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    Clinical Trial Results:
    A Study Evaluating the Efficacy and Safety of BOTOX® and Solifenacin in Patients with Overactive Bladder and Urinary Incontinence

    Summary
    EudraCT number
    		 2012-003255-11
    Trial protocol
    		 GB   DE   CZ   BE   PL  
    Global end of trial date
    27 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jun 2016
    First version publication date
    01 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    191622-125
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01767519
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan Limited
    Sponsor organisation address
    Allergan Limited Marlow International The Parkway, Marlow, United Kingdom, SL7 1YL
    Public contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com
    Scientific contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.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
    25 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy and safety of intradetrusor BOTOX 100 U compared to placebo in patients with overactive bladder (OAB) and urinary incontinence whose symptoms had not been adequately managed with anticholinergic therapy and were solifenacin-naïve.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Mar 2013
    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
    Belgium: 2
    Country: Number of subjects enrolled
    Canada: 13
    Country: Number of subjects enrolled
    Czech Republic: 49
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Poland: 96
    Country: Number of subjects enrolled
    United States: 166
    Worldwide total number of subjects
    356
    EEA total number of subjects
    177
    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)
    190
    From 65 to 84 years
    160
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participant Flow is for Treatment cycle 1, which is the double-blind portion of the study and includes the primary timepoint.

    Pre-assignment
    Screening details
    		 Patients were screened up to 28 days prior to randomization on Day 1.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BOTOX®
    Arm description
    		 Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BOTOX®
    Investigational medicinal product code
    Other name
    onabotulinumtoxinA, botulinum toxin Type A
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.

    Arm title
    		 solifenacin
    Arm description
    		 Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    solifenacin
    Investigational medicinal product code
    Other name
    Vesicare
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

    Arm title
    		 placebo
    Arm description
    		 Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

    Number of subjects in period 1
    		BOTOX® solifenacin placebo
    Started
    145
    151
    60
    Completed
    131
    138
    55
    Not completed
    14
    13
    5
         Adverse event, non-fatal
    5
    5
    1
         Other Reasons
    4
    4
    2
         Personal Reasons
    1
    -
    -
         Lost to follow-up
    3
    1
    2
         Lack of efficacy
    1
    -
    -
         Protocol deviation
    -
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BOTOX®
    Reporting group description
    		 Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.

    Reporting group title
    solifenacin
    Reporting group description
    		 Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

    Reporting group title
    placebo
    Reporting group description
    		 Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

    Reporting group values
    		 BOTOX® solifenacin placebo Total
    Number of subjects
    		 145 151 60 356
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 77 79 34 190
        From 65-84 years
    		 67 69 24 160
        85 years and over
    		 1 3 2 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.4 ( 12.82 ) 62.9 ( 11.79 ) 61.2 ( 12.19 ) -
    Gender, Male/Female
    Units: Participants
        Male
    		 22 17 9 48
        Female
    		 123 134 51 308
    Age, Customized
    Units: Subjects
        <65 years
    		 77 79 34 190
        ≥65 years
    		 68 72 26 166

    End points

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    End points reporting groups
    Reporting group title
    BOTOX®
    Reporting group description
    		 Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.

    Reporting group title
    solifenacin
    Reporting group description
    		 Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

    Reporting group title
    placebo
    Reporting group description
    		 Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

    Primary: Change from Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1

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    End point title
    		 Change from Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 [1]
    End point description
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 12
    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 is reported for this outcome measure
    End point values
    		 BOTOX® solifenacin placebo
    Number of subjects analysed
    145
    151
    60
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline
    4.86 ( 3.206 )
    5.23 ( 3.333 )
    4.38 ( 2.485 )
        Change from Study Baseline at Week 12
    -3.1 ( 2.799 )
    -2.66 ( 3.059 )
    -0.98 ( 2.417 )
    No statistical analyses for this end point

    Primary: Percentage of Patients with 100% Reduction in Incontinence Episodes in Treatment Cycle 1

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    End point title
    		 Percentage of Patients with 100% Reduction in Incontinence Episodes in Treatment Cycle 1 [2]
    End point description
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 12
    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 is reported for this outcome measure
    End point values
    		 BOTOX® solifenacin placebo
    Number of subjects analysed
    145
    151
    60
    Units: Percentage of Patients
        number (not applicable)
    33.8
    24.5
    11.7
    No statistical analyses for this end point

    Secondary: Percentage of Patients with a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1

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    End point title
    		 Percentage of Patients with a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1
    End point description
    A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing ‘greatly improved’ or ‘improved.’
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 BOTOX® solifenacin placebo
    Number of subjects analysed
    145
    151
    60
    Units: Percentage of Patients
        number (confidence interval)
    71.3 (62.9 to 78.7)
    74 (66.1 to 80.9)
    44.8 (31.7 to 58.5)
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1

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    End point title
    		 Change from Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1
    End point description
    The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12
    End point values
    		 BOTOX® solifenacin placebo
    Number of subjects analysed
    145
    151
    60
    Units: Micturition Episodes
    arithmetic mean (standard deviation)
        Study Baseline
    10.74 ( 2.52 )
    10.4 ( 2.665 )
    10.18 ( 2.491 )
        Change from Study Baseline at Wk 12 (N=135,144,57)
    -2.4 ( 2.827 )
    -2.03 ( 2.833 )
    -0.87 ( 2.413 )
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1

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    End point title
    		 Change from Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1
    End point description
    Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12
    End point values
    		 BOTOX® solifenacin placebo
    Number of subjects analysed
    145
    151
    60
    Units: Nocturia Episodes
    arithmetic mean (standard deviation)
        Study Baseline
    2.03 ( 1.159 )
    2.04 ( 1.083 )
    1.98 ( 0.937 )
        Change from Study Baseline at Wk 12 (N=135,144,57)
    -0.54 ( 1.195 )
    -0.49 ( 1.133 )
    -0.23 ( 1.091 )
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1

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    End point title
    		 Change from Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
    End point description
    The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12
    End point values
    		 BOTOX® solifenacin placebo
    Number of subjects analysed
    145
    150
    59
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline
    76.09 ( 24.281 )
    72.11 ( 26.581 )
    81.36 ( 20.781 )
        Change from Study Baseline at Wk 12 (N=135,145,57)
    -30 ( 33.259 )
    -23.79 ( 31.899 )
    -17.25 ( 29.033 )
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1

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    End point title
    		 Change from Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
    End point description
    The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12
    End point values
    		 BOTOX® solifenacin placebo
    Number of subjects analysed
    145
    150
    59
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline
    59.66 ( 21.442 )
    56.22 ( 22.708 )
    62.57 ( 22.551 )
        Change from Study Baseline at Wk 12 (N=135,145,57)
    -13.46 ( 21.906 )
    -12.7 ( 21.361 )
    -7.6 ( 21.667 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from signing the informed consent to the end of study.
    Adverse event reporting additional description
    The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    BOTOX®
    Reporting group description
    		 Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.

    Reporting group title
    placebo
    Reporting group description
    		 Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

    Reporting group title
    solifenacin
    Reporting group description
    		 Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.

    Serious adverse events
    		 BOTOX® placebo solifenacin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 145 (4.14%)
    2 / 60 (3.33%)
    6 / 147 (4.08%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 60 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Limb traumatic amputation
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 60 (0.00%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 60 (0.00%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 60 (0.00%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 60 (0.00%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Migraine
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 60 (0.00%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 60 (1.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Endometrial hyperplasia
    Additional description: FEMALE ONLY
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 60 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 60 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 145 (0.69%)
    0 / 60 (0.00%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polysubstance dependence
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 60 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 145 (0.00%)
    1 / 60 (1.67%)
    0 / 147 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 145 (0.00%)
    0 / 60 (0.00%)
    2 / 147 (1.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BOTOX® placebo solifenacin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    95 / 145 (65.52%)
    27 / 60 (45.00%)
    78 / 147 (53.06%)
    Investigations
    Residual urine volume
         subjects affected / exposed
    10 / 145 (6.90%)
    1 / 60 (1.67%)
    0 / 147 (0.00%)
         occurrences all number
    10
    1
    0
    Gastrointestinal disorders
    Dry mouth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 145 (2.76%)
    0 / 60 (0.00%)
    12 / 147 (8.16%)
         occurrences all number
    4
    0
    12
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    10 / 145 (6.90%)
    0 / 60 (0.00%)
    1 / 147 (0.68%)
         occurrences all number
    12
    0
    2
    Dysuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 145 (4.14%)
    2 / 60 (3.33%)
    8 / 147 (5.44%)
         occurrences all number
    6
    2
    11
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    37 / 145 (25.52%)
    6 / 60 (10.00%)
    15 / 147 (10.20%)
         occurrences all number
    53
    7
    19
    Bacteriuria
         subjects affected / exposed
    11 / 145 (7.59%)
    3 / 60 (5.00%)
    14 / 147 (9.52%)
         occurrences all number
    15
    3
    15
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 145 (1.38%)
    3 / 60 (5.00%)
    2 / 147 (1.36%)
         occurrences all number
    2
    3
    2

    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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