposed
    1 / 221 (0.45%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    Tinnitus
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Ear discomfort
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hearing impaired
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Middle ear effusion
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tympanic membrane disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Deafness neurosensory
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Deafness unilateral
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cerumen impaction
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ear pruritus
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 221 (0.00%)
    6 / 247 (2.43%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    7
    0
    1
    0
    Dry eye
         subjects affected / exposed
    3 / 221 (1.36%)
    5 / 247 (2.02%)
    1 / 192 (0.52%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    3
    5
    1
    2
    0
    Allergic keratitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Eye haemorrhage
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Foreign body sensation in eyes
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Keratitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    1
    0
    0
    1
    Orbital oedema
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    1
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Visual impairment
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Vitreous detachment
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Blindness
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Cataract
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Periorbital oedema
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Eye inflammation
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Retinal detachment
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Xerophthalmia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 221 (0.90%)
    24 / 247 (9.72%)
    3 / 192 (1.56%)
    3 / 184 (1.63%)
    1 / 247 (0.40%)
         occurrences all number
    2
    27
    3
    3
    1
    Vomiting
         subjects affected / exposed
    1 / 221 (0.45%)
    15 / 247 (6.07%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    21
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 221 (0.00%)
    8 / 247 (3.24%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    2 / 247 (0.81%)
         occurrences all number
    0
    10
    0
    1
    2
    Abdominal pain
         subjects affected / exposed
    1 / 221 (0.45%)
    8 / 247 (3.24%)
    2 / 192 (1.04%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    9
    2
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 221 (0.45%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    5
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    2 / 221 (0.90%)
    5 / 247 (2.02%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    5
    1
    0
    0
    Constipation
         subjects affected / exposed
    2 / 221 (0.90%)
    4 / 247 (1.62%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    2
    4
    1
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Dysphagia
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    3
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    Aphthous stomatitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    3 / 221 (1.36%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    3
    2
    1
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    Oesophagitis
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Aptyalism
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ascites
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Eructation
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Faecaloma
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Glossodynia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperchlorhydria
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lip swelling
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Oral disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Oral mucosal discolouration
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Tongue coated
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tongue discolouration
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Oral lichen planus
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Sensitivity of teeth
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Inguinal hernia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    1 / 221 (0.45%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    Hepatocellular injury
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Hepatomegaly
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cholestasis
         subjects affected / exposed
    0 / 221 (0.00%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 221 (0.00%)
    14 / 247 (5.67%)
    2 / 192 (1.04%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    0
    14
    2
    2
    0
    Pruritus
         subjects affected / exposed
    2 / 221 (0.90%)
    11 / 247 (4.45%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    2
    13
    1
    1
    0
    Dry skin
         subjects affected / exposed
    0 / 221 (0.00%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    5
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 221 (0.00%)
    4 / 247 (1.62%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    1
    0
    Erythema
         subjects affected / exposed
    1 / 221 (0.45%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    1
    3
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    1 / 221 (0.45%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    Acne
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Rash macular
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Rash papular
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Blister
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dermatosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Generalised erythema
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lichenification
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Night sweats
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Perivascular dermatitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rash generalised
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Skin discolouration
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Skin mass
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Acute febrile neutrophilic dermatosis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Pityriasis rubra pilaris
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Dermatitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Angioedema
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Intertrigo
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pruritus generalised
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Alopecia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    0
    0
    0
    1
    Redness (Any) : 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [83]
    0 / 221 (0.00%)
    23 / 168 (13.69%)
    33 / 100 (33.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    23
    33
    0
    0
    Redness (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [84]
    0 / 221 (0.00%)
    20 / 168 (11.90%)
    22 / 97 (22.68%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    20
    22
    0
    0
    Redness (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [85]
    0 / 221 (0.00%)
    6 / 165 (3.64%)
    16 / 90 (17.78%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    16
    0
    0
    Redness (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [86]
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    5 / 89 (5.62%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    5
    0
    0
    Swelling (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [87]
    0 / 221 (0.00%)
    25 / 170 (14.71%)
    41 / 108 (37.96%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    25
    41
    0
    0
    Swelling (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [88]
    0 / 221 (0.00%)
    18 / 169 (10.65%)
    25 / 100 (25.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    18
    25
    0
    0
    Swelling (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [89]
    0 / 221 (0.00%)
    9 / 167 (5.39%)
    17 / 95 (17.89%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    9
    17
    0
    0
    Swelling (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [90]
    0 / 221 (0.00%)
    1 / 165 (0.61%)
    4 / 88 (4.55%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    4
    0
    0
    Pain (Any): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [91]
    0 / 221 (0.00%)
    165 / 222 (74.32%)
    113 / 143 (79.02%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    165
    113
    0
    0
    Pain (Mild): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [92]
    0 / 221 (0.00%)
    151 / 217 (69.59%)
    94 / 130 (72.31%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    151
    94
    0
    0
    Pain (Moderate): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [93]
    0 / 221 (0.00%)
    50 / 180 (27.78%)
    42 / 109 (38.53%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    50
    42
    0
    0
    Pain (Severe): 13vPnC Dose 1 and Dose 4
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [94]
    0 / 221 (0.00%)
    5 / 166 (3.01%)
    6 / 90 (6.67%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    5
    6
    0
    0
    Redness (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [95]
    0 / 221 (0.00%)
    30 / 137 (21.90%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    30
    0
    0
    0
    Redness (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [96]
    0 / 221 (0.00%)
    26 / 134 (19.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    26
    0
    0
    0
    Redness (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [97]
    0 / 221 (0.00%)
    9 / 129 (6.98%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    9
    0
    0
    0
    Redness (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [98]
    0 / 221 (0.00%)
    2 / 127 (1.57%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Swelling (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [99]
    0 / 221 (0.00%)
    25 / 133 (18.80%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    25
    0
    0
    0
    Swelling (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [100]
    0 / 221 (0.00%)
    19 / 131 (14.50%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    19
    0
    0
    0
    Swelling (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [101]
    0 / 221 (0.00%)
    7 / 128 (5.47%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    7
    0
    0
    0
    Pain (Any): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [102]
    0 / 221 (0.00%)
    146 / 194 (75.26%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    146
    0
    0
    0
    Pain (Mild): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [103]
    0 / 221 (0.00%)
    129 / 184 (70.11%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    129
    0
    0
    0
    Pain (Moderate): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [104]
    0 / 221 (0.00%)
    49 / 148 (33.11%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    49
    0
    0
    0
    Pain (Severe): 13vPnC Dose 2
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [105]
    0 / 221 (0.00%)
    6 / 131 (4.58%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Redness (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [106]
    0 / 221 (0.00%)
    17 / 120 (14.17%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    17
    0
    0
    0
    Redness (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [107]
    0 / 221 (0.00%)
    13 / 118 (11.02%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    13
    0
    0
    0
    Redness (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [108]
    0 / 221 (0.00%)
    6 / 117 (5.13%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    6
    0
    0
    0
    Redness (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [109]
    0 / 221 (0.00%)
    2 / 116 (1.72%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Swelling (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [110]
    0 / 221 (0.00%)
    18 / 121 (14.88%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    18
    0
    0
    0
    Swelling (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [111]
    0 / 221 (0.00%)
    15 / 120 (12.50%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    15
    0
    0
    0
    Swelling (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [112]
    0 / 221 (0.00%)
    5 / 117 (4.27%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    Swelling (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [113]
    0 / 221 (0.00%)
    1 / 115 (0.87%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pain (Any): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [114]
    0 / 221 (0.00%)
    127 / 175 (72.57%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    127
    0
    0
    0
    Pain (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [115]
    0 / 221 (0.00%)
    109 / 163 (66.87%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    109
    0
    0
    0
    Pain (Moderate): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [116]
    0 / 221 (0.00%)
    42 / 141 (29.79%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    42
    0
    0
    0
    Pain (Severe): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [117]
    0 / 221 (0.00%)
    5 / 117 (4.27%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    5
    0
    0
    0
    Fatigue (Mild): 13vPnC Dose 3
    Additional description: Subjects affected and occurrences for LRs and SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.
    alternative assessment type: Systematic
         subjects affected / exposed [118]
    0 / 221 (0.00%)
    58 / 148 (39.19%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    58
    0
    0
    0
    Renal and urinary disorders
    Polyuria
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    Renal failure
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Dysuria
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Incontinence
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Renal impairment
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urethral pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Urinary tract disorder
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Urine abnormality
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Cushing's syndrome
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hypothyroidism
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Oestrogen deficiency
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 221 (2.71%)
    11 / 247 (4.45%)
    4 / 192 (2.08%)
    3 / 184 (1.63%)
    2 / 247 (0.81%)
         occurrences all number
    7
    11
    6
    3
    2
    Muscle spasms
         subjects affected / exposed
    2 / 221 (0.90%)
    7 / 247 (2.83%)
    2 / 192 (1.04%)
    1 / 184 (0.54%)
    1 / 247 (0.40%)
         occurrences all number
    2
    9
    2
    1
    1
    Back pain
         subjects affected / exposed
    1 / 221 (0.45%)
    7 / 247 (2.83%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    1 / 247 (0.40%)
         occurrences all number
    1
    8
    0
    2
    1
    Myalgia
         subjects affected / exposed
    1 / 221 (0.45%)
    5 / 247 (2.02%)
    1 / 192 (0.52%)
    3 / 184 (1.63%)
    0 / 247 (0.00%)
         occurrences all number
    1
    5
    1
    3
    0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 221 (0.90%)
    4 / 247 (1.62%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    4
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    1 / 192 (0.52%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    1
    2
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Bone pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Joint stiffness
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Myopathy
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Osteonecrosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Osteoporosis
         subjects affected / exposed
    3 / 221 (1.36%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    Synovial cyst
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Groin pain
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Osteopenia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Tendonitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sjogren's syndrome
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 221 (2.71%)
    28 / 247 (11.34%)
    11 / 192 (5.73%)
    9 / 184 (4.89%)
    0 / 247 (0.00%)
         occurrences all number
    6
    32
    11
    9
    0
    Cytomegalovirus infection
         subjects affected / exposed
    3 / 221 (1.36%)
    10 / 247 (4.05%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    4
    12
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 221 (2.71%)
    10 / 247 (4.05%)
    3 / 192 (1.56%)
    3 / 184 (1.63%)
    1 / 247 (0.40%)
         occurrences all number
    8
    12
    3
    3
    1
    Herpes zoster
         subjects affected / exposed
    5 / 221 (2.26%)
    8 / 247 (3.24%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    2 / 247 (0.81%)
         occurrences all number
    5
    11
    0
    1
    2
    Bronchitis
         subjects affected / exposed
    3 / 221 (1.36%)
    6 / 247 (2.43%)
    1 / 192 (0.52%)
    2 / 184 (1.09%)
    1 / 247 (0.40%)
         occurrences all number
    3
    6
    1
    2
    1
    Sinusitis
         subjects affected / exposed
    1 / 221 (0.45%)
    5 / 247 (2.02%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    1
    6
    0
    2
    0
    Tonsillitis
         subjects affected / exposed
    0 / 221 (0.00%)
    5 / 247 (2.02%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    5
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 221 (0.90%)
    4 / 247 (1.62%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    2
    5
    0
    0
    1
    Oral fungal infection
         subjects affected / exposed
    1 / 221 (0.45%)
    4 / 247 (1.62%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    4
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    3 / 221 (1.36%)
    4 / 247 (1.62%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    3
    4
    0
    2
    0
    Escherichia infection
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    3
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    3 / 184 (1.63%)
    0 / 247 (0.00%)
         occurrences all number
    1
    3
    0
    3
    0
    Oral herpes
         subjects affected / exposed
    4 / 221 (1.81%)
    3 / 247 (1.21%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    4
    3
    1
    1
    0
    Candidiasis
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Enterobacter sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Escherichia sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Eye infection
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Otitis media
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    0
    2
    0
    Pharyngitis
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    1 / 192 (0.52%)
    2 / 184 (1.09%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    1
    2
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Adenovirus infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Aspergillosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Bacterial infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Catheter site infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Conjunctivitis viral
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Enterobacter infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Enterococcal sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Febrile infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    10
    0
    Genital infection fungal
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Influenza
         subjects affected / exposed
    3 / 221 (1.36%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    3
    1
    0
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Mycoplasma infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pseudomonas infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Respiratory moniliasis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Systemic candida
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    2 / 221 (0.90%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    2
    0
    0
    0
    1
    Acute sinusitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Bronchitis viral
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hepatitis B
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Herpes zoster oticus
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hordeolum
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sepsis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    1
    0
    0
    0
    1
    Streptococcal urinary tract infection
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Viral pharyngitis
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Chronic sinusitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    2 / 192 (1.04%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Infected dermal cyst
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Lung infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Toxoplasmosis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Viral rhinitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection site cellulitis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Trichosporon infection
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    1 / 247 (0.40%)
         occurrences all number
    0
    0
    0
    0
    1
    Rash pustular
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 221 (0.45%)
    7 / 247 (2.83%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    1 / 247 (0.40%)
         occurrences all number
    1
    8
    0
    1
    1
    Fluid retention
         subjects affected / exposed
    0 / 221 (0.00%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    3 / 247 (1.21%)
    0 / 192 (0.00%)
    3 / 184 (1.63%)
    0 / 247 (0.00%)
         occurrences all number
    1
    3
    0
    3
    0
    Diabetes mellitus
         subjects affected / exposed
    1 / 221 (0.45%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    2 / 247 (0.81%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Cachexia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Dehydration
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Folate deficiency
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypercreatininaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vitamin K deficiency
         subjects affected / exposed
    0 / 221 (0.00%)
    1 / 247 (0.40%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 221 (0.45%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Haemochromatosis
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    1 / 192 (0.52%)
    0 / 184 (0.00%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 221 (0.00%)
    0 / 247 (0.00%)
    0 / 192 (0.00%)
    1 / 184 (0.54%)
    0 / 247 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [47] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [48] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [49] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [50] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [51] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [52] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [53] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [54] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [55] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [56] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [57] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [58] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [59] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [60] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [61] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [62] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [63] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [64] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [65] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [66] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [67] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [68] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [69] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [70] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [71] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [72] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [73] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [74] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [75] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [76] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [77] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [78] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [79] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [80] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [81] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [82] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [83] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [84] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [85] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [86] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [87] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [88] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [89] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [90] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [91] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [92] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [93] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [94] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [95] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [96] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [97] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [98] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [99] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [100] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [101] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [102] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [103] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [104] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [105] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [106] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [107] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [108] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [109] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [110] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [111] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [112] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [113] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [114] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [115] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [116] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [117] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 
    [118] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days. 

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2009
    An exclusion criteria of receipt of advanced therapy medicinal products (ATMP) including gene therapy products, somatic cell therapy products and tissue engineered products at any time before enrollment was added. Clarification regarding administration of unassigned investigational product, relapse of underlying disease and receipt of chemotherapy were added.
    14 Feb 2012
    An SAE was to be reported to Pfizer within 24 hours of investigator awareness and SAEs occurring to a subject after the study was over were to be reported to the sponsor if the investigator becomes aware of them were added. Addition of the definition of an AE (requiring documentation on CRF) was extended to include medication error and uses outside what was foreseen in the protocol, including overdose, misuse and dependency of the product, it also included drug withdrawal, extravasation, drug interactions, exposure during pregnancy, and exposure via breastfeeding. Addition of pregnancy of subject or partner required completion of the exposure in utero form (EIU) (and EIU Pregnant Partner Release of Information Form as appropriate) and additionally, if the outcome was not a live healthy birth, an SAE form was completed.

    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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