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    Clinical Trial Results:
    An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic / Pharmacodynamic Profile of VX-970 as a Single Agent in Combination With Carboplatin in Subjects With Advanced Solid Tumors

    Summary
    EudraCT number
    		 2013-005100-34
    Trial protocol
    		 GB  
    Global end of trial date
    10 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jan 2019
    First version publication date
    26 Jan 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VX13-970-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, United States,
    Public contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 8776348789, medicalinfo@vrtx.com
    Scientific contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 8776348789, medicalinfo@vrtx.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
    02 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jan 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of VX-970 in subjects with advanced solid tumors.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Council on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 May 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
    United Kingdom: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    70
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    43
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This is an open-label study conducted in 5 parts (Parts A1, A2, B1, B2 and C).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A (A1 and A2)
    Arm description
    		 Subjects received VX-970 once-weekly (Part A1) and twice-weekly (Part A2) as a single agent.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VX-970
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose of VX-970 was infused intravenously over 60 minutes (± 10 minutes).

    Arm title
    		 Part B1
    Arm description
    		 Subjects received VX-970 in combination with carboplatin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VX-970
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose of VX-970 was infused intravenously over 60 minutes (± 10 minutes).

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered as per institutional standards (up to area under the concentration versus time curve [AUC] = 6 milligram/milliliter*minute [mg/mL*min]).

    Arm title
    		 Part B2
    Arm description
    		 Subjects received VX-970 in combination with carboplatin and paclitaxel.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VX-970
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose of VX-970 was infused intravenously over 60 minutes (± 10 minutes).

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered as per institutional standards (up to area under the concentration versus time curve [AUC] = 6 milligram/milliliter*minute [mg/mL*min]).

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Paclitaxel was administered as per institutional standards (up to 225 mg/square meter).

    Arm title
    		 Part C
    Arm description
    		 Subjects received VX-970 as a single agent, followed by administration of VX-970 in combination with carboplatin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    VX-970
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The dose of VX-970 was infused intravenously over 60 minutes (± 10 minutes).

    Investigational medicinal product name
    Carboplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Carboplatin was administered as per institutional standards (up to AUC = 6 mg/mL*min).

    Number of subjects in period 1
    		Part A (A1 and A2) Part B1 Part B2 Part C
    Started
    17
    23
    15
    15
    Completed
    16
    21
    14
    13
    Not completed
    1
    2
    1
    2
         Physician Decision
    -
    -
    1
    -
         Death
    1
    -
    -
    1
         Other
    -
    2
    -
    -
         Lost to follow-up
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A (A1 and A2)
    Reporting group description
    		 Subjects received VX-970 once-weekly (Part A1) and twice-weekly (Part A2) as a single agent.

    Reporting group title
    Part B1
    Reporting group description
    		 Subjects received VX-970 in combination with carboplatin.

    Reporting group title
    Part B2
    Reporting group description
    		 Subjects received VX-970 in combination with carboplatin and paclitaxel.

    Reporting group title
    Part C
    Reporting group description
    		 Subjects received VX-970 as a single agent, followed by administration of VX-970 in combination with carboplatin.

    Reporting group values
    		 Part A (A1 and A2) Part B1 Part B2 Part C Total
    Number of subjects
    		 17 23 15 15 70
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.4 ( 10.3 ) 62.0 ( 8.8 ) 54.6 ( 9.2 ) 60.5 ( 10.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 15 10 8 43
        Male
    		 7 8 5 7 27

    End points

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    End points reporting groups
    Reporting group title
    Part A (A1 and A2)
    Reporting group description
    		 Subjects received VX-970 once-weekly (Part A1) and twice-weekly (Part A2) as a single agent.

    Reporting group title
    Part B1
    Reporting group description
    		 Subjects received VX-970 in combination with carboplatin.

    Reporting group title
    Part B2
    Reporting group description
    		 Subjects received VX-970 in combination with carboplatin and paclitaxel.

    Reporting group title
    Part C
    Reporting group description
    		 Subjects received VX-970 as a single agent, followed by administration of VX-970 in combination with carboplatin.

    Primary: Number of Subjects With Treatment-emergent Adverse Event (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Treatment-emergent Adverse Event (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    End point type
    Primary
    End point timeframe
    From first dose of Study Drug through Safety Follow-up Visit
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were planned. No statistical comparisons were planned for primary safety endpoint.
    End point values
    		 Part A (A1 and A2) Part B1 Part B2 Part C
    Number of subjects analysed
    17
    23
    15
    15
    Units: Subjects
        Subjects with TEAEs
    17
    23
    15
    15
        Subjects With Serious TEAEs
    8
    8
    7
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of Study Drug through Safety Follow-up Visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Part A (A1 and A2)
    Reporting group description
    		 -

    Reporting group title
    Part B1
    Reporting group description
    		 -

    Reporting group title
    Part B2
    Reporting group description
    		 -

    Reporting group title
    Part C
    Reporting group description
    		 -

    Serious adverse events
    		 Part A (A1 and A2) Part B1 Part B2 Part C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 17 (47.06%)
    8 / 23 (34.78%)
    7 / 15 (46.67%)
    9 / 15 (60.00%)
         number of deaths (all causes)
    1
    0
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Malignant ascites
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 23 (4.35%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Venous thrombosis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 23 (13.04%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 23 (4.35%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 23 (4.35%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 23 (4.35%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 23 (8.70%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Spinal cord compression
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 23 (4.35%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 23 (4.35%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 23 (4.35%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 23 (4.35%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal obstruction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash macular
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 23 (4.35%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Urinary tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Part A (A1 and A2) Part B1 Part B2 Part C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 17 (100.00%)
    23 / 23 (100.00%)
    15 / 15 (100.00%)
    15 / 15 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 23 (0.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    4
    0
    3
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    4 / 17 (23.53%)
    4 / 23 (17.39%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    12
    4
    0
    2
    Hypertension
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    1
    Phlebitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Superior vena cava occlusion
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Venous thrombosis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 17 (35.29%)
    11 / 23 (47.83%)
    8 / 15 (53.33%)
    7 / 15 (46.67%)
         occurrences all number
    8
    17
    8
    7
    Catheter site erythema
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Catheter site inflammation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Catheter site phlebitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Catheter site related reaction
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chills
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 23 (8.70%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Injection site rash
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Local swelling
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 23 (8.70%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infusion site erythema
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 23 (8.70%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Infusion site extravasation
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 23 (8.70%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Infusion site paraesthesia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infusion site reaction
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Face oedema
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Reproductive system and breast disorders
    Pelvic discomfort
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 23 (17.39%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    2
    6
    1
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 23 (17.39%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    1
    4
    1
    3
    Productive cough
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoxia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    2 / 15 (13.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    2
    1
    Anxiety
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 23 (0.00%)
    3 / 15 (20.00%)
    2 / 15 (13.33%)
         occurrences all number
    3
    0
    3
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    3 / 15 (20.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    3
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 23 (8.70%)
    5 / 15 (33.33%)
    5 / 15 (33.33%)
         occurrences all number
    3
    2
    7
    6
    Fall
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Incisional hernia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Post procedural discomfort
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Stoma site erythema
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Foot fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tachycardia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 17 (17.65%)
    2 / 23 (8.70%)
    0 / 15 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    3
    3
    0
    4
    Dysgeusia
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 23 (8.70%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Sciatica
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 17 (0.00%)
    4 / 23 (17.39%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    0
    4
    1
    1
    Dizziness
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    2 / 15 (13.33%)
    3 / 15 (20.00%)
         occurrences all number
    0
    0
    2
    3
    Hyperaesthesia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spinal cord compression
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 17 (29.41%)
    13 / 23 (56.52%)
    7 / 15 (46.67%)
    7 / 15 (46.67%)
         occurrences all number
    5
    21
    9
    7
    Leukocytosis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    0 / 17 (0.00%)
    11 / 23 (47.83%)
    9 / 15 (60.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    31
    18
    4
    Thrombocytopenia
         subjects affected / exposed
    0 / 17 (0.00%)
    9 / 23 (39.13%)
    5 / 15 (33.33%)
    3 / 15 (20.00%)
         occurrences all number
    0
    23
    7
    3
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    6 / 17 (35.29%)
    12 / 23 (52.17%)
    7 / 15 (46.67%)
    11 / 15 (73.33%)
         occurrences all number
    8
    17
    7
    12
    Diarrhoea
         subjects affected / exposed
    4 / 17 (23.53%)
    4 / 23 (17.39%)
    2 / 15 (13.33%)
    4 / 15 (26.67%)
         occurrences all number
    5
    6
    3
    5
    Vomiting
         subjects affected / exposed
    4 / 17 (23.53%)
    2 / 23 (8.70%)
    4 / 15 (26.67%)
    2 / 15 (13.33%)
         occurrences all number
    6
    3
    5
    4
    Constipation
         subjects affected / exposed
    2 / 17 (11.76%)
    8 / 23 (34.78%)
    2 / 15 (13.33%)
    3 / 15 (20.00%)
         occurrences all number
    2
    8
    2
    3
    Abdominal discomfort
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    2
    Abdominal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    4 / 23 (17.39%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    6
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 23 (8.70%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    0
    1
    Small intestinal haemorrhage
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Stomatitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    1
    Dyspepsia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    3 / 15 (20.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Oral pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 17 (11.76%)
    4 / 23 (17.39%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    4
    0
    0
    Decubitus ulcer
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Night sweats
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus allergic
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 23 (13.04%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    3
    3
    0
    0
    Rash macular
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    1
    Urticaria
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Alopecia
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 23 (8.70%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Erythema
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 23 (8.70%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    1
    Dry skin
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Pruritus generalised
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Micturition urgency
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pollakiuria
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 23 (8.70%)
    5 / 15 (33.33%)
    1 / 15 (6.67%)
         occurrences all number
    2
    3
    5
    1
    Groin pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 23 (8.70%)
    4 / 15 (26.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    5
    0
    Pain in extremity
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 23 (8.70%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Back pain
         subjects affected / exposed
    0 / 17 (0.00%)
    6 / 23 (26.09%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    0
    7
    1
    4
    Muscular weakness
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 17 (23.53%)
    5 / 23 (21.74%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    7
    6
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Parotitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 23 (8.70%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    3
    1
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    3 / 17 (17.65%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    2 / 17 (11.76%)
    3 / 23 (13.04%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
         occurrences all number
    2
    4
    1
    2
    Hypokalaemia
         subjects affected / exposed
    2 / 17 (11.76%)
    5 / 23 (21.74%)
    2 / 15 (13.33%)
    1 / 15 (6.67%)
         occurrences all number
    9
    8
    2
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 23 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 23 (13.04%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    4
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2014
    Changed genomic DNA sample source from blood to saliva and decreased the number of plasma DNA collection time points; Updated appropriate texts to improve clarity and consistency; Updates to support PK assessments; Clarified stopping rule for subjects with progressive disease; Removed exclusion criterion for subjects receiving medications that are mainly metabolized by CYP3A4
    22 Jan 2015
    Dose escalation for subjects in Part B was modified to allow escalation of carboplatin; Clarified the timed tumor biopsy pharmacokinetic sample collection for Part B subjects
    28 May 2015
    Subpart A2 was added to evaluate the safety and tolerability of twice-weekly dosing of single-agent VX-970; Part B was revised to include subpart B2 to evaluate the safety and tolerability of VX-970 in combination with carboplatin and paclitaxel; Part C study population was clarified; Dose Limiting Toxicity (DLT) definition was modified; Inclusion/Exclusion criteria were modified; Follow-up assessments were modified
    12 May 2016
    Dose escalation schema for Part B2 was modified; Exclusion criterion added to exclude subjects who have been diagnosed with Li-Fraumeni Syndrome or ataxia telangiectasia

    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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