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    Clinical Trial Results:
    A randomized, double-blind, parallel-group, multi-center Phase 3 comparative study investigating efficacy and safety of LA-EP2006 and Neulasta® in breast cancer patients treated with myelosuppressive chemotherapy

    Summary
    EudraCT number
    		 2011-004532-58
    Trial protocol
    		 BG  
    Global end of trial date
    11 Feb 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    21 Jul 2016
    First version publication date
    05 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    These results have been removed from public view by EMA due to a system error. Subsequently, Sponsor reviewed and updated/corrected trial results to restore posting.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    LA-EP06-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sandoz GmbH
    Sponsor organisation address
    Biochemiestrasse 10, Kundl, Austria,
    Public contact
    Strategic Planning Biopharma Clinical Development, Sandoz, +49 8024 476 - 0, biopharma.clinicaltrials@sandoz.com
    Scientific contact
    Strategic Planning Biopharma Clinical Development, Sandoz, +49 8024 476 - 0, biopharma.clinicaltrials@sandoz.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
    07 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia (DSN), defined as number of consecutive days with Grade 4 neutropenia (absolute neutrophil count [ANC] less than 0.5 x 10^9/L), during Cycle 1 of the neoadjuvant or adjuvant TAC regimen (Taxotere® [docetaxel 75 mg/m2] in combination with Adriamycin® [doxorubicin 50 mg/m2] and Cytoxan® [cyclophosphamide 500 mg/m2]) in breast cancer patients.
    Protection of trial subjects
    The study protocol and the amendment were reviewed by the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for each site. The study was conducted in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations (including Food and Drug Administration (FDA) regulations relating to GCP and clinical trials in CFR Title 21; EU legislation on GCP and the conduct of clinical trials: Directive 2001/83/EC, Directive 2001/20/EC), and with the ethical principles laid down in the Declaration of Helsinki.
    Background therapy
    		 Each patient received TAC combination chemotherapy (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2) on Day 1 of each cycle. TAC combination chemotherapy was administered intravenously at Day 1 of each chemotherapy cycle and was to be given for up to six cycles.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jun 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 197
    Country: Number of subjects enrolled
    India: 52
    Country: Number of subjects enrolled
    Romania: 23
    Country: Number of subjects enrolled
    Ukraine: 28
    Country: Number of subjects enrolled
    Brazil: 11
    Country: Number of subjects enrolled
    Mexico: 5
    Worldwide total number of subjects
    316
    EEA total number of subjects
    23
    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)
    289
    From 65 to 84 years
    27
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were screened and randomized in 6 countries (Russia, Ukraine, Romania, India, Brazil, and Mexico): 42 study sites screened patients and 38 study sites randomized patients.

    Pre-assignment
    Screening details
    		 The study started with a 21-day screening period. During the screening period, the eligibility of the patients to participate in the study was assessed based on safety evaluations.

    Pre-assignment period milestones
    Number of subjects started
    		 373 [1]
    Number of subjects completed
    		 316

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 20
    Reason: Number of subjects
    		 Not meet inclusion criteria: 7
    Reason: Number of subjects
    		 Meet eclusion criteria: 11
    Reason: Number of subjects
    		 No study drug available: 13
    Reason: Number of subjects
    		 Other: 6
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects started the pre-assignment period is the number of screened subjects. The number of subjects started the enrolment period is the number of randomized subjects.
    Period 1
    Period 1 title
    Double blind
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    An unblinded drug administrator (such as a study nurse) injected the entire volume of the IMP. This drug administrator did not participate in any study assessments. The unblinded drug administrator documented in the drug accountability log the type of IMP administered (LA-EP2006 or Neulasta), the batch number, and the kit number.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LA-EP2006
    Arm description
    		 LA-EP2006 is a colorless to slightly yellowish ready-to-use solution and was provided in pre-filled syringes (PFS) intended for subcutaneous (s.c.) administration in the strength of 6 mg/0.6 mL.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LA-EP2006
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LA-EP2006 pre-filled syringes 6 mg/0.6 mL for subcutaneous (s.c.) administration.

    Arm title
    		 Neulasta®
    Arm description
    		 Neulasta® (EU-authorized) is a colorless ready-to-use solution and was provided in prefilled syringes intended for s.c. administration in the strength of 6 mg/0.6 mL. Commercially available, EU-authorized Neulasta, was sourced by Sandoz GmbH and labelled, packaged, and supplied.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neulasta®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Neulasta® (EU-authorized) pre-filled syringes 6 mg/0.6 mL for subcutaneous (s.c.) administration.

    Number of subjects in period 1
    		LA-EP2006 Neulasta®
    Started
    159
    157
    Completed
    140
    150
    Not completed
    19
    7
         Adverse event, serious fatal
    3
    2
         Consent withdrawn by subject
    8
    2
         Physician decision
    5
    1
         Adverse event, non-fatal
    -
    2
         Other
    3
    -
    Period 2
    Period 2 title
    Safety follow up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Follow up
    Arm description
    		 Follow up, no study medication given
    Arm type
    		 Follow up no study drug given

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Follow up
    Started
    290
    Completed
    258
    Not completed
    32
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    1
         Other
    24
         Lost to follow-up
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LA-EP2006
    Reporting group description
    		 LA-EP2006 is a colorless to slightly yellowish ready-to-use solution and was provided in pre-filled syringes (PFS) intended for subcutaneous (s.c.) administration in the strength of 6 mg/0.6 mL.

    Reporting group title
    Neulasta®
    Reporting group description
    		 Neulasta® (EU-authorized) is a colorless ready-to-use solution and was provided in prefilled syringes intended for s.c. administration in the strength of 6 mg/0.6 mL. Commercially available, EU-authorized Neulasta, was sourced by Sandoz GmbH and labelled, packaged, and supplied.

    Reporting group values
    		 LA-EP2006 Neulasta® Total
    Number of subjects
    		 159 157 316
    Age categorical
    Units: Subjects
        18 - 64
    		 148 141 289
        65 - 84
    		 11 16 27
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.9 ± 9.53 50.5 ± 10.87 -
    Gender categorical
    Units: Subjects
        Female
    		 159 157 316
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients who received at least one dose of study drug. Following the intention-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at randomization.

    Subject analysis sets values
    		 FAS
    Number of subjects
    316
    Age categorical
    Units: Subjects
        18 - 64
    289
        65 - 84
    27
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    50.2 ± 10.2
    Gender categorical
    Units: Subjects
        Female
    316

    End points

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    End points reporting groups
    Reporting group title
    LA-EP2006
    Reporting group description
    		 LA-EP2006 is a colorless to slightly yellowish ready-to-use solution and was provided in pre-filled syringes (PFS) intended for subcutaneous (s.c.) administration in the strength of 6 mg/0.6 mL.

    Reporting group title
    Neulasta®
    Reporting group description
    		 Neulasta® (EU-authorized) is a colorless ready-to-use solution and was provided in prefilled syringes intended for s.c. administration in the strength of 6 mg/0.6 mL. Commercially available, EU-authorized Neulasta, was sourced by Sandoz GmbH and labelled, packaged, and supplied.
    Reporting group title
    Follow up
    Reporting group description
    		 Follow up, no study medication given

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized patients who received at least one dose of study drug. Following the intention-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at randomization.

    Primary: Duration of severe neutropenia (DSN)

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    End point title
    		 Duration of severe neutropenia (DSN)
    End point description
    DSN was calculated as the number of consecutive days from the first day when a patient’s ANC was < 0.5 × 10^9/L until the patient reached an ANC ≥ 0.5 × 10^9/L.
    End point type
    Primary
    End point timeframe
    During chemotherapy Cycle 1
    End point values
    		 LA-EP2006 Neulasta® FAS
    Number of subjects analysed
    155
    155
    310 [1]
    Units: Days
        arithmetic mean (standard deviation)
    0.75 ± 0.878
    0.83 ± 0.898
    0.79 ± 0.887
    Notes
    [1] - Number differs from patient completed due to BDRM decision (ANC not available).
    Statistical analysis title
    		 Primary Efficacy Analysis
    Comparison groups
    Neulasta® v LA-EP2006
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.26

    Secondary: Incidence of febrile neutropenia (FN)

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    End point title
    		 Incidence of febrile neutropenia (FN)
    End point description
    FN was defined as an oral temperature ≥ 38.3°C while having an ANC < 0.5 × 10^9/L.
    End point type
    Secondary
    End point timeframe
    During all chemotherapy cycles
    End point values
    		 LA-EP2006 Neulasta® FAS
    Number of subjects analysed
    159
    157
    316
    Units: Subjects
        At least one incidence
    9
    12
    21
    No statistical analyses for this end point

    Secondary: Fever episodes

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    End point title
    		 Fever episodes
    End point description
    Fever was defined as an oral temperature ≥ 38.3°C.
    End point type
    Secondary
    End point timeframe
    During all chemotherapy cycles
    End point values
    		 LA-EP2006 Neulasta® FAS
    Number of subjects analysed
    159
    157
    316
    Units: Subjects
        At lease one episode
    26
    26
    52
    No statistical analyses for this end point

    Secondary: Depth of ANC nadir

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    End point title
    		 Depth of ANC nadir
    End point description
    The depth of ANC nadir was defined as the patient’s lowest ANC (10^9/L).
    End point type
    Secondary
    End point timeframe
    During Cycle 1
    End point values
    		 LA-EP2006 Neulasta® FAS
    Number of subjects analysed
    159
    157
    316
    Units: Absolute Neutrophil Count
        arithmetic mean (standard deviation)
    1.102 ± 1.5398
    0.921 ± 1.1771
    1.012 ± 1.3719
    No statistical analyses for this end point

    Secondary: Time to ANC recovery

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    End point title
    		 Time to ANC recovery
    End point description
    Time to ANC recovery was defined as the time in days from ANC nadir until the patient’s ANC had increased to ≥ 2 × 10^9/L.
    End point type
    Secondary
    End point timeframe
    During chemotherapy Cycle 1
    End point values
    		 LA-EP2006 Neulasta® FAS
    Number of subjects analysed
    159
    157
    316
    Units: Days
        median (full range (min-max))
    2 (0 to 4)
    2 (0 to 5)
    2 (0 to 5)
    No statistical analyses for this end point

    Secondary: Frequency of infections

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    End point title
    		 Frequency of infections
    End point description
    Infections were identified by the AE documentation page selecting all events coded with SOC “Infections and Infestations”.
    End point type
    Secondary
    End point timeframe
    During all chemotherapy cycles
    End point values
    		 LA-EP2006 Neulasta® FAS
    Number of subjects analysed
    159
    157
    316
    Units: Subjects
        At least one infection
    22
    24
    46
    No statistical analyses for this end point

    Secondary: Mortality due to infection

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    End point title
    		 Mortality due to infection
    End point description
    Number of subjects who died due to infections.
    End point type
    Secondary
    End point timeframe
    During all chemotherapy cycles
    End point values
    		 LA-EP2006 Neulasta® FAS
    Number of subjects analysed
    159
    157
    316
    Units: Subjects
        Mortality due to infection
    0
    2
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    LA-EP2006
    Reporting group description
    		 -

    Reporting group title
    Neulasta®
    Reporting group description
    		 -

    Serious adverse events
    		 LA-EP2006 Neulasta®
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 159 (10.06%)
    21 / 157 (13.38%)
         number of deaths (all causes)
    4
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    9 / 159 (5.66%)
    12 / 157 (7.64%)
         occurrences causally related to treatment / all
    3 / 12
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 159 (1.89%)
    6 / 157 (3.82%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anemia
         subjects affected / exposed
    1 / 159 (0.63%)
    2 / 157 (1.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 159 (0.63%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         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
    Acute respiratory failure
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium febrile
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (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
    Myalgia
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Neutropenic sepsis
         subjects affected / exposed
    2 / 159 (1.26%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia bacterial
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Hypoglycemia
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 157 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 LA-EP2006 Neulasta®
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    140 / 159 (88.05%)
    130 / 157 (82.80%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 159 (3.77%)
    3 / 157 (1.91%)
         occurrences all number
    8
    5
    Aspartate aminotransferase increased
         subjects affected / exposed
    6 / 159 (3.77%)
    2 / 157 (1.27%)
         occurrences all number
    7
    4
    Weight decreased
         subjects affected / exposed
    3 / 159 (1.89%)
    5 / 157 (3.18%)
         occurrences all number
    3
    8
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 159 (1.26%)
    5 / 157 (3.18%)
         occurrences all number
    4
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 159 (3.14%)
    9 / 157 (5.73%)
         occurrences all number
    6
    10
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    63 / 159 (39.62%)
    56 / 157 (35.67%)
         occurrences all number
    87
    105
    Fatigue
         subjects affected / exposed
    18 / 159 (11.32%)
    21 / 157 (13.38%)
         occurrences all number
    52
    51
    Pyrexia
         subjects affected / exposed
    9 / 159 (5.66%)
    12 / 157 (7.64%)
         occurrences all number
    16
    17
    Pain
         subjects affected / exposed
    7 / 159 (4.40%)
    10 / 157 (6.37%)
         occurrences all number
    11
    13
    Edema peripheral
         subjects affected / exposed
    10 / 159 (6.29%)
    5 / 157 (3.18%)
         occurrences all number
    12
    6
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    25 / 159 (15.72%)
    30 / 157 (19.11%)
         occurrences all number
    38
    43
    Anaemia
         subjects affected / exposed
    16 / 159 (10.06%)
    17 / 157 (10.83%)
         occurrences all number
    32
    26
    Leukopenia
         subjects affected / exposed
    11 / 159 (6.92%)
    12 / 157 (7.64%)
         occurrences all number
    14
    17
    Thrombocytopenia
         subjects affected / exposed
    11 / 159 (6.92%)
    10 / 157 (6.37%)
         occurrences all number
    26
    10
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    64 / 159 (40.25%)
    58 / 157 (36.94%)
         occurrences all number
    151
    153
    Vomiting
         subjects affected / exposed
    34 / 159 (21.38%)
    32 / 157 (20.38%)
         occurrences all number
    52
    47
    Diarrhoea
         subjects affected / exposed
    23 / 159 (14.47%)
    31 / 157 (19.75%)
         occurrences all number
    37
    52
    Stomatitis
         subjects affected / exposed
    8 / 159 (5.03%)
    13 / 157 (8.28%)
         occurrences all number
    18
    23
    Constipation
         subjects affected / exposed
    10 / 159 (6.29%)
    9 / 157 (5.73%)
         occurrences all number
    12
    11
    Abdominal pain
         subjects affected / exposed
    8 / 159 (5.03%)
    7 / 157 (4.46%)
         occurrences all number
    14
    15
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 159 (2.52%)
    6 / 157 (3.82%)
         occurrences all number
    4
    7
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    82 / 159 (51.57%)
    79 / 157 (50.32%)
         occurrences all number
    88
    90
    Erythema
         subjects affected / exposed
    14 / 159 (8.81%)
    16 / 157 (10.19%)
         occurrences all number
    65
    68
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 159 (6.29%)
    13 / 157 (8.28%)
         occurrences all number
    24
    31
    Myalgia
         subjects affected / exposed
    8 / 159 (5.03%)
    13 / 157 (8.28%)
         occurrences all number
    15
    33
    Bone pain
         subjects affected / exposed
    7 / 159 (4.40%)
    8 / 157 (5.10%)
         occurrences all number
    9
    18
    Pain in extremity
         subjects affected / exposed
    6 / 159 (3.77%)
    6 / 157 (3.82%)
         occurrences all number
    9
    9
    Back pain
         subjects affected / exposed
    1 / 159 (0.63%)
    5 / 157 (3.18%)
         occurrences all number
    1
    8
    Infections and infestations
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 159 (1.89%)
    9 / 157 (5.73%)
         occurrences all number
    3
    10
    Respiratory tract infection
         subjects affected / exposed
    5 / 159 (3.14%)
    2 / 157 (1.27%)
         occurrences all number
    6
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    7 / 159 (4.40%)
    16 / 157 (10.19%)
         occurrences all number
    15
    19
    Hyperglycaemia
         subjects affected / exposed
    3 / 159 (1.89%)
    8 / 157 (5.10%)
         occurrences all number
    3
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Sep 2012
    Amendment 1 introduced the following changes: • Extension of patients’ maximum screening period from 15 to 21 days • Implementation of patients’ re-screening procedures • Changes to the wording of inclusion criterion 11 and exclusion criteria 4 and 12 • Addition of serum sample collection at the safety follow-up visit • Addition of protocol specific SAE documentation requirements • Administrative corrections/ corrections of typing errors The informed consent was updated to reflect the amendment.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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