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    Clinical Trial Results:
    A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer

    Summary
    EudraCT number
    		 2015-003693-33
    Trial protocol
    		 GB   ES   DE   AT   BE   IT  
    Global end of trial date
    07 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2019
    First version publication date
    14 Feb 2019
    Other versions
    Summary report(s)
    		 CDX011-04 CSR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    CDX011-04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01997333
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Celldex Therapeutics, Inc.
    Sponsor organisation address
    53 Frontage Road, Suite 200, Hampton, United States, 08827
    Public contact
    Director of Regulatory Affairs, Celldex Therapeutics, Inc., info@celldex.com
    Scientific contact
    Director of Regulatory Affairs, Celldex Therapeutics, Inc., info@celldex.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the anti-cancer activity of CDX-011 in metastatic, GPNMB over-expressing, triple-negative breast cancer as measured by the duration of progression-free survival (PFS).
    Protection of trial subjects
    Safety assessments occurred at every 21-day cycle including physical examination, vital signs, routine hematology, blood chemistry, urinalysis, and evaluation of adverse events using NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0. The EORTC Core Quality of Life Questionnaire (QLQ-30) was completed at screening, at first dose of study drug, and at every other dosing cycle until end of treatment by patients who were fluent in a language in which the questionnaires were validated. An independent data monitoring committee (IDMC) was convened for this study and acted in an advisory capacity to the sponsor with respect to safeguarding the interests of patients, assessing interim safety data, and for monitoring the overall conduct of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 Capecitabine was selected as the comparator as it represented a standard of care option for patients with triple negative breast cancer.
    Actual start date of recruitment
    19 Feb 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Australia: 18
    Country: Number of subjects enrolled
    Canada: 12
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    United States: 215
    Worldwide total number of subjects
    327
    EEA total number of subjects
    82
    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)
    258
    From 65 to 84 years
    67
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 1531 patients were screened between December 2013 and July 2017.

    Pre-assignment
    Screening details
    		 1531 patients screened to randomize 327 patients. Most common reasons for screen failure were tumor tissue inadequate/gpNMB negative (697), failure to meet other eligibility (256), and refusal to participate (77).

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    As this was an open-label study, there was no masking of trial participants or investigators. The imaging review committee and biostatistical team at the study sponsor were masked to treatment assignments until after study closure.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CDX-011
    Arm description
    		 CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Glembatumumab vedotin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Glembatumumab vedotin solution (injection concentrate); 1.88 mg/kg; intravenous infusion on Day 1 of repeated 21-day cycles

    Arm title
    		 Capecitabine
    Arm description
    		 Capecitabine administered on days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capecitabine administered orally; starting dose was 1250 mg/m2 twice daily (equivalent to 2500 mg/m2 total daily dose) per the package insert, days 1-14 of repeated 21 day cycles; subsequent treatment was dictated by tolerance and institutional practice.

    Number of subjects in period 1
    		CDX-011 Capecitabine
    Started
    218
    109
    Completed
    199
    76
    Not completed
    19
    33
         Consent withdrawn by subject
    6
    15
         Various
    2
    1
         Lost to follow-up
    6
    -
         Did not receive treatment
    5
    17

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CDX-011
    Reporting group description
    		 CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

    Reporting group title
    Capecitabine
    Reporting group description
    		 Capecitabine administered on days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.

    Reporting group values
    		 CDX-011 Capecitabine Total
    Number of subjects
    		 218 109 327
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 177 81 258
        From 65-84 years
    		 40 27 67
        85 years and over
    		 1 1 2
    Age continuous
    Units: years
        median (full range (min-max))
    		 55 (28 to 85) 55 (31 to 85) -
    Gender categorical
    Units: Subjects
        Female
    		 218 109 327
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    CDX-011
    Reporting group description
    		 CDX-011 administered on Day 1 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

    Reporting group title
    Capecitabine
    Reporting group description
    		 Capecitabine administered on days 1 through 14 of each 21 day cycle until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study.

    Primary: Progression Free Survival (PFS)

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    End point title
    		 Progression Free Survival (PFS)
    End point description
    PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.
    End point type
    Primary
    End point timeframe
    Evaluated every 6-9 weeks following treatment initiation.
    End point values
    		 CDX-011 Capecitabine
    Number of subjects analysed
    218
    109
    Units: months
        median (confidence interval 95%)
    2.9 (2.8 to 3.5)
    2.8 (1.6 to 3.2)
    Statistical analysis title
    		 PFS
    Comparison groups
    CDX-011 v Capecitabine
    Number of subjects included in analysis
    327
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Logrank
    Confidence interval

    Secondary: Objective Response Rate (ORR)

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    End point title
    		 Objective Response Rate (ORR)
    End point description
    ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and nontarget lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
    End point type
    Secondary
    End point timeframe
    Evaluated every 6-9 weeks following treatment initiation
    End point values
    		 CDX-011 Capecitabine
    Number of subjects analysed
    179
    100
    Units: Percentage
        median (confidence interval 95%)
    26 (20 to 33)
    21 (14 to 30)
    Statistical analysis title
    		 ORR
    Comparison groups
    CDX-011 v Capecitabine
    Number of subjects included in analysis
    279
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
    End point type
    Secondary
    End point timeframe
    Evaluated every 6-9 weeks following treatment initiation.
    End point values
    		 CDX-011 Capecitabine
    Number of subjects analysed
    46
    21
    Units: months
        median (confidence interval 95%)
    2.8 (2.3 to 5.5)
    4.2 (2.7 to 5.6)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.
    End point type
    Secondary
    End point timeframe
    During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.
    End point values
    		 CDX-011 Capecitabine
    Number of subjects analysed
    218
    109
    Units: months
        median (confidence interval 95%)
    8.9 (7.9 to 10.5)
    8.7 (6.9 to 10.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time a subject took their first dose of study treatment (CDX-011 or Capecitabine) through (whichever occurs first) either a) 28 calendar days after the last administration of study treatment, or b) initiation of alternate anticancer therapy.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Active Study Drug
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Serious adverse events
    		 Active Study Drug Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    71 / 213 (33.33%)
    19 / 92 (20.65%)
         number of deaths (all causes)
    134
    65
         number of deaths resulting from adverse events
    4
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to meninges
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Embolism
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Axillary pain
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 213 (0.94%)
    3 / 92 (3.26%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    3 / 213 (1.41%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyserositis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    7 / 213 (3.29%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    6 / 213 (2.82%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal oedema
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 213 (1.41%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 213 (0.94%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 213 (0.47%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine increased
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site haemorrhage
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Pericardial effusion
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain oedema
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 213 (1.41%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 213 (0.94%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract nuclear
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 213 (2.82%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    2 / 6
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    4 / 213 (1.88%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    6 / 213 (2.82%)
    5 / 92 (5.43%)
         occurrences causally related to treatment / all
    4 / 6
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 213 (0.00%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 213 (0.47%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    8 / 213 (3.76%)
    3 / 92 (3.26%)
         occurrences causally related to treatment / all
    6 / 9
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 213 (0.47%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 213 (0.47%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    3 / 213 (1.41%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    7 / 213 (3.29%)
    4 / 92 (4.35%)
         occurrences causally related to treatment / all
    5 / 8
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Drug eruption
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain of skin
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash generalised
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    3 / 213 (1.41%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic epidermal necrolysis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 213 (0.94%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bone pain
         subjects affected / exposed
    1 / 213 (0.47%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest wall mass
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 213 (0.94%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacterascites
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cellulitis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest wall abscess
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 213 (2.35%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    5 / 213 (2.35%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 1
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Sepsis syndrome
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    4 / 213 (1.88%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 213 (0.47%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    3 / 213 (1.41%)
    2 / 92 (2.17%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 213 (0.47%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 213 (0.94%)
    0 / 92 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 213 (0.00%)
    1 / 92 (1.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active Study Drug Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    211 / 213 (99.06%)
    91 / 92 (98.91%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    23 / 213 (10.80%)
    3 / 92 (3.26%)
         occurrences all number
    40
    7
    Aspartate aminotransferase increased
         subjects affected / exposed
    25 / 213 (11.74%)
    6 / 92 (6.52%)
         occurrences all number
    47
    11
    Blood alkaline phosphatase increased
         subjects affected / exposed
    18 / 213 (8.45%)
    2 / 92 (2.17%)
         occurrences all number
    27
    2
    Lymphocyte count decreased
         subjects affected / exposed
    12 / 213 (5.63%)
    3 / 92 (3.26%)
         occurrences all number
    25
    4
    Neutrophil count decreased
         subjects affected / exposed
    38 / 213 (17.84%)
    1 / 92 (1.09%)
         occurrences all number
    73
    5
    Weight decreased
         subjects affected / exposed
    37 / 213 (17.37%)
    5 / 92 (5.43%)
         occurrences all number
    54
    5
    White blood cell count decreased
         subjects affected / exposed
    24 / 213 (11.27%)
    2 / 92 (2.17%)
         occurrences all number
    47
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    19 / 213 (8.92%)
    4 / 92 (4.35%)
         occurrences all number
    21
    4
    Dysgeusia
         subjects affected / exposed
    23 / 213 (10.80%)
    2 / 92 (2.17%)
         occurrences all number
    26
    2
    Headache
         subjects affected / exposed
    39 / 213 (18.31%)
    5 / 92 (5.43%)
         occurrences all number
    53
    5
    Neuropathy peripheral
         subjects affected / exposed
    28 / 213 (13.15%)
    4 / 92 (4.35%)
         occurrences all number
    48
    4
    Paraesthesia
         subjects affected / exposed
    12 / 213 (5.63%)
    5 / 92 (5.43%)
         occurrences all number
    14
    7
    Peripheral sensory neuropathy
         subjects affected / exposed
    47 / 213 (22.07%)
    4 / 92 (4.35%)
         occurrences all number
    68
    6
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    33 / 213 (15.49%)
    9 / 92 (9.78%)
         occurrences all number
    48
    15
    Neutropenia
         subjects affected / exposed
    49 / 213 (23.00%)
    5 / 92 (5.43%)
         occurrences all number
    101
    12
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    14 / 213 (6.57%)
    5 / 92 (5.43%)
         occurrences all number
    21
    5
    Chills
         subjects affected / exposed
    14 / 213 (6.57%)
    4 / 92 (4.35%)
         occurrences all number
    17
    6
    Fatigue
         subjects affected / exposed
    101 / 213 (47.42%)
    37 / 92 (40.22%)
         occurrences all number
    160
    57
    Non-cardiac chest pain
         subjects affected / exposed
    4 / 213 (1.88%)
    5 / 92 (5.43%)
         occurrences all number
    4
    5
    Oedema peripheral
         subjects affected / exposed
    13 / 213 (6.10%)
    10 / 92 (10.87%)
         occurrences all number
    16
    13
    Pain
         subjects affected / exposed
    21 / 213 (9.86%)
    4 / 92 (4.35%)
         occurrences all number
    25
    4
    Pyrexia
         subjects affected / exposed
    37 / 213 (17.37%)
    12 / 92 (13.04%)
         occurrences all number
    46
    16
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    12 / 213 (5.63%)
    3 / 92 (3.26%)
         occurrences all number
    17
    3
    Abdominal pain
         subjects affected / exposed
    22 / 213 (10.33%)
    16 / 92 (17.39%)
         occurrences all number
    27
    25
    Abdominal pain upper
         subjects affected / exposed
    17 / 213 (7.98%)
    6 / 92 (6.52%)
         occurrences all number
    18
    6
    Constipation
         subjects affected / exposed
    61 / 213 (28.64%)
    13 / 92 (14.13%)
         occurrences all number
    82
    14
    Diarrhoea
         subjects affected / exposed
    55 / 213 (25.82%)
    44 / 92 (47.83%)
         occurrences all number
    88
    81
    Dry mouth
         subjects affected / exposed
    10 / 213 (4.69%)
    5 / 92 (5.43%)
         occurrences all number
    10
    5
    Dyspepsia
         subjects affected / exposed
    22 / 213 (10.33%)
    4 / 92 (4.35%)
         occurrences all number
    27
    4
    Dysphagia
         subjects affected / exposed
    12 / 213 (5.63%)
    0 / 92 (0.00%)
         occurrences all number
    15
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    16 / 213 (7.51%)
    4 / 92 (4.35%)
         occurrences all number
    16
    4
    Nausea
         subjects affected / exposed
    91 / 213 (42.72%)
    39 / 92 (42.39%)
         occurrences all number
    142
    54
    Oral pain
         subjects affected / exposed
    11 / 213 (5.16%)
    2 / 92 (2.17%)
         occurrences all number
    12
    2
    Stomatitis
         subjects affected / exposed
    37 / 213 (17.37%)
    24 / 92 (26.09%)
         occurrences all number
    56
    43
    Vomiting
         subjects affected / exposed
    46 / 213 (21.60%)
    17 / 92 (18.48%)
         occurrences all number
    68
    24
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    24 / 213 (11.27%)
    10 / 92 (10.87%)
         occurrences all number
    32
    13
    Dyspnoea
         subjects affected / exposed
    32 / 213 (15.02%)
    11 / 92 (11.96%)
         occurrences all number
    37
    11
    Oropharyngeal pain
         subjects affected / exposed
    15 / 213 (7.04%)
    2 / 92 (2.17%)
         occurrences all number
    18
    2
    Pleural effusion
         subjects affected / exposed
    5 / 213 (2.35%)
    5 / 92 (5.43%)
         occurrences all number
    17
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    88 / 213 (41.31%)
    1 / 92 (1.09%)
         occurrences all number
    101
    1
    Dry skin
         subjects affected / exposed
    8 / 213 (3.76%)
    5 / 92 (5.43%)
         occurrences all number
    9
    5
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    10 / 213 (4.69%)
    40 / 92 (43.48%)
         occurrences all number
    15
    132
    Pruritus
         subjects affected / exposed
    69 / 213 (32.39%)
    4 / 92 (4.35%)
         occurrences all number
    124
    5
    Pruritus generalised
         subjects affected / exposed
    12 / 213 (5.63%)
    0 / 92 (0.00%)
         occurrences all number
    21
    0
    Rash
         subjects affected / exposed
    29 / 213 (13.62%)
    3 / 92 (3.26%)
         occurrences all number
    65
    4
    Rash erythematous
         subjects affected / exposed
    15 / 213 (7.04%)
    1 / 92 (1.09%)
         occurrences all number
    23
    1
    Rash macular
         subjects affected / exposed
    11 / 213 (5.16%)
    0 / 92 (0.00%)
         occurrences all number
    23
    0
    Rash maculo-papular
         subjects affected / exposed
    40 / 213 (18.78%)
    5 / 92 (5.43%)
         occurrences all number
    103
    13
    Rash pruritic
         subjects affected / exposed
    18 / 213 (8.45%)
    0 / 92 (0.00%)
         occurrences all number
    48
    0
    Skin hyperpigmentation
         subjects affected / exposed
    19 / 213 (8.92%)
    3 / 92 (3.26%)
         occurrences all number
    21
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    15 / 213 (7.04%)
    5 / 92 (5.43%)
         occurrences all number
    22
    5
    Insomnia
         subjects affected / exposed
    24 / 213 (11.27%)
    6 / 92 (6.52%)
         occurrences all number
    24
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    38 / 213 (17.84%)
    3 / 92 (3.26%)
         occurrences all number
    50
    4
    Back pain
         subjects affected / exposed
    21 / 213 (9.86%)
    12 / 92 (13.04%)
         occurrences all number
    23
    12
    Bone pain
         subjects affected / exposed
    24 / 213 (11.27%)
    3 / 92 (3.26%)
         occurrences all number
    29
    5
    Muscle spasms
         subjects affected / exposed
    12 / 213 (5.63%)
    1 / 92 (1.09%)
         occurrences all number
    13
    1
    Muscular weakness
         subjects affected / exposed
    12 / 213 (5.63%)
    3 / 92 (3.26%)
         occurrences all number
    14
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    9 / 213 (4.23%)
    11 / 92 (11.96%)
         occurrences all number
    10
    12
    Musculoskeletal pain
         subjects affected / exposed
    10 / 213 (4.69%)
    8 / 92 (8.70%)
         occurrences all number
    14
    9
    Myalgia
         subjects affected / exposed
    27 / 213 (12.68%)
    4 / 92 (4.35%)
         occurrences all number
    39
    4
    Pain in extremity
         subjects affected / exposed
    25 / 213 (11.74%)
    9 / 92 (9.78%)
         occurrences all number
    36
    17
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    18 / 213 (8.45%)
    1 / 92 (1.09%)
         occurrences all number
    20
    1
    Urinary tract infection
         subjects affected / exposed
    18 / 213 (8.45%)
    3 / 92 (3.26%)
         occurrences all number
    29
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    63 / 213 (29.58%)
    17 / 92 (18.48%)
         occurrences all number
    79
    17
    Dehydration
         subjects affected / exposed
    15 / 213 (7.04%)
    6 / 92 (6.52%)
         occurrences all number
    21
    8
    Hyperglycaemia
         subjects affected / exposed
    15 / 213 (7.04%)
    0 / 92 (0.00%)
         occurrences all number
    26
    0
    Hypoalbuminaemia
         subjects affected / exposed
    11 / 213 (5.16%)
    5 / 92 (5.43%)
         occurrences all number
    24
    6
    Hypokalaemia
         subjects affected / exposed
    24 / 213 (11.27%)
    8 / 92 (8.70%)
         occurrences all number
    38
    10
    Hypophosphataemia
         subjects affected / exposed
    14 / 213 (6.57%)
    5 / 92 (5.43%)
         occurrences all number
    22
    9

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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