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    Clinical Trial Results:
    A Phase II Study of Nab-paclitaxel and Gemcitabine, in Elderly Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma

    Summary
    EudraCT number
    		 2014-003596-27
    Trial protocol
    		 ES  
    Global end of trial date
    15 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Aug 2021
    First version publication date
    11 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BIBABRAX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ASONMEC (Asociación de Oncología Médica del Hospital de Cruces)
    Sponsor organisation address
    Plaza de Cruces, s/n, Baracaldo, Vizcaya, Spain, 48903
    Public contact
    Departamento Operaciones Clínicas, APICES SOLUCIONES, S.L., +34 918166804103, ana.moreno@apices.es
    Scientific contact
    Departamento Operaciones Clínicas, APICES SOLUCIONES, S.L., +34 918166804103, ana.moreno@apices.es
    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
    15 Apr 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Mar 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of treatment through 3-months deterioration free rate
    Protection of trial subjects
    Not appicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Aug 2015
    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
    Spain: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    0
    From 65 to 84 years
    78
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were included in the study between 5th August 2015 and 6th September 2017.

    Pre-assignment
    Screening details
    		 98 patients were recruited initially in the study which were analyzed 80. 18 patients were screening failures.

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

    Arms
    Arm title
    		 Study treatment
    Arm description
    		 Patients received nab-paclitaxel 125 mg/m² plus gemcitabine 1000 mg/m² at days 1, 8 and 15 of each cycle with 1 week off.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    125 mg/m2 at days 1, 8 and 15 of each cycle.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1000 mg/m2 at days 1, 8 and 15 of each cycle.

    Number of subjects in period 1
    		Study treatment
    Started
    80
    Completed
    51
    Not completed
    29
         Physician decision
    14
         Adverse event, non-fatal
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 80 80
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 78 78
        85 years and over
    		 2 2
    Age continuous
    one patient indicated date of birth the date of informed consent.
    Units: years
        median (full range (min-max))
    		 74.6 (70.0 to 87.9) -
    Gender categorical
    Units: Subjects
        Female
    		 34 34
        Male
    		 46 46
    ECOG-PS
    Units: Subjects
        (0)
    		 23 23
        (1)
    		 57 57
    Disease diagnosis
    Units: Subjects
        Pancreatic adenocarcinoma
    		 70 70
        Ductal adenocarcinoma
    		 6 6
        Pancreatic acinar carcinoma
    		 1 1
        Pancreatobiliary adenocarcinoma
    		 1 1
        Infiltrative adenocarcinoma
    		 1 1
        Signet ring cell adenocarcinoma
    		 1 1
    Current M status
    Units: Subjects
        M0
    		 11 11
        M1
    		 69 69
    Previous surgery
    Units: Subjects
        Yes
    		 13 13
        No
    		 67 67
    Previous chemotherapy
    One patient received 3 previous lines of gemcitabine in monotherapy, each completed on 1st July 2008, 21st December 2012 and 11th June 2013
    Units: Subjects
        Gemcitabine
    		 9 9
        5-FU/LV
    		 1 1
        5-FU
    		 1 1
        No
    		 69 69
    Previous radiotherapy
    Units: Subjects
        Yes
    		 3 3
        No
    		 77 77
    Number of patients per location: Pancreas
    Units: Subjects
        Yes
    		 70 70
        No
    		 10 10
    Number of patients per location: Liver
    Units: Subjects
        Yes
    		 40 40
        No
    		 40 40
    Number of patients per location: Lymph nodes
    Units: Subjects
        Yes
    		 21 21
        No
    		 59 59
    Number of patients per location: Lung
    Units: Subjects
        Yes
    		 19 19
        No
    		 61 61
    Number of patients per location: Peritoneum
    Units: Subjects
        Yes
    		 16 16
        No
    		 64 64
    Number of location per patient
    Units: Subjects
        (1)
    		 17 17
        (2)
    		 35 35
        >3
    		 28 28
    Pancreatic tumor location: Head
    Units: Subjects
        Yes
    		 26 26
        No
    		 54 54
    Pancreatic tumor location: Tail
    Units: Subjects
        Yes
    		 20 20
        No
    		 60 60
    Pancreatic tumor location: Body
    Units: Subjects
        Yes
    		 18 18
        No
    		 62 62
    Weight
    Units: Kg
        median (full range (min-max))
    		 67.0 (41.9 to 88.0) -
    Height
    Units: Cm
        median (full range (min-max))
    		 161.5 (142.0 to 178.0) -
    Body surface area
    Units: m2
        median (full range (min-max))
    		 1.7 (1.3 to 2.0) -
    Time since initial diagnosis
    Units: Months
        median (full range (min-max))
    		 0.9 (0.0 to 108.5) -
    Number of cycles administered
    Units: Number of cycles
        median (full range (min-max))
    		 4.0 (1.0 to 19.0) -
    Relative dose intensity of Nab-paclitaxel
    Units: (%)
        median (full range (min-max))
    		 74 (32 to 100) -
    Relative dose intensity of Gemcitabine
    Units: (%)
        median (full range (min-max))
    		 76 (32 to 110) -

    End points

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    End points reporting groups
    Reporting group title
    Study treatment
    Reporting group description
    		 Patients received nab-paclitaxel 125 mg/m² plus gemcitabine 1000 mg/m² at days 1, 8 and 15 of each cycle with 1 week off.

    Primary: 3-months deterioration free rate

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    End point title
    		 3-months deterioration free rate [1]
    End point description
    Deterioration free rate was defined as the time elapsed in months since patients entry into the study until clinical deterioration defined as a decrease of at least 10 points on the global health status score of the EORTC-QLQ-C-30 scale.
    End point type
    Primary
    End point timeframe
    Every 4 weeks.
    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: Single-arm clinical trial. Only descriptive analyses performed. No comparisons.
    End point values
    		 Study treatment
    Number of subjects analysed
    80
    Units: (%)
    median (full range (min-max))
        3-months deterioration free rate
    54.3 (41.6 to 67.0)
    No statistical analyses for this end point

    Secondary: 3 months progression free survival

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    End point title
    		 3 months progression free survival
    End point description
    Progression free survival was defined as the time from the date of treatment to the first of either disease progression, relapse or death from any cause.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Study treatment
    Number of subjects analysed
    80
    Units: (%)
        median (confidence interval 95%)
    77.1 (67.7 to 86.5)
    No statistical analyses for this end point

    Secondary: Time to tumor progression

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    End point title
    		 Time to tumor progression
    End point description
    Time to tumor progression was defined as the time elapsed, in months, since date of treatment to the first of either disease progression.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    80
    Units: Months
    median (confidence interval 95%)
        Time to tumor progression
    8.299 (6.327 to 10.252)
    No statistical analyses for this end point

    Secondary: Objective response

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    End point title
    		 Objective response
    End point description
    Best treatment reponse.
    End point type
    Secondary
    End point timeframe
    Every 8 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    80
    Units: Percentage (%)
    number (confidence interval 95%)
        Objective response rate (CR + PR)
    13.8 (6.2 to 21.3)
        Clinical Benefit Rate (CR + PR + EE)
    67.5 (57.2 to 77.8)
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    		 Overall Survival
    End point description
    Overall survival has been defined as the time elapsed in months from patient entry into the study until death from any cause.
    End point type
    Secondary
    End point timeframe
    Every 8 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    79 [2]
    Units: Months
    median (confidence interval 95%)
        Overall Survival
    9.211 (6.946 to 11.475)
    Notes
    [2] - One patient has not date of éxitus.
    No statistical analyses for this end point

    Secondary: Progression free survival

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    End point title
    		 Progression free survival
    End point description
    Progression-free survival (PFS) was defined as the time from the date of treatment to the first of either disease progression, relapse or death from any cause.
    End point type
    Secondary
    End point timeframe
    Until disease progression.
    End point values
    		 Study treatment
    Number of subjects analysed
    80
    Units: Months
    median (confidence interval 95%)
        Time of follow up (months)
    7.171 (5.809 to 8.533)
    No statistical analyses for this end point

    Secondary: CA 19-9 biomarker response

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    End point title
    		 CA 19-9 biomarker response
    End point description
    CA 19-9 biomarker response has been defined as a reduction of at least 50% from baseline.
    End point type
    Secondary
    End point timeframe
    Every 4 weeks
    End point values
    		 Study treatment
    Number of subjects analysed
    71 [3]
    Units: Subjects
        Responder
    25
        No responder
    46
    Notes
    [3] - 9 patients do not indicate evaluation of CA 19-9 after baseline.
    No statistical analyses for this end point

    Secondary: Toxicities grade 3-4 frequency higher than 10%

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    End point title
    		 Toxicities grade 3-4 frequency higher than 10%
    End point description
    Number of subjects with asthenia grade 3-4: 17 Number of subjects with neurotoxicity grade 3-4: 13 Number of subjects with Neutropenia grade 3-4: 17 Number of total subjects with toxicities grade 3-4: 29
    End point type
    Secondary
    End point timeframe
    Every 4 weeks.
    End point values
    		 Study treatment
    Number of subjects analysed
    80
    Units: Percentage (%)
    number (not applicable)
        Asthenia
    21.25
        Neurotoxicity
    16.25
        Neutropenia
    21.25
        Total
    36.25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Every 4 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    68 / 80 (85.00%)
         number of deaths (all causes)
    19
         number of deaths resulting from adverse events
    9
    Vascular disorders
    Thrombosis venous deep
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Venous thrombosis deep (limbs)
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Clinical deterioration
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Fever
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Asthenia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiorgan failure
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Oedema lower limb
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Worsening PS
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Pulmonary thromboembolism
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Hypertransaminasaemia
    Additional description: Hypertransaminasaemia related with gemcitabine and nab-paclitaxel.
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Pertrochanteric fracture of the femur, open
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Right frontal subacute stroke
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
    Additional description: 2 Neutropenias related with gemcitabine and nab-paclitaxel.
         subjects affected / exposed
    2 / 80 (2.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
    Additional description: Pancytopenia related with gemcitabine.
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
    Additional description: Leukopenia related with gemcitabine and nab-paclitaxel.
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
    Additional description: Constipation related with Nab-paclitaxel.
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Intestinal perforation
    Additional description: Intestional perforation related with gemcitabine and nab-paclitaxel.
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
    Additional description: 3 diarrhoea related with gemcitabine and nab-paclitaxel.
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences causally related to treatment / all
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    Colonic obstruction
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paralysis ileum
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhage of digestive tract
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hepatobiliary disorders
    Hepatotoxicity
    Additional description: Hepatotoxicity related with gemcitabine.
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Obstructive jaundice
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Biliary vesicle perforation
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pollakiuria
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    insufficiency renal
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Knee pain
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Escherechia coli bactaraemia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Pneumonia
         subjects affected / exposed
    3 / 80 (3.75%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Aeromona nyorophyla and klebsiella pneumoniae bacteraemia
    Additional description: Aeromona nyorophyla and klebsiella pneumoniae bacteraemia related with gemcitabine and nab-paclitaxel.
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes oesophagitis
    Additional description: Herpes oesophagitis related with Gemcitabine and nab-paclitaxel.
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Reservoir infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombophlebitis septic
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multilobar pneumonia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Skin infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 80 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    80 / 80 (100.00%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Nervous system disorders
    Dysgeusiae
         subjects affected / exposed
    9 / 80 (11.25%)
         occurrences all number
    9
    Dizziness
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    7
    Neuropathy peripheral
         subjects affected / exposed
    19 / 80 (23.75%)
         occurrences all number
    19
    Neurotoxicity
         subjects affected / exposed
    20 / 80 (25.00%)
         occurrences all number
    20
    Paraesthesia
         subjects affected / exposed
    12 / 80 (15.00%)
         occurrences all number
    12
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    27 / 80 (33.75%)
         occurrences all number
    27
    Leukopenia
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    6
    Neutropenia
         subjects affected / exposed
    27 / 80 (33.75%)
         occurrences all number
    27
    Thrombocytopenia
         subjects affected / exposed
    24 / 80 (30.00%)
         occurrences all number
    24
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    65 / 80 (81.25%)
         occurrences all number
    65
    Peripheral oedema
         subjects affected / exposed
    20 / 80 (25.00%)
         occurrences all number
    20
    Mucosal inflammation
         subjects affected / exposed
    14 / 80 (17.50%)
         occurrences all number
    14
    Pyrexia
         subjects affected / exposed
    17 / 80 (21.25%)
         occurrences all number
    17
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    33 / 80 (41.25%)
         occurrences all number
    33
    Dyspepsia
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    5
    Abdominal pain
         subjects affected / exposed
    25 / 80 (31.25%)
         occurrences all number
    25
    Abdominal pain upper
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    6
    Constipation
         subjects affected / exposed
    23 / 80 (28.75%)
         occurrences all number
    23
    Nausea
         subjects affected / exposed
    21 / 80 (26.25%)
         occurrences all number
    21
    Vomiting
         subjects affected / exposed
    12 / 80 (15.00%)
         occurrences all number
    12
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Dyspnoea
         subjects affected / exposed
    11 / 80 (13.75%)
         occurrences all number
    11
    Epistaxis
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    5
    Cough
         subjects affected / exposed
    4 / 80 (5.00%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    24 / 80 (30.00%)
         occurrences all number
    24
    Eruption
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    6
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 80 (8.75%)
         occurrences all number
    7
    Back pain
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    5
    Pain in extremity
         subjects affected / exposed
    5 / 80 (6.25%)
         occurrences all number
    5
    Myalgia
         subjects affected / exposed
    6 / 80 (7.50%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    32 / 80 (40.00%)
         occurrences all number
    32

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2015
    Amendment 1: Protocol version 2.0

    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.
    Open-label single-arm study. No control group for comparison.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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