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    Clinical Trial Results:
    Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2010-018431-18
    Trial protocol
    DE   AT   GB   FR   BE   NL   IT   HU   CZ  
    Global end of trial date
    12 Dec 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Apr 2016
    First version publication date
    14 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    REMICADECRD3001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01190839
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Archimedsweg 29-2333CM, Leiden, Netherlands, B235-0
    Public contact
    Clinical Registry Group,, Janssen Research & Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group,, Janssen Research & Development, ClinicalTrialsEU@its.jnj.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
    12 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to compare the efficacy of infliximab with that of placebo in the prevention of clinical recurrence of Crohn’s disease (CD) prior to or at Week 76, defined as a composite endpoint that required endoscopic confirmation of recurrence, in participants who were at an increased risk of active CD recurrence following ileocolonic resection.
    Protection of trial subjects
    The Safety assessment was done based on reported AEs, concomitant medication use, tuberculosis (TB) screening and evaluations throughout the study, laboratory tests (hematology, blood chemistry, antinuclear antibodies [ANA], anti-double-stranded DNA [anti-dsDNA] antibodies), and vital signs.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Oct 2010
    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: 23
    Country: Number of subjects enrolled
    Austria: 11
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    Czech Republic: 13
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    Italy: 51
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    New Zealand: 11
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    United States: 55
    Worldwide total number of subjects
    297
    EEA total number of subjects
    175
    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)
    286
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Approximately 290 subjects were planned to be enrolled. A total of 297 subjects were randomized (150 to the placebo group and 147 to the infliximab 5 mg/kg group). There were 291 subjects who received at least 1 administration of study agent. Of these subjects, 2 who were randomized to the placebo group received 1 infusion of infliximab 5 mg/kg.

    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, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants were administered with Placebo intravenously once every 8 weeks.

    Arm title
    Infliximab 5 milligram per kilogram (mg/kg)
    Arm description
    Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
    Arm type
    Experimental

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants were administered with Infliximab 5 milligram (mg) intravenously once every 8 weeks.

    Number of subjects in period 1
    Placebo Infliximab 5 milligram per kilogram (mg/kg)
    Started
    150
    147
    Completed
    0
    0
    Not completed
    150
    147
         Protocol deviation
    2
    2
         Other
    108
    103
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    15
    23
         Adverse event, serious non-fatal
    17
    18
         Lost to follow-up
    7
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.

    Reporting group title
    Infliximab 5 milligram per kilogram (mg/kg)
    Reporting group description
    Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.

    Reporting group values
    Placebo Infliximab 5 milligram per kilogram (mg/kg) Total
    Number of subjects
    150 147 297
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    147 139 286
        From 65 to 84 years
    3 8 11
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    35.4 ± 12.41 37.1 ± 13.49 -
    Title for Gender
    Units: subjects
        Female
    69 70 139
        Male
    81 77 158

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.

    Reporting group title
    Infliximab 5 milligram per kilogram (mg/kg)
    Reporting group description
    Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.

    Primary: Percentage of participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76

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    End point title
    Percentage of participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76
    End point description
    CR criteria:1) >= 70-point increase from baseline in Crohn’s Disease Activity Index (CDAI) score [CDAI score ranges from 0 to 600; higher score indicates higher disease activities];2)CDAI >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent in GI tract] and 4)A negative stool test for C. difficile toxin (the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing new internal fistula.4)developing a new perianal abscess or 5) developing a new intra-abdominal abscess more than 3 months after date of index surgery. Participants who had a treatment failure (initiated a prohibited CD medication, had prohibited use of CD medication , or had a surgery for CD) before or at Week were considered to have had clinical recurrence prior to or at week 76.
    End point type
    Primary
    End point timeframe
    Baseline up to Week 76
    End point values
    Placebo Infliximab 5 milligram per kilogram (mg/kg)
    Number of subjects analysed
    150
    147
    Units: percentage of participants
        number (not applicable)
    20
    12.9
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    The proportion of subjects was summarized and compared between the infliximab 5 mg/kg group and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by the number of risk factors for recurrence of active CD (1 or >1) and baseline use of an immunomodulator (yes or no), at significance level of 0.05. A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level over the primary and secondary endpoints.
    Comparison groups
    Placebo v Infliximab 5 milligram per kilogram (mg/kg)
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.097
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval

    Secondary: Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76

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    End point title
    Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76
    End point description
    Endoscopic recurrence is defined as an ileal Rutgeert's score of >= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, or who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 76
    End point values
    Placebo Infliximab 5 milligram per kilogram (mg/kg)
    Number of subjects analysed
    150
    147
    Units: Percentage of participants
        number (not applicable)
    60
    30.6
    Statistical analysis title
    Statistical analysis 2
    Statistical analysis description
    The proportion of participants was summarized and compared between the infliximab 5 mg/kg group and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by the number of risk factors for recurrence of active CD (1 or >1) and baseline use of an immunomodulator (yes or no), at significance level of 0.05.
    Comparison groups
    Placebo v Infliximab 5 milligram per kilogram (mg/kg)
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval

    Secondary: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104

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    End point title
    Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104
    End point description
    CR criteria:1) >= 70-point increase from baseline in Crohn’s Disease Activity Index (CDAI) score [CDAI score ranges from 0 to 600; higher score indicates higher disease activities];2)CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent in GI tract] and 4)A negative stool test for C. difficile toxin (the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula.4)developing a new perianal abscess or 5) developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure (a prohibited CD medication, had prohibited use of CD medication , or had a surgery for CD) were considered to have had clinical recurrence prior to or at week 104.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 104
    End point values
    Placebo Infliximab 5 milligram per kilogram (mg/kg)
    Number of subjects analysed
    150
    147
    Units: Percentage of participants
        number (not applicable)
    25.3
    17.7
    Statistical analysis title
    Statistical analysis 3
    Statistical analysis description
    The proportion of participants was summarized and compared between the infliximab 5 mg/kg group and the placebo group using a 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by the number of risk factors for recurrence of active CD (1 or >1) and baseline use of an immunomodulator (yes or no), at significance level of 0.05.
    Comparison groups
    Placebo v Infliximab 5 milligram per kilogram (mg/kg)
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.098
    Method
    Cochran-Mantel-Haenszel chi-square test
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to the final visit (8 weeks after a Participants final infusion of study agent)
    Adverse event reporting additional description
    All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects treated with placebo through the final visit or through a protocol defined dose increase. If a subject had a protocol defined dose increase prior to or at the final visit, only safety results prior to the dose increase will be included in this group.

    Reporting group title
    Infliximab 5 mg/kg
    Reporting group description
    Subjects treated with Infliximab 5 mg/kg at any time through the final visit or through a protocol defined dose increase. If a subject had a protocol defined dose increase prior to or at the final visit, only safety results prior to the dose increase will be included in this group.

    Reporting group title
    First Placebo Then Infliximab 5 mg/kg
    Reporting group description
    Subjects had a protocol defined dose increase from Placebo to infliximab 5 mg/kg prior to or at the final visit. Only safety results after start of infliximab were included in this group.

    Reporting group title
    First Infliximab 5 mg/kg Then Infliximab 10 mg/kg
    Reporting group description
    Subjects had a protocol defined dose increase from infliximab 5 mg/kg to infliximab 10 mg/kg prior to or at the final visit. Only safety results after the dose increase were included in this group.

    Serious adverse events
    Placebo Infliximab 5 mg/kg First Placebo Then Infliximab 5 mg/kg First Infliximab 5 mg/kg Then Infliximab 10 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 146 (24.66%)
    32 / 145 (22.07%)
    5 / 27 (18.52%)
    2 / 9 (22.22%)
         number of deaths (all causes)
    1
    0
    0
    0
         number of deaths resulting from adverse events
    Surgical and medical procedures
    Intestinal Resection
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Cancer
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid Cancer
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Serum Sickness
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal Death
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Colpocele
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anastomotic Leak
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anastomotic Stenosis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional Hernia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion Related Reaction
         subjects affected / exposed
    0 / 146 (0.00%)
    3 / 145 (2.07%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Diarrhoea
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Scar
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleurisy
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 146 (2.05%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Radiculitis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Adhesions
         subjects affected / exposed
    2 / 146 (1.37%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal Hernia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    4 / 146 (2.74%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 145 (0.00%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    5 / 146 (3.42%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    2 / 9 (22.22%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileal Stenosis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal Perforation
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    2 / 146 (1.37%)
    3 / 145 (2.07%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus Ureteric
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus Urinary
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    0 / 146 (0.00%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary Colic
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lupus-Like Syndrome
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tetany
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal Wall Abscess
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus Infection
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal Cyst
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Legionella
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal Sepsis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stoma Site Infection
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo Infliximab 5 mg/kg First Placebo Then Infliximab 5 mg/kg First Infliximab 5 mg/kg Then Infliximab 10 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    122 / 146 (83.56%)
    121 / 145 (83.45%)
    18 / 27 (66.67%)
    8 / 9 (88.89%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Hypertension
         subjects affected / exposed
    3 / 146 (2.05%)
    8 / 145 (5.52%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences all number
    3
    8
    1
    0
    Poor Venous Access
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Dysplastic Naevus
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    2
    Squamous Cell Carcinoma of Skin
         subjects affected / exposed
    0 / 146 (0.00%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    17
    0
    2
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 145 (0.69%)
    2 / 27 (7.41%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Social circumstances
    Pregnancy of Partner
         subjects affected / exposed
    2 / 146 (1.37%)
    2 / 145 (1.38%)
    2 / 27 (7.41%)
    0 / 9 (0.00%)
         occurrences all number
    2
    2
    2
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    3 / 146 (2.05%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    3
    2
    0
    1
    General disorders and administration site conditions
    Adverse Drug Reaction
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Asthenia
         subjects affected / exposed
    8 / 146 (5.48%)
    5 / 145 (3.45%)
    1 / 27 (3.70%)
    1 / 9 (11.11%)
         occurrences all number
    12
    6
    2
    1
    Infusion Site Extravasation
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    0
    1
    Fatigue
         subjects affected / exposed
    10 / 146 (6.85%)
    8 / 145 (5.52%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences all number
    11
    8
    1
    0
    Pyrexia
         subjects affected / exposed
    17 / 146 (11.64%)
    22 / 145 (15.17%)
    1 / 27 (3.70%)
    3 / 9 (33.33%)
         occurrences all number
    23
    25
    1
    3
    Local Swelling
         subjects affected / exposed
    1 / 146 (0.68%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    2
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    4 / 146 (2.74%)
    9 / 145 (6.21%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    5
    9
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 146 (0.68%)
    7 / 145 (4.83%)
    1 / 27 (3.70%)
    2 / 9 (22.22%)
         occurrences all number
    1
    10
    1
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    3 / 146 (2.05%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    4
    2
    0
    1
    Facial Bones Fracture
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Infusion Related Reaction
         subjects affected / exposed
    3 / 146 (2.05%)
    7 / 145 (4.83%)
    2 / 27 (7.41%)
    0 / 9 (0.00%)
         occurrences all number
    3
    12
    3
    0
    Joint Injury
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Lower Limb Fracture
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Post Procedural Diarrhoea
         subjects affected / exposed
    0 / 146 (0.00%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    4
    0
    1
    Pulmonary Contusion
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Blood Calcium Decreased
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Blood Iron Decreased
         subjects affected / exposed
    1 / 146 (0.68%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    2
    0
    1
    Body Temperature Increased
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    2 / 27 (7.41%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Faecal Calprotectin
         subjects affected / exposed
    0 / 146 (0.00%)
    3 / 145 (2.07%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    3
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    17 / 146 (11.64%)
    14 / 145 (9.66%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    19
    17
    0
    0
    Bronchiectasis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Oropharyngeal Pain
         subjects affected / exposed
    10 / 146 (6.85%)
    14 / 145 (9.66%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    21
    16
    0
    0
    Pleural Effusion
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Respiratory Distress
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 146 (6.85%)
    8 / 145 (5.52%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    11
    8
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    31 / 146 (21.23%)
    29 / 145 (20.00%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences all number
    164
    147
    1
    0
    Dizziness Postural
         subjects affected / exposed
    2 / 146 (1.37%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    2
    0
    1
    Hypotonia
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    2 / 146 (1.37%)
    3 / 145 (2.07%)
    1 / 27 (3.70%)
    1 / 9 (11.11%)
         occurrences all number
    2
    3
    1
    1
    Migraine
         subjects affected / exposed
    3 / 146 (2.05%)
    6 / 145 (4.14%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    31
    36
    0
    1
    Lethargy
         subjects affected / exposed
    2 / 146 (1.37%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    2
    2
    0
    2
    Syncope
         subjects affected / exposed
    2 / 146 (1.37%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    2
    0
    1
    Restless Legs Syndrome
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    8 / 146 (5.48%)
    8 / 145 (5.52%)
    1 / 27 (3.70%)
    2 / 9 (22.22%)
         occurrences all number
    14
    10
    1
    3
    Abdominal Pain
         subjects affected / exposed
    36 / 146 (24.66%)
    25 / 145 (17.24%)
    4 / 27 (14.81%)
    2 / 9 (22.22%)
         occurrences all number
    70
    36
    5
    3
    Abdominal Pain Upper
         subjects affected / exposed
    8 / 146 (5.48%)
    8 / 145 (5.52%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    16
    12
    0
    1
    Abdominal Symptom
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Anal Fistula
         subjects affected / exposed
    2 / 146 (1.37%)
    1 / 145 (0.69%)
    2 / 27 (7.41%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    3
    1
    Aphthous Stomatitis
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    27 / 146 (18.49%)
    24 / 145 (16.55%)
    2 / 27 (7.41%)
    1 / 9 (11.11%)
         occurrences all number
    117
    32
    2
    1
    Crohn's Disease
         subjects affected / exposed
    13 / 146 (8.90%)
    10 / 145 (6.90%)
    6 / 27 (22.22%)
    3 / 9 (33.33%)
         occurrences all number
    14
    10
    8
    3
    Dyspepsia
         subjects affected / exposed
    5 / 146 (3.42%)
    10 / 145 (6.90%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences all number
    7
    10
    1
    0
    Diarrhoea Haemorrhagic
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Frequent Bowel Movements
         subjects affected / exposed
    7 / 146 (4.79%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    7
    2
    0
    1
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    5 / 146 (3.42%)
    5 / 145 (3.45%)
    1 / 27 (3.70%)
    1 / 9 (11.11%)
         occurrences all number
    9
    12
    1
    1
    Haemorrhoids
         subjects affected / exposed
    7 / 146 (4.79%)
    1 / 145 (0.69%)
    1 / 27 (3.70%)
    1 / 9 (11.11%)
         occurrences all number
    9
    1
    1
    1
    Ileal Ulcer
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Mouth Ulceration
         subjects affected / exposed
    1 / 146 (0.68%)
    4 / 145 (2.76%)
    0 / 27 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    4
    0
    2
    Nausea
         subjects affected / exposed
    16 / 146 (10.96%)
    25 / 145 (17.24%)
    0 / 27 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    24
    58
    0
    6
    Rectal Haemorrhage
         subjects affected / exposed
    1 / 146 (0.68%)
    6 / 145 (4.14%)
    1 / 27 (3.70%)
    1 / 9 (11.11%)
         occurrences all number
    1
    7
    2
    1
    Vomiting
         subjects affected / exposed
    11 / 146 (7.53%)
    14 / 145 (9.66%)
    0 / 27 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    21
    18
    0
    3
    Toothache
         subjects affected / exposed
    5 / 146 (3.42%)
    5 / 145 (3.45%)
    1 / 27 (3.70%)
    1 / 9 (11.11%)
         occurrences all number
    8
    7
    1
    1
    Skin and subcutaneous tissue disorders
    Dermal Cyst
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    Pruritus
         subjects affected / exposed
    5 / 146 (3.42%)
    10 / 145 (6.90%)
    2 / 27 (7.41%)
    1 / 9 (11.11%)
         occurrences all number
    6
    11
    2
    3
    Hidradenitis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    1
    Rash
         subjects affected / exposed
    9 / 146 (6.16%)
    8 / 145 (5.52%)
    0 / 27 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    16
    11
    0
    2
    Urticaria
         subjects affected / exposed
    1 / 146 (0.68%)
    4 / 145 (2.76%)
    1 / 27 (3.70%)
    1 / 9 (11.11%)
         occurrences all number
    13
    6
    1
    2
    Skin Fissures
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    32 / 146 (21.92%)
    26 / 145 (17.93%)
    4 / 27 (14.81%)
    3 / 9 (33.33%)
         occurrences all number
    60
    36
    7
    4
    Back Pain
         subjects affected / exposed
    9 / 146 (6.16%)
    16 / 145 (11.03%)
    1 / 27 (3.70%)
    3 / 9 (33.33%)
         occurrences all number
    11
    19
    1
    5
    Myalgia
         subjects affected / exposed
    3 / 146 (2.05%)
    8 / 145 (5.52%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    3
    8
    0
    0
    Musculoskeletal Pain
         subjects affected / exposed
    3 / 146 (2.05%)
    4 / 145 (2.76%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    3
    4
    0
    1
    Osteoporosis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 145 (0.00%)
    1 / 27 (3.70%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    1
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    5
    Hypokalaemia
         subjects affected / exposed
    4 / 146 (2.74%)
    1 / 145 (0.69%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    4
    1
    0
    6
    Infections and infestations
    Anal Abscess
         subjects affected / exposed
    4 / 146 (2.74%)
    0 / 145 (0.00%)
    2 / 27 (7.41%)
    0 / 9 (0.00%)
         occurrences all number
    4
    0
    2
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 146 (1.37%)
    3 / 145 (2.07%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    3
    4
    0
    1
    Bronchitis
         subjects affected / exposed
    10 / 146 (6.85%)
    7 / 145 (4.83%)
    1 / 27 (3.70%)
    0 / 9 (0.00%)
         occurrences all number
    15
    8
    2
    0
    Gastroenteritis
         subjects affected / exposed
    8 / 146 (5.48%)
    5 / 145 (3.45%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    15
    6
    0
    0
    Gastroenteritis Salmonella
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Infected Dermal Cyst
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    2
    Herpes Zoster
         subjects affected / exposed
    2 / 146 (1.37%)
    5 / 145 (3.45%)
    1 / 27 (3.70%)
    1 / 9 (11.11%)
         occurrences all number
    2
    5
    1
    1
    Influenza
         subjects affected / exposed
    15 / 146 (10.27%)
    12 / 145 (8.28%)
    0 / 27 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    26
    16
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    37 / 146 (25.34%)
    37 / 145 (25.52%)
    3 / 27 (11.11%)
    1 / 9 (11.11%)
         occurrences all number
    86
    71
    3
    2
    Purulent Discharge
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 145 (0.00%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    7 / 146 (4.79%)
    9 / 145 (6.21%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    8
    10
    0
    1
    Tooth Abscess
         subjects affected / exposed
    2 / 146 (1.37%)
    2 / 145 (1.38%)
    0 / 27 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    5
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    7 / 146 (4.79%)
    4 / 145 (2.76%)
    0 / 27 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    7
    5
    0
    4
    Upper Respiratory Tract Infection
         subjects affected / exposed
    21 / 146 (14.38%)
    21 / 145 (14.48%)
    5 / 27 (18.52%)
    3 / 9 (33.33%)
         occurrences all number
    35
    31
    5
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jul 2010
    The overall reason for the amendment was to ensure that all participants received active medication when a clinical recurrence occurred,the instructions were expanded including dosing time intervals,collection of additional follow-up information was added every 6 months for Participants who withdrew,the inclusion criterion for negative QuantiFERON-TB Gold test results prior to study agent administration was changed from 1 to 6 weeks and Rules for determining endoscopic recurrence (major secondary endpoint) based on Crohn’s Disease Activity Index (CDAI) criteria for clinical recurrence in Participants who did not discontinue study agent prior to Week 76 and who did not undergo a video ileocolonoscopy or did not have an evaluable video ileocolonoscopy by Week 76 were revised.
    23 Nov 2010
    The overall reason for the amendment was to add an interim futility analysis after the first 145 randomized participants either completed 76 weeks of the study orprior to Week 76 to allow the study to be stopped early.The clinical recurrence composite primary endpoint was updated to include a negative stool test for C. difficile prior to endoscopy,added development of a new draining fistula and surgery for Crohn’s disease (CD) to the definition of clinical recurrence,handling of missing data at Week 76 were revised,Specified CDAI collected during the screening period and recommendation added for starting administration of study agent within 3 hours after reconstitution and dilution.
    16 Mar 2011
    The overall reason for the amendment was to include participants who had an intra-abdominal operation for CD with an end ileostomy who were undergoing a reversal of the ileostomy within 1 year of the date of the original operation,Participants who tested positive only for HBV surface antibody were eligible for study,Preparation, handling, and storage of infliximab were updated,Time and Events Schedule updated to specify that stool studies at screening must have included a stool culture and C. difficile toxin assay,Clarification added that if a draining fistula was present within 3 months of screening, unless the fistula was removed at the index surgery and number of study sites was increased to 175.
    28 Jul 2011
    The overall reason for the amendment was to include the definition of clinical recurrence was modified to also include re-opening and draining of previously existing fistula, development of a new internal fistula, a new perianal abscess,under ordinary conditions through Week 208, lower endoscopic procedures were to be performed only unless medically necessary,Inclusion criterion for prior infliximab treatment was modified,those participants who had an end ileostomy who were undergoing a reversal of the ileostomy within 1 year of the date of the original operation were eligible for inclusion in the study,Description of endoscopic response evaluation was expanded,Clarified results of the video ileocolonoscopies were to be used for the analyses of endoscopic recurrence and the standard weight table was revised to include a wider range of participants heights.
    25 Apr 2013
    The overall reason for the amendment was to include clarifications made to the timing of video ileocolonoscopy and the importance of verifying negative C. difficile test,interim analysis was removed,annual chest radiograph (for Tuberculosis) for participants was added,clarified that the hematocrit value from the central laboratory would be used in the calculation of the CDAI,Use of concomitant medications was revised, Video ileocolonoscopy procedures clarified,Corrected change in Inflammatory Bowel Disease Questionnaire (IBDQ) dimensions and total scores to begin at Week 8 not at baseline,Criteria for discontinuation of study agent revised to specify use of New York Heart Association classification scale for congestive heart failure,all video ileocolonoscopies performed per protocol were to be video recorded in the electronic case report form (eCRF),additional information added for reports of malignancy and premalignant conditions and Recommendation added for periodic skin examination for all participants, particularly those with risk factors for skin cancer.
    17 Dec 2013
    The overall reason for the amendment was to include revised pursuant to a Health Authority request to specify that results from the central reader were used for the primary analysis; note that the local reader result continued to be used as a component of the dose escalation process.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    12 Dec 2014
    The study was discontinued by the sponsor following the Week 104 database lock because the primary endpoint at Week 76 and the subsequent criteria established for Week 104 were not met.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Limitation of the study was that participants were a lower-risk population than intended in a clinical recurrence rate and the use of the largely symptom-based CDAI score as part of the primary endpoint for clinical recurrence.
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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