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    Clinical Trial Results:
    Brentuximab vedotin or B-CAP in the treatment of older patients with newly diagnosed classical Hodgkin Lymphoma – a GHSG-NLG Intergroup Phase II trial –

    Summary
    EudraCT number
    		 2013-003990-89
    Trial protocol
    		 DE   NO   SE   DK   FI  
    Global end of trial date
    16 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jul 2023
    First version publication date
    27 Jul 2023
    Other versions
    Summary report(s)
    		 Clinical_Study_Report_B-CAP_V1.0

    Trial information

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    Trial identification
    Sponsor protocol code
    Uni-Koeln-1707
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02191930
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    German Hodgkin Study Group
    Sponsor organisation address
    Kerpener Str. 62 50924 Köln, Cologne, Germany,
    Public contact
    German Hodgkin Study Group, German Hodgkin Study Group, 0049 221478 88200, ghsg@uk-koeln.de
    Scientific contact
    German Hodgkin Study Group, German Hodgkin Study Group, 0049 221478 88200, ghsg@uk-koeln.de
    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
    16 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the B-CAP trial was to establish a well-known and tolerable CHOP regimen with the highly active brentuximab vedotin that might be a valuable option for the treatment of older HL patients. The primary objectives were to show efficacy of B-CAP in older patients with advanced-stage cHL, and to show efficacy of brentuximab vedotin monotherapy in older cHL patients not eligible to receive poly-chemotherapy. Secondary objectives were to show the safety and feasibility of B-CAP and brentuximab vedotin monotherapy.
    Protection of trial subjects
    Insurance protection for the patients participating in this trial in Germany is provided by HDI Gerling Versicherung AG, insurance policy no. 57 010309 03010. Insurance protection for the patients participating in this trial in Sweden, Denmark and Finland is provided by HDI-Gerling Industrial Insurance Co – UK Branch, insurance policy no. 390-01163636-14004. Insurance protection for the patients participating in this trial in Norway is in accordance with the Product Liability Act in the Drug Insurance.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Nov 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Norway: 9
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    Denmark: 14
    Country: Number of subjects enrolled
    Sweden: 11
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    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)
    20
    From 65 to 84 years
    46
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 70
    Number of subjects completed
    		 70

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 B-CAP
    Arm description
    		 Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brentuximab-Vedotin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Brentuximab vedotin is administered as a 30-minute infusion. The patient should be observed for 60 minutes following the first infusion of brentuximab vedotin. During this observation period, the i.v. line should remain open for at least one hour to allow administration of i.v. drugs if necessary. All supportive measures consistent with optimal patient care will be given throughout the study according to institutional standards. Medications for infusion-related reactions, such as epinephrine, antihistamines, and corticosteroids, should be available for immediate use.

    Arm title
    		 Brentuximab vedotin monotherapy
    Arm description
    		 Patients with CIRS-G score of 7 or more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days.
    Arm type
    		 Not eligible for B-CAP

    Investigational medicinal product name
    Brentuximab-Vedotin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Brentuximab vedotin is administered as a 30-minute infusion. The patient should be observed for 60 minutes following the first infusion of brentuximab vedotin. During this observation period, the i.v. line should remain open for at least one hour to allow administration of i.v. drugs if necessary. All supportive measures consistent with optimal patient care will be given throughout the study according to institutional standards. Medications for infusion-related reactions, such as epinephrine, antihistamines, and corticosteroids, should be available for immediate use.

    Number of subjects in period 1
    		B-CAP Brentuximab vedotin monotherapy
    Started
    50
    20
    Completed
    48
    18
    Not completed
    2
    2
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    1
    -
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    B-CAP
    Reporting group description
    		 Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days

    Reporting group title
    Brentuximab vedotin monotherapy
    Reporting group description
    		 Patients with CIRS-G score of 7 or more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days.

    Reporting group values
    		 B-CAP Brentuximab vedotin monotherapy Total
    Number of subjects
    		 50 20 70
    Age categorical
    Age categorial
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 19 1 20
        From 65-84 years
    		 31 15 46
        85 years and over
    		 0 4 4
    Age continuous
    Age continuous
    Units: years
        median (standard deviation)
    		 66 ( 5.8 ) 80.50 ( 6.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 23 7 30
        Male
    		 27 13 40
    Subject analysis sets

    Subject analysis set title
    B-CAP Group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat (ITT): 48

    Subject analysis set title
    BV Group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat (ITT): 18

    Subject analysis sets values
    		 B-CAP Group BV Group
    Number of subjects
    48
    18
    Age categorical
    Age categorial
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    19
    1
        From 65-84 years
    29
    13
        85 years and over
    0
    4
    Age continuous
    Age continuous
    Units: years
        median (standard deviation)
    66.0 ( 5.9 )
    82.0 ( 7.1 )
    Gender categorical
    Units: Subjects
        Female
    23
    7
        Male
    26
    12

    End points

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    End points reporting groups
    Reporting group title
    B-CAP
    Reporting group description
    		 Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days

    Reporting group title
    Brentuximab vedotin monotherapy
    Reporting group description
    		 Patients with CIRS-G score of 7 or more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days.

    Subject analysis set title
    B-CAP Group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat (ITT): 48

    Subject analysis set title
    BV Group
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention to treat (ITT): 18

    Primary: objective response rate (ORR)

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    End point title
    		 objective response rate (ORR) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Primary endpoint of the study is the objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy.
    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: Arms have not been compared because the BV Mono Arm is not a comparison Arm. BV Mono Arm has been created for patients that were not eligible for chemotherapy (B-CAP).
    End point values
    		 B-CAP Group BV Group
    Number of subjects analysed
    48
    18
    Units: patients
        CR
    21
    4
        PR
    26
    7
        Progressive disease
    1
    4
        missed restaging after chemotherapy
    0
    2
        no change in tumor growth
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The investigator has to report every serious adverse event and every pregnancy directly (within one working day) to the Trial Chairman. Every SAE has to be reported immediately using an SAE form and has to be sent to the stated address.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.2
    Reporting groups
    Reporting group title
    B-CAP
    Reporting group description
    		 -

    Reporting group title
    BV Mono
    Reporting group description
    		 -

    Serious adverse events
    		 B-CAP BV Mono
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 49 (57.14%)
    13 / 19 (68.42%)
         number of deaths (all causes)
    9
    7
         number of deaths resulting from adverse events
    1
    3
    Vascular disorders
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    12 / 49 (24.49%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    10 / 12
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal angina
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epigastric discomfort
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erysipelas
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Abscess soft tissue
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 19 (15.79%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    3 / 3
    Pneumonia
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 19 (10.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 B-CAP BV Mono
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 49 (10.20%)
    5 / 19 (26.32%)
    Vascular disorders
    Stasis dermatitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Therapeutic embolisation
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Oedema
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Catheter site infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Nervousness
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Polyneuropathy
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Dry mouth
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Back pain
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Bone pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Myopathy
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Infections and infestations
    Wound infection
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 19 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Weight fluctuation
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Weight loss poor
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1

    More information

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

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

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