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    Clinical Trial Results:
    A Phase III double-blind, randomised, placebo controlled trial of long term therapy on Exacerbation Rate in patients with stable COPD using Doxycycline

    Summary
    EudraCT number
    		 2012-002199-15
    Trial protocol
    		 GB  
    Global end of trial date
    12 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    12/0036
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02305940
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensingston Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Jadwiga A Wedzicha, Imperial College London, j.wedzicha@imperial.ac.uk
    Scientific contact
    Jadwiga A Wedzicha, Imperial College London, j.wedzicha@imperial.ac.uk
    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
    02 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jul 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The principal research question/objective is to assess whether the use of an antibiotic for 12 months by a group of patients with COPD reduces their rate of COPD exacerbations (periodic flare-ups of COPD symptoms) compared to a control group, taking a placebo.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 222
    Worldwide total number of subjects
    222
    EEA total number of subjects
    222
    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)
    50
    From 65 to 84 years
    172
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was between July 2014 and July 2017.

    Pre-assignment
    Screening details
    		 222 participants were eligible for the study

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The eligible and clinically stable participants randomisation into groups of 1:1 and patients remained blinded to treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Doxycycline
    Arm description
    		 Doxycycline: An oral dose of 100 mg once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doxycycline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral dose of 100 mg once daily, for a total duration of 52 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Placebo one capsule daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral dose of one capsule once daily for 52 weeks.

    Number of subjects in period 1
    		Doxycycline Placebo
    Started
    110
    112
    Completed
    89
    94
    Not completed
    21
    18
         Consent withdrawn by subject
    10
    7
         death
    4
    1
         Adverse event, non-fatal
    -
    3
         Lost to follow-up
    6
    5
         Protocol deviation
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Doxycycline
    Reporting group description
    		 Doxycycline: An oral dose of 100 mg once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo one capsule daily

    Reporting group values
    		 Doxycycline Placebo Total
    Number of subjects
    		 110 112 222
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 68.8 ( 8 ) 67 ( 8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 46 50 96
        Male
    		 64 62 126

    End points

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    End points reporting groups
    Reporting group title
    Doxycycline
    Reporting group description
    		 Doxycycline: An oral dose of 100 mg once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo one capsule daily

    Primary: Rate of Exacerbations

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    End point title
    		 Rate of Exacerbations [1]
    End point description
    Rate of exacerbations (per person/year) recorded from date of drug issue until date of end of treatment visit.
    End point type
    Primary
    End point timeframe
    12 months
    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: Rate of exacerbations (per person/year) recorded from date of drug issue until date of end of treatment visit.
    End point values
    		 Doxycycline Placebo
    Number of subjects analysed
    110
    112
    Units: Exacerbations / year
        median (inter-quartile range (Q1-Q3))
    2 (1 to 4)
    3 (1 to 5)
    No statistical analyses for this end point

    Secondary: Forced Expiratory Volume in 1 Sec (FEV1)

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    End point title
    		 Forced Expiratory Volume in 1 Sec (FEV1)
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Doxycycline Placebo
    Number of subjects analysed
    89
    94
    Units: litres
        arithmetic mean (confidence interval 95%)
    -0.017 (-010 to 0.06)
    0 (0 to 0)
    Statistical analysis title
    		 Treatments
    Comparison groups
    Doxycycline v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.22
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Total SGRQ score

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    End point title
    		 Total SGRQ score
    End point description
    The St George's Respiratory Questionnaire (SGRQ) is an instrument for the measuring of Health-Related Quality-of-Life in patients with diseases of airways obstruction. All scales have a score range between 0 and 100 with higher scores indicating a worse quality of life.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Doxycycline Placebo
    Number of subjects analysed
    89
    94
    Units: score
        geometric mean (confidence interval 95%)
    5.20 (1.80 to 8.70)
    0 (0 to 0)
    Statistical analysis title
    		 Treatments
    Comparison groups
    Doxycycline v Placebo
    Number of subjects included in analysis
    183
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0034
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 8.7

    Secondary: Adherence of the Participants

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    End point title
    		 Adherence of the Participants
    End point description
    Adherence as measured using pill counts, the odds of a patient being adherent (taking their pill) on a given day.
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Doxycycline Placebo
    Number of subjects analysed
    110
    112
    Units: odds of taking pill
        arithmetic mean (confidence interval 95%)
    0.87 (0.43 to 1.80)
    0 (0 to 0)
    Statistical analysis title
    		 Treatments
    Comparison groups
    Doxycycline v Placebo
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.71
    Method
    		 Regression, Linear
    Parameter type
    		 Log odds ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Doxycycline
    Reporting group description
    		 Doxycycline: An oral dose of 100 mg once daily.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo: Oral dose of one capsule once daily.

    Serious adverse events
    		 Doxycycline Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    34 / 110 (30.91%)
    23 / 112 (20.54%)
         number of deaths (all causes)
    4
    1
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Sarcoma diagnosis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic prostate cancer
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer diagnosis
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Trauma to left thumb requiring surgical correction
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Two night hospital stay due to broken arm requiring surgery
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trauma with fracture of 6 ribs pneumothorax
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospital admission, left rib exacerbation COPD
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospital admission, right hip
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina secondary to iron deficiency
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death of patient, out of hospital cardiac arrest
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fast AF complicated by pulmonary oedema
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Admission for percutaneous coronary intervention and insertion of stent into LAD
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dilated cardiomyopathy and mild pulmonary hypertension
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical chest pain with raised troponin
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death of patient, myocardial infarction
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial fibrillation with fast ventricular response, leading to left ventricular failure
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular systolic dysfunction
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina attack
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Elective orthopaedic surgery, correction of longstanding leg deformity
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elective left total hip replacement
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elective admission for laparotomy for division of adhesions + sigmoidopexy
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Admission for craniotomy
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonic clonic seizure, alcohol related?
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Unknown
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death of patient
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Consolidation A&E attendance
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right arm and right leg weakness, unable to smile + shaking
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    suspected DVT
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small bowel obstruction
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    perforated diverticulum
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallstone cholecystitis diagnosed
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated abdominal wall hernia
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowel blockage
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Lung cancer diagnosis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    spontaneous secondary pneumothorax
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elective admission for Endobronchial valve insertion
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death of patient, diagnosed with metastatic lung cancer
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Hepatocellular carcinoma diagnosed
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Elective Trans-Urethral Resection of Prostate with 2 day admission
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Kidney Injury and Sepsis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left sided hydronephrosis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia requiring 6 day admission
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia and Multi-organ failure
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Community acquired pneumonia complicated by fast AF, initially treated as COPD exacerbation.
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospital acquired pneumonia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suspected aspiration treated for chest infection
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspirate pneumonia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Community acquired pneumonia
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Doxycycline Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 110 (8.18%)
    23 / 112 (20.54%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Elective prostate biopsy
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Vascular disorders
    Peripheral Vascular Disease
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Elective shoulder replacement
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Tonic Clonic Seizure
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Nausea and skin flushing red
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Accidental unblinding of patient
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    A&E attendance, facial swelling following tooth extraction
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    SAE to exclude PE
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Atypical non-cardiac chest pain
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Admission to exclude PE
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Admission with sepsis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Admission with atypical chest pain
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Elective admission for investigations to assess suitability for lung transplantation
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    Right sided uncoordination
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    Elective admission for assessment for ongoing non-invasive ventilation
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Likely oesophageal spasm
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Elective cholecystectomy
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    Gastritis/oesophagitis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    Elective left inguinal hernia repair
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 112 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Scrotal abscess
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Infected sebaceous cyst on scrotum
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Elective urological operation
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Elective prostate/urethral surgery
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Endocrine disorders
    Admission with palpitations, hyperthyroidism
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 112 (1.79%)
         occurrences all number
    0
    2
    New diagnosis polymyalgia rheumatica
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 112 (0.89%)
         occurrences all number
    0
    1

    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.
    None reported
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    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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