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CAPITA: Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00744263
Collaborator
(none)
84,496
Enrollment
159
Locations
2
Arms
61
Duration (Months)
531.4
Patients Per Site
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.

Condition or Disease Intervention/Treatment Phase
  • Biological: VACCINE: placebo
  • Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
84496 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 4, Randomized, Placebo-Controlled Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine Efficacy in Prevention of Vaccine-Serotype Pneumococcal Community-Acquired Pneumonia and Invasive Pneumococcal Disease
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Biological: VACCINE: placebo
0.5 mL, single intra-muscular injection
Experimental: 13-valent pneumococcal conjugate vaccine

Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
0.5 mL, single intra-muscular injection
Other Names:
  • 13vPnC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP) [Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)]

      CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (>) 38.0 degrees Celsius (C) or less than (<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15 percent (%) bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).

    Secondary Outcome Measures

    1. Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP) [Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)]

      CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature >38.0 degrees C or <36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15% bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.

    2. Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases [Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)]

      VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).

    Other Outcome Measures

    1. Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination [Within 7 days after vaccination]

      Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.

    2. Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination [Within 7 days after vaccination]

      Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain [new muscle/joint pain], aggravated generalized muscle/joint pain [aggravated muscle/joint pain], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(<38 degrees C); Mild(greater than or equal to [>=]38 to <38.5 degrees C); Moderate(>=38.5 to <39 degrees C); Severe(>=39 to less than or equal to [<=]40 degrees C); Potentially life threatening (>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours [hrs]); Moderate(>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.

    3. Percentage of Participants Who Died [From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)]

      Deaths collected throughout the case acquisition period were presented.

    4. Percentage of Participants With Newly Diagnosed Chronic Medical Condition [From 1 month after vaccination up to 6 months after vaccination]

      Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Male or female adults aged 65 years or older on the day of vaccination and able to fulfill study requirements.
    Exclusion Criteria:

    • Previous vaccination with any licensed or experimental pneumococcal vaccine

    • Residence in a nursing home, long-term care facility, or similar facility

    • Known hypersensitivity to vaccination

    • Immune deficiency or suppression

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Tilburg Noord Brabant Netherlands 5022 JB
    2 Pfizer Investigational Site Abbekerk Netherlands 1657 AH
    3 Pfizer Investigational Site Alkmaar Netherlands 1815 JD
    4 Pfizer Investigational Site Alkmaar Netherlands 1825 PV
    5 Pfizer Investigational Site Almelo Netherlands 7609 PP
    6 Pfizer Investigational Site Almere Netherlands 1315 RA
    7 Pfizer Investigational Site Almere Netherlands 1355 EA
    8 Pfizer Investigational Site Alphen aan de Rijn Netherlands 2402 EP
    9 Pfizer Investigational Site Amersfoort Netherlands 3813 TZ
    10 Pfizer Investigational Site Amersfoort Netherlands 3821 AR
    11 Pfizer Investigational Site Amstelveen Netherlands 1186 AM
    12 Pfizer Investigational Site Amstelveen Netherlands 1186 DA
    13 Pfizer Investigational Site Amsterdam Netherlands 1043 GR
    14 Pfizer Investigational Site Amsterdam Netherlands 1061 AE
    15 Pfizer Investigational Site Amsterdam Netherlands 1066 EC
    16 Pfizer Investigational Site Amsterdam Netherlands 1081 HV
    17 Pfizer Investigational Site Amsterdam Netherlands 1091 AC
    18 Pfizer Investigational Site Amsterdam Netherlands 1098 NJ
    19 Pfizer Investigational Site Amsterdam Netherlands 1105 AZ
    20 Pfizer Investigational Site Apeldoorn Netherlands 7333 NS
    21 Pfizer Investigational Site Apeldoorn Netherlands 7334 DZ
    22 Pfizer Investigational Site Apeldoorn Netherlands 7336 BA
    23 Pfizer Investigational Site Arnhem Netherlands 6815 AD
    24 Pfizer Investigational Site Arnhem Netherlands 6842 CT
    25 Pfizer Investigational Site Assen Netherlands 9401 RK
    26 Pfizer Investigational Site Assen Netherlands 9406 GT
    27 Pfizer Investigational Site Baarle-Nassau Netherlands 5111 BX
    28 Pfizer Investigational Site Baarn Netherlands 3743 CM
    29 Pfizer Investigational Site Bedum Netherlands 9781 JG
    30 Pfizer Investigational Site Bennebroek Netherlands 2121 AJ
    31 Pfizer Investigational Site Bergen op Zoom Netherlands 4611 RD
    32 Pfizer Investigational Site Bergen op Zoom Netherlands 4624 VT
    33 Pfizer Investigational Site Berkel Enschot Netherlands 5056 PP
    34 Pfizer Investigational Site Berkhout Netherlands 1647 ME
    35 Pfizer Investigational Site Bilthoven Netherlands 3723 BM
    36 Pfizer Investigational Site Blaricum Netherlands 1261 AN
    37 Pfizer Investigational Site Breda Netherlands 4811 VC
    38 Pfizer Investigational Site Breda Netherlands 4818 CK
    39 Pfizer Investigational Site Breda Netherlands 4835 ND
    40 Pfizer Investigational Site Brunssum Netherlands 6444 AT
    41 Pfizer Investigational Site Deventer Netherlands 7416 SE
    42 Pfizer Investigational Site Deventer Netherlands 7418 EV
    43 Pfizer Investigational Site Dongen Netherlands 5104 JK
    44 Pfizer Investigational Site Eelde Netherlands 9761 AB
    45 Pfizer Investigational Site Eindhoven Netherlands 5600 HK
    46 Pfizer Investigational Site Eindhoven Netherlands 5611 ZB
    47 Pfizer Investigational Site Eindhoven Netherlands 5616 BA
    48 Pfizer Investigational Site Eindhoven Netherlands 5623 EJ
    49 Pfizer Investigational Site Eindhoven Netherlands 5631 BM
    50 Pfizer Investigational Site Emmen Netherlands 7811 HN
    51 Pfizer Investigational Site Emmen Netherlands 7824 AA
    52 Pfizer Investigational Site Enschede Netherlands 7513 ER
    53 Pfizer Investigational Site Enschede Netherlands 7521 AG
    54 Pfizer Investigational Site Epe Netherlands 8162 BD
    55 Pfizer Investigational Site Ettenleur Netherlands 4876 AS
    56 Pfizer Investigational Site Fijnaart Netherlands 4793 CB
    57 Pfizer Investigational Site Geldrop Netherlands 5664 EH
    58 Pfizer Investigational Site Geldrop Netherlands 5664 EP
    59 Pfizer Investigational Site Geldrop Netherlands 5664 HV
    60 Pfizer Investigational Site Goirle Netherlands 5051 RJ
    61 Pfizer Investigational Site Gouda Netherlands 2803 AH
    62 Pfizer Investigational Site Gouda Netherlands 2803 PL
    63 Pfizer Investigational Site Groningen Netherlands 9713 EC
    64 Pfizer Investigational Site Groningen Netherlands 9713 GZ
    65 Pfizer Investigational Site Groningen Netherlands 9728 NT
    66 Pfizer Investigational Site Groningen Netherlands 9733 CA
    67 Pfizer Investigational Site Grootebroek Netherlands 1613 SJ
    68 Pfizer Investigational Site Haarlem Netherlands 2035 RC
    69 Pfizer Investigational Site Haarlem Netherlands 2035 RJ
    70 Pfizer Investigational Site Haren Netherlands 9751 ND
    71 Pfizer Investigational Site Harmelen Netherlands 3481 EN
    72 Pfizer Investigational Site Heerhugowaard Netherlands 1701 GB
    73 Pfizer Investigational Site Heerlen Netherlands 6412 CD
    74 Pfizer Investigational Site Heerlen Netherlands 6419 PC
    75 Pfizer Investigational Site Heiloo Netherlands
    76 Pfizer Investigational Site Helmond Netherlands 5707 HA
    77 Pfizer Investigational Site Hengelo Netherlands 7555 BB
    78 Pfizer Investigational Site Hengelo Netherlands 7555 DL
    79 Pfizer Investigational Site Hilvarenbeek Netherlands 5081JV
    80 Pfizer Investigational Site Hilversum Netherlands 1213 XZ
    81 Pfizer Investigational Site Hilversum Netherlands 1217 GP
    82 Pfizer Investigational Site Hoofddorp Netherlands 2134 TM
    83 Pfizer Investigational Site Hoogezand Netherlands 9601 KE�
    84 Pfizer Investigational Site Hoorn Netherlands 1624 NP
    85 Pfizer Investigational Site Hoorn Netherlands 1628 LZ
    86 Pfizer Investigational Site Hoorn Netherlands 1642 NP
    87 Pfizer Investigational Site Houten Netherlands 3995 AA
    88 Pfizer Investigational Site Kampen Netherlands 8266 AB
    89 Pfizer Investigational Site Katwijk Netherlands 2223 BM
    90 Pfizer Investigational Site Kerkrade Netherlands 6461 AL
    91 Pfizer Investigational Site Leek Netherlands 9351 KP
    92 Pfizer Investigational Site Leeuwarden Netherlands 8915 AC
    93 Pfizer Investigational Site Leeuwarden Netherlands 8934 AD
    94 Pfizer Investigational Site Leiden Netherlands 2316 XC
    95 Pfizer Investigational Site Leiden Netherlands 2333 ZA
    96 Pfizer Investigational Site Leiden Netherlands 2334 CK
    97 Pfizer Investigational Site Leiderdorp Netherlands 2353 GA
    98 Pfizer Investigational Site Maarssen Netherlands 3603 BM
    99 Pfizer Investigational Site Maastricht Netherlands 6227 BZ
    100 Pfizer Investigational Site Maastricht Netherlands 6229 HX
    101 Pfizer Investigational Site Medemblik Netherlands 1671 CS
    102 Pfizer Investigational Site Nieuwegein Netherlands 3435 CM
    103 Pfizer Investigational Site Nieuwegein Netherlands 3439 ML
    104 Pfizer Investigational Site Nijmegen Netherlands 6525 GA
    105 Pfizer Investigational Site Nijmegen Netherlands 6532 SZ
    106 Pfizer Investigational Site Nijmegen Netherlands 6546 BC
    107 Pfizer Investigational Site Noordwijk Netherlands 2202 NS
    108 Pfizer Investigational Site Oldenzaal Netherlands 7573 AM
    109 Pfizer Investigational Site Oosterhout Netherlands 4907 AB
    110 Pfizer Investigational Site Peize Netherlands 9321 CK
    111 Pfizer Investigational Site Rheden Netherlands 6991 DV
    112 Pfizer Investigational Site Riel Netherlands 5133 AM
    113 Pfizer Investigational Site Rijsbergen Netherlands 4891 XL
    114 Pfizer Investigational Site Rijssen Netherlands 7461DA
    115 Pfizer Investigational Site Roden Netherlands 9301 JL
    116 Pfizer Investigational Site Roermond Netherlands 6042EH
    117 Pfizer Investigational Site Roermond Netherlands 6043 CV
    118 Pfizer Investigational Site Roermond Netherlands 6043 WD
    119 Pfizer Investigational Site Roosendaal Netherlands 4700 AZ
    120 Pfizer Investigational Site Roosendaal Netherlands 4708 HK
    121 Pfizer Investigational Site Schoorl Netherlands 1871 EE
    122 Pfizer Investigational Site Simpelveld Netherlands 6369 AG
    123 Pfizer Investigational Site Sittard Netherlands 6131 KJ
    124 Pfizer Investigational Site Sittard Netherlands 6162 BG
    125 Pfizer Investigational Site Sleen Netherlands 7841 CE
    126 Pfizer Investigational Site Soest Netherlands 3762 BN
    127 Pfizer Investigational Site Son Netherlands 5691 AR
    128 Pfizer Investigational Site Spaubeek Netherlands 6176 BE
    129 Pfizer Investigational Site Steenbergen Netherlands 4651 RN
    130 Pfizer Investigational Site Tiel Netherlands 4002 WP
    131 Pfizer Investigational Site Tilburg Netherlands 5022 GC
    132 Pfizer Investigational Site Tilburg Netherlands 5022 JB
    133 Pfizer Investigational Site Tilburg Netherlands 5042 AD
    134 Pfizer Investigational Site Uithoorn Netherlands 1422 LE
    135 Pfizer Investigational Site Urmond Netherlands 6129 EL
    136 Pfizer Investigational Site Utrecht Netherlands 3508 GA
    137 Pfizer Investigational Site Utrecht Netherlands 3524 SJ
    138 Pfizer Investigational Site Utrecht Netherlands 3525 AL
    139 Pfizer Investigational Site Utrecht Netherlands 3527 CE
    140 Pfizer Investigational Site Utrecht Netherlands 3565 CE
    141 Pfizer Investigational Site Utrecht Netherlands 3582 KE
    142 Pfizer Investigational Site Veldhoven Netherlands 5500 AA
    143 Pfizer Investigational Site Veldhoven Netherlands 5503 VV
    144 Pfizer Investigational Site Veldhoven Netherlands 5504 DB
    145 Pfizer Investigational Site Velp Netherlands 6883 AW
    146 Pfizer Investigational Site Venlo Netherlands 5911HH
    147 Pfizer Investigational Site Venlo Netherlands 5912 BL
    148 Pfizer Investigational Site Waalwijk Netherlands 5141 BM
    149 Pfizer Investigational Site Warmenhuizen Netherlands 1749 AK
    150 Pfizer Investigational Site Weert Netherlands 3001 BE
    151 Pfizer Investigational Site Woerden Netherlands 3447 GN
    152 Pfizer Investigational Site Zeist Netherlands 3703 CD
    153 Pfizer Investigational Site Zeist Netherlands 3707 HL
    154 Pfizer Investigational Site Zeist Netherlands 3707 HX
    155 Pfizer Investigational Site Zevenaar Netherlands 6903 ZN
    156 Pfizer Investigational Site Zutphen Netherlands 7201 NC
    157 Pfizer Investigational Site Zutphen Netherlands 7207 BA
    158 Pfizer Investigational Site Zwolle Netherlands 8025 AB
    159 Pfizer Investigational Site Zwolle Netherlands 8025 BT

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00744263
    Other Study ID Numbers:
    • 6115A1-3006
    • B1851025
    First Posted:
    Aug 29, 2008
    Last Update Posted:
    Oct 6, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Pneumonia
    Pneumococcal Infections
    Pneumonia, Pneumococcal
    Vaccines
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    Participant Flow

    Recruitment Details Of 84496 participants who were randomized in this study, 2011 participants were included in the immunogenicity subset. Participants in the immunogenicity subset were analyzed for local reactions and systemic events as per planned analysis.
    Pre-assignment Detail
    Arm/Group Title 13vPnC Placebo
    Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
    Period Title: Overall Study
    STARTED 42240 42256
    COMPLETED 37004 36936
    NOT COMPLETED 5236 5320

    Baseline Characteristics

    Arm/Group Title 13vPnC Placebo Total
    Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1. Total of all reporting groups
    Overall Participants 42237 42255 84492
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    72.8
    (5.7)
    72.8
    (5.6)
    72.8
    (5.7)
    Sex: Female, Male (Count of Participants)
    Female
    18790
    44.5%
    18454
    43.7%
    37244
    44.1%
    Male
    23447
    55.5%
    23801
    56.3%
    47248
    55.9%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With First Episode of Confirmed Vaccine-type Community-acquired Pneumonia (VT-CAP)
    Description CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature greater than (>) 38.0 degrees Celsius (C) or less than (<) 36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15 percent (%) bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 millimeter of mercury (mmHg). Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: VT Streptococcus pneumonia culture from blood, pleural fluid or other sterile site and/or positive VT serotype-specific urinary antigen detection (SSUAD).
    Time Frame Baseline up to occurrence of first episode of VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)

    Outcome Measure Data

    Analysis Population Description
    Per-protocol(PP) population: eligible participants who received study vaccine, 65 years or older, identified with CAP(pre-defined criteria) or had invasive pneumococcal disease(IPD); symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.
    Arm/Group Title 13vPnC Placebo
    Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
    Measure Participants 42240 42256
    Number [participants]
    49
    0.1%
    90
    0.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
    Comments Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1 - (proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method Clopper-Pearson method
    Comments
    Method of Estimation Estimation Parameter Vaccine Efficacy
    Estimated Value 45.56
    Confidence Interval (2-Sided) 95.2%
    21.82 to 62.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Number of Participants With First Episode of Nonbacteremic/Noninvasive (NB/NI) Vaccine-type Community-acquired Pneumonia (VT-CAP)
    Description CAP was defined based on clinical and radiological criteria. Microbiological criteria differentiate different categories of CAP. Clinical criteria: presence of 2 or more criteria from following: cough, production of purulent sputum/change in sputum character, temperature >38.0 degrees C or <36.1 degrees C, auscultatory findings consistent with pneumonia including rales and/or evidence of pulmonary consolidation, leukocytosis (>10*10^9 white blood cells/liter or >15% bands), C-reactive protein level >3 times upper limit of normal, hypoxemia with partial oxygen pressure <60 mmHg. Radiological criteria: pneumonia confirmation by adjudication committee via lateral, posterior-anterior chest x-ray or anterior-posterior chest x-ray. Microbiological criteria: Confirmed VT pneumococcal CAP (by SSUAD) where a blood culture result was available and was negative and for which any other sterile culture results were negative for Streptococcus pneumoniae.
    Time Frame Baseline up to occurrence of first episode of NB/NI VT-CAP, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)

    Outcome Measure Data

    Analysis Population Description
    PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.
    Arm/Group Title 13vPnC Placebo
    Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
    Measure Participants 42240 42256
    Number [participants]
    33
    0.1%
    60
    0.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
    Comments Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0067
    Comments
    Method Clopper-Pearson method
    Comments
    Method of Estimation Estimation Parameter Vaccine Efficacy
    Estimated Value 45.00
    Confidence Interval (2-Sided) 95.2%
    14.21 to 65.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Number of Participants With First Episodes of Vaccine-type Invasive Pneumococcal Disease (VT-IPD) Cases
    Description VT-IPD was defined as the presence of Streptococcus pneumoniae in a sterile site (blood, cerebrospinal fluid, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, or joint fluid).
    Time Frame Baseline up to occurrence of first episode of VT-IPD, death, withdrawal of consent, loss to follow-up, participant request or end of case acquisition defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)

    Outcome Measure Data

    Analysis Population Description
    PP population: eligible participants who received study vaccine, 65 years or older, identified with CAP (pre-defined criteria) or had IPD; symptom onset at least 14 days after vaccination; immunocompetent at time of episode; no major protocol violations as determined by clinical scientist/medical monitor.
    Arm/Group Title 13vPnC Placebo
    Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
    Measure Participants 42240 42256
    Number [participants]
    7
    0%
    28
    0.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
    Comments Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0005
    Comments
    Method Clopper-Pearson method
    Comments
    Method of Estimation Estimation Parameter Vaccine Efficacy
    Estimated Value 75.00
    Confidence Interval (2-Sided) 95%
    41.43 to 90.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Other Pre-specified Outcome
    Title Percentage of Participants With Pre-specified Local Reactions Within 7 Days After Vaccination
    Description Local reactions were reported using electronic diary (e-diary). Redness and swelling scaled as Any (redness or swelling present); Absent (no or minimal); Mild (2.5 centimeter [cm] to 5.0 cm); Moderate (5.1 to 10.0 cm); Severe (>10.0 cm). Pain scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity). Limitation of arm movement scaled as Any (limitation present); Absent (no limitation of arm movement); Mild (some limitation of arm movement); Moderate (unable to move arm above head, but able to move arm above shoulder); Severe (unable to move arm above shoulder). Percentage of participants with local reactions were reported. Participants may be represented in more than 1 category.
    Time Frame Within 7 days after vaccination

    Outcome Measure Data

    Analysis Population Description
    Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Here 'N' (number of participants analyzed) signifies participants with known values for any local reaction and 'n' signifies participants with known values for specified local reaction.
    Arm/Group Title 13vPnC Placebo
    Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
    Measure Participants 917 867
    Redness: Any (n = 886, 859)
    4.9
    0%
    1.2
    0%
    Redness: Mild (n = 886, 859)
    3.7
    0%
    0.8
    0%
    Redness: Moderate (n = 881, 859)
    1.7
    0%
    0.3
    0%
    Redness: Severe (n = 881, 859)
    0.5
    0%
    0.1
    0%
    Swelling: Any (n = 888, 859)
    6.8
    0%
    1.2
    0%
    Swelling: Mild (n = 888, 859)
    5.5
    0%
    0.7
    0%
    Swelling: Moderate (n = 884, 859)
    2.6
    0%
    0.6
    0%
    Swelling: Severe (n = 881, 859)
    0.1
    0%
    0.1
    0%
    Pain: Any (n = 914, 863)
    36.1
    0.1%
    6.1
    0%
    Pain: Mild (n = 913, 861)
    32.9
    0.1%
    5.6
    0%
    Pain: Moderate (n = 886, 860)
    7.7
    0%
    0.6
    0%
    Pain: Severe (n = 881, 860)
    0.3
    0%
    0.1
    0%
    Limitation of arm movement: Any (n = 891, 865)
    14.1
    0%
    3.2
    0%
    Limitation of arm movement: Mild (n = 888, 863)
    12.4
    0%
    2.5
    0%
    Limitation of arm movement: Moderate (n =883, 860)
    1.7
    0%
    0.5
    0%
    Limitation of arm movement: Severe (n = 882, 861)
    1.2
    0%
    0.7
    0%
    5. Other Pre-specified Outcome
    Title Percentage of Participants With Pre-specified Systemic Events Within 7 Days After Vaccination
    Description Systemic events (fever, fatigue, headache, chills, rash, vomiting, decreased appetite, diarrhea, new generalized muscle/joint pain [new muscle/joint pain], aggravated generalized muscle/joint pain [aggravated muscle/joint pain], use of medication to treat pain/fever) reported using an e-diary. Fever scaled as Absent(<38 degrees C); Mild(greater than or equal to [>=]38 to <38.5 degrees C); Moderate(>=38.5 to <39 degrees C); Severe(>=39 to less than or equal to [<=]40 degrees C); Potentially life threatening (>40 degrees C). Fatigue, headache, new/aggravated muscle/joint pain scaled as Mild(no interference); Moderate(some interference); Severe(prevented routine activity). Vomiting scaled as Mild(1-2 times in 24 hours [hrs]); Moderate(>2 times in 24 hrs); Severe(required intravenous hydration). Diarrhea scaled as Mild(2-3 loose stools in 24 hrs); Moderate(4-5 loose stools in 24 hrs); Severe(>=6 loose stools in 24 hrs). Percentage of participants with systemic events were reported.
    Time Frame Within 7 days after vaccination

    Outcome Measure Data

    Analysis Population Description
    Immunogenicity subset. Participants may be represented in more than 1 category. Here 'N' (number of participants analyzed) signifies participants with known values for any systemic event and 'n' signifies participants with known values for specified systemic event.
    Arm/Group Title 13vPnC Placebo
    Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
    Measure Participants 918 907
    Fever: >=38 to <38.5 degrees C (n = 883, 859)
    1.1
    0%
    0.6
    0%
    Fever: >=38.5 to <39 degrees C (n = 881, 859)
    0.6
    0%
    0.2
    0%
    Fever: >=39 to =<40 degrees C (n = 882, 859)
    0.7
    0%
    0.2
    0%
    Fever: >40 degrees C (n = 882, 860)
    0.8
    0%
    0.3
    0%
    Fatigue: Mild (n = 892, 871)
    13.8
    0%
    11.7
    0%
    Fatigue: Moderate (n = 886, 866)
    7.8
    0%
    6.2
    0%
    Fatigue: Severe (n = 883, 863)
    1.4
    0%
    0.9
    0%
    Headache: Mild (n = 891, 870)
    13.0
    0%
    13.1
    0%
    Headache: Moderate (n = 883, 868)
    5.2
    0%
    3.8
    0%
    Headache: Severe (n = 881, 861)
    0.6
    0%
    0.6
    0%
    Chills (n = 891, 866)
    9.4
    0%
    8.4
    0%
    Rash (n = 882, 860)
    3.3
    0%
    0.8
    0%
    Vomiting: Mild (n = 881, 860)
    0.0
    0%
    0.7
    0%
    Vomiting: Moderate (n =881, 860)
    0.1
    0%
    0.1
    0%
    Vomiting: Severe (n = 881, 860)
    0.2
    0%
    0.1
    0%
    Decreased appetite (n = 886, 865)
    5.3
    0%
    3.7
    0%
    Diarrhea: Mild (n = 887, 868)
    5.1
    0%
    7.7
    0%
    Diarrhea: Moderate (n = 882, 863)
    1.2
    0%
    1.0
    0%
    Diarrhea: Severe (n = 881, 862)
    0.7
    0%
    0.5
    0%
    New muscle pain: Mild (n = 894, 865)
    14.5
    0%
    6.7
    0%
    New muscle pain: Moderate (n = 886, 863)
    5.9
    0%
    2.8
    0%
    New muscle pain: Severe (n = 882, 860)
    0.7
    0%
    0.5
    0%
    Aggravated muscle pain: Mild (n = 886, 862)
    4.6
    0%
    1.9
    0%
    Aggravated muscle pain: Moderate (n = 885, 863)
    5.1
    0%
    2.8
    0%
    Aggravated muscle pain: Severe (n = 882, 860)
    0.7
    0%
    0.1
    0%
    New joint pain: Mild (n = 884, 862)
    5.0
    0%
    3.9
    0%
    New joint pain: Moderate (n = 883, 864)
    2.9
    0%
    2.2
    0%
    New joint pain: Severe (n = 882, 860)
    0.3
    0%
    0.3
    0%
    Aggravated joint pain: Mild (n = 883, 861)
    2.3
    0%
    1.7
    0%
    Aggravated joint pain: Moderate (n = 884, 862)
    3.2
    0%
    2.6
    0%
    Aggravated joint pain: Severe (n = 882, 860)
    0.3
    0%
    0.3
    0%
    Use of medication to treat pain (n = 887, 872)
    8.0
    0%
    6.2
    0%
    Use of medication to treat fever (n = 883, 863)
    3.2
    0%
    1.5
    0%
    6. Other Pre-specified Outcome
    Title Percentage of Participants Who Died
    Description Deaths collected throughout the case acquisition period were presented.
    Time Frame From signing of informed consent form up to case acquisition period defined as accumulation of 130 VT cases (mean follow-up was 3.97 years)

    Outcome Measure Data

    Analysis Population Description
    Safety population included all participants who received study vaccine and who had any safety data.
    Arm/Group Title 13vPnC Placebo
    Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
    Measure Participants 42237 42255
    Number [percentage of participants]
    7.1
    0%
    7.1
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
    Comments Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.979
    Comments
    Method Fisher Exact
    Comments
    7. Other Pre-specified Outcome
    Title Percentage of Participants With Newly Diagnosed Chronic Medical Condition
    Description Percentage of participants with newly diagnosed chronic medical conditions (including autoimmune or neuroinflammatory disease) in the immunogenicity subset were reported as per planned analysis.
    Time Frame From 1 month after vaccination up to 6 months after vaccination

    Outcome Measure Data

    Analysis Population Description
    Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
    Arm/Group Title 13vPnC Placebo
    Arm/Group Description Participants received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1. Participants received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1.
    Measure Participants 1006 1005
    Number [percentage of participants]
    1.7
    0%
    1.2
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 13vPnC, Placebo
    Comments Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.455
    Comments
    Method Fisher Exact
    Comments

    Adverse Events

    Time Frame Safety set (SAEs: Day 1 up to 1 month after vaccination); Immunogenicity subset (SAEs:1 month up to 6 month after vaccination; Other AEs: Day 1 up to 1 month after vaccination; pre-specified local reactions, systemic events:up to 7 days after vaccination)
    Adverse Event Reporting Description SAEs were collected up to 1 month after vaccination for safety set. For immunogenicity subset, other AEs were collected up to 1 month after vaccination and SAEs collected from 1 month up to 6 months after vaccination. Deaths collected throughout case acquisition period but reported as SAE only during SAE collection periods as per planned analysis.
    Arm/Group Title 13vPnC Safety Set Placebo Safety Set 13vPnC Immunogenicity Subset Placebo Immunogenicity Subset
    Arm/Group Description All Participants who received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection on Day 1, were assessed for serious adverse events (SAEs) from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data. All participants who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from vaccination up to 1 month after vaccination. Safety set included all participants who received study vaccine and who had any safety data. Participants included in immunogenicity subset who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other adverse events (AEs) from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures. Participants included in immunogenicity subset who received placebo matched to a single dose of 13vPnC intramuscular injection on Day 1, were assessed for SAEs from 1 month after vaccination up to 6 months after vaccination and for Other AEs from vaccination up to 1 month after vaccination. Immunogenicity subset included participants enrolled in the subset who received study vaccine, were able to complete e-diary and fulfilled other study procedures.
    All Cause Mortality
    13vPnC Safety Set Placebo Safety Set 13vPnC Immunogenicity Subset Placebo Immunogenicity Subset
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    13vPnC Safety Set Placebo Safety Set 13vPnC Immunogenicity Subset Placebo Immunogenicity Subset
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 327/42237 (0.8%) 314/42255 (0.7%) 55/1006 (5.5%) 48/1005 (4.8%)
    Blood and lymphatic system disorders
    Anaemia 2/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Idiopathic thrombocytopenic purpura 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Iron deficiency anaemia 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Pancytopenia 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cardiac disorders
    Angina pectoris 19/42237 (0%) 19/42255 (0%) 3/1006 (0.3%) 1/1005 (0.1%)
    Atrial fibrillation 13/42237 (0%) 9/42255 (0%) 3/1006 (0.3%) 1/1005 (0.1%)
    Myocardial infarction 12/42237 (0%) 6/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Cardiac failure 7/42237 (0%) 10/42255 (0%) 4/1006 (0.4%) 0/1005 (0%)
    Atrial flutter 5/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Coronary artery disease 3/42237 (0%) 4/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Acute coronary syndrome 2/42237 (0%) 3/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Cardiac asthma 2/42237 (0%) 3/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Angina unstable 2/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cardiac arrest 2/42237 (0%) 1/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Sick sinus syndrome 1/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Aortic valve stenosis 1/42237 (0%) 1/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Atrioventricular block 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Atrioventricular block complete 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Myocardial ischaemia 1/42237 (0%) 1/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Pericarditis 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Supraventricular tachycardia 0/42237 (0%) 2/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Acute myocardial infarction 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Arrhythmia 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Atrial tachycardia 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Bradycardia 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cardio-respiratory arrest 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Coronary artery dissection 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Left ventricular failure 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Mitral valve incompetence 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Palpitations 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Silent myocardial infarction 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Sinus bradycardia 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Ventricular tachycardia 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Atrioventricular block second degree 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Cardiac failure congestive 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Coronary artery stenosis 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Ear and labyrinth disorders
    Vertigo positional 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Vertigo 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Eye disorders
    Retinal detachment 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Retinal artery occlusion 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Macular fibrosis 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Gastrointestinal disorders
    Ileus 2/42237 (0%) 4/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Constipation 4/42237 (0%) 1/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Rectal haemorrhage 1/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Colitis 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Diarrhoea 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Gastrooesophageal reflux disease 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Pancreatitis acute 2/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Abdominal pain 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Duodenal perforation 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Duodenal ulcer 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Gastric perforation 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Gastritis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Inguinal hernia, obstructive 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Intestinal obstruction 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Intestinal perforation 1/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Melaena 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Pancreatitis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Subileus 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Upper gastrointestinal haemorrhage 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Varices oesophageal 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Abdominal hernia 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Diverticulum intestinal haemorrhagic 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Large intestinal stenosis 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Umbilical hernia 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    General disorders
    Non-cardiac chest pain 12/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Chest pain 5/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Device dislocation 2/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Accidental death 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Death 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Device occlusion 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Hernia obstructive 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Malaise 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Medical device complication 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Pyrexia 1/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Sudden cardiac death 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Implant site fibrosis 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Hepatobiliary disorders
    Cholecystitis 2/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Bile duct stone 0/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cholangitis 2/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cholecystitis acute 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cholelithiasis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Immune system disorders
    Anaphylactic reaction 0/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Anaphylactic shock 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Corneal graft rejection 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Infections and infestations
    Pneumonia 14/42237 (0%) 6/42255 (0%) 4/1006 (0.4%) 1/1005 (0.1%)
    Appendicitis 2/42237 (0%) 4/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Device related infection 3/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Urinary tract infection 2/42237 (0%) 3/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Urosepsis 1/42237 (0%) 3/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Gastroenteritis 0/42237 (0%) 3/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Pneumonia pneumococcal 1/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Diverticulitis 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Pneumonia legionella 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Wound infection 0/42237 (0%) 2/42255 (0%) 2/1006 (0.2%) 1/1005 (0.1%)
    Bronchiolitis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cholangitis suppurative 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cystitis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Erysipelas 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Herpes zoster 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Infective exacerbation of chronic obstructive airways disease 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Meningitis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Peritonitis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Peritonsillar abscess 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Respiratory tract infection 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Staphylococcal bacteraemia 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Staphylococcal infection 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Tuberculosis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Upper respiratory tract infection 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Vestibular neuronitis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Viral infection 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Viral upper respiratory tract infection 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Abdominal abscess 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Injury, poisoning and procedural complications
    Femur fracture 5/42237 (0%) 4/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Hip fracture 3/42237 (0%) 3/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Femoral neck fracture 3/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Humerus fracture 1/42237 (0%) 4/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Brain contusion 2/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Radius fracture 1/42237 (0%) 3/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Ankle fracture 2/42237 (0%) 1/42255 (0%) 0/1006 (0%) 2/1005 (0.2%)
    Contusion 0/42237 (0%) 3/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Head injury 1/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Rib fracture 3/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Subdural haematoma 2/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Tendon rupture 0/42237 (0%) 3/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Fracture 0/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Pelvic fracture 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Ulna fracture 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Wrist fracture 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Accidental overdose 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Anaemia postoperative 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cardiac valve replacement complication 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Concussion 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Facial bones fracture 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Forearm fracture 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Foreign body aspiration 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Incisional hernia 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Injury 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Joint dislocation 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Kidney contusion 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Ligament injury 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Lower limb fracture 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Mental status changes postoperative 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Multiple injuries 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Periprosthetic fracture 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Post laminectomy syndrome 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Procedural intestinal perforation 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Procedural pain 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Tendon injury 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Thermal burn 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Urinary retention postoperative 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Vascular graft occlusion 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Wound dehiscence 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Procedural haemorrhage 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Investigations
    Weight decreased 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Metabolism and nutrition disorders
    Electrolyte imbalance 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Hypoglycaemia 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Musculoskeletal and connective tissue disorders
    Finger deformity 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Intervertebral disc protrusion 1/42237 (0%) 0/42255 (0%) 2/1006 (0.2%) 1/1005 (0.1%)
    Lumbar spinal stenosis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Osteoarthritis 1/42237 (0%) 0/42255 (0%) 2/1006 (0.2%) 10/1005 (1%)
    Arthralgia 0/42237 (0%) 0/42255 (0%) 2/1006 (0.2%) 0/1005 (0%)
    Bone cyst 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Polymyalgia rheumatica 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Rotator cuff syndrome 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Spondylolisthesis 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 22/42237 (0.1%) 16/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Prostate cancer 10/42237 (0%) 7/42255 (0%) 0/1006 (0%) 2/1005 (0.2%)
    Colon cancer 7/42237 (0%) 6/42255 (0%) 2/1006 (0.2%) 1/1005 (0.1%)
    Breast cancer 2/42237 (0%) 3/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Malignant melanoma 2/42237 (0%) 3/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Transitional cell carcinoma 2/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Gastric cancer 2/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Adenocarcinoma of colon 0/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Bladder cancer 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Colon cancer metastatic 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Endometrial adenocarcinoma 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Non-small cell lung cancer 2/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Plasma cell myeloma 2/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Rectal cancer 2/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Bladder adenocarcinoma stage unspecified 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Bowen's disease 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Bronchial carcinoma 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Clear cell renal cell carcinoma 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Colorectal cancer metastatic 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Glioblastoma 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Glioma 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Hepatic adenoma 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Hypopharyngeal cancer 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Laryngeal cancer 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Leukaemia 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Lung adenocarcinoma metastatic 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Lung neoplasm malignant 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Malignant neoplasm of renal pelvis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Melanoma recurrent 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Mesothelioma 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Metastasis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Metastatic gastric cancer 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Metastatic renal cell carcinoma 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Myelodysplastic syndrome 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Neoplasm prostate 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Oesophageal adenocarcinoma 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Oesophageal carcinoma recurrent 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Prostate cancer metastatic 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Prostate cancer recurrent 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Renal cancer 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Renal cell carcinoma 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Small cell lung cancer 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Squamous cell carcinoma 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Squamous cell carcinoma of skin 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Tonsil cancer 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Bile duct adenocarcinoma 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Bladder transitional cell carcinoma 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Colon neoplasm 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Endometrial cancer 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Renal cancer recurrent 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Nervous system disorders
    Cerebrovascular accident 9/42237 (0%) 8/42255 (0%) 3/1006 (0.3%) 1/1005 (0.1%)
    Cerebral infarction 4/42237 (0%) 9/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Transient ischaemic attack 8/42237 (0%) 5/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Syncope 3/42237 (0%) 3/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Presyncope 1/42237 (0%) 3/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cerebral haemorrhage 2/42237 (0%) 1/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Subarachnoid haemorrhage 1/42237 (0%) 2/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Dizziness 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Epilepsy 0/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Loss of consciousness 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Transient global amnesia 0/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Acute disseminated encephalomyelitis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Cerebral ischaemia 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Convulsion 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Hemiparesis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Peroneal nerve palsy 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Radicular pain 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Radiculitis lumbosacral 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Trigeminal neuralgia 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Carotid artery stenosis 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Hepatic encephalopathy 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Ischaemic stroke 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Peripheral nerve lesion 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Psychiatric disorders
    Bipolar disorder 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Delirium 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Psychotic disorder 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Suicidal ideation 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Renal and urinary disorders
    Calculus bladder 2/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Haematuria 2/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Cystitis noninfective 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Nephrolithiasis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Renal impairment 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Ureteric stenosis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Urethral stenosis 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Urinary retention 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/42237 (0%) 2/42255 (0%) 1/1006 (0.1%) 1/1005 (0.1%)
    Acquired phimosis 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Female genital tract fistula 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Vaginal prolapse 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 13/42237 (0%) 8/42255 (0%) 2/1006 (0.2%) 1/1005 (0.1%)
    Pulmonary embolism 3/42237 (0%) 2/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Pneumothorax 1/42237 (0%) 3/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Epistaxis 2/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Dyspnoea exertional 0/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Sleep apnoea syndrome 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Alveolitis allergic 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Asphyxia 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Dyspnoea 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Hydrothorax 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Lung infiltration 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Pleural effusion 0/42237 (0%) 0/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Skin and subcutaneous tissue disorders
    Skin ulcer 0/42237 (0%) 2/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Rash 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Vascular disorders
    Circulatory collapse 3/42237 (0%) 2/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Aortic aneurysm 2/42237 (0%) 1/42255 (0%) 2/1006 (0.2%) 0/1005 (0%)
    Aortic aneurysm rupture 3/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Hypertension 1/42237 (0%) 1/42255 (0%) 0/1006 (0%) 1/1005 (0.1%)
    Hypotension 2/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Deep vein thrombosis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Haematoma 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Intermittent claudication 0/42237 (0%) 1/42255 (0%) 2/1006 (0.2%) 1/1005 (0.1%)
    Peripheral arterial occlusive disease 0/42237 (0%) 1/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Temporal arteritis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Thrombophlebitis 1/42237 (0%) 0/42255 (0%) 0/1006 (0%) 0/1005 (0%)
    Malignant hypertension 0/42237 (0%) 0/42255 (0%) 1/1006 (0.1%) 0/1005 (0%)
    Other (Not Including Serious) Adverse Events
    13vPnC Safety Set Placebo Safety Set 13vPnC Immunogenicity Subset Placebo Immunogenicity Subset
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 363/1006 (36.1%) 315/1005 (31.3%)
    Cardiac disorders
    Angina pectoris 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 2/1005 (0.2%)
    Atrial fibrillation 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Cardiac failure 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Mitral valve incompetence 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Palpitations 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Tachycardia 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Ear and labyrinth disorders
    Vertigo 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Eye disorders
    Conjunctivitis 0/0 (NaN) 0/0 (NaN) 5/1006 (0.5%) 0/1005 (0%)
    Cataract 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Conjunctivitis allergic 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Ocular hyperaemia 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Vitreous floaters 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Gastrointestinal disorders
    Diarrhoea 0/0 (NaN) 0/0 (NaN) 3/1006 (0.3%) 5/1005 (0.5%)
    Nausea 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 3/1005 (0.3%)
    Abdominal pain upper 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 1/1005 (0.1%)
    Gastrooesophageal reflux disease 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 2/1005 (0.2%)
    Change of bowel habit 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Eructation 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Gastritis 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Haemorrhoids 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Vomiting 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    General disorders
    Injection site erythema 0/0 (NaN) 0/0 (NaN) 30/1006 (3%) 0/1005 (0%)
    Injection site pain 0/0 (NaN) 0/0 (NaN) 18/1006 (1.8%) 2/1005 (0.2%)
    Injection site pruritus 0/0 (NaN) 0/0 (NaN) 10/1006 (1%) 0/1005 (0%)
    Injection site swelling 0/0 (NaN) 0/0 (NaN) 10/1006 (1%) 0/1005 (0%)
    Malaise 0/0 (NaN) 0/0 (NaN) 4/1006 (0.4%) 3/1005 (0.3%)
    Fatigue 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 4/1005 (0.4%)
    Injection site haematoma 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 2/1005 (0.2%)
    Injection site exfoliation 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 0/1005 (0%)
    Pyrexia 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 1/1005 (0.1%)
    Chills 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Cyst 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Device breakage 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Ill-defined disorder 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Injection site rash 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Injection site reaction 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Oedema peripheral 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Vaccination site erythema 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Vessel puncture site haematoma 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Fever: >=38 to <38.5 degrees C 0/0 (NaN) 0/0 (NaN) 10/883 (1.1%) 5/859 (0.6%)
    Fever: >=38.5 to <39 degrees C 0/0 (NaN) 0/0 (NaN) 5/881 (0.6%) 2/859 (0.2%)
    Fever: >=39 to =<40 degrees C 0/0 (NaN) 0/0 (NaN) 6/882 (0.7%) 2/859 (0.2%)
    Fever: >40 degrees C 0/0 (NaN) 0/0 (NaN) 7/882 (0.8%) 3/860 (0.3%)
    Fatigue: Mild 0/0 (NaN) 0/0 (NaN) 123/892 (13.8%) 102/871 (11.7%)
    Fatigue: Moderate 0/0 (NaN) 0/0 (NaN) 69/886 (7.8%) 54/866 (6.2%)
    Fatigue: Severe 0/0 (NaN) 0/0 (NaN) 12/883 (1.4%) 8/863 (0.9%)
    Headache: Mild 0/0 (NaN) 0/0 (NaN) 116/891 (13%) 114/870 (13.1%)
    Headache: Moderate 0/0 (NaN) 0/0 (NaN) 46/883 (5.2%) 33/868 (3.8%)
    Headache: Severe 0/0 (NaN) 0/0 (NaN) 5/881 (0.6%) 5/861 (0.6%)
    Chills 0/0 (NaN) 0/0 (NaN) 84/891 (9.4%) 73/866 (8.4%)
    Rash 0/0 (NaN) 0/0 (NaN) 29/882 (3.3%) 7/860 (0.8%)
    Vomiting: Mild 0/0 (NaN) 0/0 (NaN) 0/881 (0%) 6/860 (0.7%)
    Vomiting: Moderate 0/0 (NaN) 0/0 (NaN) 1/881 (0.1%) 1/860 (0.1%)
    Vomiting: Severe 0/0 (NaN) 0/0 (NaN) 2/881 (0.2%) 1/860 (0.1%)
    Decreased appetite 0/0 (NaN) 0/0 (NaN) 47/886 (5.3%) 32/865 (3.7%)
    Diarrhea: Mild 0/0 (NaN) 0/0 (NaN) 45/887 (5.1%) 67/868 (7.7%)
    Diarrhea: Moderate 0/0 (NaN) 0/0 (NaN) 11/882 (1.2%) 9/863 (1%)
    Diarrhea: Severe 0/0 (NaN) 0/0 (NaN) 6/881 (0.7%) 4/862 (0.5%)
    New generalized muscle pain: Mild 0/0 (NaN) 0/0 (NaN) 130/894 (14.5%) 58/865 (6.7%)
    New generalized muscle pain: Moderate 0/0 (NaN) 0/0 (NaN) 52/886 (5.9%) 24/863 (2.8%)
    New generalized muscle pain: Severe 0/0 (NaN) 0/0 (NaN) 6/882 (0.7%) 4/860 (0.5%)
    Aggravated generalized muscle pain: Mild 0/0 (NaN) 0/0 (NaN) 41/886 (4.6%) 16/862 (1.9%)
    Aggravated generalized muscle pain: Moderate 0/0 (NaN) 0/0 (NaN) 45/885 (5.1%) 24/863 (2.8%)
    Aggravated generalized muscle pain: Severe 0/0 (NaN) 0/0 (NaN) 6/882 (0.7%) 1/860 (0.1%)
    New generalized joint pain: Mild 0/0 (NaN) 0/0 (NaN) 44/884 (5%) 34/862 (3.9%)
    New generalized joint pain: Moderate 0/0 (NaN) 0/0 (NaN) 26/883 (2.9%) 19/864 (2.2%)
    New generalized joint pain: Severe 0/0 (NaN) 0/0 (NaN) 3/882 (0.3%) 3/860 (0.3%)
    Aggravated generalized joint pain: Mild 0/0 (NaN) 0/0 (NaN) 20/883 (2.3%) 15/861 (1.7%)
    Aggravated generalized joint pain: Moderate 0/0 (NaN) 0/0 (NaN) 28/884 (3.2%) 22/862 (2.6%)
    Aggravated generalized joint pain: Severe 0/0 (NaN) 0/0 (NaN) 3/882 (0.3%) 3/860 (0.3%)
    Hepatobiliary disorders
    Cholelithiasis 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Infections and infestations
    Nasopharyngitis 0/0 (NaN) 0/0 (NaN) 12/1006 (1.2%) 20/1005 (2%)
    Upper respiratory tract infection 0/0 (NaN) 0/0 (NaN) 8/1006 (0.8%) 17/1005 (1.7%)
    Cystitis 0/0 (NaN) 0/0 (NaN) 5/1006 (0.5%) 8/1005 (0.8%)
    Gastroenteritis 0/0 (NaN) 0/0 (NaN) 4/1006 (0.4%) 9/1005 (0.9%)
    Bronchitis 0/0 (NaN) 0/0 (NaN) 5/1006 (0.5%) 4/1005 (0.4%)
    Influenza 0/0 (NaN) 0/0 (NaN) 4/1006 (0.4%) 5/1005 (0.5%)
    Herpes zoster 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 1/1005 (0.1%)
    Pneumonia 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 3/1005 (0.3%)
    Sinusitis 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 1/1005 (0.1%)
    Fungal infection 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 0/1005 (0%)
    Urinary tract infection 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 1/1005 (0.1%)
    Wound infection 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 2/1005 (0.2%)
    Abscess oral 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Enteritis infectious 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Folliculitis 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Fungal skin infection 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Lower respiratory tract infection 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Oral herpes 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Otitis externa 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Otitis media 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Tinea barbae 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Injury, poisoning and procedural complications
    Limb injury 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 1/1005 (0.1%)
    Contusion 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 1/1005 (0.1%)
    Procedural pain 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 2/1005 (0.2%)
    Bone contusion 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Concussion 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Epicondylitis 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Face injury 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Muscle strain 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Periorbital contusion 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Traumatic haemorrhage 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Investigations
    International normalised ratio decreased 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 3/1005 (0.3%)
    Gout 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 2/1005 (0.2%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/0 (NaN) 0/0 (NaN) 5/1006 (0.5%) 1/1005 (0.1%)
    Myalgia 0/0 (NaN) 0/0 (NaN) 3/1006 (0.3%) 3/1005 (0.3%)
    Arthralgia 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 3/1005 (0.3%)
    Musculoskeletal stiffness 0/0 (NaN) 0/0 (NaN) 4/1006 (0.4%) 1/1005 (0.1%)
    Pain in extremity 0/0 (NaN) 0/0 (NaN) 3/1006 (0.3%) 0/1005 (0%)
    Tendonitis 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 2/1005 (0.2%)
    Intervertebral disc protrusion 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 1/1005 (0.1%)
    Fibromyalgia 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Inclusion body myositis 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Joint range of motion decreased 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Joint stiffness 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Muscle spasms 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Muscular weakness 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Musculoskeletal chest pain 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Musculoskeletal discomfort 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Musculoskeletal disorder 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Musculoskeletal pain 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Myositis 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Osteitis 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Pain in jaw 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Keratoacanthoma 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Nervous system disorders
    Headache 0/0 (NaN) 0/0 (NaN) 7/1006 (0.7%) 1/1005 (0.1%)
    Dizziness 0/0 (NaN) 0/0 (NaN) 3/1006 (0.3%) 3/1005 (0.3%)
    Ageusia 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Aphonia 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Cerebrovascular accident 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Neuropathy peripheral 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Paraesthesia 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Sciatica 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Syncope 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Transient ischaemic attack 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Renal and urinary disorders
    Haematuria 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Nephrolithiasis 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Urinary retention 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Respiratory, thoracic and mediastinal disorders
    Epistaxis 0/0 (NaN) 0/0 (NaN) 5/1006 (0.5%) 2/1005 (0.2%)
    Cough 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 1/1005 (0.1%)
    Productive cough 0/0 (NaN) 0/0 (NaN) 3/1006 (0.3%) 0/1005 (0%)
    Chronic obstructive pulmonary disease 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Dyspnoea 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Hyperventilation 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Lung disorder 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Rhinalgia 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Rhinorrhoea 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Sneezing 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Skin and subcutaneous tissue disorders
    Rash 0/0 (NaN) 0/0 (NaN) 2/1006 (0.2%) 1/1005 (0.1%)
    Dermatitis allergic 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 1/1005 (0.1%)
    Dry skin 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 1/1005 (0.1%)
    Blood blister 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Eczema 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Pruritus 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Pruritus generalised 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Skin ulcer 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Urticaria 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)
    Redness: Any 0/0 (NaN) 0/0 (NaN) 43/886 (4.9%) 10/859 (1.2%)
    Redness: Mild 0/0 (NaN) 0/0 (NaN) 33/886 (3.7%) 7/859 (0.8%)
    Redness: Moderate 0/0 (NaN) 0/0 (NaN) 15/881 (1.7%) 3/859 (0.3%)
    Redness: Severe 0/0 (NaN) 0/0 (NaN) 4/881 (0.5%) 1/859 (0.1%)
    Swelling: Any 0/0 (NaN) 0/0 (NaN) 60/888 (6.8%) 10/859 (1.2%)
    Swelling: Mild 0/0 (NaN) 0/0 (NaN) 49/888 (5.5%) 6/859 (0.7%)
    Swelling: Moderate 0/0 (NaN) 0/0 (NaN) 23/884 (2.6%) 5/859 (0.6%)
    Swelling: Severe 0/0 (NaN) 0/0 (NaN) 1/881 (0.1%) 1/859 (0.1%)
    Pain: Any 0/0 (NaN) 0/0 (NaN) 330/914 (36.1%) 53/863 (6.1%)
    Pain: Mild 0/0 (NaN) 0/0 (NaN) 300/913 (32.9%) 48/861 (5.6%)
    Pain: Moderate 0/0 (NaN) 0/0 (NaN) 68/886 (7.7%) 5/860 (0.6%)
    Pain: Severe 0/0 (NaN) 0/0 (NaN) 3/881 (0.3%) 1/860 (0.1%)
    Limitation of arm movement: Any 0/0 (NaN) 0/0 (NaN) 126/891 (14.1%) 28/865 (3.2%)
    Limitation of arm movement: Mild 0/0 (NaN) 0/0 (NaN) 110/888 (12.4%) 22/863 (2.5%)
    Limitation of arm movement: Moderate 0/0 (NaN) 0/0 (NaN) 15/883 (1.7%) 4/860 (0.5%)
    Limitation of arm movement: Severe 0/0 (NaN) 0/0 (NaN) 11/882 (1.2%) 6/861 (0.7%)
    Vascular disorders
    Hypertension 0/0 (NaN) 0/0 (NaN) 1/1006 (0.1%) 0/1005 (0%)
    Peripheral coldness 0/0 (NaN) 0/0 (NaN) 0/1006 (0%) 1/1005 (0.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00744263
    Other Study ID Numbers:
    • 6115A1-3006
    • B1851025
    First Posted:
    Aug 29, 2008
    Last Update Posted:
    Oct 6, 2014
    Last Verified:
    Oct 1, 2014