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    Clinical Trial Results:
    A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn's Disease

    Summary
    EudraCT number
    		 2017-004209-41
    Trial protocol
    		 ES   CZ   FR   PL   DE   GB   NL   BG   BE   IT  
    Global end of trial date
    21 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 May 2022
    First version publication date
    29 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1275CRD3007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03464136
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Welsh & McKean Roads, Spring House, United States, PA 19477
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, 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
    21 May 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naïve subjects with moderately-to-severely active Crohn’s disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, that is, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]), as measured by clinical remission at one year.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations included adverse events (AEs), adverse events temporally related to infusion, clinical laboratory tests, and injection site reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jun 2018
    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
    Australia: 7
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Brazil: 23
    Country: Number of subjects enrolled
    Bulgaria: 6
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Czechia: 22
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 29
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Poland: 60
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Russian Federation: 47
    Country: Number of subjects enrolled
    Serbia: 12
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    United States: 67
    Worldwide total number of subjects
    386
    EEA total number of subjects
    180
    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)
    372
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 386 subjects (195 in the adalimumab group, and 191 in ustekinumab group) were randomized in this study and received the study drug. Out of 386 subjects, 331 subjects completed the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adalimumab
    Arm description
    		 Subjects received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, subjects self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC injections of adalimumab (each 40 mg, total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, subjects self-administered 1 SC injection of adalimumab 40 mg.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received placebo as IV infusion to blind adalimumab.

    Arm title
    		 Ustekinumab
    Arm description
    		 Subjects received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, subjects self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo for adalimumab at the other designated q2w dosing intervals.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Stelara
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects self-administered SC injection of ustekinumab 90 mg.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo as as SC injection to blind ustekinumab.

    Number of subjects in period 1
    		Adalimumab Ustekinumab
    Started
    195
    191
    Completed
    165
    166
    Not completed
    30
    25
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    16
    13
         Unspecified
    8
    4
         Lost to follow-up
    5
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Subjects received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, subjects self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).

    Reporting group title
    Ustekinumab
    Reporting group description
    		 Subjects received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, subjects self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo for adalimumab at the other designated q2w dosing intervals.

    Reporting group values
    		 Adalimumab Ustekinumab Total
    Number of subjects
    		 195 191 386
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 189 183 372
        From 65 to 84 years
    		 6 8 14
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.4 ( 12.99 ) 37 ( 13.23 ) -
    Title for Gender
    Units: subjects
        Female
    		 100 101 201
        Male
    		 95 90 185

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Subjects received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, subjects self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).

    Reporting group title
    Ustekinumab
    Reporting group description
    		 Subjects received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, subjects self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo for adalimumab at the other designated q2w dosing intervals.

    Primary: Percentage of Subjects with Clinical Remission at Week 52

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    End point title
    		 Percentage of Subjects with Clinical Remission at Week 52 [1]
    End point description
    Percentage of Subjects with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. Full analysis set (FAS) included all randomized subjects.
    End point type
    Primary
    End point timeframe
    Week 52
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were reported. No inferential statistics was planned for the primary endpoints.
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
        number (not applicable)
    61.0
    64.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Corticosteroid-free Remission at Week 52

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    End point title
    		 Percentage of Subjects with Corticosteroid-free Remission at Week 52
    End point description
    Percentage of subjects with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score <150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. FAS included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
        number (not applicable)
    57.4
    60.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Response at Week 52

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    End point title
    		 Percentage of Subjects with Clinical Response at Week 52
    End point description
    Percentage of subjects with clinical response at Week 52 were assessed. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of >=100 points or CDAI score<150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. FAS included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
        number (not applicable)
    66.2
    72.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52

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    End point title
    		 Percentage of Subjects in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52
    End point description
    PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools (total number of soft/liquid stools in the last 7 days) and abdominal pain (on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO-2 symptom remission was defined as an abdominal pain (AP) mean daily score at or below 1 and also stool frequency (SF) mean daily score at or below 3, that is, AP <=1 and SF <=3. PRO2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. FAS included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
        number (not applicable)
    55.4
    56.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Remission at Week 16

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    End point title
    		 Percentage of Subjects with Clinical Remission at Week 16
    End point description
    Percentage of subject with clinical remission (defined as CDAI <150 points) at Week 16 were assessed. Clinical remission was defined as a CDAI score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. FAS included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of Subject
        number (not applicable)
    60
    57.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Endoscopic Remission at Week 52

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    End point title
    		 Percentage of Subjects with Endoscopic Remission at Week 52
    End point description
    Percentage of subjects with endoscopic remission at Week 52 were assessed. Endoscopic remission was defined as Simple Endoscopic Score for Crohn’s Disease (SES-CD) score less than or equal to (<=) 3, or SES-CD =0 for subjects who entered the study with a SES-CD =3 at Week 52. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis) each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total score is the sum of 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. FAS among participants with SES-CD Score >=3 at Baseline.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    179
    179
    Units: percentage of subjects
        number (not applicable)
    30.7
    28.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Remission Through Week 52

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    End point title
    		 Percentage of Subjects with Clinical Remission Through Week 52
    End point description
    Percentage of subjects with clinical remission at each postbaseline visit through Week 52 were reported. Clinical remission was defined as a CDAI score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. FAS included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 8, 16, 24, 32, 40, 48, and 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
    number (not applicable)
        Week 2
    28.7
    23.0
        Week 8
    47.7
    50.3
        Week 16
    60.0
    57.1
        Week 24
    66.2
    57.6
        Week 32
    65.1
    59.7
        Week 40
    60.5
    64.9
        Week 48
    59.0
    62.8
        Week 52
    61.0
    64.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical Response Through Week 52

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    End point title
    		 Percentage of Subjects with Clinical Response Through Week 52
    End point description
    Percentage of subjects with clinical response at each postbaseline visit through Week 52 were reported. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of >=100 points or CDAI score < 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. FAS included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 8, 16, 24, 32, 40, 48, and 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
    number (not applicable)
        Week 2
    46.2
    38.2
        Week 8
    66.2
    68.1
        Week 16
    72.3
    73.3
        Week 24
    76.4
    70.7
        Week 32
    74.9
    71.2
        Week 40
    69.2
    74.3
        Week 48
    66.7
    69.1
        Week 52
    66.2
    72.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects with Durable Clinical Response at Week 52

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    End point title
    		 Percentage of subjects with Durable Clinical Response at Week 52
    End point description
    Percentage of subjects with durable clinical response at Week 52 were reported. Durable clinical response was defined as CDAI score decreased at least 100 from baseline or CDAI <150 at Week 52 and was >= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. FAS included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
        number (not applicable)
    60.5
    65.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Durable Clinical Remission at Week 52

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    End point title
    		 Percentage of Subjects with Durable Clinical Remission at Week 52
    End point description
    Percentage of subject with durable clinical remission at Week 52 were reported. Clinical remission was defined as CDAI score <150 at Week 52 and was >= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. FAS included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
        number (not applicable)
    51.8
    50.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abdominal Pain (AP) Improvement Through Week 52

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    End point title
    		 Percentage of Subjects with Abdominal Pain (AP) Improvement Through Week 52
    End point description
    Percentage of subjects with AP improvement through Week 52 were reported. AP improvement was defined as at least 1 point or greater improvement in mean daily CDAI AP score (ranges from 0 to 3, where higher score indicates severity of pain) from baseline, or a mean score of zero among subjects with mean AP>0 at baseline, compared at each visit through Week 52. FAS among subjects with mean daily AP Score >0 at Baseline. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 8, 16, 24, 32, 40, 48, and 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    194
    191
    Units: percentage of subjects
    number (not applicable)
        Week 2
    29.9
    23.0
        Week 8
    54.1
    53.9
        Week 16
    62.9
    59.2
        Week 24
    66.5
    61.8
        Week 32
    63.9
    63.9
        Week 40
    60.3
    63.9
        Week 48
    61.9
    61.8
        Week 52
    62.4
    64.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Reduction in Frequency of Diarrhea Through Week 52

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    End point title
    		 Percentage of Subjects with Reduction in Frequency of Diarrhea Through Week 52
    End point description
    Percentage of subjects with reduction in frequency of diarrhea were reported. Reduction in frequency of diarrhea was defined as a reduction of at least 3 (or a mean number <1) in SF (that is, mean daily number of liquid or very soft stools from CDAI score [ranges from 0 to 3 where higher score indicates severity of pain] in the week prior to the visit) from baseline, among subjects with mean SF >1 at baseline, compared at each visit through Week 52. FAS among subjects with mean daily stool frequency >1 at baseline. Here 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 8, 16, 24, 32, 40, 48, and 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    186
    179
    Units: percentage of subjects
    number (not applicable)
        Week 2
    33.3
    30.7
        Week 8
    52.7
    60.3
        Week 16
    53.8
    60.9
        Week 24
    58.1
    60.9
        Week 32
    58.1
    60.9
        Week 40
    54.8
    64.2
        Week 48
    53.8
    57.5
        Week 52
    52.7
    60.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Clinical and Biomarker Remission at Weeks 8, 16 and 52

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    End point title
    		 Percentage of Subjects with Clinical and Biomarker Remission at Weeks 8, 16 and 52
    End point description
    Percentage of subjects with clinical and biomarker remission was defined as the percentage of subjects with CDAI <150, CRP <= 3 mg/L, and also fecal calprotectin <=250 micrograms per gram (mcg/g). The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity. FAS included all randomized subjects.
    End point type
    Secondary
    End point timeframe
    At Weeks 8, 16 and 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
    number (not applicable)
        Week 8
    19.5
    14.1
        Week 16
    29.7
    18.8
        Week 52
    27.2
    20.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Adverse Events (AEs)

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    End point title
    		 Percentage of Subjects with Adverse Events (AEs)
    End point description
    Percentage of subjects with AE were reported. An AE is any untoward medical occurrence in a subjects participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Safety analysis set included all the subjects who were randomized and received at least one administration of study agent in the study.
    End point type
    Secondary
    End point timeframe
    Up to Week 52 and up to Week 76
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
    number (not applicable)
        Up to Week 52
    77.9
    80.1
        Up to Week 76
    80.0
    81.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Infections

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    End point title
    		 Percentage of Subjects with Infections
    End point description
    Percentage of subjects with infections were reported. Safety analysis set included all the subjects who were randomized and received at least one administration of study agent in the study.
    End point type
    Secondary
    End point timeframe
    Up to Week 52 and up to Week 76
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
    number (not applicable)
        Up to Week 52
    40.5
    34.0
        Up to Week 76
    43.1
    37.2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Serious Infections

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    End point title
    		 Percentage of Subjects with Serious Infections
    End point description
    Percentage of subjects with serious infections were reported. Safety analysis set included all the subjects who were randomized and received at least one administration of study agent in the study.
    End point type
    Secondary
    End point timeframe
    Up to Week 52 and up to Week 76
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
    number (not applicable)
        Up to Week 52
    2.6
    2.1
        Up to Week 76
    3.1
    3.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Subjects with Serious Adverse Events (SAEs)
    End point description
    Percentage of subjects with SAEs were reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize subjects and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Coronavirus disease 2019 (COVID-19) related serious adverse events are adverse events with any of the following preferred terms “COVID-19”, ”Asymptomatic COVID-19”, ”Suspected COVID-19”, “COVID-19 pneumonia”, “severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive” or with a reported term containing the string “COVI". Safety analysis set included all the subjects who were randomized and received at least one administration of study agent in the study.
    End point type
    Secondary
    End point timeframe
    Up to Week 52 and up to Week 76
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    191
    Units: percentage of subjects
    number (not applicable)
        Up to Week 52
    16.4
    13.1
        Up to Week 52: COVID-19 related SAEs
    0
    0
        Up to Week 76
    19.5
    15.2
        Up to Week 76: COVID-19 related SAEs
    0
    0.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Anti-drug Antibodies

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    End point title
    		 Percentage of Subjects with Anti-drug Antibodies
    End point description
    Percentage of subjects with anti-drug antibodies were reported. Serum samples were assessed for anti-drug antibodies. Anti-drug assays were performed for ustekinumab and adalimumab. Immunogenicity analysis set included all subjects who had received at least 1 administration of study agent and have at least one valid blood sample drawn for detection of antibodies to study agent.
    End point type
    Secondary
    End point timeframe
    Up to Week 52
    End point values
    		 Adalimumab Ustekinumab
    Number of subjects analysed
    195
    190
    Units: percentage of subjects
        number (not applicable)
    74.4
    2.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 76
    Adverse event reporting additional description
    Safety analysis set included all the subjects who were randomized and received at least one administration of study agent in the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Subjects received intravenous (IV) infusion of placebo for ustekinumab and 4 subcutaneous (SC) injections of adalimumab (each 40 milligrams [mg], total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, subjects self-administered 1 SC injection of adalimumab 40 mg every 2 weeks (q2w).

    Reporting group title
    Ustekinumab
    Reporting group description
    		 Subjects received IV infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 SC injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, subjects self-administered one SC injection of ustekinumab 90 mg every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated q2w dosing intervals.

    Serious adverse events
    		 Adalimumab Ustekinumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 195 (19.49%)
    29 / 191 (15.18%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Peripheral Vascular Disorder
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Death
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Ovarian Cyst
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychotic Disorder
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         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
    Crush Injury
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Venolymphatic Malformation
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Unstable
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness Postural
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         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
    Anaemia
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    17 / 195 (8.72%)
    5 / 191 (2.62%)
         occurrences causally related to treatment / all
    0 / 18
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Stenosis
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal Stenosis
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Perforation
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Stenosis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Obstruction
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot Deformity
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (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 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paracoccidioides Infection
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         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 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Abscess
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (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: 0%
    Non-serious adverse events
    		 Adalimumab Ustekinumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    151 / 195 (77.44%)
    152 / 191 (79.58%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Colon Adenoma
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Benign Neoplasm of Eye
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Seborrhoeic Keratosis
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Dysplastic Naevus
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Vascular disorders
    Aortic Arteriosclerosis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Flushing
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    5 / 195 (2.56%)
    3 / 191 (1.57%)
         occurrences all number
    5
    3
    Hot Flush
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Raynaud's Phenomenon
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Tonsillectomy
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Chest Discomfort
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Chest Pain
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Drug Intolerance
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 195 (0.51%)
    8 / 191 (4.19%)
         occurrences all number
    1
    10
    Impaired Healing
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Injection Site Erythema
         subjects affected / exposed
    13 / 195 (6.67%)
    3 / 191 (1.57%)
         occurrences all number
    65
    11
    Injection Site Bruising
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Influenza Like Illness
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Injection Site Haematoma
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Injection Site Irritation
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Injection Site Oedema
         subjects affected / exposed
    3 / 195 (1.54%)
    0 / 191 (0.00%)
         occurrences all number
    6
    0
    Injection Site Pain
         subjects affected / exposed
    3 / 195 (1.54%)
    1 / 191 (0.52%)
         occurrences all number
    14
    1
    Injection Site Reaction
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Injection Site Rash
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    3
    1
    Injection Site Pruritus
         subjects affected / exposed
    7 / 195 (3.59%)
    2 / 191 (1.05%)
         occurrences all number
    28
    10
    Malaise
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Medical Device Pain
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Injection Site Swelling
         subjects affected / exposed
    4 / 195 (2.05%)
    0 / 191 (0.00%)
         occurrences all number
    7
    0
    Oedema Peripheral
         subjects affected / exposed
    0 / 195 (0.00%)
    5 / 191 (2.62%)
         occurrences all number
    0
    6
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Peripheral Swelling
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 191 (1.05%)
         occurrences all number
    2
    2
    Pyrexia
         subjects affected / exposed
    8 / 195 (4.10%)
    6 / 191 (3.14%)
         occurrences all number
    10
    7
    Suprapubic Pain
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Vessel Puncture Site Haematoma
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Amenorrhoea
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Cervical Dysplasia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Dysmenorrhoea
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Semen Discolouration
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Ovarian Cyst
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Nipple Pain
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Uterine Haemorrhage
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal Discomfort
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Asthma Late Onset
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea Exertional
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Dyspnoea
         subjects affected / exposed
    2 / 195 (1.03%)
    4 / 191 (2.09%)
         occurrences all number
    2
    4
    Cough
         subjects affected / exposed
    5 / 195 (2.56%)
    3 / 191 (1.57%)
         occurrences all number
    6
    3
    Bronchitis Chronic
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal Pain
         subjects affected / exposed
    3 / 195 (1.54%)
    9 / 191 (4.71%)
         occurrences all number
    3
    11
    Nasal Crusting
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Rhinitis Allergic
         subjects affected / exposed
    2 / 195 (1.03%)
    3 / 191 (1.57%)
         occurrences all number
    4
    3
    Pulmonary Embolism
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Pharyngeal Inflammation
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Respiratory Tract Congestion
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Psychiatric disorders
    Depressed Mood
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Affect Lability
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    3 / 195 (1.54%)
    6 / 191 (3.14%)
         occurrences all number
    3
    6
    Anxiety Disorder
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Sleep Disorder
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Panic Attack
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    4 / 195 (2.05%)
    2 / 191 (1.05%)
         occurrences all number
    4
    2
    Insomnia
         subjects affected / exposed
    3 / 195 (1.54%)
    1 / 191 (0.52%)
         occurrences all number
    3
    1
    Stress
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Investigations
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    3 / 195 (1.54%)
    3 / 191 (1.57%)
         occurrences all number
    3
    3
    Alanine Aminotransferase Increased
         subjects affected / exposed
    6 / 195 (3.08%)
    2 / 191 (1.05%)
         occurrences all number
    7
    2
    Blood Creatinine Increased
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Blood Folate Decreased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Blood Phosphorus Increased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Blood Glucose Increased
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Blood Pressure Increased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Blood Testosterone Decreased
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Body Temperature Increased
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    C-Reactive Protein Increased
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 191 (1.05%)
         occurrences all number
    2
    2
    Colonoscopy Abnormal
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Faecal Calprotectin Increased
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Haematocrit Increased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Heart Rate Increased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Granulocyte Count Decreased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Human Chorionic Gonadotropin Increased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Mycobacterium Tuberculosis Complex Test Positive
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Transaminases Increased
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Urine Output Increased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Vitamin B12 Decreased
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Liver Function Test Increased
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 191 (1.05%)
         occurrences all number
    2
    2
    Weight Increased
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Weight Decreased
         subjects affected / exposed
    3 / 195 (1.54%)
    0 / 191 (0.00%)
         occurrences all number
    3
    0
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Exposure to Toxic Agent
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Foreign Body in Eye
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Hand Fracture
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Joint Injury
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Ligament Sprain
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 191 (1.05%)
         occurrences all number
    2
    2
    Muscle Strain
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    3
    Post Procedural Inflammation
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Procedural Anxiety
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Procedural Dizziness
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Procedural Pain
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Road Traffic Accident
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    2
    Skin Laceration
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Spinal Fracture
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Splinter
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Tibia Fracture
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Tooth Fracture
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Tooth Injury
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Syringomyelia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Extrasystoles
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Supraventricular Tachycardia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Nervous system disorders
    Cervical Radiculopathy
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Amnesia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Dysgeusia
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    14 / 195 (7.18%)
    25 / 191 (13.09%)
         occurrences all number
    25
    40
    Dizziness
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Dizziness Postural
         subjects affected / exposed
    0 / 195 (0.00%)
    4 / 191 (2.09%)
         occurrences all number
    0
    4
    Hypoaesthesia
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Lethargy
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Hemiplegic Migraine
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Migraine with Aura
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Nerve Compression
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Paraesthesia
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    2
    Memory Impairment
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Sinus Headache
         subjects affected / exposed
    0 / 195 (0.00%)
    4 / 191 (2.09%)
         occurrences all number
    0
    4
    Presyncope
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    3
    Tremor
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    3
    Tension Headache
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Syncope
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    2
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Anaemia
         subjects affected / exposed
    7 / 195 (3.59%)
    6 / 191 (3.14%)
         occurrences all number
    9
    6
    Lymphadenopathy
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Lymphadenitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Lymphopenia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear Haemorrhage
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Ear Pain
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Ear Swelling
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Vertigo
         subjects affected / exposed
    4 / 195 (2.05%)
    7 / 191 (3.66%)
         occurrences all number
    4
    7
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Cataract
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Choroidal Effusion
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    2
    Dry Eye
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Conjunctivitis Allergic
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Eye Pruritus
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Eyelid Oedema
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Eyelid Cyst
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Foreign Body Sensation in Eyes
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Iritis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Iridocyclitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Glaucoma
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Keratitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Uveitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Swelling of Eyelid
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Retinal Detachment
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Vision Blurred
         subjects affected / exposed
    3 / 195 (1.54%)
    1 / 191 (0.52%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 191 (1.05%)
         occurrences all number
    2
    2
    Abdominal Hernia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Abdominal Pain
         subjects affected / exposed
    16 / 195 (8.21%)
    25 / 191 (13.09%)
         occurrences all number
    20
    36
    Abdominal Pain Lower
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Abdominal Pain Upper
         subjects affected / exposed
    5 / 195 (2.56%)
    7 / 191 (3.66%)
         occurrences all number
    6
    7
    Abdominal Tenderness
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Anal Fissure
         subjects affected / exposed
    2 / 195 (1.03%)
    7 / 191 (3.66%)
         occurrences all number
    2
    7
    Anal Stenosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Anal Pruritus
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    3
    Anal Fistula
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Anorectal Discomfort
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Chronic Gastritis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Crohn's Disease
         subjects affected / exposed
    29 / 195 (14.87%)
    20 / 191 (10.47%)
         occurrences all number
    33
    25
    Constipation
         subjects affected / exposed
    7 / 195 (3.59%)
    7 / 191 (3.66%)
         occurrences all number
    7
    7
    Defaecation Urgency
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Dental Caries
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Diarrhoea Haemorrhagic
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    2 / 195 (1.03%)
    11 / 191 (5.76%)
         occurrences all number
    2
    11
    Dyspepsia
         subjects affected / exposed
    4 / 195 (2.05%)
    4 / 191 (2.09%)
         occurrences all number
    5
    6
    Eosinophilic Oesophagitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Enlarged Uvula
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 195 (0.51%)
    4 / 191 (2.09%)
         occurrences all number
    1
    7
    Food Poisoning
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Gastric Ulcer
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Frequent Bowel Movements
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Gastritis
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Gastritis Erosive
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    5 / 195 (2.56%)
    6 / 191 (3.14%)
         occurrences all number
    5
    6
    Gingival Swelling
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    3
    Haemorrhoids
         subjects affected / exposed
    1 / 195 (0.51%)
    3 / 191 (1.57%)
         occurrences all number
    1
    3
    Ileal Stenosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Large Intestinal Stenosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Mouth Ulceration
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Mouth Haemorrhage
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Lip Blister
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    3
    Proctitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    9 / 195 (4.62%)
    12 / 191 (6.28%)
         occurrences all number
    9
    13
    Rectal Tenesmus
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    4 / 195 (2.05%)
    11 / 191 (5.76%)
         occurrences all number
    4
    15
    Toothache
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Subileus
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholangitis Sclerosing
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Hepatic Steatosis
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Cholecystitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Jaundice
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    3 / 195 (1.54%)
    2 / 191 (1.05%)
         occurrences all number
    3
    2
    Alopecia
         subjects affected / exposed
    3 / 195 (1.54%)
    7 / 191 (3.66%)
         occurrences all number
    3
    7
    Brow Ptosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Dermatitis
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Dermatitis Contact
         subjects affected / exposed
    0 / 195 (0.00%)
    4 / 191 (2.09%)
         occurrences all number
    0
    5
    Drug Eruption
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Dry Skin
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Eczema
         subjects affected / exposed
    4 / 195 (2.05%)
    4 / 191 (2.09%)
         occurrences all number
    4
    4
    Eczema Nummular
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Erythema Nodosum
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    4 / 195 (2.05%)
    0 / 191 (0.00%)
         occurrences all number
    5
    0
    Hidradenitis
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Ingrowing Nail
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Night Sweats
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Photosensitivity Reaction
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Petechiae
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Post Inflammatory Pigmentation Change
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Pseudofolliculitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    3 / 195 (1.54%)
    2 / 191 (1.05%)
         occurrences all number
    3
    2
    Psoriasis
         subjects affected / exposed
    3 / 195 (1.54%)
    2 / 191 (1.05%)
         occurrences all number
    4
    2
    Rash
         subjects affected / exposed
    6 / 195 (3.08%)
    3 / 191 (1.57%)
         occurrences all number
    6
    3
    Rash Erythematous
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Rash Papular
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Rash Pruritic
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Rosacea
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Scar Pain
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Sebaceous Hyperplasia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Seborrhoeic Dermatitis
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Skin Exfoliation
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Skin Fissures
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Skin Lesion
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Vitiligo
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Urticaria
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 191 (1.05%)
         occurrences all number
    2
    2
    Skin Ulcer
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Chronic Kidney Disease
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Haematuria
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Dysuria
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Ankylosing Spondylitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Arthralgia
         subjects affected / exposed
    15 / 195 (7.69%)
    13 / 191 (6.81%)
         occurrences all number
    19
    19
    Back Pain
         subjects affected / exposed
    4 / 195 (2.05%)
    8 / 191 (4.19%)
         occurrences all number
    4
    9
    Arthritis Enteropathic
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Bone Pain
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Arthritis
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Intervertebral Disc Protrusion
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Fistula
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Fibromyalgia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Diastasis Recti Abdominis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Flank Pain
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Lupus-Like Syndrome
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Muscle Spasms
         subjects affected / exposed
    3 / 195 (1.54%)
    2 / 191 (1.05%)
         occurrences all number
    3
    2
    Musculoskeletal Chest Pain
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Joint Swelling
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Osteopenia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Neck Pain
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Plantar Fasciitis
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Pain in Extremity
         subjects affected / exposed
    1 / 195 (0.51%)
    3 / 191 (1.57%)
         occurrences all number
    1
    3
    Periarthritis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Pathological Fracture
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Sacroiliitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Rotator Cuff Syndrome
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Psoriatic Arthropathy
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    SAPHO Syndrome
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Synovial Cyst
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Temporomandibular Joint Syndrome
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Spinal Pain
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    3
    Tenosynovitis Stenosans
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Abscess Limb
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Acute Sinusitis
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Abscess Oral
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Anal Abscess
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    2
    Asymptomatic COVID-19
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 191 (1.05%)
         occurrences all number
    2
    2
    Bacterial Vulvovaginitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Blister Infected
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    3 / 195 (1.54%)
    0 / 191 (0.00%)
         occurrences all number
    3
    0
    COVID-19
         subjects affected / exposed
    4 / 195 (2.05%)
    1 / 191 (0.52%)
         occurrences all number
    4
    1
    Bronchitis Bacterial
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Candida Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Cervicitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    3
    Dermatophytosis of Nail
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Ear Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    3 / 191 (1.57%)
         occurrences all number
    1
    3
    Eye Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Eczema Infected
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Furuncle
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    3
    Fungal Skin Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    3 / 195 (1.54%)
    3 / 191 (1.57%)
         occurrences all number
    3
    4
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Hepatitis E
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Genital Herpes
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Gastrointestinal Viral Infection
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Gastrointestinal Bacterial Overgrowth
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Laryngitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    5 / 195 (2.56%)
    6 / 191 (3.14%)
         occurrences all number
    5
    6
    Herpes Zoster Disseminated
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Large Intestine Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Herpes Zoster
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Latent Tuberculosis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Localised Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    20 / 195 (10.26%)
    14 / 191 (7.33%)
         occurrences all number
    22
    17
    Lower Respiratory Tract Infection
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Oral Herpes
         subjects affected / exposed
    11 / 195 (5.64%)
    1 / 191 (0.52%)
         occurrences all number
    13
    1
    Oral Candidiasis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Onychomycosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Oropharyngeal Candidiasis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Otitis Externa
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Otitis Media
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Pharyngitis
         subjects affected / exposed
    2 / 195 (1.03%)
    1 / 191 (0.52%)
         occurrences all number
    2
    1
    Pharyngitis Streptococcal
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    2
    Pneumonia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Post Procedural Infection
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Rectal Abscess
         subjects affected / exposed
    0 / 195 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    0
    2
    Respiratory Tract Infection
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Respiratory Tract Infection Viral
         subjects affected / exposed
    3 / 195 (1.54%)
    1 / 191 (0.52%)
         occurrences all number
    3
    1
    Salmonellosis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Rhinitis
         subjects affected / exposed
    3 / 195 (1.54%)
    2 / 191 (1.05%)
         occurrences all number
    3
    3
    Septic Shock
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Sinobronchitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Streptococcal Infection
         subjects affected / exposed
    2 / 195 (1.03%)
    0 / 191 (0.00%)
         occurrences all number
    2
    0
    Staphylococcal Skin Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    7 / 195 (3.59%)
    3 / 191 (1.57%)
         occurrences all number
    8
    3
    Suspected COVID-19
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    3 / 195 (1.54%)
    3 / 191 (1.57%)
         occurrences all number
    4
    3
    Tooth Abscess
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    3
    Tooth Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Tracheobronchitis
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    15 / 195 (7.69%)
    13 / 191 (6.81%)
         occurrences all number
    16
    16
    Vaginal Infection
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    2
    Urinary Tract Infection
         subjects affected / exposed
    11 / 195 (5.64%)
    7 / 191 (3.66%)
         occurrences all number
    12
    13
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 195 (1.03%)
    2 / 191 (1.05%)
         occurrences all number
    2
    2
    Viral Infection
         subjects affected / exposed
    4 / 195 (2.05%)
    3 / 191 (1.57%)
         occurrences all number
    4
    3
    Vulvitis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Vulvovaginal Candidiasis
         subjects affected / exposed
    1 / 195 (0.51%)
    4 / 191 (2.09%)
         occurrences all number
    1
    5
    Vulvovaginal Mycotic Infection
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Decreased Appetite
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Hypoferritinaemia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 195 (0.51%)
    2 / 191 (1.05%)
         occurrences all number
    1
    2
    Hypercalcaemia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 195 (0.51%)
    0 / 191 (0.00%)
         occurrences all number
    1
    0
    Folate Deficiency
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1
    Iron Deficiency
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Impaired Fasting Glucose
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Hypovitaminosis
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    1
    Hypophosphataemia
         subjects affected / exposed
    0 / 195 (0.00%)
    1 / 191 (0.52%)
         occurrences all number
    0
    2
    Vitamin D Deficiency
         subjects affected / exposed
    1 / 195 (0.51%)
    5 / 191 (2.62%)
         occurrences all number
    1
    5
    Vitamin B12 Deficiency
         subjects affected / exposed
    0 / 195 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    3
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    1 / 195 (0.51%)
    1 / 191 (0.52%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Feb 2019
    The overall reason of the amendment was to clarify the definition of endoscopic remission, to update the tuberculosis test being used; to add instructions for emergency un-blinding; and add a few clarifications.
    14 Dec 2020
    The overall reason of the amendment was to revise or clarify secondary, other, and patient-reported outcome (PRO) endpoints for this study, adding Type 1 error control for major secondary endpoints, updating several secondary endpoints, adding or revising several PRO endpoints, and clarifying the wording of some endpoints. The added endpoints were to better address subject concerns regarding treatment of Crohn’s disease, and health authority interest pertaining to efficacy. With this amendment, the updated revisions to the study endpoints were pre-specified prior to database lock.

    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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