Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44358   clinical trials with a EudraCT protocol, of which   7384   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized, Double-Blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Stelara® in Patients with Moderate to Severe Chronic Plaque Psoriasis

    Summary
    EudraCT number
    		 2021-006668-25
    Trial protocol
    		 EE   LV  
    Global end of trial date
    15 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2025
    First version publication date
    17 Aug 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BM12H-PSO-03-G-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05335356
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 153118
    Sponsors
    Sponsor organisation name
    Biocon Biologics UK Limited
    Sponsor organisation address
    16 Great Queen Street, Covent Garden, London, United Kingdom, WC2B 5AH, London, United Kingdom, WC2B 5AH
    Public contact
    Clinical Development, Biocon Biologics Limited, +91 80 6775 1323, subramanian.l101@biocon.com
    Scientific contact
    Clinical Development, Biocon Biologics Limited, +91 80 6775 1323, subramanian.l101@biocon.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Sep 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Nov 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate equivalent efficacy between Bmab 1200 and Stelara® in patients with moderate to severe chronic plaque psoriasis.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Ethics committee approval was obtained prior to trial initiation. All participants provided written informed consent. Confidentiality was maintained through coded identifiers and secure data systems. Adverse events were monitored continuously
    Background therapy
    		 Concomitant medications/procedures were those where the medication/procedure started after the date of the first dose of study drug, or where the medication/procedure started before the first dose of study drug and continued after the first dose of study drug until anytime up to the Week 52 visit. Concomitance was assessed for TP1 on the FAS, TP2 on the FAS2, and TP2 plus TP3 on the FAS3. Thus, a medication/procedure may have been concomitant over TP1 and TP2, TP2 and TP3, or TP1, TP2, and TP3 if it occurred during multiple treatment periods.
    Evidence for comparator
    		 Psoriasis was selected for this Phase 3 study as Stelara® is used as monotherapy in this indication, allowing a clearer demonstration of biosimilarity compared to conditions like psoriatic arthritis, Crohn’s disease, or ulcerative colitis, where concomitant immunosuppressants are common. Psoriasis also shows a strong treatment effect and notable immunogenicity in Stelara® studies, aiding in detecting differences between Bmab 1200 and Stelara®. To ensure balanced treatment arms across countries, patients will be stratified by region. Body weight (≤100 kg or >100 kg) will determine dosing (45 mg or 90 mg) and is a stratification factor to maintain dose balance. Additional stratification includes prior biologic therapy exposure (Yes/No) and presence of psoriatic arthritis (Yes/No), as both may influence treatment response. A single switch via rerandomization at Week 16 is included to assess immunogenicity and safety after transitioning from Stelara® to Bmab 1200 using descriptive statistics.
    Actual start date of recruitment
    29 Apr 2022
    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
    European Union: 378
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    384
    EEA total number of subjects
    0
    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)
    354
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted in Europe and North America and enrolled patients across 41 sites in 5 countries.

    Pre-assignment
    Screening details
    		 A suitable number of patients were to be screened to enroll a total of 384 patients with moderate to severe chronic plaque psoriasis who were deemed eligible for receiving systemic therapy or phototherapy and were naïve to ustekinumab.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    The study was double-blind, with treatment assignments concealed from patients and investigators. Randomization and drug dispensing were managed by unblinded staff using standardized secondary packaging. Unblinding occurred only in emergencies or for regulatory reasons. Two database locks were set at Week 28 and Week 52, with separate teams handling analyses to maintain blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bmab 1200
    Arm description
    		 Bmab 1200 45 mg Bmab1200 90 mg Bmab1200: 45 mg , 90mg at Week 0, 4, 16, 28and 40
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bmab1200
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bmab1200:- 45 mg , 90 mg at Week 0, 4, 16, 28 and 40.

    Arm title
    		 Stelara
    Arm description
    		 Stelara: 45 mg , 90 mg at Week0, 4, 16, 28 and 40; Beforedosing at Week 16, patients inthe Stelara group wererandomly assigned in a 1:1 ratioto receive either Bmab 1200 orStelara
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Stelara
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Stelara: 45 mg , 90 mg at Week0, 4, 16, 28 and 40; Beforedosing at Week 16, patients inthe Stelara group wererandomly assigned in a 1:1 ratioto receive either Bmab 1200 orStelara

    Number of subjects in period 1
    		Bmab 1200 Stelara
    Started
    191
    193
    Completed
    163
    161
    Not completed
    28
    32
         Consent withdrawn by subject
    6
    6
         Physician decision
    4
    7
         Other
    16
    16
         Lost to follow-up
    1
    1
         Patient does not achieve at least PASI 75 response
    1
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 384 384
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 354 354
        From 65-84 years
    		 30 30
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.2 ( 13.34 ) -
    Gender categorical
    Units: Subjects
        Female
    		 127 127
        Male
    		 257 257
    Subject analysis sets

    Subject analysis set title
    Bmab1200
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set

    Subject analysis set title
    Stelara
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set

    Subject analysis sets values
    		 Bmab1200 Stelara
    Number of subjects
    191
    193
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    178
    176
        From 65-84 years
    13
    17
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.5 ( 13.09 )
    43.9 ( 13.58 )
    Gender categorical
    Units: Subjects
        Female
    70
    57
        Male
    121
    136

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Bmab 1200
    Reporting group description
    		 Bmab 1200 45 mg Bmab1200 90 mg Bmab1200: 45 mg , 90mg at Week 0, 4, 16, 28and 40

    Reporting group title
    Stelara
    Reporting group description
    		 Stelara: 45 mg , 90 mg at Week0, 4, 16, 28 and 40; Beforedosing at Week 16, patients inthe Stelara group wererandomly assigned in a 1:1 ratioto receive either Bmab 1200 orStelara

    Subject analysis set title
    Bmab1200
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set

    Subject analysis set title
    Stelara
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set

    Primary: Psoriasis Area and Severity Index (PASI)

    		 Close Top of page
    End point title
    		 Psoriasis Area and Severity Index (PASI)
    End point description
    Percentage change from baseline in the Psoriasis Area and Severity Index score at Week12
    End point type
    Primary
    End point timeframe
    Baseline to Week 12
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    191
    193
    Units: Percentage change from baseline
        least squares mean (standard error)
    -79.87 ( 2.818 )
    -80.55 ( 2.783 )
    Statistical analysis title
    		 Analysis of the Primary Estimand
    Statistical analysis description
    ANCOVA will assess percentage change in PASI score at Week 12 on the FAS, using imputed datasets. The model includes baseline stratification factors as fixed effects. Treatment differences, estimated via least squares means and restricted maximum likelihood, will be pooled using Rubin’s rule with 90% and 95% confidence intervals
    Comparison groups
    Bmab1200 v Stelara
    Number of subjects included in analysis
    384
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.68
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 2.63
    Variability estimate
    Standard error of the mean

    Secondary: PASI Score

    		 Close Top of page
    End point title
    		 PASI Score
    End point description
    Percentage change from baseline in the PASI score at Baseline through Week 28 and 52
    End point type
    Secondary
    End point timeframe
    Baseline through Week 28
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    168
    81
    Units: Percentage change from Baseline
        arithmetic mean (standard deviation)
    -95.50 ( 6.068 )
    -96.01 ( 6.461 )
    No statistical analyses for this end point

    Secondary: PASI Improvement

    		 Close Top of page
    End point title
    		 PASI Improvement
    End point description
    PASI improvement of ≥50% relative to baseline (PASI 50), PASI improvement of ≥75%relative to baseline (PASI 75), and PASI improvement of ≥90% relative to Baseline throughWeek 28 and 52
    End point type
    Secondary
    End point timeframe
    Baseline through Week 28
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    168
    80
    Units: participants
        PASI 50
    168
    80
        PASI 75
    168
    79
        PASI 90
    140
    70
    No statistical analyses for this end point

    Secondary: Static Physician’s Global Assessment (sPGA)

    		 Close Top of page
    End point title
    		 Static Physician’s Global Assessment (sPGA)
    End point description
    Static Physician's Global Assessment (sPGA) response of cleared or almost clear/minimal(PGA of 0 or 1) at Weeks 4, 8, 12, 16, 20, 28, and 52
    End point type
    Secondary
    End point timeframe
    Baseline through Week 28
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    168
    81
    Units: Change from Baseline
        arithmetic mean (standard deviation)
    -3.0 ( 1.21 )
    -2.9 ( 1.21 )
    No statistical analyses for this end point

    Secondary: Affected Body Surface Area

    		 Close Top of page
    End point title
    		 Affected Body Surface Area
    End point description
    Change from baseline in affected body surface area at Weeks 4, 8, 12, 16, 20, 28 and 52
    End point type
    Secondary
    End point timeframe
    Baseline through Week 28
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    168
    81
    Units: Change from Baseline
        arithmetic mean (standard deviation)
    -26.52 ( 15.152 )
    -25.91 ( 13.323 )
    No statistical analyses for this end point

    Secondary: Dermatology Life Quality Index Scores

    		 Close Top of page
    End point title
    		 Dermatology Life Quality Index Scores
    End point description
    Change from baseline in quality of life as measured by Dermatology Life Quality Index scores at Weeks 4, 8, 12, 16, 20, 28 and 52
    End point type
    Secondary
    End point timeframe
    Baseline through Week 28
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    170
    90
    Units: Change from Baseline
        arithmetic mean (standard deviation)
    -12.2 ( 6.84 )
    -10.5 ( 6.74 )
    No statistical analyses for this end point

    Secondary: Dermatology Life Quality Index Scores

    		 Close Top of page
    End point title
    		 Dermatology Life Quality Index Scores
    End point description
    Change from baseline in quality of life as measured by Dermatology Life Quality Indexscores at Weeks 4, 8, 12, 16, 20, 28 and 52
    End point type
    Secondary
    End point timeframe
    Baseline through Week 52
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    152
    79
    Units: Change from Baseline
        arithmetic mean (standard deviation)
    -12.8 ( 6.73 )
    -11.5 ( 6.35 )
    No statistical analyses for this end point

    Secondary: Static Physician’s Global Assessment (sPGA)

    		 Close Top of page
    End point title
    		 Static Physician’s Global Assessment (sPGA)
    End point description
    Static Physician's Global Assessment (sPGA) response of cleared or almost clear/minimal(PGA of 0 or 1) at Weeks 4, 8, 12, 16, 20, 28, and 52
    End point type
    Secondary
    End point timeframe
    Baseline through Week 52
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    163
    80
    Units: Change from Baseline
        arithmetic mean (standard deviation)
    -3.1 ( 1.21 )
    -3.0 ( 1.29 )
    No statistical analyses for this end point

    Secondary: Affected Body Surface Area

    		 Close Top of page
    End point title
    		 Affected Body Surface Area
    End point description
    Change from baseline in affected body surface area at Weeks 4, 8, 12, 16, 20, 28 and 52
    End point type
    Secondary
    End point timeframe
    Baseline through Week 52
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    163
    80
    Units: Change from Baseline
        arithmetic mean (standard deviation)
    -27.42 ( 15.119 )
    -26.50 ( 13.160 )
    No statistical analyses for this end point

    Secondary: PASI Improvement

    		 Close Top of page
    End point title
    		 PASI Improvement
    End point description
    PASI improvement of ≥50% relative to baseline (PASI 50), PASI improvement of ≥75%relative to baseline (PASI 75), and PASI improvement of ≥90% relative to Baseline through Week 28 and 52
    End point type
    Secondary
    End point timeframe
    Baseline through week 52
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    163
    80
    Units: Participants
        PASI 50
    163
    80
        PASI 75
    159
    80
        PASI 90
    133
    70
    No statistical analyses for this end point

    Secondary: PASI Score

    		 Close Top of page
    End point title
    		 PASI Score
    End point description
    Percentage change from baseline in the PASI score at Baseline through Week 28 and 52
    End point type
    Secondary
    End point timeframe
    Baseline through Week 52
    End point values
    		 Bmab1200 Stelara
    Number of subjects analysed
    163
    81
    Units: Percentage change from Baseline
        arithmetic mean (standard deviation)
    -95.50 ( 7.507 )
    -96.60 ( 5.671 )
    No statistical analyses for this end point

    Other pre-specified: Safety:-TEAEs Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period

    		 Close Top of page
    End point title
    		 Safety:-TEAEs Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period
    End point description
    Safety:-Treatment-emergent Adverse Events, Including Adverse Events of Special Interest and Adverse Reactions During the Treatment Period
    End point type
    Other pre-specified
    End point timeframe
    Baseline to Week 52
    End point values
    		 Bmab1200
    Number of subjects analysed
    Units: Participants
        Endometrial adenocarcinoma
    1
        Squamous cell carcinoma of the tongue
    1
        Angioedema
    0
        Rash maculo-papular
    0
        Abdominal pain
    1
        Jaundice cholestatic
    1
        Alcohol poisoning
    0
    No statistical analyses for this end point

    Other pre-specified: Safety:- Injection-site Reactions

    		 Close Top of page
    End point title
    		 Safety:- Injection-site Reactions
    End point description
    Injection-site reactions at Day 1, Week 4, Week 16, and throughout the study
    End point type
    Other pre-specified
    End point timeframe
    Baseline through Week 28 and 52
    End point values
    		 Bmab1200
    Number of subjects analysed
    Units: Participants
    0
    No statistical analyses for this end point

    Other pre-specified: Safety:- Hypersensitivity

    		 Close Top of page
    End point title
    		 Safety:- Hypersensitivity
    End point description
    Hypersensitivity at Day 1, Week 4, Week 16, and throughout the study
    End point type
    Other pre-specified
    End point timeframe
    Baseline through Week 28 and 52
    End point values
    		 Bmab1200
    Number of subjects analysed
    191
    Units: Participants
    1
    No statistical analyses for this end point

    Other pre-specified: Immunogenicity:-Developing Antidrug Antibodies

    		 Close Top of page
    End point title
    		 Immunogenicity:-Developing Antidrug Antibodies
    End point description
    Proportion of patients developing antidrug antibodies
    End point type
    Other pre-specified
    End point timeframe
    Baseline through Week 28
    End point values
    		 Bmab1200
    Number of subjects analysed
    185
    Units: Participants
        ADA positive
    129
        ADA negative
    53
    No statistical analyses for this end point

    Other pre-specified: Immunogenicity:-Developing Antidrug Antibodies

    		 Close Top of page
    End point title
    		 Immunogenicity:-Developing Antidrug Antibodies
    End point description
    Proportion of patients developing antidrug antibodies
    End point type
    Other pre-specified
    End point timeframe
    Postdosing on Week 28 through Week 52
    End point values
    		 Bmab1200
    Number of subjects analysed
    168
    Units: Participants
        ADA positive
    107
        ADA negative
    56
    No statistical analyses for this end point

    Other pre-specified: Developing Neutralizing Antibodies

    		 Close Top of page
    End point title
    		 Developing Neutralizing Antibodies
    End point description
    Proportion of patients with neutralizing antibodies
    End point type
    Other pre-specified
    End point timeframe
    Baseline through Week 28
    End point values
    		 Bmab1200
    Number of subjects analysed
    185
    Units: Participants
        Nab reactive
    18
        Nab negative
    111
    No statistical analyses for this end point

    Other pre-specified: Developing Neutralizing Antibodies

    		 Close Top of page
    End point title
    		 Developing Neutralizing Antibodies
    End point description
    Proportion of patients neutralizing antibodies
    End point type
    Other pre-specified
    End point timeframe
    Postdosing on Week 28 through Week 52
    End point values
    		 Bmab1200
    Number of subjects analysed
    168
    Units: Participants
        Nab reactive
    17
        Nab negative
    90
    No statistical analyses for this end point

    Other pre-specified: Pharmacokinetic:-Serum Concentrations

    		 Close Top of page
    End point title
    		 Pharmacokinetic:-Serum Concentrations
    End point description
    Serum concentrations of ustekinumab
    End point type
    Other pre-specified
    End point timeframe
    Postdosing on Week 28
    End point values
    Number of subjects analysed
    Units: ng/mL
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Other pre-specified: Pharmacokinetic:-Serum Concentrations

    		 Close Top of page
    End point title
    		 Pharmacokinetic:-Serum Concentrations
    End point description
    Serum concentrations of Ustekinumab
    End point type
    Other pre-specified
    End point timeframe
    Postdosing on Week 52
    End point values
    Number of subjects analysed
    Units: ng/mL
        arithmetic mean (standard deviation)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Treatment-Emergent Adverse Events (TEAEs) During TP1 and Through the Study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Bmab1200
    Reporting group description
    		 Bmab 1200 45 mg Bmab 1200 90 mg Bmab1200: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40

    Reporting group title
    Stelara
    Reporting group description
    		 Stelara 45 mg Stelara 90 mg Stelara: 45 mg , 90 mg at Week 0, 4, 16, 28 and 40; Before dosing at Week 16, patients in the Stelara group were randomly assigned in a 1:1 ratio to receive either Bmab 1200 or Stelara

    Reporting group title
    Stelara-Bmab1200
    Reporting group description
    		 Bmab 1200 45 mg 90 mg Stelara 45 mg 90 mg Subject who received Stelara 45 mg dose have received Bmab 1200 dose 45 mg Subject who received Stelara 90 mg dose have received Bmab 1200 dose 90 mg

    Serious adverse events
    		 Bmab1200 Stelara Stelara-Bmab1200
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 191 (3.14%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterovaginal prolapse
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Bmab1200 Stelara Stelara-Bmab1200
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    111 / 191 (58.12%)
    48 / 101 (47.52%)
    51 / 92 (55.43%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Haemangioma
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Meningioma
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Essential hypertension
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertension
         subjects affected / exposed
    3 / 191 (1.57%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    3
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Genital haemorrhage
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Menstruation irregular
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatitis
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Uterovaginal prolapse
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    1
    1
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Anxiety disorder
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Illness anxiety disorder
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Alanine amino transferase increased
         subjects affected / exposed
    12 / 191 (6.28%)
    6 / 101 (5.94%)
    2 / 92 (2.17%)
         occurrences all number
    14
    9
    3
    Aspartate amino transferase increased
         subjects affected / exposed
    7 / 191 (3.66%)
    2 / 101 (1.98%)
    0 / 92 (0.00%)
         occurrences all number
    7
    2
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Blood bilirubin increased †
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Blood cholesterol increased
         subjects affected / exposed
    4 / 191 (2.09%)
    2 / 101 (1.98%)
    2 / 92 (2.17%)
         occurrences all number
    6
    3
    2
    Blood glucose abnormal
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Blood glucose increased
         subjects affected / exposed
    2 / 191 (1.05%)
    3 / 101 (2.97%)
    1 / 92 (1.09%)
         occurrences all number
    3
    3
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    1
    1
    0
    Blood phosphorus decreased
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure increased
         subjects affected / exposed
    3 / 191 (1.57%)
    2 / 101 (1.98%)
    2 / 92 (2.17%)
         occurrences all number
    3
    2
    2
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    11 / 191 (5.76%)
    3 / 101 (2.97%)
    3 / 92 (3.26%)
         occurrences all number
    13
    4
    5
    C-reactive protein increased
         subjects affected / exposed
    0 / 191 (0.00%)
    2 / 101 (1.98%)
    2 / 92 (2.17%)
         occurrences all number
    0
    2
    2
    Creatinine renal clearance decreased
         subjects affected / exposed
    2 / 191 (1.05%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    2
    1
    0
    Gamma-glutamy ltransferase increased
         subjects affected / exposed
    6 / 191 (3.14%)
    2 / 101 (1.98%)
    1 / 92 (1.09%)
         occurrences all number
    7
    2
    1
    Glucose urine present
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Haemoglobin increased
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    High density lipoprotein decreased
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Lipids increased
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 101 (0.99%)
    1 / 92 (1.09%)
         occurrences all number
    1
    1
    2
    Monocyte count increased
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    1
    Weight increased
         subjects affected / exposed
    3 / 191 (1.57%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    3
    0
    1
    White blood cells urine positive
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Fibula fracture
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Foot fracture
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Fractured coccyx
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Hand fracture
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Post-traumatic neck syndrome
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Post-traumatic pain
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Tendon rupture
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Angina pectoris
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Atrial fibrillation
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Bundle branch block right
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac discomfort
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Cardiac failure
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Left atrial enlargement
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 191 (1.57%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    4
    0
    0
    Headache
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 101 (0.99%)
    1 / 92 (1.09%)
         occurrences all number
    2
    2
    1
    Ischaemic stroke
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    2 / 191 (1.05%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    2
    1
    0
    Depressed mood
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    1
    0
    1
    Depression
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 191 (2.09%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    4
    0
    0
    Eosinophilia
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 101 (0.99%)
    1 / 92 (1.09%)
         occurrences all number
    1
    1
    1
    Erythropenia
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Leukocytosis
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 101 (0.99%)
    1 / 92 (1.09%)
         occurrences all number
    1
    1
    1
    Leukopenia
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Neutropenia
         subjects affected / exposed
    4 / 191 (2.09%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    4
    0
    0
    Secondary thrombocytosis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Eye pruritus
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 191 (1.05%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    2
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    1
    1
    0
    Food poisoning
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Cholecystitis acute
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Cholestasis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic steatosis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatomegaly
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Angioedema
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    2 / 191 (1.05%)
    2 / 101 (1.98%)
    1 / 92 (1.09%)
         occurrences all number
    2
    2
    1
    Psoriasis
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 101 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    2
    0
    2
    Rash maculo-papular
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Rosacea
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Sensitive skin
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    2
    0
    1
    Renal and urinary disorders
    Glycosuria
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    1
    Hyperoxaluria
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Ketonuria
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    1
    1
    0
    Leukocyturia
         subjects affected / exposed
    3 / 191 (1.57%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    3
    0
    1
    Nephrolithiasis
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Proteinuria
         subjects affected / exposed
    4 / 191 (2.09%)
    1 / 101 (0.99%)
    3 / 92 (3.26%)
         occurrences all number
    4
    1
    3
    Renal impairment
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary retention
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 191 (1.05%)
    3 / 101 (2.97%)
    0 / 92 (0.00%)
         occurrences all number
    2
    4
    0
    Joint contracture
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Psoriatic arthropathy
         subjects affected / exposed
    3 / 191 (1.57%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    3
    2
    0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal pain
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Asymptomatic bacteriuria
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Bacteriuria
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    3 / 191 (1.57%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    3
    0
    0
    COVID-19
         subjects affected / exposed
    4 / 191 (2.09%)
    0 / 101 (0.00%)
    3 / 92 (3.26%)
         occurrences all number
    4
    0
    3
    Conjunctivitis
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    1
    0
    2
    Folliculitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    1
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Giardiasis
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Herpes simplex
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Herpes zoster
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Influenza
         subjects affected / exposed
    4 / 191 (2.09%)
    5 / 101 (4.95%)
    5 / 92 (5.43%)
         occurrences all number
    4
    8
    5
    Nasopharyngitis
         subjects affected / exposed
    18 / 191 (9.42%)
    6 / 101 (5.94%)
    8 / 92 (8.70%)
         occurrences all number
    23
    6
    8
    Onychomycosis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 191 (0.52%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    1
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 191 (0.52%)
    2 / 101 (1.98%)
    1 / 92 (1.09%)
         occurrences all number
    1
    2
    1
    Otitis externa
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis media
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Periodontitis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    4 / 191 (2.09%)
    1 / 101 (0.99%)
    2 / 92 (2.17%)
         occurrences all number
    5
    1
    2
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 191 (0.00%)
    2 / 101 (1.98%)
    0 / 92 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 191 (0.00%)
    1 / 101 (0.99%)
    1 / 92 (1.09%)
         occurrences all number
    0
    1
    2
    Rhinitis
         subjects affected / exposed
    2 / 191 (1.05%)
    2 / 101 (1.98%)
    3 / 92 (3.26%)
         occurrences all number
    3
    3
    3
    Sinusitis
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Sinusitis bacterial
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Tongue fungal infection
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    2 / 191 (1.05%)
    1 / 101 (0.99%)
    1 / 92 (1.09%)
         occurrences all number
    2
    1
    2
    Tonsillitis bacterial
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Tooth abscess
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 191 (3.14%)
    1 / 101 (0.99%)
    6 / 92 (6.52%)
         occurrences all number
    7
    1
    7
    Urethritis
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    6 / 191 (3.14%)
    2 / 101 (1.98%)
    3 / 92 (3.26%)
         occurrences all number
    6
    2
    3
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Vaginal infection
         subjects affected / exposed
    3 / 191 (1.57%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    3
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    2
    0
    2
    Bone contusion
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Acquired mixed hyperlipidaemia
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Diabetes mellitus
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    2
    0
    0
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    4 / 191 (2.09%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    4
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    5 / 191 (2.62%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    5
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    6 / 191 (3.14%)
    1 / 101 (0.99%)
    0 / 92 (0.00%)
         occurrences all number
    8
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Latent autoimmune diabetes in adults
         subjects affected / exposed
    0 / 191 (0.00%)
    0 / 101 (0.00%)
    1 / 92 (1.09%)
         occurrences all number
    0
    0
    1
    Metabolic syndrome
         subjects affected / exposed
    1 / 191 (0.52%)
    0 / 101 (0.00%)
    0 / 92 (0.00%)
         occurrences all number
    1
    0
    0
    Obesity
         subjects affected / exposed
    0 / 191 (0.00%)
    2 / 101 (1.98%)
    1 / 92 (1.09%)
         occurrences all number
    0
    2
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 191 (1.05%)
    0 / 101 (0.00%)
    2 / 92 (2.17%)
         occurrences all number
    2
    0
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Sep 01 05:48:53 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA