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    Clinical Trial Results:
    A phase II Study of the Efficacy and Safety of lenalidomide, subcutaneous bortezomib, and dexamethasone combination therapy for patients with newly diagnosed multiple myeloma

    Summary
    EudraCT number
    		 2013-005008-32
    Trial protocol
    		 IE  
    Global end of trial date
    31 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Dec 2025
    First version publication date
    24 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CTRIAL (ICORG) 13-17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02219178
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cancer Trials Ireland
    Sponsor organisation address
    RCSI House, 121 St. Stephen's Green, Dublin, Ireland, D02 H903
    Public contact
    Clinical Trials Information, Cancer Trials Ireland, +353 16677211, info@cancertrials.ie
    Scientific contact
    Clinical Trials Information, Cancer Trials Ireland, +353 16677211, info@cancertrials.ie
    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
    23 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the overall response rate after 4 cycles and the best response to induction therapy with combination of lenalidomide, subcutaneous bortezomib, and dexamethasone (RsqVD) in patients with newly diagnosed multiple myeloma.
    Protection of trial subjects
    The study was conducted in accordance with the EU Directive 2001/20/EC and International Conference on Harmonisation (ICH) for Good Clinical Practice (GCP) and the ethical principles founded in the Declaration of Helsinki. All regulatory requirements were followed, and appropriate study documentation was reviewed by the competent authority/ ethics committee in order to safeguard the rights, safety and well-being of the patients.
    Background therapy
    		 N/A
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    28 Nov 2014
    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
    Ireland: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    21
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This is an open label, single arm phase II study that planned to enroll up to 42 eligible patients with newly diagnosed multiple myeloma in Ireland. 42 patients were registered on the study from 28-Nov-2024 to 29-Feb-2016.

    Pre-assignment
    Screening details
    		 Patients with newly diagnosed multiple myeloma, who met all of the inclusion criteria and none of the exclusion criteria were eligible for enrollment in this study.

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

    Arms
    Arm title
    		 Single Arm
    Arm description
    		 Combination of Lenalidomide + Subcutaneous Bortezomib + Dexamethasone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Revlimid
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide will be given as a single daily oral dose (25mg) on days 1-14 followed by a 7-day rest period. On commencement of maintenance therapy, patients who have undergone transplantation will receive lenalidomide at 10 mg administered days 1-21 of each 28 day cycle starting at approximately 3 months post-transplant. If the 10 mg dose is tolerated well, the dose of lenalidomide will be increased to 15 mg after three 28 day cycles of maintenance. Patients who do not undergo transplantation will receive lenalidomide at the same dose taken in the final cycle of induction provided this dose was tolerated well, administered days 1 – 21 of each 28 day cycle. Lenalidomide capsules should be swallowed whole, and should not be broken, chewed or opened. Administration of lenalidomide will be at approximately the same time each day. Drug may be taken with or without food.

    Investigational medicinal product name
    Bortezomib
    Investigational medicinal product code
    Other name
    Velcade
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Bortezomib (1.3 mg/m2) will be administered subcutaneously on days 1, 4, 8, and 11 followed by a 10-day rest period during induction cycles. Each induction cycle has a duration of 21 days. Patients with high-risk disease will receive bortezomib during the maintenance period, with subcutaneous bortezomib 1.3 mg/m2 days 1 and 15 of each 28-day maintenance cycle. All patients on maintenance treatment will complete an end of treatment/study withdrawal visit by 31 October 2019 and continue with treatment as per standard of care. Drug to be administered under supervision of the investigator/sub-investigator. The amount (in mg) of drug to be administered will be determined based on Body Surface Area (BSA).

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dexamethasone will be given as a single daily oral dose on days 1, 2, 4, 5, 8, 9, 11 and 12, followed by a 9-day rest period during induction cycles only. All participants will receive a dexamethasone dose of 20 mg. Dexamethasone should be taken at approximately the same time each day. It is recommended that dexamethasone be taken in the morning to reduce insomnia. Each dose should be taken with food. Drug diary provided to participants to record oral administration of doses.

    Number of subjects in period 1
    		Single Arm
    Started
    42
    Completed
    31
    Not completed
    11
         Physician decision
    1
         Participant decided to withdraw from the study
    4
         Failed criterion for study eligibility
    1
         Death
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study (overall period) Total
    Number of subjects
    		 42 42
    Age categorical
    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)
    		 21 21
        From 65-84 years
    		 21 21
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 64 (45 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 27 27
    Durie Salmon Stage at Initial Diagnosis
    Recorded for Full Analysis Set (N=37 patients who were eligible for the study and had at least 2 cycles of study treatment)
    Units: Subjects
        Missing
    		 5 5
        IA
    		 3 3
        IIA
    		 11 11
        IIB
    		 1 1
        IIIA
    		 16 16
        IIIB
    		 1 1
        Not Recorded
    		 5 5
    ISS Grade at Initial Diagnosis
    Recorded for Full Analysis Set (N=37 patients who were eligible for the study and had at least 2 cycles of study treatment)
    Units: Subjects
        Grade I
    		 15 15
        Grade II
    		 13 13
        Grade III
    		 9 9
        Not recorded
    		 5 5
    Time from Initial Diagnosis to First Study Treatment
    Units: Weeks
        median (full range (min-max))
    		 -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Consists of 37 patients who were eligible for the study and had at least two cycles of study treatment. One ineligible patient (creatinine clearance at screening was < 45 ml/min) and four patients who only had one cycle of study treatment were excluded. All efficacy analyses are performed for the FAS

    Subject analysis sets values
    		 Full Analysis Set
    Number of subjects
    37
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male
    Durie Salmon Stage at Initial Diagnosis
    Recorded for Full Analysis Set (N=37 patients who were eligible for the study and had at least 2 cycles of study treatment)
    Units: Subjects
        Missing
    5
        IA
    3
        IIA
    11
        IIB
    1
        IIIA
    16
        IIIB
    1
        Not Recorded
    ISS Grade at Initial Diagnosis
    Recorded for Full Analysis Set (N=37 patients who were eligible for the study and had at least 2 cycles of study treatment)
    Units: Subjects
        Grade I
    15
        Grade II
    13
        Grade III
    9
        Not recorded
    Time from Initial Diagnosis to First Study Treatment
    Units: Weeks
        median (full range (min-max))
    2.1 (0.3 to 15.7)

    End points

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    End points reporting groups
    Reporting group title
    Single Arm
    Reporting group description
    		 Combination of Lenalidomide + Subcutaneous Bortezomib + Dexamethasone

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Consists of 37 patients who were eligible for the study and had at least two cycles of study treatment. One ineligible patient (creatinine clearance at screening was < 45 ml/min) and four patients who only had one cycle of study treatment were excluded. All efficacy analyses are performed for the FAS

    Primary: Overall response rate (ORR) after 4 induction cycles

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    End point title
    		 Overall response rate (ORR) after 4 induction cycles [1]
    End point description
    The ORR after 4 induction cycles was 91.9%, with a CI of [78.1 – 98.3], and a CR/VGPR rate of 59.5%. The lower bound of the CI exceeds the ORR of 70% as pre-specified in the assumptions for the sample size calculation.
    End point type
    Primary
    End point timeframe
    Overall response rate (ORR) after 4 induction cycles, defined as Complete Response (CR) or Stringent Complete Response (SCR) or Very Good Partial Response (VGPR) or Partial Response (PR).
    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: This is a single arm study with no comparison groups therefore statistical analyses(comparison analysis) were not conducted.
    End point values
    		 Single Arm
    Number of subjects analysed
    37
    Units: % of Participants
    number (not applicable)
        Complete Response (CR)
    8.1
        Very Good Partial Response (VGPR)
    51.4
        Partial Response (PR)
    32.4
        Stable Disease
    2.7
        Progressive Disease
    5.4
    No statistical analyses for this end point

    Primary: Overall response rate (ORR) at End of Induction

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    End point title
    		 Overall response rate (ORR) at End of Induction [2]
    End point description
    The ORR at the end of induction therapy was also 91.9%, with a CI of [78.1 – 98.3], and a CR/VGPR rate of 62.2%.
    End point type
    Primary
    End point timeframe
    Overall response rate (ORR) at end of induction, defined as Complete Response (CR) or Stringent Complete Response (SCR) or Very Good Partial Response (VGPR) or Partial Response (PR)
    Notes
    [2] - 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: This is a single arm study with no comparison groups therefore statistical analyses(comparison analysis) were not conducted.
    End point values
    		 Single Arm
    Number of subjects analysed
    37
    Units: % of patients
    number (not applicable)
        Complete Response (CR)
    8.1
        Very Good Partial Response (VGPR)
    54.1
        Partial Response (PR)
    29.7
        Stable Disease
    2.7
        Progressive Disease
    5.4
    No statistical analyses for this end point

    Primary: Best Response Rate During Induction

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    End point title
    		 Best Response Rate During Induction [3]
    End point description
    The best ORR during induction therapy was 94.6%, with a CI of [81.8 – 99.3], and a CR/VGPR rate of 62.2%.
    End point type
    Primary
    End point timeframe
    Best response to induction therapy, defined as Complete Response (CR) or Stringent Complete Response (SCR) or Very Good Partial Response (VGPR) or Partial Response (PR).
    Notes
    [3] - 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: This is a single arm study with no comparison groups therefore statistical analyses(comparison analysis) were not conducted.
    End point values
    		 Single Arm
    Number of subjects analysed
    37
    Units: % of patients
    number (not applicable)
        Complete Response (CR)
    8.1
        Very Good Partial Response (VGPR)
    54.1
        Partial Response (PR)
    32.4
        Stable Disease
    5.4
    No statistical analyses for this end point

    Primary: Best Response During Study Treatment

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    End point title
    		 Best Response During Study Treatment [4]
    End point description
    The best ORR during the entire study treatment period was also 94.6%, with a CI of [81.8 – 99.3], an SCR/CR/VGPR rate of 75.6% and an SCR/CR rate of 43.2%
    End point type
    Primary
    End point timeframe
    Best Response During Study Treatment defined as Complete Response (CR) or Stringent Complete Response (SCR) or Very Good Partial Response (VGPR) or Partial Response (PR)
    Notes
    [4] - 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: This is a single arm study with no comparison groups therefore statistical analyses(comparison analysis) were not conducted.
    End point values
    		 Single Arm
    Number of subjects analysed
    37
    Units: % of patients
    number (not applicable)
        Stringent Complete Response (SCR)
    18.9
        Complete Response (CR)
    24.3
        Very Good Partial Response (VGPR)
    32.4
        Partial Response (PR)
    18.9
        Stable Disease
    5.4
    No statistical analyses for this end point

    Secondary: Progression during Study Treatment

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    End point title
    		 Progression during Study Treatment
    End point description
    Only six patients progressed on study treatment, so the median time to progression was not estimable. Only the lower bound for the 95% confidence interval for median TTP can be estimated (as 2.8 years). Patients who have not progressed or died are censored at the date last known to be progression-free. Should a patient be progression-free at end of study treatment, TTP will be censored at the most recent prior response assessment. Median Time to Progression (years) Inestimable 95% CI for Median Time to Progression [ 2.8 - Inestimable]
    End point type
    Secondary
    End point timeframe
    Time to progression (TTP), defined as the length of time between the date of registration and date of disease progression, with death before progression censored at date of death.
    End point values
    		 Single Arm
    Number of subjects analysed
    37
    Units: % of patients
    number (not applicable)
        Progressed on Study Treatment
    16.2
        Censored
    83.8
    No statistical analyses for this end point

    Secondary: Progression-Free Status After One Year on Study Treatment

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    End point title
    		 Progression-Free Status After One Year on Study Treatment
    End point description
    Six patients discontinued study treatment before one year for reasons other than progression, leaving 31 patients assessable for progression-free status. Three patients progressed before completing a year on study treatment and 28 patients (90.3%, 95% CI of [74.2% - 98.0%]) were progression-free after one year on study treatment. Patients who have not progressed or died are censored at the date last known to be progression-free. Should a patient be progression-free at end of study treatment, PFS will be censored at the most recent prior response assessment.
    End point type
    Secondary
    End point timeframe
    Progression-free survival (PFS), defined as the length of time between the date of registration and the earliest date of disease progression or death due to any cause.
    End point values
    		 Single Arm
    Number of subjects analysed
    37 [5]
    Units: % of patients
    number (not applicable)
        Progressed Before One Year
    9.7
        Progression-Free at One Year
    90.3
    Notes
    [5] - Six patients discontinued study treatment before one year for reasons other than progression.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment Emergent Adverse Events
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 -

    Serious adverse events
    		 Group 1
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 42 (69.05%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Colon cancer metastatic
    Additional description: Colon cancer metastatic
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Metastatic malignant melanoma
    Additional description: Metastatic malignant melanoma
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Squamous cell carcinoma of skin
    Additional description: Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Circulatory collapse
    Additional description: Circulatory collapse
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Orthostatic hypotension
    Additional description: Orthostatic hypotension
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Hernia repair
    Additional description: Hernia repair
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stoma closure
    Additional description: Stoma closure
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal operation
    Additional description: Spinal operation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    8 / 42 (19.05%)
         occurrences causally related to treatment / all
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pain
    Additional description: Pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple organ dysfunction syndrome
    Additional description: Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
    Additional description: Atelectasis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Cough
    Additional description: Cough
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
    Additional description: Hypoxia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Lung consolidation
    Additional description: Lung consolidation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Agitation
    Additional description: Agitation
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Delirium
    Additional description: Delirium
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Fibrin D dimer increased
    Additional description: Fibrin D dimer increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Platelet count decreased
    Additional description: Platelet count decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutrophil count decreased
    Additional description: Neutrophil count decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    White blood cell count decreased
    Additional description: White blood cell count decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Facial bones fracture
    Additional description: Facial bones fracture
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
    Additional description: Fall
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
    Additional description: Cardio-respiratory arrest
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Encephalopathy
    Additional description: Encephalopathy
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
    Additional description: Headache
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presyncope
    Additional description: Presyncope
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Peripheral sensory neuropathy
    Additional description: Peripheral sensory neuropathy
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
    Additional description: Febrile neutropenia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Disseminated intravascular coagulation
    Additional description: Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Retinal vein occlusion
    Additional description: Retinal vein occlusion
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Enteritis
    Additional description: Enteritis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric ulcer
    Additional description: Gastric ulcer
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Large intestine perforation
    Additional description: Large intestine perforation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Melaena
    Additional description: Melaena
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Upper gastrointestinal haemorrhage
    Additional description: Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Hypersensitivity vasculitis
    Additional description: Hypersensitivity vasculitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash maculo-papular
    Additional description: Rash maculo-papular
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash
    Additional description: Rash
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal impairment
    Additional description: Renal impairment
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Campylobacter gastroenteritis
    Additional description: Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Biliary sepsis
    Additional description: Biliary sepsis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea infectious
    Additional description: Diarrhoea infectious
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    H1N1 influenza
    Additional description: H1N1 influenza
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatitis B
    Additional description: Hepatitis B
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infectious colitis
    Additional description: Infectious colitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
    Additional description: Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Laryngitis
    Additional description: Laryngitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Listeriosis
    Additional description: Listeriosis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences causally related to treatment / all
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection viral
    Additional description: Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences causally related to treatment / all
    6 / 7
         deaths causally related to treatment / all
    0 / 0
    Otitis media acute
    Additional description: Otitis media acute
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic sepsis
    Additional description: Neutropenic sepsis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis media
    Additional description: Otitis media
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences causally related to treatment / all
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    Hypercalcaemia
    Additional description: Hypercalcaemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoalbuminaemia
    Additional description: Hypoalbuminaemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypocalcaemia
    Additional description: Hypocalcaemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypomagnesaemia
    Additional description: Hypomagnesaemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypophagia
    Additional description: Hypophagia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypophosphataemia
    Additional description: Hypophosphataemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 1
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 42 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Dysplastic naevus
    Additional description: Dysplastic naevus
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Vascular disorders
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Flushing
    Additional description: Flushing
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hot flush
    Additional description: Hot flush
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    7
    Orthostatic hypotension
    Additional description: Orthostatic hypotension
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Phlebitis
    Additional description: Phlebitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Raynaud's phenomenon
    Additional description: Raynaud's phenomenon
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Varicose vein
    Additional description: Varicose vein
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Surgical and medical procedures
    Cataract operation
    Additional description: Cataract operation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Skin graft
    Additional description: Skin graft
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Tooth extraction
    Additional description: Tooth extraction
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Tooth repair
    Additional description: Tooth repair
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    6
    Chills
    Additional description: Chills
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Cyst
    Additional description: Cyst
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    25 / 42 (59.52%)
         occurrences all number
    45
    Gait disturbance
    Additional description: Gait disturbance
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Generalised oedema
    Additional description: Generalised oedema
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hernia pain
    Additional description: Hernia pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Influenza like illness
    Additional description: Influenza like illness
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    8
    Injection site bruising
    Additional description: Injection site bruising
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Injection site erythema
    Additional description: Injection site erythema
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Injection site pain
    Additional description: Injection site pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Injection site rash
    Additional description: Injection site rash
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    5
    Mucosal inflammation
    Additional description: Mucosal inflammation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    3
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    12 / 42 (28.57%)
         occurrences all number
    19
    Pain
    Additional description: Pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    9 / 42 (21.43%)
         occurrences all number
    15
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    13 / 42 (30.95%)
         occurrences all number
    17
    Immune system disorders
    Allergy to arthropod sting
    Additional description: Allergy to arthropod sting
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Seasonal allergy
    Additional description: Seasonal allergy
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Breast tenderness
    Additional description: Breast tenderness
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Erectile dysfunction
    Additional description: Erectile dysfunction
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Perineal erythema
    Additional description: Perineal erythema
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    Additional description: Cough
         subjects affected / exposed
    19 / 42 (45.24%)
         occurrences all number
    50
    Dysphonia
    Additional description: Dysphonia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    3
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    8 / 42 (19.05%)
         occurrences all number
    13
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    5
    Haemoptysis
    Additional description: Haemoptysis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hiccups
    Additional description: Hiccups
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    5
    Obstructive airways disorder
    Additional description: Obstructive airways disorder
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Oropharyngeal pain
    Additional description: Oropharyngeal pain
         subjects affected / exposed
    16 / 42 (38.10%)
         occurrences all number
    23
    Nasal congestion
    Additional description: Nasal congestion
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Productive cough
    Additional description: Productive cough
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    8
    Pulmonary congestion
    Additional description: Pulmonary congestion
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Pulmonary oedema
    Additional description: Pulmonary oedema
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Rales
    Additional description: Rales
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Rhinitis allergic
    Additional description: Rhinitis allergic
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Tachypnoea
    Additional description: Tachypnoea
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Wheezing
    Additional description: Wheezing
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Psychiatric disorders
    Abnormal dreams
    Additional description: Abnormal dreams
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Agitation
    Additional description: Agitation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    8
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Delirium
    Additional description: Delirium
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Depressed mood
    Additional description: Depressed mood
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    5
    Depression
    Additional description: Depression
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Depressive symptom
    Additional description: Depressive symptom
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    9 / 42 (21.43%)
         occurrences all number
    13
    Libido decreased
    Additional description: Libido decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Mood altered
    Additional description: Mood altered
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Nightmare
    Additional description: Nightmare
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Restlessness
    Additional description: Restlessness
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    3
    Sleep disorder
    Additional description: Sleep disorder
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Investigations
    Adjusted calcium decreased
    Additional description: Adjusted calcium decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Alanine aminotransferase increased
    Additional description: Alanine aminotransferase increased
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    14
    Aspartate aminotransferase increased
    Additional description: Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    7
    Biopsy skin
    Additional description: Biopsy skin
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Blood albumin decreased
    Additional description: Blood albumin decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Blood alkaline phosphatase increased
    Additional description: Blood alkaline phosphatase increased
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    5
    Blood bilirubin increased
    Additional description: Blood bilirubin increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    3
    Blood cholesterol increased
    Additional description: Blood cholesterol increased
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    9
    Blood folate decreased
    Additional description: Blood folate decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Blood glucose decreased
    Additional description: Blood glucose decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Blood magnesium decreased
    Additional description: Blood magnesium decreased
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Blood phosphorus decreased
    Additional description: Blood phosphorus decreased
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    6
    Blood potassium decreased
    Additional description: Blood potassium decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    5
    Blood pressure increased
    Additional description: Blood pressure increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Blood urea increased
    Additional description: Blood urea increased
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Body mass index increased
    Additional description: Body mass index increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Body temperature increased
    Additional description: Body temperature increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Breath sounds abnormal
    Additional description: Breath sounds abnormal
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Ejection fraction decreased
    Additional description: Ejection fraction decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
    Additional description: Gamma-glutamyltransferase increased
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    9
    Heart rate irregular
    Additional description: Heart rate irregular
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    International normalised ratio increased
    Additional description: International normalised ratio increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    3
    Lymphocyte count decreased
    Additional description: Lymphocyte count decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Liver function test increased
    Additional description: Liver function test increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Neutrophil count decreased
    Additional description: Neutrophil count decreased
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    36
    Neutrophil count increased
    Additional description: Neutrophil count increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Platelet count decreased
    Additional description: Platelet count decreased
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    9
    Wound healing normal
    Additional description: Wound healing normal
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    12 / 42 (28.57%)
         occurrences all number
    23
    Weight increased
    Additional description: Weight increased
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    11
    White blood cell count increased
    Additional description: White blood cell count increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Troponin increased
    Additional description: Troponin increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Excoriation
    Additional description: Excoriation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Fall
    Additional description: Fall
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Foot fracture
    Additional description: Foot fracture
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Laceration
    Additional description: Laceration
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Limb injury
    Additional description: Limb injury
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    3
    Muscle strain
    Additional description: Muscle strain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Nasal injury
    Additional description: Nasal injury
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Post operative Ileus
    Additional description: Post operative Ileus
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Post procedural haemorrhage
    Additional description: Post procedural haemorrhage
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Skin abrasion
    Additional description: Skin abrasion
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Skin laceration
    Additional description: Skin laceration
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Soft tissue injury
    Additional description: Soft tissue injury
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Sunburn
    Additional description: Sunburn
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Tooth fracture
    Additional description: Tooth fracture
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Upper limb fracture
    Additional description: Upper limb fracture
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Wound
    Additional description: Wound
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Cardiac disorders
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Nervous system disorders
    Amnesia
    Additional description: Amnesia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    4
    Burning feet syndrome
    Additional description: Burning feet syndrome
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    7
    Cerebral infarction
    Additional description: Cerebral infarction
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Dysaesthesia
    Additional description: Dysaesthesia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Encephalopathy
    Additional description: Encephalopathy
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Headache
    Additional description: Headache
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    10
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Lethargy
    Additional description: Lethargy
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Hyporeflexia
    Additional description: Hyporeflexia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Loss of consciousness
    Additional description: Loss of consciousness
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Memory impairment
    Additional description: Memory impairment
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Neuropathy peripheral
    Additional description: Neuropathy peripheral
         subjects affected / exposed
    15 / 42 (35.71%)
         occurrences all number
    27
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    7
    Peripheral sensory neuropathy
    Additional description: Peripheral sensory neuropathy
         subjects affected / exposed
    11 / 42 (26.19%)
         occurrences all number
    17
    Presyncope
    Additional description: Presyncope
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Restless legs syndrome
    Additional description: Restless legs syndrome
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Retinal migraine
    Additional description: Retinal migraine
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Somnolence
    Additional description: Somnolence
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Taste disorder
    Additional description: Taste disorder
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    14 / 42 (33.33%)
         occurrences all number
    28
    Lymphopenia
    Additional description: Lymphopenia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Neutropenia
    Additional description: Neutropenia
         subjects affected / exposed
    13 / 42 (30.95%)
         occurrences all number
    65
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    9 / 42 (21.43%)
         occurrences all number
    15
    Ear and labyrinth disorders
    Deafness
    Additional description: Deafness
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Ear congestion
    Additional description: Ear congestion
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hypoacusis
    Additional description: Hypoacusis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Eye disorders
    Asthenopia
    Additional description: Asthenopia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Blepharitis
    Additional description: Blepharitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Cataract
    Additional description: Cataract
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Dry eye
    Additional description: Dry eye
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Conjunctival haemorrhage
    Additional description: Conjunctival haemorrhage
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Erythema of eyelid
    Additional description: Erythema of eyelid
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Eye discharge
    Additional description: Eye discharge
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Eye disorder
    Additional description: Eye disorder
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Eye pain
    Additional description: Eye pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Eyelid ptosis
    Additional description: Eyelid ptosis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Lacrimation increased
    Additional description: Lacrimation increased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Myopia
    Additional description: Myopia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Macular degeneration
    Additional description: Macular degeneration
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Ocular hyperaemia
    Additional description: Ocular hyperaemia
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    9
    Photophobia
    Additional description: Photophobia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Gastrointestinal disorders
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    7
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    5
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Anal incontinence
    Additional description: Anal incontinence
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Aphthous ulcer
    Additional description: Aphthous ulcer
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    20 / 42 (47.62%)
         occurrences all number
    31
    Dental caries
    Additional description: Dental caries
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    28 / 42 (66.67%)
         occurrences all number
    74
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    5
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    5
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Gastric dilatation
    Additional description: Gastric dilatation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Gastrointestinal wall thickening
    Additional description: Gastrointestinal wall thickening
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Lip swelling
    Additional description: Lip swelling
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Mouth ulceration
    Additional description: Mouth ulceration
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    19 / 42 (45.24%)
         occurrences all number
    31
    Oral disorder
    Additional description: Oral disorder
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Oral pain
    Additional description: Oral pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Small intestinal obstruction
    Additional description: Small intestinal obstruction
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Stomatitis
    Additional description: Stomatitis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    3
    Tongue discolouration
    Additional description: Tongue discolouration
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    12 / 42 (28.57%)
         occurrences all number
    18
    Hepatobiliary disorders
    Cholecystitis
    Additional description: Cholecystitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
    Additional description: Acne
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    3
    Dermal cyst
    Additional description: Dermal cyst
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Drug eruption
    Additional description: Drug eruption
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Ecchymosis
    Additional description: Ecchymosis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Eczema
    Additional description: Eczema
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Dry skin
    Additional description: Dry skin
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    6
    Hyperhidrosis
    Additional description: Hyperhidrosis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Lipohypertrophy
    Additional description: Lipohypertrophy
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Miliaria
    Additional description: Miliaria
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Nail ridging
    Additional description: Nail ridging
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Night sweats
    Additional description: Night sweats
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    3
    Petechiae
    Additional description: Petechiae
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Pigmentation disorder
    Additional description: Pigmentation disorder
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    5 / 42 (11.90%)
         occurrences all number
    7
    Pruritus generalised
    Additional description: Pruritus generalised
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Purpura
    Additional description: Purpura
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Rash
    Additional description: Rash
         subjects affected / exposed
    17 / 42 (40.48%)
         occurrences all number
    22
    Rash generalised
    Additional description: Rash generalised
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Rash macular
    Additional description: Rash macular
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Rash maculo-papular
    Additional description: Rash maculo-papular
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    15
    Rash papular
    Additional description: Rash papular
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    3
    Skin disorder
    Additional description: Skin disorder
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Skin lesion
    Additional description: Skin lesion
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Skin reaction
    Additional description: Skin reaction
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Stasis dermatitis
    Additional description: Stasis dermatitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Urticaria
    Additional description: Urticaria
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Renal and urinary disorders
    Chromaturia
    Additional description: Chromaturia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Chronic kidney disease
    Additional description: Chronic kidney disease
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Cystitis haemorrhagic
    Additional description: Cystitis haemorrhagic
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Pollakiuria
    Additional description: Pollakiuria
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    10 / 42 (23.81%)
         occurrences all number
    17
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    16 / 42 (38.10%)
         occurrences all number
    26
    Bone pain
    Additional description: Bone pain
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Bone swelling
    Additional description: Bone swelling
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Flank pain
    Additional description: Flank pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Groin pain
    Additional description: Groin pain
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Joint Effusion
    Additional description: Joint Effusion
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Joint range of motion decreased
    Additional description: Joint range of motion decreased
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Joint swelling
    Additional description: Joint swelling
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    8
    Limb discomfort
    Additional description: Limb discomfort
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    4
    Muscle fatigue
    Additional description: Muscle fatigue
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    10 / 42 (23.81%)
         occurrences all number
    14
    Muscular weakness
    Additional description: Muscular weakness
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Musculoskeletal discomfort
    Additional description: Musculoskeletal discomfort
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    8
    Musculoskeletal stiffness
    Additional description: Musculoskeletal stiffness
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    6 / 42 (14.29%)
         occurrences all number
    6
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Osteonecrosis of jaw
    Additional description: Osteonecrosis of jaw
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    13 / 42 (30.95%)
         occurrences all number
    20
    Pain in jaw
    Additional description: Pain in jaw
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Rotator cuff syndrome
    Additional description: Rotator cuff syndrome
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Infections and infestations
    Aspergillus infection
    Additional description: Aspergillus infection
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    6
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    4
    Conjunctivitis viral
    Additional description: Conjunctivitis viral
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    2
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Enterococcal infection
    Additional description: Enterococcal infection
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Eye infection
    Additional description: Eye infection
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Fungal infection
    Additional description: Fungal infection
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hordeolum
    Additional description: Hordeolum
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    5
    Laryngitis
    Additional description: Laryngitis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Infected dermal cyst
    Additional description: Infected dermal cyst
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Infection
    Additional description: Infection
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Listeriosis
    Additional description: Listeriosis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    21 / 42 (50.00%)
         occurrences all number
    38
    Lower respiratory tract infection viral
    Additional description: Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    17 / 42 (40.48%)
         occurrences all number
    38
    Onychomycosis
    Additional description: Onychomycosis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Oral candidiasis
    Additional description: Oral candidiasis
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Oral herpes
    Additional description: Oral herpes
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    4
    Pharyngitis
    Additional description: Pharyngitis
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Pharyngitis streptococcal
    Additional description: Pharyngitis streptococcal
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    8 / 42 (19.05%)
         occurrences all number
    11
    Respiratory tract infection viral
    Additional description: Respiratory tract infection viral
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    15
    Skin candida
    Additional description: Skin candida
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Tonsillitis
    Additional description: Tonsillitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Tooth abscess
    Additional description: Tooth abscess
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Tooth infection
    Additional description: Tooth infection
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Rhinitis
    Additional description: Rhinitis
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    3
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    16 / 42 (38.10%)
         occurrences all number
    32
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Viral upper respiratory tract infection
    Additional description: Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Vulvitis
    Additional description: Vulvitis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Acidosis
    Additional description: Acidosis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    12 / 42 (28.57%)
         occurrences all number
    16
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Fluid overload
    Additional description: Fluid overload
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    2
    Hypomagnesaemia
    Additional description: Hypomagnesaemia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    6
    Hypercholesterolaemia
    Additional description: Hypercholesterolaemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences all number
    4
    Hypernatraemia
    Additional description: Hypernatraemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    4
    Hypoalbuminaemia
    Additional description: Hypoalbuminaemia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hypocalcaemia
    Additional description: Hypocalcaemia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    4
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    8 / 42 (19.05%)
         occurrences all number
    19
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Hypophagia
    Additional description: Hypophagia
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1
    Hypophosphataemia
    Additional description: Hypophosphataemia
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    14
    Vitamin D deficiency
    Additional description: Vitamin D deficiency
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Sep 2014
    Protocol Version 2_25Aug2014 Updates included: - Revision of Exclusion Criteria #20 - Revision of Haematological Toxicities Platelet Count - Revision of Adverse Events List for Lenalidomide - Revision of Lenolidamide Risks and SAE reporting - Administrative changes to protocol - Updates to resolve minor protocol inconsistencies.
    29 Oct 2014
    Protocol Version 3_17Oct2014 Updates included: - Clarification on the Lenalidomide dosing regimen for patients who undergo transplantation - Updated Study Schema for clarity - Updated Study Calendar
    22 Apr 2015
    Protocol Version 4_07April2015 Updates included: - Added reference to Bortezomib SPC - Updated inclusion criteria number 2 - Updated Study Calendar - Updated Study Schema - Added RsqVD Substudy details - Added additional method of submitting SAE reports - Other administration changes
    28 Oct 2015
    Protocol Version 5_23Sep2015 Updates included - Change to protocol that stem cell collection is not mandatory. - Updated Inclusion Criteria Number 1 - Update to Inclusion Criteria Number 5 - Added Inclusion Criteria Number 9 - Updates to Section 12 Study Calendar - Deletion of Appendix I - Clarification of sentence in relation to Bortezomib dosing - Updates to Section 12 Study Calendar - Updates to Section 17 Safety - Updates to Appendix J
    25 Apr 2016
    Protocol Version 6_02Feb2016 Updates inlcuded: - Administrative change to criteria of removal from study due to consent withdrawal. - Clarification on concomitant medications to be recorded during the study - Revised definition of evaluable for response. - Clarification of data to be included in efficacy analysis and safety analysis. - Clarification of SAE reporting procedure to pharmaceutical manufacturers of Investigational Medicinal Products.
    07 Sep 2016
    Protocol Version 7_08Jun2016 Updates included: - Change of sub study contact details - Update that central review is now planned for response assessments - Correction to creatinine clearance formulas
    30 Jul 2019
    Protocol Version _13Jun2019 Updates included: -Administrative changes -Update to maintenance cycles -Secondary objectives updated to clarify that safety of induction therapy and maintenance therapy is evaluated. -Clarification on sub-study sample collection -Survival data post EOT -Confirmation of follow up duration -Confirmation of EOS enrolment

    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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