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    Clinical Trial Results:
    Phase 3B, Randomized Trail of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade (Bortezomib) Induction Therapy In Newly Diagnosed Multiple Myeloma

    Summary
    EudraCT number
    		 2013-001729-26
    Trial protocol
    		 BE   ES   IT   FR   GR  
    Global end of trial date
    12 Oct 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Apr 2023
    First version publication date
    28 Oct 2021
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CC-5013-MM-026
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Oct 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Investigate efficacy and safety of maintenance therapy with lenalidomide versus placebo after melphalan prednisone Velcade (MPV) induction therapy in subjects with newly-diagnosed multiple myeloma (NDMM)
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 6 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Italy: 16
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Greece: 4
    Country: Number of subjects enrolled
    Belgium: 2
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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)
    1
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 46 participants randomized and treated

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lenalidomide
    Arm description
    		 10mg/day PO from Days 1 to 21 (given in 28-day cycles)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10mg/day from Days 1 to 21 (given in 28-day cycles)

    Arm title
    		 Placebo
    Arm description
    		 Placebo PO from Days 1 to 21 (given in 28-day cycles)
    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
    PO from Days 1 to 21 (given in 28-day cycles)

    Number of subjects in period 1
    		Lenalidomide Placebo
    Started
    29
    17
    Completed
    0
    0
    Not completed
    29
    17
         Adverse event, serious fatal
    17
    7
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    -
         Progressive Disease
    -
    1
         Study Terminated by Sponsor
    10
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lenalidomide
    Reporting group description
    		 10mg/day PO from Days 1 to 21 (given in 28-day cycles)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo PO from Days 1 to 21 (given in 28-day cycles)

    Reporting group values
    		 Lenalidomide Placebo Total
    Number of subjects
    		 29 17 46
    Age categorical
    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)
    		 0 1 1
        From 65-84 years
    		 29 16 45
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 73.1 ± 4.41 72.9 ± 6.77 -
    Sex: Female, Male
    Units: Participants
        Female
    		 8 5 13
        Male
    		 21 12 33
    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
    		 17 9 26
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 12 8 20
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 4 1 5
        Not Hispanic or Latino
    		 13 8 21
        Unknown or Not Reported
    		 12 8 20

    End points

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    End points reporting groups
    Reporting group title
    Lenalidomide
    Reporting group description
    		 10mg/day PO from Days 1 to 21 (given in 28-day cycles)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo PO from Days 1 to 21 (given in 28-day cycles)

    Primary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS) [1]
    End point description
    Overall Survival is defined as the time from the date of randomization to the date of death due to any cause.
    End point type
    Primary
    End point timeframe
    Up to 76 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics planned for this endpoint
    End point values
    		 Lenalidomide Placebo
    Number of subjects analysed
    29
    17
    Units: Months
        median (confidence interval 95%)
    52.5 (39.1 to 99999)
    99999 (30.1 to 99999)
    No statistical analyses for this end point

    Secondary: Incidence of Participants with Adverse Events (AEs)

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    End point title
    		 Incidence of Participants with Adverse Events (AEs)
    End point description
    Incidence of participants with adverse events (AEs) that measure type, frequency and severity of AEs graded by National Cancer Institute Common Terminology Criteria (NCI CTCAE V 4.0) including any grade adverse events (AEs), Grade 3-4 AEs, AEs related to study drug, grade 3-4 AEs related to study drug, any grade serious adverse events (SAEs), and SAEs related to study drug.
    End point type
    Secondary
    End point timeframe
    From first dose to up to 28 days post last dose (Up to 44 months)
    End point values
    		 Lenalidomide Placebo
    Number of subjects analysed
    29
    17
    Units: Participants
        Adverse Events (AEs)
    29
    15
        Grade 3-4 AEs
    20
    5
        AEs related to Study Drug
    22
    6
        Grade 3-4 AEs related to Study Drug
    11
    2
        Serious Adverse Events (SAEs)
    15
    4
        SAEs related to Study Drug
    9
    0
    No statistical analyses for this end point

    Secondary: Incidence of Participants with Laboratory Abnormalities Shift from Baseline to Worst During Treatment

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    End point title
    		 Incidence of Participants with Laboratory Abnormalities Shift from Baseline to Worst During Treatment
    End point description
    Incidence of participants with laboratory abnormalities shift from baseline to worst during treatment in Hematology and Chemistry. Normal ranges will be used to determine the categories of high, low, and normal for lab tests that have no severity grade. low=participants with at least one value that was low relative to the normal range high=participants with at least one values that was high relative to the normal range both low and high=participants with at least one value that was low relative to the normal range and at least one value that was high relative to the normal range.
    End point type
    Secondary
    End point timeframe
    Up to 44 months
    End point values
    		 Lenalidomide Placebo
    Number of subjects analysed
    29
    17
    Units: Participants
        Absolute neutrophils (Normal)
    17
    4
        Hemoglobin (Low)
    1
    0
        Hemoglobin (Normal)
    10
    2
        Platelets (Low)
    1
    1
        Platelets (Normal)
    10
    2
        White Blood Cell Count (Low)
    2
    0
        White Blood Cell Count (Normal)
    14
    4
        Corrected Serum Calcium (Normal)
    11
    3
        Corrected Serum Calcium (High)
    1
    0
        Creatinine Clearance (Normal)
    11
    2
        Creatinine Clearance (High)
    1
    0
        Serum Calcium (Low)
    0
    1
        Serum Calcium (Normal)
    15
    1
        Serum Creatinine (Low)
    1
    0
        Serum Creatinine (Normal)
    11
    4
    No statistical analyses for this end point

    Secondary: Incidence of Participants with Vital Signs Abnormalities Shift from Baseline to Worst During Treatment

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    End point title
    		 Incidence of Participants with Vital Signs Abnormalities Shift from Baseline to Worst During Treatment
    End point description
    Incidence of participant with vital signs abnormalities shift from baseline to worst during treatment. Assessment is based on shift from normal and abnormal baseline categories. Normal range= ; 90 <= Systolic Blood pressure <= 120 (mmHg) ; 60 <= Diastolic Blood Pressure <= 80 (mmHg) ; 60 <= Pulse <= 100 (beats/min) ; 36.6 <= Temperature < 37.3 (°C)
    End point type
    Secondary
    End point timeframe
    Up to 44 months
    End point values
    		 Lenalidomide Placebo
    Number of subjects analysed
    29
    17
    Units: Participants
        Diastolic Blood Pressure (Normal)
    15
    8
        Diastolic Blood Pressure (Abnormal)
    2
    0
        Systolic Blood Pressure (Normal)
    9
    3
        Systolic Blood Pressure (Abnormal)
    1
    0
        Pulse (Normal)
    12
    2
        Pulse (Abnormal)
    1
    0
        Temperature (Normal)
    6
    3
    No statistical analyses for this end point

    Secondary: Incidence of Participants with Second Primary Malignancies (SPMs)

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    End point title
    		 Incidence of Participants with Second Primary Malignancies (SPMs)
    End point description
    Incidence of participants with second primary malignancies (SPMs) including all SPMs, Invasive SPMs (hematologic malignancies and solid tumors), and non-invasive SPMs (non-melanoma skin cancers).
    End point type
    Secondary
    End point timeframe
    Up to 76 months
    End point values
    		 Lenalidomide Placebo
    Number of subjects analysed
    29
    17
    Units: Participants
        All SPMs
    6
    1
        Invasive SPMs
    5
    1
        Non-Invasive SPMs
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to up to 28 days post last dose (Up to 44 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo PO from Days 1 to 21 (given in 28-day cycles) until documented progression disease

    Reporting group title
    Lenalidomide
    Reporting group description
    		 10mg/day PO from Days 1 to 21 (given in 28-day cycles) until documented progression disease

    Serious adverse events
    		 Placebo Lenalidomide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 17 (23.53%)
    15 / 29 (51.72%)
         number of deaths (all causes)
    8
    17
         number of deaths resulting from adverse events
    Investigations
    General physical condition abnormal
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic bronchial carcinoma
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer metastatic
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (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 / 17 (0.00%)
    1 / 29 (3.45%)
         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
    Dyspnoea
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin toxicity
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pathological fracture
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial prostatitis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 29 (3.45%)
         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
    		 Placebo Lenalidomide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 17 (82.35%)
    27 / 29 (93.10%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 29 (10.34%)
         occurrences all number
    1
    3
    Hypotension
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 17 (17.65%)
    5 / 29 (17.24%)
         occurrences all number
    4
    7
    Asthenia
         subjects affected / exposed
    0 / 17 (0.00%)
    13 / 29 (44.83%)
         occurrences all number
    0
    22
    Oedema peripheral
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 29 (13.79%)
         occurrences all number
    3
    5
    Fatigue
         subjects affected / exposed
    3 / 17 (17.65%)
    3 / 29 (10.34%)
         occurrences all number
    4
    3
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Prostatitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Dyspnoea
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 29 (6.90%)
         occurrences all number
    2
    4
    Cough
         subjects affected / exposed
    5 / 17 (29.41%)
    5 / 29 (17.24%)
         occurrences all number
    5
    8
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    1
    3
    Investigations
    Blood pressure increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Nervous system disorders
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 17 (0.00%)
    4 / 29 (13.79%)
         occurrences all number
    0
    4
    Paraesthesia
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Restless legs syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Somnolence
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 29 (10.34%)
         occurrences all number
    4
    4
    Neutropenia
         subjects affected / exposed
    0 / 17 (0.00%)
    11 / 29 (37.93%)
         occurrences all number
    0
    27
    Thrombocytopenia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    4
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Diverticulum
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Dry mouth
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Enterocolitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    1 / 17 (5.88%)
    8 / 29 (27.59%)
         occurrences all number
    1
    10
    Abdominal pain upper
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Gastrointestinal angiectasia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    4 / 17 (23.53%)
    7 / 29 (24.14%)
         occurrences all number
    6
    19
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 29 (13.79%)
         occurrences all number
    1
    4
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    3
    Rash
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    6
    Ingrowing nail
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Pruritus
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 29 (10.34%)
         occurrences all number
    5
    4
    Erythema
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Diabetic foot
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Pollakiuria
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 29 (6.90%)
         occurrences all number
    2
    3
    Bone pain
         subjects affected / exposed
    4 / 17 (23.53%)
    0 / 29 (0.00%)
         occurrences all number
    5
    0
    Back pain
         subjects affected / exposed
    3 / 17 (17.65%)
    5 / 29 (17.24%)
         occurrences all number
    4
    7
    Muscle contracture
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Muscle spasms
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 29 (13.79%)
         occurrences all number
    2
    9
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Spinal pain
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 17 (11.76%)
    8 / 29 (27.59%)
         occurrences all number
    4
    13
    Conjunctivitis
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 29 (13.79%)
         occurrences all number
    2
    4
    Pneumonia
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 29 (13.79%)
         occurrences all number
    1
    5
    Influenza
         subjects affected / exposed
    3 / 17 (17.65%)
    6 / 29 (20.69%)
         occurrences all number
    3
    6
    Nasopharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    2
    Pharyngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    3
    Urinary tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 29 (3.45%)
         occurrences all number
    1
    1
    Hypercalcaemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Nov 2013
    Study Design Update
    06 Mar 2014
    Study Endpoints Update
    31 Oct 2014
    Exclusion and Inclusion Criteria Update
    30 Aug 2015
    Study Design Update
    22 Nov 2017
    Study Design and Endpoints Update

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

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

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