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    Clinical Trial Results:
    An exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease

    Summary
    EudraCT number
    		 2019-003521-21
    Trial protocol
    		 BE   NL   DE   ES   CZ   IT  
    Global end of trial date
    04 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Apr 2024
    First version publication date
    11 Apr 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GLPG2737-CL-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04578548
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Galapagos NV
    Sponsor organisation address
    Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800
    Public contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com
    Scientific contact
    Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.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
    04 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Apr 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To characterize the effect of GLPG2737 on growth in total kidney volume (TKV) compared to placebo, safety and tolerability of oral doses of GLPG2737 compared to placebo.
    Protection of trial subjects
    This study is being conducted under a US investigational new drug (IND) application and in accordance with recognized international scientific and ethical standards, including but not limited to the International Council for Harmonisation (ICH) guideline for Good Clinical Practice (GCP), and the original principles embodied in the Declaration of Helsinki. These standards are consistent with the requirements of the US Code of Federal Regulations (CFR) Title 21, Part 312 (21CFR312), and the EU Clinical Trials Directive 2001/20/EC as well as other local legislation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 10
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Spain: 19
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Czechia: 9
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 11
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    66
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with autosomal dominant polycystic kidney disease (ADPKD) were enrolled. The study was conducted at 20 sites in 7 countries i.e. Belgium, Czech Republic, Germany, Italy, Netherlands, Poland, and Spain. Of these 20 activated sites, 3 sites did not enroll any participants. 89 participants were screened, out of which 66 were randomized.

    Pre-assignment
    Screening details
    		 Participants who met protocol eligibility criteria were assigned to GLPG2737 or placebo in the double-blind (DB) treatment period and open-label extension (OLE) period. The study was prematurely terminated on 02 March 2023, due to the lack of efficacy of GLPG2737, making the expected benefit-risk balance negative.

    Period 1
    Period 1 title
    Double-blind treatment period (52 weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GLPG2737 During DB
    Arm description
    		 Participants received 150 milligrams (mg) GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG2737
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules administered orally for 52 weeks.

    Arm title
    		 Placebo During DB
    Arm description
    		 Participants received placebo matched to GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules administered orally for 52 weeks.

    Number of subjects in period 1
    		GLPG2737 During DB Placebo During DB
    Started
    44
    22
    Completed
    41
    20
    Not completed
    3
    2
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    1
    1
         Non compliance with study drug
    1
    1
    Period 2
    Period 2 title
    Open-Label treatment period (52 weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GLPG2737 During DB + During OLE
    Arm description
    		 Eligible participants who received GLPG2737 in DB period were rolled over to an OLE period to receive 150 mg GLPG2737 capsules orally once daily for 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG2737
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules administered orally.

    Arm title
    		 Placebo During DB + GLPG2737 During OLE
    Arm description
    		 Eligible participants who received placebo in DB period were rolled over to an OLE period to receive 150 mg GLPG2737 capsules orally once daily for 52 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GLPG2737
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules administered orally

    Number of subjects in period 2 [1]
    		GLPG2737 During DB + During OLE Placebo During DB + GLPG2737 During OLE
    Started
    39
    20
    Completed
    3
    4
    Not completed
    36
    16
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    1
         Study terminated by sponsor
    34
    15
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Not all participants who completed the DB treatment period entered the OLE treatment period

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GLPG2737 During DB
    Reporting group description
    		 Participants received 150 milligrams (mg) GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period.

    Reporting group title
    Placebo During DB
    Reporting group description
    		 Participants received placebo matched to GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period.

    Reporting group values
    		 GLPG2737 During DB Placebo During DB Total
    Number of subjects
    		 44 22 66
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.6 ( 6.3 ) 39.6 ( 6.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 8 32
        Male
    		 20 14 34
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 9 2 11
        Not Hispanic or Latino
    		 35 20 55
        Other
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 44 22 66
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Height-Adjusted Total Kidney Volume(htTKV) (n=41, 20)
    htTKV is used in participants with ADPKD disease to predict the onset of renal insufficiency. htTKV was calculated using TKV (in milliliter [mL]) obtained from magnetic resonance imaging (MRI) divided by height (in meter [m]). MRI Baseline: For MRI assessments, all non-missing values before the first study drug administration in the study +14 days (included) was considered as the primary baseline definition. Participants with MRI baseline (41 for GLPG2737 and 20 for placebo) were analyzed.
    Units: mL/m
        arithmetic mean (standard deviation)
    		 1069.18 ( 438.06 ) 1439.23 ( 737.67 ) -
    Estimated Glomerular filtration rate(GFR)
    eGFR is a test that measures level of kidney function and determines your stage of kidney disease. eGFR was based on chronic kidney disease-Epidemiology (CKD-EPI) formula (2009) calculated from serum creatinine concentrations. eGFR was measured as milliliters per minute per 1.73 square meter (mL/min/1.73 m^2).
    Units: mL/min/1.73 m^2
        arithmetic mean (standard deviation)
    		 55.5 ( 16.3 ) 51.6 ( 15.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    GLPG2737 During DB
    Reporting group description
    		 Participants received 150 milligrams (mg) GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period.

    Reporting group title
    Placebo During DB
    Reporting group description
    		 Participants received placebo matched to GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period.
    Reporting group title
    GLPG2737 During DB + During OLE
    Reporting group description
    		 Eligible participants who received GLPG2737 in DB period were rolled over to an OLE period to receive 150 mg GLPG2737 capsules orally once daily for 52 weeks.

    Reporting group title
    Placebo During DB + GLPG2737 During OLE
    Reporting group description
    		 Eligible participants who received placebo in DB period were rolled over to an OLE period to receive 150 mg GLPG2737 capsules orally once daily for 52 weeks.

    Primary: DB Period: Mean Percent Change From MRI Baseline in htTKV

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    End point title
    		 DB Period: Mean Percent Change From MRI Baseline in htTKV
    End point description
    htTKV is used in participants with ADPKD disease to predict the onset of renal insufficiency. htTKV was calculated using TKV (in mL) obtained from MRI divided by height (in m). MRI Baseline: For MRI assessments, all non-missing values before the first study drug administration in the study +14 days (included) was considered as the primary baseline definition. Results were derived by mean of the individual slopes (i.e. using all MRI performed between baseline and Week 52). Full Analysis Set (FAS): All randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    MRI Baseline up to Week 52
    End point values
    		 GLPG2737 During DB Placebo During DB
    Number of subjects analysed
    44
    22
    Units: percent change
        geometric mean (confidence interval 95%)
    8.18 (6.04 to 10.36)
    9.17 (6.05 to 12.38)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Based on a random coefficient regression model (linear slope model) on htTKV log-transformed values with time (in weeks) as a continuous variable, treatment, time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.
    Comparison groups
    GLPG2737 During DB v Placebo During DB
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.606
    Method
    		 Random coefficient regression model
    Parameter type
    		 Geometric Mean Difference
    Point estimate
    -0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.34
         upper limit
    		 2.64

    Primary: DB Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

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    End point title
    		 DB Period: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [1]
    End point description
    AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have causal relationship with this treatment. AE can therefore be any unfavorable/unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug, whether or not considered related to it. Serious adverse event (SAE) is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect or other medically important event. TEAE is defined as AE observed after starting administration of study drug until 30 days after last DB dose or 1 day before OLE dose, whichever occurred first. Safety Analysis Set (SAS): All randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    From first dose to Week 56
    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: The statistical analysis was not planned to be carried out.
    End point values
    		 GLPG2737 During DB Placebo During DB
    Number of subjects analysed
    44
    22
    Units: participants
    number (not applicable)
        TEAEs
    44
    22
        Serious TEAEs
    1
    3
    No statistical analyses for this end point

    Secondary: DB Period: Mean Change From Baseline in eGFR

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    End point title
    		 DB Period: Mean Change From Baseline in eGFR
    End point description
    The eGFR is a test that measures level of kidney function and determines the stage of kidney disease. eGFR was based on CKD-EPI formula (2009) calculated from serum creatinine concentrations. Results were derived by mean of the individual slopes (i.e. using data between baseline and Week 52). FAS.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 52
    End point values
    		 GLPG2737 During DB Placebo During DB
    Number of subjects analysed
    44
    22
    Units: mL/min/1.73m^2
        least squares mean (confidence interval 95%)
    -5.44 (-7.34 to -3.54)
    -3.13 (-5.87 to -0.39)
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Least-squares mean difference (95% CI) from a random coefficient regression model (linear slope model) on eGFR values with time (in weeks) as a continuous variable, the time-by-treatment interaction and a random intercept and slope. The treatment effect was determined by using estimated slopes for each treatment group on the basis of the time-by-treatment interaction term from the mixed model.
    Comparison groups
    GLPG2737 During DB v Placebo During DB
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.171
    Method
    		 Random coefficient regression model
    Parameter type
    		 Least-squares mean difference
    Point estimate
    -2.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.64
         upper limit
    		 1.02

    Secondary: DB Period: Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of GLPG2737 and its metabolite

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    End point title
    		 DB Period: Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of GLPG2737 and its metabolite [2]
    End point description
    AUC0-tau described the area under the curve limited to the end of a dosing interval. The metabolite of GLPG2737 is M4. Pharmacokinetic Analysis Set (PKAS): All randomized participants who received at least one dose of study drug for which plasma concentration data was available to facilitate development of the Population PK model and for whom the time of the dose on the days of PK sampling was known.
    End point type
    Secondary
    End point timeframe
    Predose (within 30 minutes prior to dosing), 1, 1.5, 2, 3, 4, 5, 6, 7 hours post dose through Week 52
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For PK analysis only the GLPG2737 arm was analyzed.
    End point values
    		 GLPG2737 During DB
    Number of subjects analysed
    44
    Units: nanogram* hour per milliliter (ng*h/mL)
    geometric mean (confidence interval 95%)
        GLPG2737
    18500 (17500 to 19500)
        Metabolite M4
    18700 (17400 to 20200)
    No statistical analyses for this end point

    Secondary: DB Period: Maximum Observed Plasma Concentration (Cmax) of GLPG2737 and its metabolite

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    End point title
    		 DB Period: Maximum Observed Plasma Concentration (Cmax) of GLPG2737 and its metabolite [3]
    End point description
    Cmax is the maximum observed plasma concentration of the drug. The metabolite of GLPG2737 is M4. PKAS.
    End point type
    Secondary
    End point timeframe
    Predose (within 30 minutes prior to dosing), 1, 1.5, 2, 3, 4, 5, 6, 7 hours post dose through Week 52
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: For PK analysis only the GLPG2737 arm was analyzed.
    End point values
    		 GLPG2737 During DB
    Number of subjects analysed
    44
    Units: ng/mL
    geometric mean (confidence interval 95%)
        GLPG2737
    1160 (1110 to 1220)
        Metabolite M4
    873 (813 to 939)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    DB Period: From first dose to Week 56 OLE Period: From first dose to Week 56
    Adverse event reporting additional description
    DB Period: SAS. OLE Period: All OLE enrolled participants who received one dose of study drug during the OLE period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    GLPG2737 During DB + During OLE
    Reporting group description
    		 Participants received 150 mg GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period. Eligible participants were rolled over to an OLE period to receive 150 mg GLPG2737 capsules orally once daily for 52 weeks.

    Reporting group title
    Placebo During DB + GLPG2737 During OLE
    Reporting group description
    		 Eligible participants from Placebo DB were rolled over to an OLE period to receive 150 mg GLPG2737 capsules orally once daily for 52 weeks.

    Reporting group title
    Placebo During DB
    Reporting group description
    		 Participants received placebo matched to GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period.

    Serious adverse events
    		 GLPG2737 During DB + During OLE Placebo During DB + GLPG2737 During OLE Placebo During DB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 20 (10.00%)
    3 / 22 (13.64%)
         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)
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (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
    Uterine leiomyoma
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive emergency
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Cyst rupture
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (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
    Renal and urinary disorders
    Renal cyst
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Hepatic cyst infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (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
    Renal abscess
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cyst infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (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: 0%
    Non-serious adverse events
    		 GLPG2737 During DB + During OLE Placebo During DB + GLPG2737 During OLE Placebo During DB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 44 (100.00%)
    15 / 20 (75.00%)
    22 / 22 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    13 / 44 (29.55%)
    0 / 20 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    16
    0
    4
    Hypotension
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Raynaud's phenomenon
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    4
    0
    0
    Asthenia
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    3
    0
    3
    Malaise
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Injection site pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema mucosal
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    4
    0
    2
    Peripheral swelling
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Pyrexia
         subjects affected / exposed
    6 / 44 (13.64%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    10
    0
    3
    Thirst
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Discomfort
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Drug intolerance
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    5 / 44 (11.36%)
    0 / 20 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    6
    0
    4
    Hyperthermia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    1
    Rubber sensitivity
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Seasonal allergy
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    Reproductive system and breast disorders
    Amenorrhoea
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Erectile dysfunction
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Prostatitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Ovarian cyst
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    8 / 44 (18.18%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    11
    1
    3
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 20 (5.00%)
    3 / 22 (13.64%)
         occurrences all number
    4
    1
    3
    Dyspnoea
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Mediastinal cyst
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    2
    0
    3
    Psychiatric disorders
    Stress
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Panic attack
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Amylase increased
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Aortic bruit
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Lipase increased
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Arthropod bite
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Arthropod sting
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Chillblains
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Clavicle fracture
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Fall
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Ligament sprain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Limb fracture
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Limb injury
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural hemorrhage
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Post vaccination syndrome
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    3
    Post-traumatic pain
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Skin abrasion
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Traumatic renal injury
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Vaccination complication
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    9
    0
    1
    Haematuria traumatic
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    0
    2
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Defect conduction intraventricular
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Palpitations
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    3
    0
    1
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Tachycardia
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Bradycardia
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Cerebellar infarction
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Dizziness
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    5
    0
    1
    Headache
         subjects affected / exposed
    11 / 44 (25.00%)
    0 / 20 (0.00%)
    8 / 22 (36.36%)
         occurrences all number
    44
    0
    18
    Hypoaesthesia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphopenia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Tinnitus
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Gingival swelling
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal discomfort
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal distension
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Abdominal pain
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    7
    0
    6
    Abdominal pain lower
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    5
    0
    3
    Chronic gastritis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    4 / 44 (9.09%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    6
    1
    3
    Dry mouth
         subjects affected / exposed
    11 / 44 (25.00%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    21
    1
    1
    Dyspepsia
         subjects affected / exposed
    5 / 44 (11.36%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    5
    0
    2
    Flatulence
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    7
    0
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    4
    Odynophagia
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    2
    Oesophageal pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Stomatitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Toothache
         subjects affected / exposed
    4 / 44 (9.09%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    8
    1
    2
    Umbilical hernia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Lip dry
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Hepatobiliary disorders
    Gallbladder polyp
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Hepatic cyst
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Hair texture abnormal
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Rash
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Skin depigmentation
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Skin mass
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Renal cyst ruptured
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    1
    Albuminuria
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Dysuria
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Haematuria
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    11
    0
    1
    Micturition urgency
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    2
    Renal cyst
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Renal cyst haemorrhage
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Renal impairment
         subjects affected / exposed
    4 / 44 (9.09%)
    2 / 20 (10.00%)
    2 / 22 (9.09%)
         occurrences all number
    4
    2
    2
    Renal pain
         subjects affected / exposed
    8 / 44 (18.18%)
    2 / 20 (10.00%)
    6 / 22 (27.27%)
         occurrences all number
    15
    2
    19
    Renal injury
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Hyperparathyroidism secondary
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Plantar fasciitis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    Arthralgia
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    5
    0
    2
    Back pain
         subjects affected / exposed
    8 / 44 (18.18%)
    0 / 20 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    10
    0
    9
    Flank pain
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    6
    0
    3
    Limb discomfort
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    5
    0
    2
    Myalgia
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    1
    Neck pain
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Tendonitis
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal infection
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Bacterial vulvovaginitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    4 / 44 (9.09%)
    2 / 20 (10.00%)
    1 / 22 (4.55%)
         occurrences all number
    4
    2
    1
    COVID-19
         subjects affected / exposed
    21 / 44 (47.73%)
    1 / 20 (5.00%)
    5 / 22 (22.73%)
         occurrences all number
    25
    1
    5
    Cystitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Folliculitis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Gardnerella infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Gastric infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Helicobacter gastritis
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic cyst infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Hordeolum
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Influenza
         subjects affected / exposed
    8 / 44 (18.18%)
    1 / 20 (5.00%)
    2 / 22 (9.09%)
         occurrences all number
    10
    1
    3
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    10 / 44 (22.73%)
    2 / 20 (10.00%)
    5 / 22 (22.73%)
         occurrences all number
    16
    2
    7
    Norovirus infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    Otitis externa
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Otitis media
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 44 (2.27%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    Phlebitis infective
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Renal cyst infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 44 (0.00%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    3
    0
    1
    Tonsillitis
         subjects affected / exposed
    2 / 44 (4.55%)
    1 / 20 (5.00%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    1
    Tooth abscess
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 44 (11.36%)
    5 / 20 (25.00%)
    3 / 22 (13.64%)
         occurrences all number
    8
    6
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    1
    0
    2
    Viral infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Wound infection
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Otitis media acute
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Gout
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    Hyperlipasaemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    2
    Hyperuricaemia
         subjects affected / exposed
    4 / 44 (9.09%)
    0 / 20 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    4
    0
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolic acidosis
         subjects affected / exposed
    0 / 44 (0.00%)
    1 / 20 (5.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    Polydipsia
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 20 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2019
    Clarification of prohibited medication was added.
    11 Feb 2020
    Update of CSP in order to extend treatment period from 24 weeks to 52 weeks.
    25 Jun 2020
    Change in contraceptive language, mitigation on the SARS-CoV-2 pandemic, updated wording related to IDMC, collection and storage of biological samples.
    13 Aug 2021
    Incorporation of an open label extension period, removal of the interim analysis in combination with a change in the composition from iDMC to DMC, clarification on vaccinations including covid vaccination, and operational changes (including update of timing of MRI assessments).
    20 Dec 2021
    The CSP was updated to change the composition of the DMC by removing the sponsor’s representative to create a fully independent DMC.

    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.
    The early termination was decided due to the lack of efficacy of GLPG2737, making the expected benefit-risk balance negative.
    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.

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