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    Clinical Trial Results:
    A Phase III, Randomized, Multi-Centre, Open-Label, Fixed Dose, Neulasta Active-Controlled Clinical Trial of F-627 in Women with Breast Cancer Receiving Myelotoxic Chemotherapy

    Summary
    EudraCT number
    		 2016-003553-15
    Trial protocol
    		 LV   HU   BG  
    Global end of trial date
    18 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2024
    First version publication date
    16 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GC-627-05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03252431
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Evive Biotechnology (Shanghai) Ltd
    Sponsor organisation address
    Building 2-B, 797 Puxing HWY, Shanghai, China, 201114
    Public contact
    GCR, Evive Biotechnology (Shanghai) Ltd, prr@evivebiotech.com
    Scientific contact
    GCR, Evive Biotechnology (Shanghai) Ltd, prr@evivebiotech.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
    18 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of F-627 given as a single fixed dose (20 mg) pre-filled syringe as compared to Neulasta® standard dosing (6 mg) in the first chemotherapy cycle.
    Protection of trial subjects
    This study was conducted in accordance with ICH GCP regulations/guidelines. The protocol, informed consent form and other subject information were approved by the Independent Ethics Committer / Institutional Review Board.
    Background therapy
    		 75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide
    Evidence for comparator
    		 Neulasta® standard dosing (6 mg)
    Actual start date of recruitment
    12 Apr 2018
    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?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 145
    Country: Number of subjects enrolled
    Ukraine: 166
    Country: Number of subjects enrolled
    United States: 1
    Country: Number of subjects enrolled
    Bulgaria: 36
    Country: Number of subjects enrolled
    Hungary: 45
    Worldwide total number of subjects
    393
    EEA total number of subjects
    81
    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)
    332
    From 65 to 84 years
    61
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted between 12 Apr 2018 and 05 Mar 2020 at 41 study sites across five countries, including Bulgaria, Hungary, Russia, Ukraine, and the United States.

    Pre-assignment
    Screening details
    		 A total of 416 subjects were screened and 393 were randomized to the study (197 randomized to F-627 and 196 randomized to Neulasta®). Overall, 373 (94.9%) subjects completed the treatment program, and 363 subjects (92.4%) who completed the 6 month follow-up.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 F-627
    Arm description
    		 F-627, 20mg fixed dose prefilled syringe, dosed on Day 2 of each of 4 chemotherapy cycles
    Arm type
    		 Experimental

    Investigational medicinal product name
    efbemalenograstim alfa
    Investigational medicinal product code
    L03AA18
    Other name
    Ryzneuta, F-627
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Solution for injection , Subcutaneous use
    Dosage and administration details
    F-627, prefilled syringe administered on Day 2 of each of the 4 chemotherapy cycles

    Arm title
    		 Neulasta
    Arm description
    		 Neulasta, 6mg fixed dose prefilled syringe, dosed on Day 2 of each of the 4 chemotherapy cycles
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neulasta (pegfilgrastim)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use, Solution for injection
    Dosage and administration details
    Neulasta, 6mg fixed dose prefilled syringe, dosed by subcutaneous injection on Day 2 of each of the 4 chemotherapy cycles

    Number of subjects in period 1
    		F-627 Neulasta
    Started
    197
    196
    Completed
    186
    187
    Not completed
    11
    9
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    2
    1
         Physician decision
    2
    2
         Adverse event, non-fatal
    5
    5
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    F-627
    Reporting group description
    		 F-627, 20mg fixed dose prefilled syringe, dosed on Day 2 of each of 4 chemotherapy cycles

    Reporting group title
    Neulasta
    Reporting group description
    		 Neulasta, 6mg fixed dose prefilled syringe, dosed on Day 2 of each of the 4 chemotherapy cycles

    Reporting group values
    		 F-627 Neulasta Total
    Number of subjects
    		 197 196 393
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 171 161 332
        From 65-84 years
    		 26 35 61
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.4 ± 11.82 53.4 ± 11.11 -
    Gender categorical
    Units: Subjects
        Female
    		 197 196 393
        Male
    		 0 0 0
    Race
    Units: Subjects
        White
    		 197 196 393
        Black or African American
    		 0 0 0
        Asian
    		 0 0 0
        American Indian or Alaska Native
    		 0 0 0
        Native Hawaiian or other Pacific Islander
    		 0 0 0
        Other
    		 0 0 0
    Reproductive Status
    Units: Subjects
        Childbearing potential
    		 86 70 156
        Post-menopausal
    		 100 116 216
        Surgically sterile
    		 11 10 21
    Baseline ECOG performance Status
    Units: Subjects
        EOCG 0
    		 153 146 299
        EOCG 1
    		 44 50 94
        EOCG 2
    		 0 0 0
        EOCG 3
    		 0 0 0
        EOCG 4
    		 0 0 0
        EOCG 5
    		 0 0 0
    Weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 75.84 ± 16.88 74.93 ± 16.87 -
    BMI
    Units: Weight(kg) / [Height(m)^2]
        arithmetic mean (standard deviation)
    		 28.72 ± 6.36 28.51 ± 6.20 -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 162.6 ± 6.27 162.2 ± 6.67 -
    BSA
    Units: [Height(cm) X Weight(kg)] / 3600]^1/2
        arithmetic mean (standard deviation)
    		 1.84 ± 0.21 1.83 ± 0.21 -
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat analysis set (ITT) included all randomized subjects

    Subject analysis sets values
    		 ITT
    Number of subjects
    393
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    332
        From 65-84 years
    61
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.4 ± 11.50
    Gender categorical
    Units: Subjects
        Female
    393
        Male
    0
    Race
    Units: Subjects
        White
    393
        Black or African American
    0
        Asian
    0
        American Indian or Alaska Native
    0
        Native Hawaiian or other Pacific Islander
    0
        Other
    0
    Reproductive Status
    Units: Subjects
        Childbearing potential
    156
        Post-menopausal
    216
        Surgically sterile
    21
    Baseline ECOG performance Status
    Units: Subjects
        EOCG 0
    299
        EOCG 1
    94
        EOCG 2
    0
        EOCG 3
    0
        EOCG 4
    0
        EOCG 5
    0
    Weight
    Units: Kg
        arithmetic mean (standard deviation)
    75.39 ± 16.86
    BMI
    Units: Weight(kg) / [Height(m)^2]
        arithmetic mean (standard deviation)
    28.62 ± 6.27
    Height
    Units: cm
        arithmetic mean (standard deviation)
    162.4 ± 6.47
    BSA
    Units: [Height(cm) X Weight(kg)] / 3600]^1/2
        arithmetic mean (standard deviation)
    1.83 ± 0.21

    End points

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    End points reporting groups
    Reporting group title
    F-627
    Reporting group description
    		 F-627, 20mg fixed dose prefilled syringe, dosed on Day 2 of each of 4 chemotherapy cycles

    Reporting group title
    Neulasta
    Reporting group description
    		 Neulasta, 6mg fixed dose prefilled syringe, dosed on Day 2 of each of the 4 chemotherapy cycles

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-treat analysis set (ITT) included all randomized subjects

    Primary: Duration of severe neutropenia (DSN) in Cycle 1

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    End point title
    		 Duration of severe neutropenia (DSN) in Cycle 1
    End point description
    End point type
    Primary
    End point timeframe
    Chemotherapy cycle 1
    End point values
    		 F-627 Neulasta
    Number of subjects analysed
    197
    196
    Units: days
        arithmetic mean (standard deviation)
    0.2 ± 0.51
    0.2 ± 0.45
    Statistical analysis title
    		 FAS
    Comparison groups
    F-627 v Neulasta
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7074 [1]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - p-value was for the testing of mean (F-627) = mean (Neulasta®)

    Secondary: Number of Days of Intravenous Antibiotic Use

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    End point title
    		 Number of Days of Intravenous Antibiotic Use
    End point description
    End point type
    Secondary
    End point timeframe
    Across all 4 chemotherapy cycles
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    197
    196
    393
    Units: Days
        arithmetic mean (standard deviation)
    0.3 ± 1.36
    0.1 ± 0.70
    0.2 ± 1.09
    Statistical analysis title
    		 FAS
    Comparison groups
    F-627 v Neulasta
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0538 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - p-value was based on the two-sided exact test from a Wilcoxon Rank Sum test

    Secondary: Number of Days of Hospitalization for Infection

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    End point title
    		 Number of Days of Hospitalization for Infection
    End point description
    End point type
    Secondary
    End point timeframe
    Across all 4 chemotherapy cycles
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    197
    196
    393
    Units: Days
        arithmetic mean (standard deviation)
    0.1 ± 0.78
    0.0 ± 0.57
    0.0 ± 0.69
    Statistical analysis title
    		 FAS
    Comparison groups
    F-627 v Neulasta
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [3]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - p-value was based on the two-sided exact test from a Wilcoxon Rank Sum test

    Secondary: Incidence of Febrile Neutropenia

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    End point title
    		 Incidence of Febrile Neutropenia
    End point description
    End point type
    Secondary
    End point timeframe
    Across all 4 chemotherapy cycles
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    197
    196
    393
    Units: event
    6
    1
    7
    Statistical analysis title
    		 FAS
    Comparison groups
    F-627 v Neulasta
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1217 [4]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [4] - p-value was for the proportion difference between F-627and Neulasta® using Fisher’s Exact Test

    Secondary: Incidence of Severe Neutropenia for Chemotherapy Cycle 1

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    End point title
    		 Incidence of Severe Neutropenia for Chemotherapy Cycle 1
    End point description
    End point type
    Secondary
    End point timeframe
    Chemotherapy cycle 1
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    197
    196
    393
    Units: event
    23
    23
    46
    Statistical analysis title
    		 FAS
    Comparison groups
    F-627 v Neulasta
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9853 [5]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [5] - p-value was for the proportion difference between F-627 and Neulasta® using Chi-Square Test

    Secondary: Incidence of Use of Intravenous Antibiotics

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    End point title
    		 Incidence of Use of Intravenous Antibiotics
    End point description
    End point type
    Secondary
    End point timeframe
    Across all 4 chemotherapy cycles
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    197
    196
    393
    Units: event
    9
    2
    11
    Statistical analysis title
    		 FAS
    Comparison groups
    F-627 v Neulasta
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0618 [6]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [6] - p-value was for the proportion difference between F-627 and Neulasta® using Fisher’s Exact Test

    Secondary: Incidence of Hospitalization for Infection

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    End point title
    		 Incidence of Hospitalization for Infection
    End point description
    End point type
    Secondary
    End point timeframe
    Across all 4 chemotherapy cycles
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    197
    196
    393
    Units: event
    1
    1
    2
    Statistical analysis title
    		 FAS
    Comparison groups
    F-627 v Neulasta
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [7]
    Method
    		 Fisher exact
    Confidence interval
    Notes
    [7] - p-value was for the proportion difference between F-627 and Neulasta® using Fisher’s Exact Test

    Other pre-specified: Incidence of Severe Neutropenia in Cycle 3

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    End point title
    		 Incidence of Severe Neutropenia in Cycle 3
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Chemotherapy Cycle 3
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    193
    191
    384
    Units: Event
        Severe Neutropenia
    5
    12
    17
    No statistical analyses for this end point

    Other pre-specified: Incidence of Severe Neutropenia in Cycle 4

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    End point title
    		 Incidence of Severe Neutropenia in Cycle 4
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Cycle 4
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    186
    188
    374
    Units: event
        Severe Neutropenia
    3
    10
    13
    No statistical analyses for this end point

    Other pre-specified: Incidence of Severe Neutropenia in Cycle 2

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    End point title
    		 Incidence of Severe Neutropenia in Cycle 2
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Cycle 2
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    194
    196
    390
    Units: event
        Severe Neutropenia
    9
    10
    19
    No statistical analyses for this end point

    Post-hoc: Incidence of Protocol-defined Febrile Neutropenia

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    End point title
    		 Incidence of Protocol-defined Febrile Neutropenia
    End point description
    End point type
    Post-hoc
    End point timeframe
    All cycles
    End point values
    		 F-627 Neulasta ITT
    Number of subjects analysed
    197
    196
    393
    Units: events
        Febrile Neutropenia
    3
    1
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 12 weeks (4 treatment cycles)
    Adverse event reporting additional description
    All subjects who received at least 1 dose of F-627 or Neulasta were included in the safety analysis set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    F-627
    Reporting group description
    		 F-627, 20mg fixed dose prefilled syringe, dosed on Day 2 of each of 4 chemotherapy cycles

    Reporting group title
    Neulasta
    Reporting group description
    		 Neulasta, 6mg fixed dose prefilled syringe, dosed on Day 2 of each of the 4 chemotherapy cycles

    Serious adverse events
    		 F-627 Neulasta
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 197 (6.09%)
    5 / 196 (2.55%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 197 (0.51%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 197 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 197 (0.51%)
    0 / 196 (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
    2 / 197 (1.02%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anemia
         subjects affected / exposed
    0 / 197 (0.00%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 197 (0.00%)
    1 / 196 (0.51%)
         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
    Fatigue
         subjects affected / exposed
    1 / 197 (0.51%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis toxic
         subjects affected / exposed
    0 / 197 (0.00%)
    1 / 196 (0.51%)
         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
    Pulmonary embolism
         subjects affected / exposed
    1 / 197 (0.51%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 197 (0.51%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 197 (0.51%)
    0 / 196 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 197 (0.51%)
    0 / 196 (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
    Pneumonia
         subjects affected / exposed
    2 / 197 (1.02%)
    1 / 196 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 197 (0.51%)
    0 / 196 (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: 5%
    Non-serious adverse events
    		 F-627 Neulasta
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    178 / 197 (90.36%)
    169 / 196 (86.22%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    19 / 197 (9.64%)
    13 / 196 (6.63%)
         occurrences all number
    22
    13
    Neutrophil count decreased
         subjects affected / exposed
    15 / 197 (7.61%)
    6 / 196 (3.06%)
         occurrences all number
    23
    9
    Aspartate aminotransferase increased
         subjects affected / exposed
    11 / 197 (5.58%)
    10 / 196 (5.10%)
         occurrences all number
    14
    10
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 197 (9.14%)
    10 / 196 (5.10%)
         occurrences all number
    23
    12
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    40 / 197 (20.30%)
    50 / 196 (25.51%)
         occurrences all number
    87
    110
    Anaemia
         subjects affected / exposed
    47 / 197 (23.86%)
    38 / 196 (19.39%)
         occurrences all number
    75
    73
    Leukopenia
         subjects affected / exposed
    39 / 197 (19.80%)
    44 / 196 (22.45%)
         occurrences all number
    98
    104
    Thrombocytopenia
         subjects affected / exposed
    20 / 197 (10.15%)
    20 / 196 (10.20%)
         occurrences all number
    39
    39
    Leukocytosis
         subjects affected / exposed
    14 / 197 (7.11%)
    10 / 196 (5.10%)
         occurrences all number
    59
    41
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    58 / 197 (29.44%)
    46 / 196 (23.47%)
         occurrences all number
    153
    132
    Fatigue
         subjects affected / exposed
    24 / 197 (12.18%)
    17 / 196 (8.67%)
         occurrences all number
    53
    28
    Pyrexia
         subjects affected / exposed
    18 / 197 (9.14%)
    9 / 196 (4.59%)
         occurrences all number
    25
    14
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    71 / 197 (36.04%)
    58 / 196 (29.59%)
         occurrences all number
    143
    115
    Diarrhoea
         subjects affected / exposed
    32 / 197 (16.24%)
    27 / 196 (13.78%)
         occurrences all number
    48
    37
    Stomatitis
         subjects affected / exposed
    13 / 197 (6.60%)
    12 / 196 (6.12%)
         occurrences all number
    26
    23
    Vomiting
         subjects affected / exposed
    12 / 197 (6.09%)
    7 / 196 (3.57%)
         occurrences all number
    14
    10
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    103 / 197 (52.28%)
    100 / 196 (51.02%)
         occurrences all number
    108
    101
    Erythema
         subjects affected / exposed
    17 / 197 (8.63%)
    17 / 196 (8.67%)
         occurrences all number
    35
    40
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    41 / 197 (20.81%)
    34 / 196 (17.35%)
         occurrences all number
    77
    63
    Arthralgia
         subjects affected / exposed
    30 / 197 (15.23%)
    22 / 196 (11.22%)
         occurrences all number
    70
    46
    Myalgia
         subjects affected / exposed
    21 / 197 (10.66%)
    18 / 196 (9.18%)
         occurrences all number
    31
    29
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    11 / 197 (5.58%)
    7 / 196 (3.57%)
         occurrences all number
    13
    11

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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