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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared with Meropenem in Complicated Intra-abdominal Infections

    Summary
    EudraCT number
    		 2016-002208-21
    Trial protocol
    		 HU   CZ   LV   EE   LT   BG  
    Global end of trial date
    19 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Dec 2021
    First version publication date
    25 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TP-434-025
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02784704
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Tetraphase Pharmaceuticals, Inc.
    Sponsor organisation address
    201 Jones Road, Suite 400, Waltham, United States, 02451
    Public contact
    Stew Kroll, Tetraphase Pharmaceuticals, Inc., 1 858-207-4264, ljpcregulatory@ljpc.com
    Scientific contact
    Stew Kroll, Tetraphase Pharmaceuticals, Inc., 1 858-207-4264, ljpcregulatory@ljpc.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
    15 Jul 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that eravacycline is non-inferior to meropenem in clinical response at the test-of-cure (TOC) visit in the all-treated (MITT) and the clinically evaluable (CE) populations
    Protection of trial subjects
    This study was conducted in compliance with ICH E6 GCP (consolidated guidelines and the ethical principles of the Declaration of Helsinki), and any additional national or IRB/IED- required procedures
    Background therapy
    		 -
    Evidence for comparator
    		 The comparator, meropenem, was chosen because it is approved by the FDA and other regulatory authorities for the treatment of cIAI. It was given at the recommended dose of 1g q8 for a minimum of four-24h dose cycles
    Actual start date of recruitment
    13 Oct 2016
    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
    Bulgaria: 93
    Country: Number of subjects enrolled
    Czech Republic: 29
    Country: Number of subjects enrolled
    Estonia: 31
    Country: Number of subjects enrolled
    Hungary: 30
    Country: Number of subjects enrolled
    Latvia: 68
    Country: Number of subjects enrolled
    Lithuania: 40
    Country: Number of subjects enrolled
    Romania: 57
    Country: Number of subjects enrolled
    Georgia: 24
    Country: Number of subjects enrolled
    Russian Federation: 34
    Country: Number of subjects enrolled
    Ukraine: 82
    Country: Number of subjects enrolled
    United States: 12
    Worldwide total number of subjects
    500
    EEA total number of subjects
    348
    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)
    355
    From 65 to 84 years
    140
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants at least 18 years of age with a diagnosis of cIAI were recruited into the study

    Pre-assignment
    Screening details
    		 Screening and baseline were performed after informed consent was obtained and within 48 hours prior to initial dose. Participants were eligible to participate if they met all of the inclusion criteria and none of the exclusion criteria at the Screening visit.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Subjects were assigned to study drug regimens using computerized randomization. Except for the responsible study site pharmacist or designee, and separate unblinded clinical research associates (CRAs) to monitor drug supply and adherence to study drug blinding and randomization procedures, all study staff and participants were blinded to the IV dosing regimens of subjects. The study blind codes were broken after the statistical analysis plan was finalized and the database was locked.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eravacycline (MITT)
    Arm description
    		 Eravacycline IV (MITT) modified intent-to treat population defined as subjects that were randomized and received at least 1 dose of study drug.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eravacycline IV
    Investigational medicinal product code
    Other name
    TP-434
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram (mg/kg) of body weight every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days.

    Arm title
    		 Meropenem (MITT)
    Arm description
    		 Meropenem IV (MITT) modified intent-to treat population defined as subjects that were randomized and received at least 1 dose of study drug. Please note that one subject randomized to Meropenem did not receive study drug.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meropenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Meropenem was administered intravenously (IV) at a dose of 1.0 grams (g) every 8 hours (q8h) for minimum of 4 days and a maximum of 14 days.

    Number of subjects in period 1 [1]
    		Eravacycline (MITT) Meropenem (MITT)
    Started
    250
    249
    Completed
    237
    241
    Not completed
    13
    8
         Consent withdrawn by subject
    1
    2
         Adverse event, non-fatal
    4
    2
         noncompliance
    2
    -
         Lost to follow-up
    6
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number reported in the baseline period differs by 1 subject versus the worldwide number enrolled due to 1 subject being enrolled in the meropenem group who did not receive study drug.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eravacycline (MITT)
    Reporting group description
    		 Eravacycline IV (MITT) modified intent-to treat population defined as subjects that were randomized and received at least 1 dose of study drug.

    Reporting group title
    Meropenem (MITT)
    Reporting group description
    		 Meropenem IV (MITT) modified intent-to treat population defined as subjects that were randomized and received at least 1 dose of study drug. Please note that one subject randomized to Meropenem did not receive study drug.

    Reporting group values
    		 Eravacycline (MITT) Meropenem (MITT) Total
    Number of subjects
    		 250 249 499
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 180 174 354
        From 65-84 years
    		 68 72 140
        85 years and over
    		 2 3 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.1 ± 17.69 52.8 ± 18.24 -
    Gender categorical
    Units: Subjects
        Female
    		 111 120 231
        Male
    		 139 129 268

    End points

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    End points reporting groups
    Reporting group title
    Eravacycline (MITT)
    Reporting group description
    		 Eravacycline IV (MITT) modified intent-to treat population defined as subjects that were randomized and received at least 1 dose of study drug.

    Reporting group title
    Meropenem (MITT)
    Reporting group description
    		 Meropenem IV (MITT) modified intent-to treat population defined as subjects that were randomized and received at least 1 dose of study drug. Please note that one subject randomized to Meropenem did not receive study drug.

    Primary: Clinical Response at the test of cure (TOC) visit in the MITT population

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    End point title
    		 Clinical Response at the test of cure (TOC) visit in the MITT population
    End point description
    This was a co-primary outcome measure for the European Medicines Agency (EMA). Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required), failure (death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI), or indeterminate (outcome was neither cure nor failure, or assessment was not available). The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
    End point type
    Primary
    End point timeframe
    TOC visit: 25-31 days after the first study dose
    End point values
    		 Eravacycline (MITT) Meropenem (MITT)
    Number of subjects analysed
    250
    249
    Units: subjects
        Clinical Cure
    231
    228
        Clinical Failure
    7
    9
        Indeterminate/Missing
    12
    12
    Statistical analysis title
    		 MITT
    Statistical analysis description
    A 2-sided 95% confidence interval (CI) for the observed difference in primary outcome rates (eravacycline treatment group minus meropenem treatment group) was calculated. If the lower limit of the 95% CI for the difference in clinical cure rates exceeded −12.5%, then the null hypothesis was rejected, and the non-inferiority of eravacycline to meropenem was declared
    Comparison groups
    Eravacycline (MITT) v Meropenem (MITT)
    Number of subjects included in analysis
    499
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 5.8
    Variability estimate
    Standard deviation
    Notes
    [1] - pre-specified

    Primary: Clinical Response at the TOC visit in the CE population

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    End point title
    		 Clinical Response at the TOC visit in the CE population
    End point description
    This was a co-primary outcome measure for the European Medicines Agency (EMA). Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required) or failure (death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI). The number of participants with a clinical response classification of cure or failure is presented.
    End point type
    Primary
    End point timeframe
    TOC visit: 25-31 days after the first dose of study drug
    End point values
    		 Eravacycline (MITT) Meropenem (MITT)
    Number of subjects analysed
    225
    231
    Units: subjects
        Clinical Cure
    218
    222
        Clinical Failure
    7
    9
    Statistical analysis title
    		 CE
    Statistical analysis description
    A 2-sided 95% confidence interval (CI) for the observed difference in primary outcome rates (eravacycline treatment group minus meropenem treatment group) was calculated. If the lower limit of the 95% CI for the difference in clinical cure rates exceeded −12.5%, then the null hypothesis was rejected, and the non-inferiority of eravacycline to meropenem was declared.
    Comparison groups
    Eravacycline (MITT) v Meropenem (MITT)
    Number of subjects included in analysis
    456
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 4.5
    Variability estimate
    Standard deviation
    Notes
    [2] - treatment difference

    Secondary: Clinical Response at the test of cure (TOC) visit in the micro-ITT population

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    End point title
    		 Clinical Response at the test of cure (TOC) visit in the micro-ITT population
    End point description
    This was the primary outcome measure for the United States Food and Drug Administration (FDA). Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required), failure (death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI), or indeterminate (outcome was neither cure nor failure, or assessment was not available). The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.
    End point type
    Secondary
    End point timeframe
    TOC visit: 25-31 days after the first dose of study drug
    End point values
    		 Eravacycline (MITT) Meropenem (MITT)
    Number of subjects analysed
    195
    205
    Units: subjects
        Clinical Cure
    177
    187
        Clinical Failure
    7
    7
        Indeterminate/Missing
    11
    11
    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 the first dose of study drug through 30 days after the last dose of study drug or the follow-up visit, which occurred 38 to 50 days after the first dose of study drug (whichever was later).
    Adverse event reporting additional description
    Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram (mg/kg) of body weight every 12 hours (q12h) for a minimum of 4 days and maximum of 14 days. Meropenem was administered intravenously (IV) at a dose of 1.0 grams (g) every 8 hours (q8h) for a minimum of 4 days and a maximum of 14 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Eravacycline
    Reporting group description
    		 Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram (mg/kg) of body weight every 12 hours (q12h) for a minimum of 4 days and maximum of 14 days.

    Reporting group title
    Meropenem
    Reporting group description
    		 Meropenem was administered intravenously (IV) at a dose of 1.0 grams (g) every 8 hours (q8h) for a minimum of 4 days and a maximum of 14 days

    Serious adverse events
    		 Eravacycline Meropenem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 250 (6.00%)
    16 / 249 (6.43%)
         number of deaths (all causes)
    4
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         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
    Pyrexia
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic fluid collection
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         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
    Chronic obstructive pulmonary disorders
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 250 (0.40%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 250 (0.40%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suture related complication
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound decomposition
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Splenic haematoma
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric rupture
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (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
    Abdominal abscess
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 250 (0.80%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 250 (0.00%)
    1 / 249 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 250 (0.40%)
    0 / 249 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Eravacycline Meropenem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 250 (11.60%)
    8 / 249 (3.21%)
    General disorders and administration site conditions
    Infusion site phlebitis
         subjects affected / exposed
    8 / 250 (3.20%)
    1 / 249 (0.40%)
         occurrences all number
    10
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    12 / 250 (4.80%)
    2 / 249 (0.80%)
         occurrences all number
    13
    3
    Vomiting
         subjects affected / exposed
    9 / 250 (3.60%)
    5 / 249 (2.01%)
         occurrences all number
    10
    6

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Mar 2017
    Amendment number 1 was implemented to documented the following: the increase in study sample size based on the pre-specified, blinded assessment of the proportion of participants who qualified for the micro-ITT population; global administrative changes and clarifications

    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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    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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