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    Clinical Trial Results:
    Effect of the administration of different Hidroferol® Soft Gelatine Capsules (calcifediol) and cholecalciferol (Dibase®) regimens on 25(OH)D levels and markers of bone remodelling in postmenopausal women with 25(OH)D deficiency. Influence of clinical and genetic factors in the osteoporotic and non-osteoporotic population.

    Summary
    EudraCT number
    		 2017-004028-31
    Trial protocol
    		 ES   IT  
    Global end of trial date
    11 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2025
    First version publication date
    15 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HIDR-0217/OST
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    FAES FARMA, S.A.
    Sponsor organisation address
    Avenida Autonomía 10, Leioa, Spain, 48940
    Public contact
    Inmaculada Gilaberte, FAES FARMA, S.A., 0034 94 481 83 00, igilaberte@faes.es
    Scientific contact
    Inmaculada Gilaberte, FAES FARMA, S.A., 0034 94 481 83 00, igilaberte@faes.es
    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
    24 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy and safety in postmenopausal women with vitamin D deficiency, with or without osteoporosis, of the long-term treatment with Hidroferol® Soft Gelatine Capsules (SGC) in the correction and maintenance of normal values of vitamin D comparing with the approved regimen and with the treatment recommended by the current European Guidance .
    Protection of trial subjects
    The study is conducted in accordance with the Declaration of Helsinki (2013) as well as with the valid national laws of the participating countries, with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice (GCP) (E6), and with the Commission Directives 2001/20/EC, 2005/28/EC and 2001/83/EC.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2017
    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
    Spain: 289
    Country: Number of subjects enrolled
    Italy: 14
    Worldwide total number of subjects
    303
    EEA total number of subjects
    303
    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)
    187
    From 65 to 84 years
    113
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 401 subjects were enrolled at 13 study sites in 2 countries (Spain and Italy). Of these, 98 subjects failed screening. In total 303 subjects of both cohorts (Cohort1: 270 subjects, Cohort2: 33 subjects) were randomised.

    Pre-assignment
    Screening details
    		 98 subjects failed screening. In total 303 subjects of both cohorts (Cohort1: 270 subjects, Cohort2: 33 subjects) were randomised by 11 AUG 2020.

    Period 1
    Period 1 title
    Randomization
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A1
    Arm description
    		 Hidroferol® experimental treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hidroferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    group A1 (test group, 102 patients). Hidroferol® experimental treatment. Patients received: o 1 soft gelatin capsule of calcifediol (0.266 mg) once a month for 12 months, plus o 1 jar (single dose container) of 2.5 mL of placebo oral solution once a month for 12 months.

    Arm title
    		 Group A2
    Arm description
    		 Hidroferol® treatment according to approved SmPC posology
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hidroferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    • group A2 (SmPC group, 101 patients). Hidroferol® treatment according to approved SmPC posology. Patients received: o 1 soft gelatin capsule of calcifediol (0.266 mg) once a month for 4 months. o 1 soft gelatin capsule of placebo once a month from Month 5 to Month 12. o 1 jar (single dose container) of 2.5 mL of placebo oral solution once a month for 12 months.

    Arm title
    		 Group B
    Arm description
    		 Cholecalciferol (Dibase®) as recommended by therapeutic guidelines
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cholecalciferol (Dibase)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution in bottle
    Routes of administration
    Oral use
    Dosage and administration details
    • group B (reference group, 100 patients). Cholecalciferol (Dibase®) as recommended by therapeutic guidelines. Patients received: o 1 jar (single dose container) of 2.5 mL of cholecalciferol (25,000 IU) once a month for 12 months. o 1 soft gelatin capsule of placebo once a month for 12 months.

    Number of subjects in period 1
    		Group A1 Group A2 Group B
    Started
    102
    101
    100
    Completed
    102
    101
    100
    Period 2
    Period 2 title
    Period 1: 0-4 months
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A1
    Arm description
    		 Hidroferol® experimental treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hidroferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    group A1 (test group, 102 patients). Hidroferol® experimental treatment. Patients received: o 1 soft gelatin capsule of calcifediol (0.266 mg) once a month for 12 months, plus o 1 jar (single dose container) of 2.5 mL of placebo oral solution once a month for 12 months.

    Arm title
    		 Group A2
    Arm description
    		 Hidroferol® treatment according to approved SmPC posology
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hidroferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    • group A2 (SmPC group, 101 patients). Hidroferol® treatment according to approved SmPC posology. Patients received: o 1 soft gelatin capsule of calcifediol (0.266 mg) once a month for 4 months. o 1 soft gelatin capsule of placebo once a month from Month 5 to Month 12. o 1 jar (single dose container) of 2.5 mL of placebo oral solution once a month for 12 months.

    Arm title
    		 Group B
    Arm description
    		 Cholecalciferol (Dibase®) as recommended by therapeutic guidelines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cholecalciferol (Dibase)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution in bottle
    Routes of administration
    Oral use
    Dosage and administration details
    • group B (reference group, 100 patients). Cholecalciferol (Dibase®) as recommended by therapeutic guidelines. Patients received: o 1 jar (single dose container) of 2.5 mL of cholecalciferol (25,000 IU) once a month for 12 months. o 1 soft gelatin capsule of placebo once a month for 12 months.

    Number of subjects in period 2
    		Group A1 Group A2 Group B
    Started
    102
    101
    100
    Completed
    99
    96
    96
    Not completed
    3
    5
    4
         Consent withdrawn by subject
    -
    5
    2
         Adverse event, non-fatal
    -
    -
    1
         Protocol deviation
    3
    -
    1
    Period 3
    Period 3 title
    Period 2: 4-12 months
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A1
    Arm description
    		 Hidroferol® experimental treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hidroferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    group A1 (test group, 102 patients). Hidroferol® experimental treatment. Patients received: o 1 soft gelatin capsule of calcifediol (0.266 mg) once a month for 12 months, plus o 1 jar (single dose container) of 2.5 mL of placebo oral solution once a month for 12 months.

    Arm title
    		 Group A2
    Arm description
    		 Hidroferol® treatment according to approved SmPC posology.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hidroferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    • group A2 (SmPC group, 101 patients). Hidroferol® treatment according to approved SmPC posology. Patients received: o 1 soft gelatin capsule of calcifediol (0.266 mg) once a month for 4 months. o 1 soft gelatin capsule of placebo once a month from Month 5 to Month 12. o 1 jar (single dose container) of 2.5 mL of placebo oral solution once a month for 12 months.

    Arm title
    		 Group B
    Arm description
    		 Cholecalciferol (Dibase®) as recommended by therapeutic guidelines
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cholecalciferol (Dibase)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution in bottle
    Routes of administration
    Oral use
    Dosage and administration details
    • group B (reference group, 100 patients). Cholecalciferol (Dibase®) as recommended by therapeutic guidelines. Patients received: o 1 jar (single dose container) of 2.5 mL of cholecalciferol (25,000 IU) once a month for 12 months. o 1 soft gelatin capsule of placebo once a month for 12 months.

    Number of subjects in period 3
    		Group A1 Group A2 Group B
    Started
    99
    96
    96
    Completed
    95
    75
    88
    Not completed
    4
    21
    8
         Consent withdrawn by subject
    -
    2
    3
         Serum 25(OH)D<10ng/mL
    -
    14
    -
         COVID Pandemic
    -
    -
    1
         Adverse event, non-fatal
    1
    -
    1
         Low adherence
    1
    1
    1
         Lost to follow-up
    -
    2
    -
         Protocol deviation
    2
    2
    2
    Period 4
    Period 4 title
    Safety Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hidroferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    group A1 (test group, 102 patients). Hidroferol® experimental treatment. Patients received: o 1 soft gelatin capsule of calcifediol (0.266 mg) once a month for 12 months, plus o 1 jar (single dose container) of 2.5 mL of placebo oral solution once a month for 12 months.

    Arm title
    		 Group A2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hidroferol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    • group A2 (SmPC group, 101 patients). Hidroferol® treatment according to approved SmPC posology. Patients received: o 1 soft gelatin capsule of calcifediol (0.266 mg) once a month for 4 months. o 1 soft gelatin capsule of placebo once a month from Month 5 to Month 12. o 1 jar (single dose container) of 2.5 mL of placebo oral solution once a month for 12 months.

    Arm title
    		 Group B
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cholecalciferol (Dibase)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution in bottle
    Routes of administration
    Oral use
    Dosage and administration details
    • group B (reference group, 100 patients). Cholecalciferol (Dibase®) as recommended by therapeutic guidelines. Patients received: o 1 jar (single dose container) of 2.5 mL of cholecalciferol (25,000 IU) once a month for 12 months. o 1 soft gelatin capsule of placebo once a month for 12 months.

    Number of subjects in period 4
    		Group A1 Group A2 Group B
    Started
    95
    75
    88
    Completed
    95
    75
    88

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A1
    Reporting group description
    		 Hidroferol® experimental treatment

    Reporting group title
    Group A2
    Reporting group description
    		 Hidroferol® treatment according to approved SmPC posology

    Reporting group title
    Group B
    Reporting group description
    		 Cholecalciferol (Dibase®) as recommended by therapeutic guidelines

    Reporting group values
    		 Group A1 Group A2 Group B Total
    Number of subjects
    		 102 101 100 303
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 59 67 61 187
        From 65-84 years
    		 43 33 37 113
        85 years and over
    		 0 1 2 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.3 ( 8.2 ) 62.4 ( 7.6 ) 63.9 ( 9.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 102 101 100 303
        Male
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Group A1
    Reporting group description
    		 Hidroferol® experimental treatment

    Reporting group title
    Group A2
    Reporting group description
    		 Hidroferol® treatment according to approved SmPC posology

    Reporting group title
    Group B
    Reporting group description
    		 Cholecalciferol (Dibase®) as recommended by therapeutic guidelines
    Reporting group title
    Group A1
    Reporting group description
    		 Hidroferol® experimental treatment.

    Reporting group title
    Group A2
    Reporting group description
    		 Hidroferol® treatment according to approved SmPC posology

    Reporting group title
    Group B
    Reporting group description
    		 Cholecalciferol (Dibase®) as recommended by therapeutic guidelines.
    Reporting group title
    Group A1
    Reporting group description
    		 Hidroferol® experimental treatment.

    Reporting group title
    Group A2
    Reporting group description
    		 Hidroferol® treatment according to approved SmPC posology.

    Reporting group title
    Group B
    Reporting group description
    		 Cholecalciferol (Dibase®) as recommended by therapeutic guidelines
    Reporting group title
    Group A1
    Reporting group description
    		 -

    Reporting group title
    Group A2
    Reporting group description
    		 -

    Reporting group title
    Group B
    Reporting group description
    		 -

    Primary: Primary efficacy endpoint

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    End point title
    		 Primary efficacy endpoint
    End point description
    The primary efficacy endpoint was the percentage of patients achieving 25(OH)D levels >30 ng/mL at month 4, for each treatment group
    End point type
    Primary
    End point timeframe
    Month 4
    End point values
    		 Group A1 Group A2 Group B
    Number of subjects analysed
    85 [1]
    77 [2]
    78 [3]
    Units: ng/mL
        number (confidence interval 95%)
    29.4 (20.0 to 40.3)
    37.7 (26.9 to 49.4)
    5.1 (1.4 to 12.6)
    Notes
    [1] - Main efficacy endpoint performed in Per Protocol population
    [2] - Main efficacy endpoint performed in Per Protocol population
    [3] - Main efficacy endpoint performed in Per Protocol population
    Statistical analysis title
    		 chi-square test
    Comparison groups
    Group A1 v Group A2 v Group B
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.0001
    Method
    		 Chi-squared
    Confidence interval
         level
    		 95%
    Notes
    [4] - The primary efficacy analysis was to evaluate the superiority of the group A (A.1+A.2) versus group B, based on the percentage of patients achieving 25(OH)D levels above 30 ng/mL at month 4. The comparison was performed using the chi-square test (without continuity correction) and the corresponding 95% asymptotic (Wald) CI for the proportion difference.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The investigator must report all directly observed and all spontaneously reported untoward events (n-TEAEs/TEAEs) from the time informed consent is obtained through patients last study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Group A1
    Reporting group description
    		 -

    Reporting group title
    Group A2
    Reporting group description
    		 -

    Reporting group title
    Group B
    Reporting group description
    		 -

    Serious adverse events
    		 Group A1 Group A2 Group B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 102 (7.84%)
    4 / 101 (3.96%)
    5 / 100 (5.00%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast neoplasm
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (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
    Plasmacytoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (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
    Injury, poisoning and procedural complications
    Radius fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (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
    Cardiac disorders
    Atrioventricular block complete
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (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
    Atrial fibrillation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (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
    Atrial flutter
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (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
    Blood and lymphatic system disorders
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (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
    Intestinal obstruction
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Infections and infestations
    Atypical Pneumonia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (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
    Appendicitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (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
    Emphysematous pyelonephritis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (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
    Coronavirus infection
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (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
    Pneumonia viral
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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
    		 Group A1 Group A2 Group B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 102 (44.12%)
    43 / 101 (42.57%)
    41 / 100 (41.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast neoplasm
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Monoclonal gammopathy
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Plasmacytoma
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 102 (1.96%)
    2 / 101 (1.98%)
    0 / 100 (0.00%)
         occurrences all number
    2
    2
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Essential hypertension
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral venous disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Phlebitis superficial
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Vasculitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Surgical and medical procedures
    Facet joint block
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Foot operation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Inguinal hernia repair
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Knee operation
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Limb operation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Spinal laminectomy
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth extraction
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Urethral operation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Feeling cold
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    1
    1
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    0
    Asthenia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Social circumstances
    Dental prosthesis user
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    1
    Reproductive system and breast disorders
    Cervical polyp
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dysphonia
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    1
    1
    0
    Productive cough
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    1
    Acute respiratory failure
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Allergic bronchitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Noninfective bronchitis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Adjustment disorder with mixed anxiety and depressed mood
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Anxiety
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Differential white blood cell count abnormal
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    1
    Anaemia postoperative
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Hand fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Radius fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Rib fracture
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    0
    Angina pectoris
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Atrial flutter
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 102 (1.96%)
    2 / 101 (1.98%)
    1 / 100 (1.00%)
         occurrences all number
    2
    2
    1
    Dizziness
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0
    0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Migraine with aura
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Parkinson's disease
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Sciatic nerve neuropathy
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Syncope
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    White blood cell disorder
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    1
    Tinnitus
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Vertigo positional
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Keratitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    2
    1
    1
    Dyspepsia
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 101 (1.98%)
    1 / 100 (1.00%)
         occurrences all number
    0
    2
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    1
    Intestinal obstruction
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    0
    1
    Abdominal discomfort
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Intra-abdominal fluid collection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Cold sweat
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    1
    Eczema
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    0
    1
    Proteinuria
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Renal artery stenosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Renal pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 102 (0.98%)
    3 / 101 (2.97%)
    3 / 100 (3.00%)
         occurrences all number
    1
    3
    3
    Back pain
         subjects affected / exposed
    0 / 102 (0.00%)
    4 / 101 (3.96%)
    3 / 100 (3.00%)
         occurrences all number
    0
    4
    3
    Osteoarthritis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    3 / 100 (3.00%)
         occurrences all number
    0
    1
    3
    Pain in extremity
         subjects affected / exposed
    3 / 102 (2.94%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    3
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    1
    1
    0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    0
    1
    Tenosynovitis stenosans
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    2
    Bone pain
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Bursitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Osteitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Osteopenia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Osteoporosis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Periarthritis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 102 (2.94%)
    4 / 101 (3.96%)
    2 / 100 (2.00%)
         occurrences all number
    3
    4
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    3 / 100 (3.00%)
         occurrences all number
    1
    1
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    3 / 100 (3.00%)
         occurrences all number
    1
    1
    3
    Cystitis
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 101 (1.98%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 102 (0.98%)
    3 / 101 (2.97%)
    0 / 100 (0.00%)
         occurrences all number
    1
    3
    0
    Otitis externa
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    1
    1
    1
    Influenza
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    2
    Pneumonia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    1
    Adenoviral conjunctivitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Adenoviral upper respiratory infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Appendicitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Atypical pneumonia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Chronic sinusitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Coronavirus infection
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Ear infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Emphysematous pyelonephritis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Pneumonia viral
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Tinea cruris
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    Tracheitis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    1
    1
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    1
    0
    1
    Food intolerance
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 101 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 101 (0.99%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Dec 2017
    Key modifications covered by protocol V.2.0 were related to the possibility of storing study samples at a biobank (Basque Biobank), the update of contact details of the CRO in charge of study monitoring in Italy and rewording of some paragraphs to better clarify certain sections of the protocol.
    30 May 2018
    Changes at protocol V.2.1 essentially included an interim analysis when 100% of patients had completed 4 months of study - or had early discontinued prior to this visit. This interim analysis included the planned analysis of primary efficacy endpoint based on the Hidroferol® treatment duration recommended in the currently approved SmPC (i.e. 4 months). Assessment of primary endpoint at month 4 was already included in the statistical plan of previous protocol version V.2.0, but to be analyzed after the end of study, i.e. in the overall study analysis. According to protocol V.2.1, the primary endpoint along with secondary endpoints planned at month 4 were then timely analyzed in an interim analysis before the end of study (refer to the ‘Interim Analysis CSR for Primary Endpoint’ of the study HIDR- 0217/OST).

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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