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    Clinical Trial Results:
    A Phase 3, Multicenter, Long-Term Observational Study of Subjects From Tanezumab Studies who Undergo a Total Knee, Hip or Shoulder Replacement

    Summary
    EudraCT number
    		 2013-002549-12
    Trial protocol
    		 HU   AT   ES   BG   DE   PT   FI   GB   SE   LT   HR  
    Global end of trial date
    15 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2020
    First version publication date
    23 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A4091064
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02674386
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 TJR FOLLOW-UP: TJR FOLLOW-UP
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., +1 1-800-718-1021, 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the post-operative outcome of subjects who underwent a total knee, hip, or shoulder replacement while participating in tanezumab Study A4091056, A4091057 or A4091058 (treatment period and safety follow-up period).
    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 Council for Harmonisation (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
    23 Aug 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 32
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Lithuania: 4
    Country: Number of subjects enrolled
    New Zealand: 6
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    Serbia: 1
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    United States: 80
    Worldwide total number of subjects
    150
    EEA total number of subjects
    48
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    73
    From 65 to 84 years
    75
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Included subjects from studies A4091056 (NCT02697773), A4091057 (NCT02709486) and A4091058 (NCT02528188) who had undergone a total joint replacement (TJR) surgery of knee, hip, or shoulder. If subject underwent an additional TJR surgery, data for that was also assessed.154 subjects were enrolled out of which only 150 met study eligibility criteria.

    Pre-assignment
    Screening details
    		 Pre-specified intent of this study was to compare results regardless of treatment group/doses in parent studies and also to report data for overall (combined subjects from all parent studies).

    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
    		 Placebo
    Arm description
    		 Subjects who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486).

    Arm title
    		 Tanezumab Combined
    Arm description
    		 Subjects who received tanezumab subcutaneous (SC) injection of 2.5 milligram (mg) or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tanezumab Combined
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058.

    Arm title
    		 NSAID
    Arm description
    		 Subjects who received non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NSAID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058.

    Number of subjects in period 1
    		Placebo Tanezumab Combined NSAID
    Started
    20
    113
    17
    Completed
    20
    107
    16
    Not completed
    0
    6
    1
         Consent withdrawn by subject
    -
    4
    -
         Unspecified
    -
    1
    -
         Lost to follow-up
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.

    Reporting group title
    Tanezumab Combined
    Reporting group description
    		 Subjects who received tanezumab subcutaneous (SC) injection of 2.5 milligram (mg) or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.

    Reporting group title
    NSAID
    Reporting group description
    		 Subjects who received non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.

    Reporting group values
    		 Placebo Tanezumab Combined NSAID Total
    Number of subjects
    		 20 113 17 150
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 9 55 9 73
        From 65-84 years
    		 10 57 8 75
        85 years and over
    		 0 0 0 0
        Unspecified
    		 1 1 0 2
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 65.26 ( 8.77 ) 64.57 ( 8.18 ) 62.94 ( 9.13 ) -
    Sex/Gender, Customized
    Units: Subjects
        Male
    		 6 50 4 60
        Female
    		 13 62 13 88
        Unspecified
    		 1 1 0 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 6 0 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 6 3 9
        White
    		 17 100 14 131
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 1 1 0 2
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 3 3 7
        Not Hispanic or Latino
    		 18 109 14 141
        Unknown or Not Reported
    		 1 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.

    Reporting group title
    Tanezumab Combined
    Reporting group description
    		 Subjects who received tanezumab subcutaneous (SC) injection of 2.5 milligram (mg) or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.

    Reporting group title
    NSAID
    Reporting group description
    		 Subjects who received non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.

    Subject analysis set title
    All Subjects
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.

    Primary: Number of Subjects With Surgeon's Assessment of Procedural Difficulty

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    End point title
    		 Number of Subjects With Surgeon's Assessment of Procedural Difficulty [1]
    End point description
    Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question (Q): “taking into consideration the subject's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications.” Subjects were reported based on these categories for knee, hip and shoulder joint. Subjects may have been counted more than once if they had TJR surgery in more than one joint. Safety analysis set: all enrolled subjects of this study who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying i.e. total (not partial) joint replacement surgery. Here, ‘number of subjects analysed (N)' = only those subjects who had data available for this endpoint. ‘Number analysed (n)’ = subjects evaluable for this endpoint at specified categories.
    End point type
    Primary
    End point timeframe
    Day 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    17
    92
    13
    122
    Units: subjects
        Knee: Uneventful (n=9,51,8,68)
    9
    49
    8
    66
        Knee: Minor Complications (n=9,51,8,68)
    0
    2
    0
    2
        Knee: Major Complications (n=9,51,8,68)
    0
    0
    0
    0
        Hip: Uneventful (n=8,41,4,53)
    8
    37
    4
    49
        Hip: Minor Complications (n=8,41,4,53)
    0
    4
    0
    4
        Hip: Major Complications (n=8,41,4,53)
    0
    0
    0
    0
        Shoulder: Uneventful (n=0,0,1,1)
    0
    0
    1
    1
        Shoulder: Minor Complications (n=0,0,1,1)
    0
    0
    0
    0
        Shoulder: Major Complications (n=0,0,1,1)
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale by Total Joint Replacement (TJR) at Week 24

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    End point title
    		 Number of Subjects With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale by Total Joint Replacement (TJR) at Week 24 [2]
    End point description
    SAPS has 4 questions; (Q1) How satisfied are you with the results of your surgery; results of surgery for improving (Q2) pain, (Q3) ability to do home/yard work, and (Q4) ability to do recreational activities. Items scored on a 4-point Likert scale with response of ‘very satisfied’ (100 points), ‘somewhat satisfied’ (75 points), ‘somewhat dissatisfied’ (50 points), and ‘very dissatisfied’ (25 points). Scale score=mean of scores of individual items, ranging from 25 to 100, higher scores= greater satisfaction. Here, number of subjects are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Subjects may have been counted more than once if they had TJR surgery in more than one joint. Safety analysis set analyzed. ‘N’=subjects who had data available for this endpoint. ‘n’=subjects evaluable for this endpoint at specified categories.
    End point type
    Primary
    End point timeframe
    Week 24
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    19
    99
    13
    131
    Units: subjects
        Knee: Q1: Satisfied (n=9,58,6,73)
    9
    53
    5
    67
        Knee: Q1: Dissatisfied (n=9,58,6,73)
    0
    5
    1
    6
        Knee: Q2: Satisfied (n=9,58,6,73)
    9
    52
    5
    66
        Knee: Q2: Dissatisfied (n=9,58,6,73)
    0
    6
    1
    7
        Knee: Q3: Satisfied (n=9,58,6,73)
    9
    48
    5
    62
        Knee: Q3: Dissatisfied (n=9,58,6,73)
    0
    10
    1
    11
        Knee: Q4: Satisfied (n=9,58,6,73)
    9
    50
    5
    64
        Knee: Q4: Dissatisfied (n=9,58,6,73)
    0
    8
    1
    9
        Hip: Q1: Satisfied (n=10,41,6,57)
    9
    40
    6
    55
        Hip: Q1: Dissatisfied (n=10,41,6,57)
    1
    1
    0
    2
        Hip: Q2: Satisfied (n=10,41,6,57)
    9
    41
    6
    56
        Hip: Q2: Dissatisfied (n=10,41,6,57)
    1
    0
    0
    1
        Hip: Q3: Satisfied (n=10,41,6,57)
    9
    41
    6
    56
        Hip: Q3: Dissatisfied (n=10,41,6,57)
    1
    0
    0
    1
        Hip: Q4: Satisfied (n=10,41,6,57)
    9
    40
    6
    55
        Hip: Q4: Dissatisfied (n=10,41,6,57)
    1
    1
    0
    2
        Shoulder: Q1: Satisfied (n=0,0,1,1)
    0
    0
    1
    1
        Shoulder: Q1: Dissatisfied (n=0,0,1,1)
    0
    0
    0
    0
        Shoulder: Q2: Satisfied (n=0,0,1,1)
    0
    0
    1
    1
        Shoulder: Q2: Dissatisfied (n=0,0,1,1)
    0
    0
    0
    0
        Shoulder: Q3: Satisfied (n=0,0,1,1)
    0
    0
    1
    1
        Shoulder: Q3: Dissatisfied (n=0,0,1,1)
    0
    0
    0
    0
        Shoulder:Q4: Satisfied (n=0,0,1,1)
    0
    0
    1
    1
        Shoulder: Q4: Dissatisfied (n=0,0,1,1)
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Post-Surgical Complications Upto Week 24

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    End point title
    		 Number of Subjects with Post-Surgical Complications Upto Week 24 [3]
    End point description
    Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Subjects may have been counted more than once if they had TJR surgery in more than one joint. Safety analysis set: enrolled subjects who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. ‘n’ = subjects evaluable for this endpoint at specified categories.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 24
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    20
    113
    17
    150
    Units: subjects
        Knee (n=10,66,9,85)
    0
    1
    0
    1
        Hip (n=10,48,7,65)
    0
    5
    0
    5
        Shoulder (n=0,0,1,1)
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24

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    End point title
    		 Number of Subjects With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 [4]
    End point description
    Subjects were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Subjects, who responded as yes have been reported here. Subjects may have been counted more than once if they had TJR surgery in more than one joint. Safety analysis set: enrolled subjects who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. ‘n’ = subjects evaluable for this endpoint at specified categories.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 24
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    20
    113
    17
    150
    Units: subjects
        Knee (n=10,66,9,85)
    0
    4
    0
    4
        Hip (n=10,48,7,65)
    0
    5
    1
    6
        Shoulder (n=0,0,1,1)
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Subjects who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24

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    End point title
    		 Number of Subjects who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 [5]
    End point description
    Subjects responded with a yes or no to the following question “are you participating in physical rehabilitation activities related to your replaced joint” Subjects responded with a yes, have been reported here. Subjects may have been counted more than once if they had TJR surgery in more than one joint. Safety analysis set: enrolled subjects who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. ‘n’ = subjects evaluable for this endpoint at specified categories.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 24
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    20
    113
    17
    150
    Units: subjects
        Knee (n=10,66,9,85)
    10
    55
    7
    72
        Hip (n=10,48,7,65)
    9
    33
    3
    45
        Shoulder (n=0,0,1,1)
    0
    0
    1
    1
    No statistical analyses for this end point

    Primary: Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24

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    End point title
    		 Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 [6]
    End point description
    Subjects assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Subjects may have been counted more than once if they had TJR surgery in more than one joint. Safety analysis set: enrolled subjects who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. ‘n’ = subjects evaluable for this endpoint at specified categories.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    20
    113
    17
    150
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: Knee (n=10,71,10,91)
    6.00 ( 2.31 )
    6.86 ( 2.14 )
    6.80 ( 2.20 )
    6.76 ( 2.16 )
        Baseline: Hip (n=10,48,7,65)
    6.10 ( 2.13 )
    6.81 ( 2.27 )
    5.86 ( 3.44 )
    6.60 ( 2.38 )
        Change at Week 24: Knee (n=9,63,7,79)
    -4.56 ( 1.24 )
    -5.32 ( 2.63 )
    -5.43 ( 2.51 )
    -5.24 ( 2.49 )
        Change at Week 24: Hip (n=10,42,6,58)
    -5.20 ( 2.30 )
    -5.67 ( 2.37 )
    -5.00 ( 4.10 )
    -5.52 ( 2.53 )
    No statistical analyses for this end point

    Primary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24

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    End point title
    		 Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 [7]
    End point description
    WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, subject-relevant symptoms for pain, stiffness and physical function in subjects with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Subjects may have been counted more than once if they had TJR surgery in more than one joint. Safety analysis set. Here, ‘N’ signifies only those subjects who had data available for this endpoint. ‘n’ = subjects evaluable for this endpoint at specified categories.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    20
    113
    15
    148
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: Knee (n=10,68,9,87)
    4.66 ( 3.05 )
    5.62 ( 2.33 )
    6.11 ( 2.31 )
    5.56 ( 2.41 )
        Baseline: Hip (n=10,46,6,62)
    4.80 ( 2.61 )
    5.97 ( 2.46 )
    6.13 ( 1.98 )
    5.80 ( 2.45 )
        Change at Week 24: Knee (n=9,61,7,77)
    -3.13 ( 1.74 )
    -4.50 ( 2.43 )
    -4.54 ( 3.15 )
    -4.34 ( 2.44 )
        Change at Week 24: Hip (n=10,40,5,55)
    -4.34 ( 2.52 )
    -4.92 ( 2.62 )
    -5.92 ( 2.40 )
    -4.91 ( 2.57 )
    No statistical analyses for this end point

    Primary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24

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    End point title
    		 Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 [8]
    End point description
    WOMAC: self-administered, disease-specific questionnaire, which assesses clinically important, subject-relevant symptoms for pain, stiffness and physical function in subjects with OA. Stiffness was defined as a sensation of decreased ease of movement in index joint (knee or hip). WOMAC stiffness subscale is a 2-item questionnaire used to assess amount of stiffness experienced due to OA in replaced/to be replaced index joint (knee or hip) during past 48 hours. It was calculated as mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. Subjects may have been counted more than once if they had TJR surgery in more than one joint. Safety analysis set. Here, ‘N’ signifies only those subjects who had data available for this endpoint. ‘n’ = subjects evaluable for this endpoint at specified categories.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    20
    113
    15
    148
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: Knee (n=10,68,9,87)
    4.80 ( 2.78 )
    5.75 ( 2.52 )
    6.44 ( 2.58 )
    5.71 ( 2.55 )
        Baseline: Hip (10,46,6,62)
    4.70 ( 2.75 )
    5.96 ( 2.69 )
    5.25 ( 3.50 )
    5.69 ( 2.77 )
        Change at Week 24: Knee (n=9,61,7,77)
    -1.78 ( 1.52 )
    -4.13 ( 2.58 )
    -3.43 ( 3.13 )
    -3.79 ( 2.62 )
        Change at Week 24: Hip (n=10,40,5,55)
    -4.00 ( 2.66 )
    -4.48 ( 2.87 )
    -3.80 ( 3.70 )
    -4.33 ( 2.86 )
    No statistical analyses for this end point

    Primary: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24

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    End point title
    		 Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 [9]
    End point description
    WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, subject-relevant symptoms for pain, stiffness and physical function in subjects with OA. It refers to subject's ability to move around and perform usual activities of daily living. WOMAC physical function subscale=17-item questionnaire used to assess degree of difficulty experienced due to OA in replaced joint during past 48 hours. Calculated as mean of scores from 17 individual questions, which may not be a whole (integer) number, scored on an NRS. Scores for each question and WOMAC physical function subscale score ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores=extreme difficulty/worse physical function. Subjects may have been counted more than once if they had TJR surgery in more than one joint. Safety analysis set. ‘N’= only those subjects who had data available for this OM. ‘n’ = subjects evaluable for this OM at specified categories.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    20
    113
    15
    148
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline: Knee (n=10,68,9,87)
    4.83 ( 2.99 )
    5.82 ( 2.11 )
    6.63 ( 1.98 )
    5.79 ( 2.23 )
        Baseline: Hip (n=10,46,6,62)
    5.56 ( 2.21 )
    6.50 ( 2.22 )
    6.86 ( 1.48 )
    6.38 ( 2.17 )
        Change at Week 24: Knee (n=9,61,7,77)
    -2.69 ( 1.51 )
    -4.42 ( 2.19 )
    -4.59 ( 2.90 )
    -4.24 ( 2.24 )
        Change at Week 24: Hip (n=10,40,5,55)
    -4.64 ( 2.13 )
    -5.05 ( 2.44 )
    -5.95 ( 1.84 )
    -5.06 ( 2.33 )
    No statistical analyses for this end point

    Primary: Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24

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    End point title
    		 Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 [10]
    End point description
    SPADI:self-administered questionnaire to measure pain and disability associated with shoulder pathology.Pain dimension:5 questions,scores for each question ranged from 0=no pain to 10=worst pain imaginable,higher scores=extreme pain. Functional activities: 8 questions to measure degree of difficulty, scores for each question ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as sum of non-missing scores divided by the maximum possible score (50 [for pain] and 80 with no missing items [for disability]) multiplied by 100.Total score=mean of two dimensions, ranged from 0=best to 100=worst,higher scores indicated worsening of condition.Safety analysis set analysed who had qualifying shoulder replacement.“N”=subjects who had data available for this endpoint. Data for arms placebo and tanezumab not reported as no subjects were evaluable. SD cannot be calculated and has been denoted as 99999.
    End point type
    Primary
    End point timeframe
    Baseline, Week 24
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    0 [11]
    0 [12]
    1
    1
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    ( )
    ( )
    89.88 ( 99999 )
    89.88 ( 99999 )
        Change at Week 24
    ( )
    ( )
    -89.88 ( 99999 )
    -89.88 ( 99999 )
    Notes
    [11] - Data for arm placebo not reported as no subjects were evaluable for this endpoint.
    [12] - Data for arm tanezumab not reported as no subjects were evaluable for this endpoint.
    No statistical analyses for this end point

    Primary: Number of Subjects who Used Concomitant Analgesic Medications

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    End point title
    		 Number of Subjects who Used Concomitant Analgesic Medications [13]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline up to Week 24
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Placebo Tanezumab Combined NSAID All Subjects
    Number of subjects analysed
    20
    113
    17
    150
    Units: subjects
    18
    100
    15
    133
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 24
    Adverse event reporting additional description
    Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one subject may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.

    Reporting group title
    Tanezumab Combined
    Reporting group description
    		 Subjects who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.

    Reporting group title
    NSAID
    Reporting group description
    		 Subjects who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.

    Reporting group title
    All Subjects
    Reporting group description
    		 All subjects who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.

    Reporting group title
    Tanezumab 2.5 mg
    Reporting group description
    		 Subjects who received tanezumab 2.5 mg SC injection in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.

    Reporting group title
    Tanezumab 2.5/5 mg
    Reporting group description
    		 Subjects who received tanezumab 2.5/5 mg SC injection in study A4091056 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.

    Reporting group title
    Tanezumab 5 mg
    Reporting group description
    		 Subjects who received tanezumab 5 mg SC injection in studies A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.

    Serious adverse events
    		 Placebo Tanezumab Combined NSAID All Subjects Tanezumab 2.5 mg Tanezumab 2.5/5 mg Tanezumab 5 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    15 / 113 (13.27%)
    2 / 17 (11.76%)
    17 / 150 (11.33%)
    5 / 52 (9.62%)
    3 / 8 (37.50%)
    7 / 53 (13.21%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    1 / 8 (12.50%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Periprosthetic fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery occlusion
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Parkinson's disease
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ischaemic
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    1 / 8 (12.50%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    1 / 8 (12.50%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 113 (2.65%)
    2 / 17 (11.76%)
    5 / 150 (3.33%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
    0 / 6
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    1 / 8 (12.50%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    0 / 17 (0.00%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Tanezumab Combined NSAID All Subjects Tanezumab 2.5 mg Tanezumab 2.5/5 mg Tanezumab 5 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    21 / 113 (18.58%)
    4 / 17 (23.53%)
    25 / 150 (16.67%)
    9 / 52 (17.31%)
    3 / 8 (37.50%)
    9 / 53 (16.98%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 20 (0.00%)
    9 / 113 (7.96%)
    0 / 17 (0.00%)
    9 / 150 (6.00%)
    3 / 52 (5.77%)
    0 / 8 (0.00%)
    6 / 53 (11.32%)
         occurrences all number
    0
    10
    0
    10
    3
    0
    7
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 113 (0.00%)
    1 / 17 (5.88%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Cardiac disorders
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 113 (0.00%)
    1 / 17 (5.88%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 113 (0.00%)
    1 / 17 (5.88%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 113 (0.00%)
    1 / 17 (5.88%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 113 (0.00%)
    1 / 17 (5.88%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 113 (0.00%)
    1 / 17 (5.88%)
    1 / 150 (0.67%)
    0 / 52 (0.00%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 113 (1.77%)
    0 / 17 (0.00%)
    2 / 150 (1.33%)
    0 / 52 (0.00%)
    1 / 8 (12.50%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    0
    2
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 113 (2.65%)
    0 / 17 (0.00%)
    3 / 150 (2.00%)
    0 / 52 (0.00%)
    1 / 8 (12.50%)
    2 / 53 (3.77%)
         occurrences all number
    0
    3
    0
    3
    0
    1
    2
    Joint swelling
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    1 / 17 (5.88%)
    2 / 150 (1.33%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    1
    2
    1
    0
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 113 (2.65%)
    0 / 17 (0.00%)
    3 / 150 (2.00%)
    3 / 52 (5.77%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    3
    0
    3
    3
    0
    0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 113 (1.77%)
    0 / 17 (0.00%)
    2 / 150 (1.33%)
    1 / 52 (1.92%)
    1 / 8 (12.50%)
    0 / 53 (0.00%)
         occurrences all number
    0
    2
    0
    2
    1
    1
    0
    Tendonitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 113 (0.88%)
    1 / 17 (5.88%)
    2 / 150 (1.33%)
    1 / 52 (1.92%)
    0 / 8 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    1
    2
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    For ‘age group breakdown of trial’ 2 subjects have incorrectly been placed under ‘elderly 85 years and over’, due to database limitation. The age for these 2 subjects are ‘unspecified’ as correctly captured under ‘age characteristics’
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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