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    Clinical Trial Results:
    A Phase 1-2 Ascending Dose Study to Assess the Pharmacodynamics, Pharmacokinetics, and Safety of HSP-130 in Subjects With Non-Metastatic Breast Cancer Following Single Dose and Multiple-Dose Administration By Subcutaneous Injection.

    Summary
    EudraCT number
    		 2015-002057-35
    Trial protocol
    		 HU   ES  
    Global end of trial date
    05 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Oct 2018
    First version publication date
    06 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C1221002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02650193
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    31 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to characterize the pharmacodynamic (PD) response of absolute neutrophil count (ANC) and CD34+ count to PF-06881894 at doses of 3 mg and 6 mg when administered as a single subcutaneous (SC) dose without chemotherapy to determine whether it would be appropriate to study multiple doses of 3 mg in the context of background chemotherapy and to characterize the PD response of duration of severe neutropenia (DSN) in Cycle 1 to PF-06881894 over a range of doses when administered as single and multiple SC doses.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 19
    Country: Number of subjects enrolled
    Spain: 6
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    17
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of twenty-five subjects were enrolled at 3 centers in Hungary and 4 centers in Spain. Study started on 21 Dec 2015 and completed on 05 Oct 2017.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cycle 0: HSP-130 3mg
    Arm description
    		 Subjects who had not received background chemotherapy treatment in the study were administered a single dose of 3 milligram (mg) of HSP-130 subcutaneously (SC) at Day 1 of Cycle 0. Subjects were followed approximately 30 days after last dose of study treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HSP-130
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0.

    Arm title
    		 Cycle 0: HSP-130 6mg
    Arm description
    		 Subjects who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Subjects were followed approximately 30 days after last dose of study treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HSP-130
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0.

    Arm title
    		 Cycles 1-4: HSP-130 6mg
    Arm description
    		 Subjects in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Subjects were followed approximately 30 days after last dose of study treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    HSP-130
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4.

    Number of subjects in period 1
    		Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Started
    6
    6
    13
    Completed
    6
    6
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cycle 0: HSP-130 3mg
    Reporting group description
    		 Subjects who had not received background chemotherapy treatment in the study were administered a single dose of 3 milligram (mg) of HSP-130 subcutaneously (SC) at Day 1 of Cycle 0. Subjects were followed approximately 30 days after last dose of study treatment.

    Reporting group title
    Cycle 0: HSP-130 6mg
    Reporting group description
    		 Subjects who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Subjects were followed approximately 30 days after last dose of study treatment.

    Reporting group title
    Cycles 1-4: HSP-130 6mg
    Reporting group description
    		 Subjects in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Subjects were followed approximately 30 days after last dose of study treatment.

    Reporting group values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg Total
    Number of subjects
    		 6 6 13 25
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 3 3 11 17
        From 65-84 years
    		 3 3 2 8
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.8 ( 8.89 ) 60.8 ( 13.60 ) 55.1 ( 8.95 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 6 6 13 25
        Male
    		 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 1 0 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 0 0 0
        White
    		 5 6 13 24
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0
        Not Hispanic or Latino
    		 6 5 10 21
        Unknown or Not Reported
    		 0 1 3 4

    End points

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    End points reporting groups
    Reporting group title
    Cycle 0: HSP-130 3mg
    Reporting group description
    		 Subjects who had not received background chemotherapy treatment in the study were administered a single dose of 3 milligram (mg) of HSP-130 subcutaneously (SC) at Day 1 of Cycle 0. Subjects were followed approximately 30 days after last dose of study treatment.

    Reporting group title
    Cycle 0: HSP-130 6mg
    Reporting group description
    		 Subjects who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Subjects were followed approximately 30 days after last dose of study treatment.

    Reporting group title
    Cycles 1-4: HSP-130 6mg
    Reporting group description
    		 Subjects in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Subjects were followed approximately 30 days after last dose of study treatment.

    Subject analysis set title
    Cycle 1: HSP-130 6mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects in Cycle 1 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycle 1 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Subjects were followed approximately 30 days after last dose of study treatment.

    Subject analysis set title
    Cycle 4: HSP-130 6mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects in Cycle 4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycle 4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Subjects were followed approximately 30 days after last dose of study treatment.

    Primary: Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0

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    End point title
    		 Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0 [1] [2]
    End point description
    Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. Full Analysis Set (FAS) included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycles 1-4: HSP-130 6mg arm.
    End point type
    Primary
    End point timeframe
    Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: hour*10^9 Neutrophils per Liter
        arithmetic mean (standard deviation)
    3900.482 ( 683.6870 )
    5880.985 ( 1287.2887 )
    No statistical analyses for this end point

    Primary: Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0

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    End point title
    		 Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0 [3] [4]
    End point description
    AUCinf = Area under the serum concentration of HSP-130 versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf). FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: hour*picogram per milliliter (h*pg/mL)
        arithmetic mean (standard deviation)
    1425862.2 ( 949518.8 )
    5689476.1 ( 3757035.5 )
    No statistical analyses for this end point

    Primary: Maximum Observed Serum Concentration (Cmax): Cycle 0

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    End point title
    		 Maximum Observed Serum Concentration (Cmax): Cycle 0 [5] [6]
    End point description
    FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: picogram per milliliter (pg/mL)
        arithmetic mean (standard deviation)
    38026.7 ( 28821.7 )
    155766.7 ( 99051.8 )
    No statistical analyses for this end point

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

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    End point title
    		 Duration of Severe Neutropenia (DSN): Cycle 1 [7]
    End point description
    Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9 per liter. DSN is defined as the days with grade 4 neutropenia (ANC < 0.5 x10^9/L). FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, ' Overall number of subjects analyzed' signifies number of subjects evaluable for the specified endpoint.
    End point type
    Primary
    End point timeframe
    Cycle 1: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint
    End point values
    		 Cycle 1: HSP-130 6mg
    Number of subjects analysed
    12
    Units: days
        arithmetic mean (standard deviation)
    0.667 ( 0.9847 )
    No statistical analyses for this end point

    Primary: Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4

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    End point title
    		 Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4 [8]
    End point description
    AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t). FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: h*pg/mL
        arithmetic mean (standard deviation)
    10084193.7 ( 14047222.7 )
    6017621.6 ( 5920395.4 )
    No statistical analyses for this end point

    Primary: Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4

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    End point title
    		 Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4 [9]
    End point description
    FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: pg/mL
        arithmetic mean (standard deviation)
    118130.8 ( 119028.6 )
    95200.0 ( 93544.1 )
    No statistical analyses for this end point

    Secondary: Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0

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    End point title
    		 Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0 [10]
    End point description
    ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. FAS included all subjects who received at least 1 dose of study medication. This end point was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: *10^9 Neutrophils per Liter
        arithmetic mean (standard deviation)
    24.512 ( 6.0710 )
    43.257 ( 5.5683 )
    No statistical analyses for this end point

    Secondary: Time of Maximum Effect for Absolute Neutrophil Count (ANC_Tmax): Cycle 0

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    End point title
    		 Time of Maximum Effect for Absolute Neutrophil Count (ANC_Tmax): Cycle 0 [11]
    End point description
    ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. FAS included all subjects who received at least 1 dose of study medication. This end point was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: hour
        median (full range (min-max))
    71.950 (48.00 to 144.10)
    47.800 (46.90 to 48.30)
    No statistical analyses for this end point

    Secondary: Area Under the Effect Curve for CD34+ (AUECCD34+): Cycle 0

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    End point title
    		 Area Under the Effect Curve for CD34+ (AUECCD34+): Cycle 0 [12]
    End point description
    FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycles 1-4: HSP-130 6mg arm.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: hour*cells per microliter (h*cells/ mcL)
        arithmetic mean (standard deviation)
    1749.523 ( 1022.3037 )
    2752.198 ( 2152.8794 )
    No statistical analyses for this end point

    Secondary: Maximum Effect for CD34+ Count (CD34+_Emax): Cycle 0

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    End point title
    		 Maximum Effect for CD34+ Count (CD34+_Emax): Cycle 0 [13]
    End point description
    FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycles 1-4: HSP-130 6mg arm.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: cells per microliter (cells/mcL)
        arithmetic mean (standard deviation)
    13.970 ( 6.8536 )
    27.343 ( 18.4805 )
    No statistical analyses for this end point

    Secondary: Time of Maximum Effect for CD34+ Count (CD34+ Tmax): Cycle 0

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    End point title
    		 Time of Maximum Effect for CD34+ Count (CD34+ Tmax): Cycle 0 [14]
    End point description
    FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycles 1-4: HSP-130 6mg arm.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: hour
        median (full range (min-max))
    96.000 (48.00 to 96.10)
    96.600 (95.80 to 191.30)
    No statistical analyses for this end point

    Secondary: Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC inf): Cycle 0

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    End point title
    		 Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC inf): Cycle 0 [15]
    End point description
    ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. FAS included all subjects who received at least 1 dose of study medication. Here, 'number of subjects analyzed' signifies number of subjects evaluable for the specified endpoint.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    5
    6
    Units: hour*10^9 Neutrophils per Liter
        arithmetic mean (standard deviation)
    5254.288 ( 1699.7088 )
    6576.165 ( 1821.9919 )
    No statistical analyses for this end point

    Secondary: Area Under the Effect Curve From Time of Dose Administration to Time Infinity for CD34 + (AUEC_CD34+ inf): Cycle 0

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    End point title
    		 Area Under the Effect Curve From Time of Dose Administration to Time Infinity for CD34 + (AUEC_CD34+ inf): Cycle 0 [16]
    End point description
    FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycles 1-4: HSP-130 6mg arm. Here, 'Overall number of subjects analyzed" signifies number of subjects evaluable for the specified endpoint.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    5
    Units: hour*cells per microliter (h*cells/mcL)
        arithmetic mean (standard deviation)
    1835.221 ( 1036.6473 )
    3159.470 ( 2197.4774 )
    No statistical analyses for this end point

    Secondary: Area Under the Serum Concentration Time Curve From the Time of Dose Administration to the Time of Last Measurable Concentration (AUCt): Cycle 0

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    End point title
    		 Area Under the Serum Concentration Time Curve From the Time of Dose Administration to the Time of Last Measurable Concentration (AUCt): Cycle 0 [17]
    End point description
    AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t). FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: h*pg/mL
        arithmetic mean (standard deviation)
    1410202.6 ( 948443.5 )
    5677700.3 ( 3756049.2 )
    No statistical analyses for this end point

    Secondary: Time To Achieve Maximum Serum Concentration (Tmax): Cycle 0

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    End point title
    		 Time To Achieve Maximum Serum Concentration (Tmax): Cycle 0 [18]
    End point description
    FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: hour
        median (full range (min-max))
    12.0 (12 to 12)
    23.5 (6 to 24)
    No statistical analyses for this end point

    Secondary: Elimination Half-Life (t1/2): Cycle 0

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    End point title
    		 Elimination Half-Life (t1/2): Cycle 0 [19]
    End point description
    t1/2 is the time taken for plasma concentration of HSP 130 to reduce by 50 percent (%) of its initial value. FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: hour
        arithmetic mean (standard deviation)
    50.0 ( 15.5 )
    48.8 ( 12.5 )
    No statistical analyses for this end point

    Secondary: Elimination Rate Constant (λz): Cycle 0

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    End point title
    		 Elimination Rate Constant (λz): Cycle 0 [20]
    End point description
    Elimination rate constant was defined as the rate at which the drug was removed from the body. FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: per hour
        arithmetic mean (standard deviation)
    0.015 ( 0.0051 )
    0.015 ( 0.0041 )
    No statistical analyses for this end point

    Secondary: Apparent Clearance (CL/F): Cycle 0

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    End point title
    		 Apparent Clearance (CL/F): Cycle 0 [21]
    End point description
    Clearance of a drug was defined as the rate at which a drug was metabolized or eliminated by normal biological processes. FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: milliliter per hour (mL/h)
        arithmetic mean (standard deviation)
    4235.6 ( 4714.4 )
    1655.9 ( 1242.6 )
    No statistical analyses for this end point

    Secondary: Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0

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    End point title
    		 Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0 [22]
    End point description
    The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL). FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: h*pg/mL
        arithmetic mean (standard deviation)
    1440264.8 ( 959109.9 )
    5689476.1 ( 3757035.5 )
    No statistical analyses for this end point

    Secondary: Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 0

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    End point title
    		 Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 0 [23]
    End point description
    The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL). FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: h*pg/mL
        arithmetic mean (standard deviation)
    1424447.1 ( 958023.7 )
    5677700.3 ( 3756049.2 )
    No statistical analyses for this end point

    Secondary: Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 0

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    End point title
    		 Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 0 [24]
    End point description
    The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL). FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was only planned to be analyzed for the arms in the Cycle(s) identified
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg
    Number of subjects analysed
    6
    6
    Units: pg/mL
        arithmetic mean (standard deviation)
    38410.8 ( 29112.8 )
    155766.7 ( 99051.8 )
    No statistical analyses for this end point

    Secondary: Duration of Severe Neutropenia (DSN): Cycle 4

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    End point title
    		 Duration of Severe Neutropenia (DSN): Cycle 4
    End point description
    Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L. DSN was defined as the days with grade 4 neutropenia (ANC < 0.5 x10^9/L). FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, "Number of subjects analyzed (N)" signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Cycle 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 4: HSP-130 6mg
    Number of subjects analysed
    12
    Units: days
        arithmetic mean (standard deviation)
    0.667 ( 0.9847 )
    No statistical analyses for this end point

    Secondary: Absolute Neutrophil Count Nadir Concentration: Cycle 1 and Cycle 4

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    End point title
    		 Absolute Neutrophil Count Nadir Concentration: Cycle 1 and Cycle 4
    End point description
    Nadir was defined as the lowest count for ANC concentration reported after first dose of study treatment. FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: *10^9 Neutrophils per Liter
        arithmetic mean (standard deviation)
    1.132 ( 1.1480 )
    1.623 ( 1.8364 )
    No statistical analyses for this end point

    Secondary: Time of ANC Nadir Concentration: Cycle 1 and Cycle 4

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    End point title
    		 Time of ANC Nadir Concentration: Cycle 1 and Cycle 4
    End point description
    Time of ANC Nadir (in hours) was defined as the time from first dose of study treatment on Day 2 of Cycle 1 and 4 to the time the lowest value was recorded. FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: hour
        arithmetic mean (standard deviation)
    129.231 ( 23.0585 )
    142.154 ( 65.3323 )
    No statistical analyses for this end point

    Secondary: Area Under the Effect Curve (AUEC_ANCt): Cycle 1 and Cycle 4

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    End point title
    		 Area Under the Effect Curve (AUEC_ANCt): Cycle 1 and Cycle 4
    End point description
    ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: hour*10^9 Neutrophils per Liter
        arithmetic mean (standard deviation)
    2540.285 ( 854.2237 )
    3186.542 ( 1362.0079 )
    No statistical analyses for this end point

    Secondary: Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC inf): Cycle 1 and Cycle 4

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    End point title
    		 Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC inf): Cycle 1 and Cycle 4
    End point description
    Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. FAS included all subjects who received at least 1 dose of study medication. Here, "Number of subjects analyzed (N)" signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    8
    7
    Units: hour*10^9 Neutrophils per Liter
        arithmetic mean (standard deviation)
    5636.963 ( 1974.1635 )
    12399.370 ( 18345.3366 )
    No statistical analyses for this end point

    Secondary: Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4

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    End point title
    		 Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4
    End point description
    Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 °C for >1 hour and ANC less than (<) 1.0 *10^9/L. FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: subjects
    1
    0
    No statistical analyses for this end point

    Secondary: Incidence of Severe Neutropenia: Cycle 1 and Cycle 4

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    End point title
    		 Incidence of Severe Neutropenia: Cycle 1 and Cycle 4
    End point description
    Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L. FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: subjects
    5
    5
    No statistical analyses for this end point

    Secondary: Time to ANC Recovery: Cycle 1 and Cycle 4

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    End point title
    		 Time to ANC Recovery: Cycle 1 and Cycle 4
    End point description
    Time to ANC recovery was defined as the time from documentation of the first day with ANC greater than equal to (>=) 2.0 x10^9/L after any day with ANC <2.0 x10^9/L. FAS included all subjects who received at least 1 dose of study medication. This endpoint was not planned to be analysed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: days
        arithmetic mean (standard deviation)
    2.615 ( 1.7097 )
    2.000 ( 1.633 )
    No statistical analyses for this end point

    Secondary: Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4

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    End point title
    		 Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4
    End point description
    AUC0-inf = Area under the serum concentration versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf). FAS included all subjects who received at least 1 dose of study medication. Here, "N" signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    12
    Units: h*pg/mL
        arithmetic mean (standard deviation)
    10093213.5 ( 14047936.2 )
    6425013.3 ( 6000938.3 )
    No statistical analyses for this end point

    Secondary: Time To Achieve Maximum Serum Concentration (Tmax): Cycle 1 and Cycle 4

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    End point title
    		 Time To Achieve Maximum Serum Concentration (Tmax): Cycle 1 and Cycle 4
    End point description
    FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: hour
        median (full range (min-max))
    24.1 (12 to 48)
    23.5 (6 to 142)
    No statistical analyses for this end point

    Secondary: Elimination Half-Life (t1/2): Cycle 1 and Cycle 4

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    End point title
    		 Elimination Half-Life (t1/2): Cycle 1 and Cycle 4
    End point description
    t1/2 is the time taken for plasma concentration of a drug to reduce by 50% of its initial value. FAS included all subjects who received at least 1 dose of study medication. Here, "N" signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    12
    Units: hour
        arithmetic mean (standard deviation)
    30.7 ( 10.8 )
    29.5 ( 9.5 )
    No statistical analyses for this end point

    Secondary: Elimination Rate Constant (λz): Cycle 1 and Cycle 4

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    End point title
    		 Elimination Rate Constant (λz): Cycle 1 and Cycle 4
    End point description
    Elimination rate constant was defined as the rate at which the drug was removed from the body. FAS included all subjects who received at least 1 dose of study medication. Here, "N" signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    12
    Units: per hour
        arithmetic mean (standard deviation)
    0.026 ( 0.0099 )
    0.025 ( 0.0060 )
    No statistical analyses for this end point

    Secondary: Apparent Clearance (CL/F): Cycle 1 and Cycle 4

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    End point title
    		 Apparent Clearance (CL/F): Cycle 1 and Cycle 4
    End point description
    CL/F was defined as a quantitative measure of the rate at which a drug substance is removed from the body. FAS included all subjects who received at least 1 dose of study medication. Here, "N" signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    12
    Units: mL/h
        arithmetic mean (standard deviation)
    1326.8 ( 1010.2 )
    2342.8 ( 2043.8 )
    No statistical analyses for this end point

    Secondary: Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4

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    End point title
    		 Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4
    End point description
    The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL). FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: h*pg/mL
        arithmetic mean (standard deviation)
    10087666.8 ( 14045724.4 )
    6045733.4 ( 5955438.5 )
    No statistical analyses for this end point

    Secondary: Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4

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    End point title
    		 Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4
    End point description
    The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL). FAS included all subjects who received at least 1 dose of study medication. Here, "N" signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    12
    Units: h*pg/mL
        arithmetic mean (standard deviation)
    10096698.3 ( 14046434.6 )
    6454443.8 ( 6037499.6 )
    No statistical analyses for this end point

    Secondary: Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4

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    End point title
    		 Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4
    End point description
    The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL). FAS included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose
    End point values
    		 Cycle 1: HSP-130 6mg Cycle 4: HSP-130 6mg
    Number of subjects analysed
    13
    13
    Units: pg/mL
        arithmetic mean (standard deviation)
    118173.0 ( 119004.2 )
    95670.1 ( 94209.4 )
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    An AE was any untoward medical occurrence in subjects who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after the HSP-130 administration up to and including 30 days post HSP-130 administration (up to Day 94). AEs included both serious and non-serious. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to approximately Day 94
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Number of subjects analysed
    6
    6
    13
    Units: subjects
        AEs
    6
    6
    13
        SAEs
    0
    0
    2
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Treatment-Emergent Adverse Events (AEs) of Special Interest

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (AEs) of Special Interest
    End point description
    AEs of Special Interest (AESI) included Potential Allergic Reactions, Splenomegaly, Splenic Rupture, Acute Respiratory Distress Syndrome, Alveolar Hemorrhage, Hemoptysis, Leukocytosis, Thrombocytopenia, Capillary Leak Syndrome, Cytokine Release Syndrome, Cutaneous Vasculitis and Glomerulonephritis. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to approximately Day 94
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Number of subjects analysed
    6
    6
    13
    Units: subjects
    0
    2
    2
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Laboratory Abnormalities

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    End point title
    		 Number of Subjects With Laboratory Abnormalities
    End point description
    Criteria: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, neutrophils); chemistry (alkaline phosphatase, glucose, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, albumin, creatinine and gamma-glutamyl transpeptidase, blood urea nitrogen, total protein, phosphate, and uric acid); urinalysis. The clinical laboratory results and patterns observed were consistent with the known therapeutic response and the safety profile for the US and EU approved pegylated filgrastim (Neulasta).
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to approximately Day 94
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Number of subjects analysed
    6
    6
    13
    Units: subjects
    6
    6
    13
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Clinically Significant Vital Sign Abnormalities

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    End point title
    		 Number of Subjects With Clinically Significant Vital Sign Abnormalities
    End point description
    Vital sign assessment included body temperature (tympanic or axillary), heart rate (sitting), blood pressure (sitting systolic and diastolic), and respiratory rate. Clinically significant abnormality was based upon investigator's discretion. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to approximately Day 94
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Number of subjects analysed
    6
    6
    13
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Clinically Significant Physical Examination Abnormalities

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    End point title
    		 Number of Subjects With Clinically Significant Physical Examination Abnormalities
    End point description
    Physical examination included physical assessment of the spleen. Clinically significant abnormality was based on investigator’s discretion. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to approximately Day 94
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Number of subjects analysed
    6
    6
    13
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Clinically Significant Electrocardiogram (ECG) Abnormalities

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    End point title
    		 Number of Subjects With Clinically Significant Electrocardiogram (ECG) Abnormalities
    End point description
    Clinically significant abnormality was based upon investigator's discretion. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to approximately Day 94
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Number of subjects analysed
    6
    6
    13
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With At Least 1 Concomitant Medication

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    End point title
    		 Number of Subjects With At Least 1 Concomitant Medication
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to approximately Day 94
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Number of subjects analysed
    6
    6
    13
    Units: subjects
    6
    6
    13
    No statistical analyses for this end point

    Other pre-specified: Duration of Exposure to Study Drug Medication

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    End point title
    		 Duration of Exposure to Study Drug Medication
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to approximately Day 94
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Number of subjects analysed
    6
    6
    13
    Units: days
        median (full range (min-max))
    3.00 (3.00 to 3.00)
    6.00 (6.00 to 6.00)
    24.0 (24.0 to 24.0)
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Positive Anti-pegfilgrastim (Anti-drug) Antibodies

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    End point title
    		 Number of Subjects With Positive Anti-pegfilgrastim (Anti-drug) Antibodies
    End point description
    Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to approximately Day 94
    End point values
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Number of subjects analysed
    6
    6
    13
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to approximately Day 94
    Adverse event reporting additional description
    Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Cycle 0: HSP-130 3mg
    Reporting group description
    		 Subjects who had not received background chemotherapy treatment in the study were administered a single dose of 3 mg of HSP-130 SC at Day 1 of Cycle 0. Subjects were followed approximately 30 days after last dose of study treatment.

    Reporting group title
    Cycle 0: HSP-130 6mg
    Reporting group description
    		 Subjects who had not received background chemotherapy treatment in the study were administered a single dose of 6 mg of HSP-130 SC at Day 1 of Cycle 0. Subjects were followed approximately 30 days after last dose of study treatment.

    Reporting group title
    Cycles 1-4: HSP-130 6mg
    Reporting group description
    		 Subjects in Cycles 1-4 received background chemotherapy treatment at Day 1 and were administered a single dose of 6 mg of HSP-130 SC at Day 2 of Cycles 1-4 (each cycle was approximately 3 weeks if there were no chemotherapy treatment delays). Subjects were followed approximately 30 days after last dose of study treatment.

    Serious adverse events
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Blood and lymphatic system disorders
    Febrile Neutropenia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cycle 0: HSP-130 3mg Cycle 0: HSP-130 6mg Cycles 1-4: HSP-130 6mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    6 / 6 (100.00%)
    13 / 13 (100.00%)
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Flushing
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Hypotension
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Varicose vein
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    5
    Chest discomfort
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Chills
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Face oedema
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    0
    7
    Inflammation
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Reproductive system and breast disorders
    Ovarian cyst
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Dysphonia
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    White blood cell count decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Injury, poisoning and procedural complications
    Seroma
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Wound
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Arachnoid cyst
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Cerebral atrophy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 6 (66.67%)
    5 / 13 (38.46%)
         occurrences all number
    1
    6
    6
    Neuropathy peripheral
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Neutropenia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    1
    Eye disorders
    Keratitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    4 / 13 (30.77%)
         occurrences all number
    0
    0
    7
    Aphthous ulcer
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Constipation
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    4 / 13 (30.77%)
         occurrences all number
    0
    1
    4
    Dry mouth
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Gingival pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Hyperchlorhydria
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 6 (33.33%)
    7 / 13 (53.85%)
         occurrences all number
    0
    2
    19
    Vomiting
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    1
    0
    4
    Hepatobiliary disorders
    Hepatic cyst
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatomegaly
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    8 / 13 (61.54%)
         occurrences all number
    0
    0
    8
    Dermatitis contact
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    3 / 13 (23.08%)
         occurrences all number
    0
    1
    4
    Intertrigo
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 6 (33.33%)
    4 / 13 (30.77%)
         occurrences all number
    2
    2
    4
    Bone pain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Myalgia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    0
    3
    Pain in extremity
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 6 (16.67%)
    3 / 13 (23.08%)
         occurrences all number
    1
    1
    4
    Spinal pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Viral infection
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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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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