Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)

    Summary
    EudraCT number
    		 2016-003469-24
    Trial protocol
    		 HU  
    Global end of trial date
    06 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2022
    First version publication date
    06 Feb 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SPI-GCF-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02953340
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Spectrum Pharmaceuticals, Inc
    Sponsor organisation address
    Research and Development Office, 157 Technology Dr W, Irvine, California, United States, 92618
    Public contact
    Shanta Chawla, Spectrum Pharmaceuticals, Inc., +1 (949) 788-6700, shanta.chawla@sppirx.com
    Scientific contact
    Shanta Chawla, Spectrum Pharmaceuticals, Inc., +1 (949) 788-6700, shanta.chawla@sppirx.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
    06 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to prevent and reduce neutropenia that is associated with cancer chemotherapy.
    Protection of trial subjects
    This study was conducted in accordance with good clinical practice (GCP) and with the internal standard operating procedures (SOPs) of Spectrum Pharmaceuticals, Inc. A study-specific written informed consent was signed by each subject prior to any study-related assessments or procedures that were conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 May 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 24
    Country: Number of subjects enrolled
    Hungary: 47
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    India: 8
    Country: Number of subjects enrolled
    United States: 131
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 22
    Worldwide total number of subjects
    237
    EEA total number of subjects
    71
    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)
    153
    From 65 to 84 years
    83
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was conducted at 74 sites in the United States, Canada, Hungary, Poland, India, Korea from 10 May 2017 to 06 May 2019. The study was conducted in two periods: treatment period (first dose of TC until 35 (± 5) days after last dose of treatment) and safety follow-up period (End of Treatment Visit through 12 months after last dose of study)

    Pre-assignment
    Screening details
    		 A total of 237 participants were randomized into study, 118 participants in Arm 1 (SPI-2012 and TC)and 119 participants in Arm 2 (Pegfilgrastim and TC). 235 participants were treated, out of which 181 participants completed the study. All participants who received at least one dose of drug (treatment period) entered the safety follow-up period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC)
    Arm description
    		 At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 millilitre (mL), [3.6 mg granulocyte colony-stimulating factor {G-CSF} ] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SPI-2012
    Investigational medicinal product code
    Other name
    Eflapegrastim, HM10460A, Rolontis, LAPS-G-CSF
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SPI-2012 13.2 mg administered SC once per cycle on Day 2.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 75mg/m^2 IV infusion administered on Day 1 of each cycle.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Cytoxan
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cyclophosphamide 600 mg/m^2 IV infusion administered on Day 1 of each cycle.

    Arm title
    		 (Arm 2): Pegfilgrastim and TC
    Arm description
    		 At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pegfilgrastim
    Investigational medicinal product code
    Other name
    Neulasta
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pegfilgrastim 6 mg administered SC once per cycle on Day 2.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Taxotere
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 75mg/m^2 IV infusion administered on Day 1 of each cycle.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Cytoxan
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cyclophosphamide 600 mg/m^2 IV infusion administered on Day 1 of each cycle.

    Number of subjects in period 1
    		(Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Started
    118
    119
    Entered Follow-up Period
    118
    119
    Completed
    96
    85
    Not completed
    22
    34
         Consent withdrawn by subject
    9
    9
         Death
    -
    1
         Initiated Non-Protocol Therapy
    5
    14
         Investigator Decision
    3
    3
         Reason not specified
    2
    2
         Lost to follow-up
    3
    2
         Myeloid Growth Factors Treatment
    -
    1
         Sponsor decision
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    (Arm 1): SPI-2012 and Cyclophosphamide (TC)
    Reporting group description
    		 At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 millilitre (mL), [3.6 mg granulocyte colony-stimulating factor {G-CSF} ] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

    Reporting group title
    (Arm 2): Pegfilgrastim and TC
    Reporting group description
    		 At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

    Reporting group values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC Total
    Number of subjects
    		 118 119 237
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.9 ( 11.27 ) 58.1 ( 12.67 ) -
    Gender categorical
    Units: Subjects
        Female
    		 118 119 237
        Male
    		 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 18 15 33
        Not Hispanic or Latino
    		 100 104 204
        Unknown or Not Reported
    		 0 0 0
    Race
    Units: Subjects
        Black or African American
    		 11 7 18
        Asian
    		 20 16 36
        American Indian or Alaska Native
    		 1 0 1
        Other
    		 1 0 1
        White or Caucasian
    		 85 96 181

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    (Arm 1): SPI-2012 and Cyclophosphamide (TC)
    Reporting group description
    		 At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 millilitre (mL), [3.6 mg granulocyte colony-stimulating factor {G-CSF} ] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

    Reporting group title
    (Arm 2): Pegfilgrastim and TC
    Reporting group description
    		 At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.

    Subject analysis set title
    Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Treatment Period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg / 0.6 mL, [3.6 mg G-CSF] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.

    Subject analysis set title
    Arm 2: Pegfilgrastim 6 mg and TC: Treatment Period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.

    Subject analysis set title
    Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Follow-up Period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.

    Subject analysis set title
    Arm 2: Pegfilgrastim 6 mg and TC: Follow-up Period
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.

    Primary: Duration of Severe Neutropenia (DSN) in Cycle 1

    		 Close Top of page
    End point title
    		 Duration of Severe Neutropenia (DSN) in Cycle 1
    End point description
    DSN was defined as the number of days of severe neutropenia (absolute neutrophil count [ANC] <0.5×10^9 per liter [L]) from the first occurrence of ANC below the threshold. Intent-to-treat (ITT) population included all subjects who were randomized.
    End point type
    Primary
    End point timeframe
    Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
    End point values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Number of subjects analysed
    118
    119
    Units: Days
        arithmetic mean (standard deviation)
    0.31 ( 0.688 )
    0.39 ( 0.949 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    (Arm 1): SPI-2012 and Cyclophosphamide (TC) v (Arm 2): Pegfilgrastim and TC
    Number of subjects included in analysis
    237
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.0001 [2]
    Method
    		 t-statistics
    Parameter type
    		 Mean difference
    Point estimate
    -0.074
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.292
         upper limit
    		 0.129
    Notes
    [1] - The study used non inferiority margin of 0.62 days for the above comparison. The non-inferiority of SPI-2012 to Pegfilgrastim was declared if the upper bound of 95% CI of the difference in mean DSN between the treatment arms was <0.62 days.
    [2] - The p-values are based on the calculated t-statistics from the bootstrapped sample mean and standard deviation.

    Secondary: Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1

    		 Close Top of page
    End point title
    		 Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
    End point description
    Time to ANC recovery was defined as the time from chemotherapy administration until the subject’s ANC increased to ≥1.5×10^9/L after the expected nadir. For subjects with ANC value ≥1.5×10^9/L at all times, time to ANC Recovery was assigned a value of 0. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
    End point values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Number of subjects analysed
    118
    119
    Units: Days
        arithmetic mean (standard deviation)
    3.49 ( 3.723 )
    3.35 ( 3.745 )
    No statistical analyses for this end point

    Secondary: Depth of ANC Nadir in Cycle 1

    		 Close Top of page
    End point title
    		 Depth of ANC Nadir in Cycle 1
    End point description
    The depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or pegfilgrastim) in Cycle 1. ITT population included all subjects who were randomized. Here ‘N’ (number of subjects analysed) signifies the number of subjects evaluable for this endpoint at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
    End point values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Number of subjects analysed
    115
    116
    Units: x10^9/L
        arithmetic mean (standard deviation)
    2.67 ( 3.504 )
    2.06 ( 2.034 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Febrile Neutropenia (FN) in Cycle 1

    		 Close Top of page
    End point title
    		 Number of Subjects with Febrile Neutropenia (FN) in Cycle 1
    End point description
    FN was defined as an oral temperature >38.3 degree Celsius (°C) (101.0 degrees Fahrenheit [°F]) or two consecutive readings of >38.0°C (100.4°F) for 2 hours and ANC <1.0×10^9/L. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
    End point values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Number of subjects analysed
    118
    119
    Units: Subjects
    1
    4
    No statistical analyses for this end point

    Secondary: Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4

    		 Close Top of page
    End point title
    		 Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
    End point description
    DSN was defined as the number of days of severe neutropenia (ANC <0.5×10^9/L) from the first occurrence of ANC below the threshold. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
    End point values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Number of subjects analysed
    118
    119
    Units: Days
    arithmetic mean (standard deviation)
        Cycle 2
    0.08 ( 0.267 )
    0.09 ( 0.432 )
        Cycle 3
    0.07 ( 0.252 )
    0.07 ( 0.283 )
        Cycle 4
    0.07 ( 0.252 )
    0.08 ( 0.266 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Neutropenic Complications in Cycle 1

    		 Close Top of page
    End point title
    		 Number of Subjects with Neutropenic Complications in Cycle 1
    End point description
    Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
    End point values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Number of subjects analysed
    118
    119
    Units: Subjects
    1
    5
    No statistical analyses for this end point

    Secondary: Number of Subjects with Febrile Neutropenia in Cycles 2, 3 and 4

    		 Close Top of page
    End point title
    		 Number of Subjects with Febrile Neutropenia in Cycles 2, 3 and 4
    End point description
    FN was defined as an oral temperature >38.3°C (101.0°F) or two consecutive readings of >38.0°C (100.4°F) for 2 hours and ANC <1.0×10^9/L. ITT population included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
    End point values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Number of subjects analysed
    118
    119
    Units: Subjects
        Cycle 2
    0
    2
        Cycle 3
    0
    0
        Cycle 4
    0
    0
    No statistical analyses for this end point

    Secondary: Relative Dose Intensity (RDI) of TC Chemotherapy

    		 Close Top of page
    End point title
    		 Relative Dose Intensity (RDI) of TC Chemotherapy
    End point description
    RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles. Safety analysis (SAF) population included all subjects who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim).
    End point type
    Secondary
    End point timeframe
    Cycles 1, 2, 3 and 4 (each cycle = 21 days)
    End point values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Number of subjects analysed
    117
    118
    Units: Percentage of planned dose
    arithmetic mean (standard deviation)
        Docetaxel
    96.9 ( 7.70 )
    98.4 ( 7.89 )
        Cyclophosphamide
    98.4 ( 5.27 )
    98.8 ( 6.40 )
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death

    		 Close Top of page
    End point title
    		 Number of Subjects with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events. SAF population included all subjects who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Data was summarized and reported for Treatment and Follow-up period separately for both groups.
    End point type
    Secondary
    End point timeframe
    Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
    End point values
    		 Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Treatment Period Arm 2: Pegfilgrastim 6 mg and TC: Treatment Period Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Follow-up Period Arm 2: Pegfilgrastim 6 mg and TC: Follow-up Period
    Number of subjects analysed
    117
    118
    117
    118
    Units: Subjects
        TEAEs
    115
    116
    33
    48
        SAEs
    12
    19
    2
    4
        Death
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Laboratory Abnormalities

    		 Close Top of page
    End point title
    		 Number of Subjects with Clinically Significant Laboratory Abnormalities
    End point description
    The number of subjects with clinically significant hematology (including basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils, neutrophils/leukocytes, platelets, and white blood cells) and serum chemistry (including alanine aminotransferase [ALT], alkaline phosphatase [ALP], aspartate aminotransferase [AST], bilirubin, calcium, cholesterol, creatinine, potassium, sodium, and triglycerides) laboratory abnormalities were reported. SAF population included all subjects who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim).
    End point type
    Secondary
    End point timeframe
    Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
    End point values
    		 (Arm 1): SPI-2012 and Cyclophosphamide (TC) (Arm 2): Pegfilgrastim and TC
    Number of subjects analysed
    117
    118
    Units: Subjects
        Hematology: Basophils
    0
    0
        Hematology: Basophils/Leukocytes
    0
    0
        Hematology: Eosinophils
    0
    0
        Hematology: Eosinophils/Leukocytes
    0
    0
        Hematology: Hematocrit
    4
    2
        Hematology: Hemoglobin
    6
    4
        Hematology: Lymphocytes
    0
    0
        Hematology: Lymphocytes/Leukocytes
    6
    13
        Hematology: Monocytes
    0
    0
        Hematology: Monocytes/Leukocytes
    0
    0
        Hematology: Neutrophils
    17
    23
        Hematology: Neutrophils/Leukocytes
    12
    9
        Hematology: Platelets
    10
    2
        Hematology: White Blood Cells
    16
    18
        Chemistry: ALT
    2
    1
        Chemistry: ALP
    0
    1
        Chemistry: AST
    1
    1
        Chemistry: Bilirubin
    0
    0
        Chemistry: Calcium
    1
    1
        Chemistry: Cholesterol
    0
    0
        Chemistry: Creatinine
    0
    0
        Chemistry: Potassium
    0
    1
        Chemistry: Sodium
    0
    2
        Chemistry: Triglycerides
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
    Adverse event reporting additional description
    The Safety Analysis Population included all participants who received at least one dose of any protocol-specified drug (TC or SPI-2012 or pegfilgrastim). Adverse events data was summarized and reported for Treatment and Follow-up period separately for both groups.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Treatment Period
    Reporting group description
    		 At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 mg / 0.6 mL, [3.6 mg G-CSF] SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.

    Reporting group title
    Arm 2: Pegfilgrastim 6 mg and TC: Treatment Period
    Reporting group description
    		 At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m^2 and cyclophosphamide 600 mg/m^2 IV infusion per institute’s standard of care. All participants were followed for 35 (±5) days after the last study treatment or patient discontinuation.

    Reporting group title
    Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Follow-up Period
    Reporting group description
    		 In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.

    Reporting group title
    Arm 2: Pegfilgrastim 6 mg and TC: Follow-up Period
    Reporting group description
    		 In addition to the treatment period, long-term safety follow-up continued for 12 months after last study treatment.

    Serious adverse events
    		 Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Treatment Period Arm 2: Pegfilgrastim 6 mg and TC: Treatment Period Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Follow-up Period Arm 2: Pegfilgrastim 6 mg and TC: Follow-up Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 117 (10.26%)
    19 / 118 (16.10%)
    2 / 117 (1.71%)
    4 / 118 (3.39%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    1
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Administration site reaction
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 117 (0.00%)
    2 / 118 (1.69%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 117 (1.71%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 118 (0.00%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 118 (0.00%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 117 (0.00%)
    2 / 118 (1.69%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 117 (0.00%)
    3 / 118 (2.54%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin disorder
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest wall abscess
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 117 (0.00%)
    2 / 118 (1.69%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 117 (0.85%)
    0 / 118 (0.00%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 117 (0.85%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    0 / 117 (0.00%)
    1 / 118 (0.85%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Treatment Period Arm 2: Pegfilgrastim 6 mg and TC: Treatment Period Arm 1: SPI-2012 13.2 mg/0.6 mL and TC: Follow-up Period Arm 2: Pegfilgrastim 6 mg and TC: Follow-up Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    115 / 117 (98.29%)
    116 / 118 (98.31%)
    33 / 117 (28.21%)
    48 / 118 (40.68%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    9 / 117 (7.69%)
    10 / 118 (8.47%)
    0 / 117 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    12
    12
    0
    2
    Hot flush
         subjects affected / exposed
    10 / 117 (8.55%)
    8 / 118 (6.78%)
    1 / 117 (0.85%)
    3 / 118 (2.54%)
         occurrences all number
    10
    8
    1
    3
    Hypertension
         subjects affected / exposed
    4 / 117 (3.42%)
    8 / 118 (6.78%)
    1 / 117 (0.85%)
    3 / 118 (2.54%)
         occurrences all number
    13
    17
    1
    4
    Hypotension
         subjects affected / exposed
    6 / 117 (5.13%)
    3 / 118 (2.54%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    6
    2
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    40 / 117 (34.19%)
    51 / 118 (43.22%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    59
    72
    0
    0
    Pyrexia
         subjects affected / exposed
    25 / 117 (21.37%)
    26 / 118 (22.03%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences all number
    41
    43
    1
    0
    Oedema peripheral
         subjects affected / exposed
    12 / 117 (10.26%)
    15 / 118 (12.71%)
    2 / 117 (1.71%)
    2 / 118 (1.69%)
         occurrences all number
    18
    21
    3
    2
    Asthenia
         subjects affected / exposed
    15 / 117 (12.82%)
    11 / 118 (9.32%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    18
    16
    0
    0
    Pain
         subjects affected / exposed
    5 / 117 (4.27%)
    11 / 118 (9.32%)
    0 / 117 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    5
    12
    0
    1
    Chills
         subjects affected / exposed
    4 / 117 (3.42%)
    6 / 118 (5.08%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    5
    9
    0
    1
    Malaise
         subjects affected / exposed
    3 / 117 (2.56%)
    6 / 118 (5.08%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    4
    11
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    8 / 117 (6.84%)
    17 / 118 (14.41%)
    2 / 117 (1.71%)
    0 / 118 (0.00%)
         occurrences all number
    12
    21
    3
    0
    Cough
         subjects affected / exposed
    8 / 117 (6.84%)
    14 / 118 (11.86%)
    1 / 117 (0.85%)
    1 / 118 (0.85%)
         occurrences all number
    9
    18
    2
    1
    Oropharyngeal pain
         subjects affected / exposed
    9 / 117 (7.69%)
    10 / 118 (8.47%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    9
    12
    0
    0
    Epistaxis
         subjects affected / exposed
    4 / 117 (3.42%)
    7 / 118 (5.93%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    7
    9
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    18 / 117 (15.38%)
    11 / 118 (9.32%)
    1 / 117 (0.85%)
    1 / 118 (0.85%)
         occurrences all number
    22
    11
    1
    1
    Anxiety
         subjects affected / exposed
    5 / 117 (4.27%)
    8 / 118 (6.78%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    5
    8
    0
    0
    Investigations
    Lymphocyte count decreased
         subjects affected / exposed
    44 / 117 (37.61%)
    54 / 118 (45.76%)
    0 / 117 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    69
    109
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    22 / 117 (18.80%)
    31 / 118 (26.27%)
    1 / 117 (0.85%)
    2 / 118 (1.69%)
         occurrences all number
    30
    59
    2
    2
    Neutrophil count decreased
         subjects affected / exposed
    16 / 117 (13.68%)
    22 / 118 (18.64%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences all number
    30
    49
    1
    0
    Platelet count decreased
         subjects affected / exposed
    12 / 117 (10.26%)
    3 / 118 (2.54%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    17
    4
    0
    0
    White blood cell count increased
         subjects affected / exposed
    9 / 117 (7.69%)
    3 / 118 (2.54%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    11
    4
    0
    0
    Injury, poisoning and procedural complications
    Radiation skin injury
         subjects affected / exposed
    0 / 117 (0.00%)
    0 / 118 (0.00%)
    2 / 117 (1.71%)
    6 / 118 (5.08%)
         occurrences all number
    1
    0
    2
    6
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    5 / 117 (4.27%)
    6 / 118 (5.08%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    6
    9
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    31 / 117 (26.50%)
    35 / 118 (29.66%)
    0 / 117 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    50
    43
    0
    1
    Dysgeusia
         subjects affected / exposed
    9 / 117 (7.69%)
    16 / 118 (13.56%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    10
    19
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    9 / 117 (7.69%)
    14 / 118 (11.86%)
    1 / 117 (0.85%)
    1 / 118 (0.85%)
         occurrences all number
    14
    16
    0
    1
    Dizziness
         subjects affected / exposed
    6 / 117 (5.13%)
    12 / 118 (10.17%)
    1 / 117 (0.85%)
    1 / 118 (0.85%)
         occurrences all number
    7
    15
    1
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    37 / 117 (31.62%)
    37 / 118 (31.36%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    77
    59
    0
    0
    Anaemia
         subjects affected / exposed
    22 / 117 (18.80%)
    11 / 118 (9.32%)
    1 / 117 (0.85%)
    2 / 118 (1.69%)
         occurrences all number
    33
    26
    1
    2
    Lymphopenia
         subjects affected / exposed
    10 / 117 (8.55%)
    9 / 118 (7.63%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences all number
    18
    13
    1
    0
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    2 / 117 (1.71%)
    7 / 118 (5.93%)
    0 / 117 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    3
    8
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    50 / 117 (42.74%)
    61 / 118 (51.69%)
    1 / 117 (0.85%)
    1 / 118 (0.85%)
         occurrences all number
    97
    107
    1
    1
    Diarrhoea
         subjects affected / exposed
    38 / 117 (32.48%)
    40 / 118 (33.90%)
    1 / 117 (0.85%)
    3 / 118 (2.54%)
         occurrences all number
    74
    60
    1
    3
    Constipation
         subjects affected / exposed
    26 / 117 (22.22%)
    24 / 118 (20.34%)
    0 / 117 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    29
    31
    0
    2
    Abdominal pain
         subjects affected / exposed
    14 / 117 (11.97%)
    20 / 118 (16.95%)
    0 / 117 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    20
    22
    0
    2
    Vomiting
         subjects affected / exposed
    14 / 117 (11.97%)
    19 / 118 (16.10%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences all number
    15
    26
    1
    0
    Dyspepsia
         subjects affected / exposed
    14 / 117 (11.97%)
    9 / 118 (7.63%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences all number
    14
    10
    1
    0
    Stomatitis
         subjects affected / exposed
    9 / 117 (7.69%)
    10 / 118 (8.47%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    10
    13
    0
    0
    Dry mouth
         subjects affected / exposed
    3 / 117 (2.56%)
    9 / 118 (7.63%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    3
    9
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    40 / 117 (34.19%)
    43 / 118 (36.44%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences all number
    41
    46
    1
    0
    Rash
         subjects affected / exposed
    13 / 117 (11.11%)
    11 / 118 (9.32%)
    0 / 117 (0.00%)
    1 / 118 (0.85%)
         occurrences all number
    21
    15
    0
    1
    Pruritus
         subjects affected / exposed
    10 / 117 (8.55%)
    9 / 118 (7.63%)
    0 / 117 (0.00%)
    2 / 118 (1.69%)
         occurrences all number
    11
    11
    0
    2
    Erythema
         subjects affected / exposed
    4 / 117 (3.42%)
    6 / 118 (5.08%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    5
    7
    0
    0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    47 / 117 (40.17%)
    51 / 118 (43.22%)
    1 / 117 (0.85%)
    1 / 118 (0.85%)
         occurrences all number
    91
    85
    1
    1
    Myalgia
         subjects affected / exposed
    26 / 117 (22.22%)
    23 / 118 (19.49%)
    0 / 117 (0.00%)
    3 / 118 (2.54%)
         occurrences all number
    44
    39
    0
    3
    Back pain
         subjects affected / exposed
    18 / 117 (15.38%)
    15 / 118 (12.71%)
    2 / 117 (1.71%)
    3 / 118 (2.54%)
         occurrences all number
    21
    15
    2
    3
    Arthralgia
         subjects affected / exposed
    17 / 117 (14.53%)
    12 / 118 (10.17%)
    4 / 117 (3.42%)
    7 / 118 (5.93%)
         occurrences all number
    21
    17
    4
    7
    Pain in extremity
         subjects affected / exposed
    14 / 117 (11.97%)
    11 / 118 (9.32%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences all number
    17
    20
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 117 (4.27%)
    9 / 118 (7.63%)
    1 / 117 (0.85%)
    2 / 118 (1.69%)
         occurrences all number
    7
    9
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    3 / 117 (2.56%)
    6 / 118 (5.08%)
    1 / 117 (0.85%)
    0 / 118 (0.00%)
         occurrences all number
    3
    6
    1
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 117 (2.56%)
    7 / 118 (5.93%)
    0 / 117 (0.00%)
    3 / 118 (2.54%)
         occurrences all number
    3
    7
    0
    4
    Candida infection
         subjects affected / exposed
    1 / 117 (0.85%)
    7 / 118 (5.93%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    1
    8
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    23 / 117 (19.66%)
    19 / 118 (16.10%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    26
    21
    0
    0
    Hypokalaemia
         subjects affected / exposed
    4 / 117 (3.42%)
    8 / 118 (6.78%)
    2 / 117 (1.71%)
    2 / 118 (1.69%)
         occurrences all number
    4
    12
    2
    2
    Dehydration
         subjects affected / exposed
    3 / 117 (2.56%)
    8 / 118 (6.78%)
    0 / 117 (0.00%)
    0 / 118 (0.00%)
         occurrences all number
    3
    10
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jul 2017
    The overall reason for this amendment was to make sure that the eligibility criteria and procedures for SPI-GCF-302 matched the criteria in the other Phase 3 trial, SPI-GCF-301.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue Apr 30 19:41:42 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA