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    Clinical Trial Results:
    A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in Patients with Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated with an Anthracycline, a Taxane, and Capecitabine

    Summary
    EudraCT number
    		 2016-002453-38
    Trial protocol
    		 GB   ES   CZ   BE   PT   FR   HU   IT  
    Global end of trial date
    06 Nov 2019

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

    Trial information

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    Trial identification
    Sponsor protocol code
    15-102-14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02915744
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nektar Therapeutics
    Sponsor organisation address
    455 Mission Bay Blvd South, San Francisco, United States, 94158
    Public contact
    Medical Affairs, Nektar Therapeutics, 855 482-8676, medicalaffairs@nektar.com
    Scientific contact
    Medical Affairs, Nektar Therapeutics, 855 482-8676, medicalaffairs@nektar.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
    21 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare overall survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician’s Choice (TPC) selected from the following list of 7 single-agent intravenous (IV) therapies: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel. TPC drugs will be administered per the standard of care.
    Protection of trial subjects
    Written informed consent was obtained from patients at the Screening Visit prior to performance of any study-specific tests or evaluations. The Investigator, or a person designated by the Investigator, explained to each patient or the patient’s legally authorized representative (LAR) the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits involved, and any discomfort participation in the study may entail. Each patient or the patient’s LAR was informed that participation in the study was voluntary and that the patient would be able to withdraw from the study at any time, and that withdrawal of consent would not affect the patient’s subsequent medical treatment or relationship with the treating physician.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 6
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    Belgium: 17
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    United States: 85
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Israel: 7
    Worldwide total number of subjects
    178
    EEA total number of subjects
    66
    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)
    149
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eligibility to the study was inclusive of patients with breast cancer brain metastases and any breast cancer tumor subtype.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NKTR-102
    Arm description
    		 NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etirinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in administration system
    Routes of administration
    Intravenous use
    Dosage and administration details
    NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.

    Arm title
    		 Treatment of Physician's Choice (TPC)
    Arm description
    		 TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Eribulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Give specified dose on specified days

    Investigational medicinal product name
    Ixabepilone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Give specified dose on specified days

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Give specified dose on specified days

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Give specified dose on specified days

    Investigational medicinal product name
    Paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Solution for infusion
    Dosage and administration details
    Give specified dose on specified days

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Give specified dose on specified days

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Give specified dose on specified days

    Number of subjects in period 1
    		NKTR-102 Treatment of Physician's Choice (TPC)
    Started
    92
    86
    Completed
    13
    9
    Not completed
    79
    77
         Adverse event, serious fatal
    3
    2
         Consent withdrawn by subject
    4
    14
         Physician decision
    8
    12
         Adverse event, non-fatal
    11
    3
         Lost to follow-up
    -
    1
         Lack of efficacy
    53
    45

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NKTR-102
    Reporting group description
    		 NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.

    Reporting group title
    Treatment of Physician's Choice (TPC)
    Reporting group description
    		 TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.

    Reporting group values
    		 NKTR-102 Treatment of Physician's Choice (TPC) Total
    Number of subjects
    		 92 86 178
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 74 75 149
        From 65-84 years
    		 18 11 29
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.7 ( 10.13 ) 51.9 ( 10.50 ) -
    Gender categorical
    Units: Subjects
        Female
    		 92 86 178
        Male
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 6 8
        Not Hispanic or Latino
    		 69 60 129
        Unknown or Not Reported
    		 21 20 41
    ECOG
    Measure Description: Grade - ECOG Performance Status 0 - Fully active, able to carry on all pre-disease performance without restriction 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
    Units: Subjects
        Score of 0
    		 25 25 50
        Score of 1
    		 67 61 128
    Reproductive Status
    Units: Subjects
        Of Child-Bearing Potential
    		 16 13 29
        Surgically Sterile
    		 11 14 25
        Post-Menopausal
    		 65 55 120
        Other
    		 0 4 4
        Missing
    		 0 0 0
    Pregnancy Test at Screening
    Units: Subjects
        Positive
    		 1 1 2
        Negative
    		 22 24 46
        Borderline
    		 6 1 7
        Not Performed
    		 63 60 123
    Breast Cancer Stage at Initial Diagnosis
    Units: Subjects
        Stage I
    		 5 10 15
        Stage II
    		 41 29 70
        Stage III
    		 22 17 39
        Stage IV
    		 10 16 26
        Unknown
    		 14 14 28
    Cancer History at Initial Diagnosis
    Units: Subjects
        Invasive Ductal Carcinoma
    		 80 77 157
        Invasive Lobular Carcinoma
    		 6 1 7
        Other
    		 6 8 14
    Estrogen Receptor Status at Initial Diagnosis
    Units: Subjects
        ER Positive
    		 52 49 101
        ER Negative
    		 40 34 74
        Unknown
    		 0 3 3
    Progesterone Receptor Status at Initial Diagnosis
    Units: Subjects
        PgR Positive
    		 40 42 82
        PgR Negative
    		 50 41 91
        Unknown
    		 2 3 5
    HER2 Receptor Status at Initial Diagnosis
    Units: Subjects
        HER2 Positive
    		 15 14 29
        HER2 Negative
    		 76 66 142
        Unknown
    		 1 6 7
    Estrogen Receptor Status at Last Biopsy
    Units: Subjects
        ER Positive
    		 47 48 95
        ER Negative
    		 38 36 74
        Unknown
    		 7 2 9
    Progesterone Receptor Status at Last Biopsy
    Units: Subjects
        PgR Positive
    		 32 31 63
        PgR Negative
    		 51 52 103
        Unknown
    		 9 3 12
    HER2 Receptor Status at Last Biopsy
    Units: Subjects
        HER2 Positive
    		 12 13 25
        HER2 Negative
    		 74 69 143
        Unknown
    		 6 4 10
    Estrogen Receptor/Progesterone Receptor Status at Last Biopsy
    Units: Subjects
        ER/PgR Positive
    		 49 49 98
        ER/PgR Negative
    		 36 35 71
        Unknown
    		 7 2 9
    Race
    Units: Subjects
        White
    		 66 57 123
        Black or African-American
    		 3 5 8
        Asian
    		 3 6 9
        American Indian or Alaska Native
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Other
    		 0 0 0
        Not Reported
    		 20 18 38
        Missing
    		 0 0 0
    Height
    Units: centimeters
        arithmetic mean (standard deviation)
    		 162.7 ( 6.67 ) 162.1 ( 7.73 ) -
    Weight
    Units: kilograms
        arithmetic mean (standard deviation)
    		 67.16 ( 17.468 ) 65.97 ( 15.561 ) -
    Time since Initial Breast Cancer Diagnosis
    Units: Years
        arithmetic mean (standard deviation)
    		 8.094 ( 5.17 ) 6.950 ( 5.0941 ) -
    Time Since Initial Brain Metastasis Diagnosis
    Units: years
        arithmetic mean (standard deviation)
    		 1.137 ( 1.1061 ) 1.194 ( 1.1748 ) -

    End points

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    End points reporting groups
    Reporting group title
    NKTR-102
    Reporting group description
    		 NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle.

    Reporting group title
    Treatment of Physician's Choice (TPC)
    Reporting group description
    		 TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.

    Subject analysis set title
    Subject Analysis Set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients who were randomized in the study were included in the ITT population.

    Primary: Overall Survival (OS) of Patients

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    End point title
    		 Overall Survival (OS) of Patients
    End point description
    To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis.
    End point type
    Primary
    End point timeframe
    Within 3 years from study start
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    92
    86
    Units: Months
        median (confidence interval 95%)
    7.8 (6.1 to 10.2)
    7.5 (5.8 to 10.4)
    Statistical analysis title
    		 Primary Endpoint Analysis
    Statistical analysis description
    The primary analysis of OS was the CHW test with pre-specified weights (Cui, Hung, Wang, 1999). The conventional test with equal weights for every patient was conducted as a sensitivity analysis. The median survival times and their 95% confidence intervals (CIs) as well as survival curves were estimated using the Kaplan-Meier method and were summarized by treatment group. The 2-sided significance level for superiority at final analysis of OS was 0.0499.
    Comparison groups
    NKTR-102 v Treatment of Physician's Choice (TPC)
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 ≤ 0.0499
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.901
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.612
         upper limit
    		 1.326
    Variability estimate
    Standard deviation
    Notes
    [1] - At final analysis, the primary analysis of OS for statistical significance claim will be based on the CHW version of the logrank test statistic with weights (Cui, Hung, & Wang, 1999). Based on the correlation between interim and final CHW test statistic, statistical significance can be claimed if the two-sided p-value for CHW test statistic is no greater than 0.0499. The conventional logrank test with equal weights for every patient will be conducted as a sensitivity analysis.

    Secondary: Progression-Free Survival (Outside the Central Nervous System)

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    End point title
    		 Progression-Free Survival (Outside the Central Nervous System)
    End point description
    Progression-Free Survival (PFS) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) or of death from any cause. The date of global deterioration or symptomatic deterioration will not be used as the date of PD.
    End point type
    Secondary
    End point timeframe
    Through study completion, an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    92
    86
    Units: Months
        median (confidence interval 95%)
    2.8 (2.0 to 4.1)
    1.9 (1.9 to 2.1)
    No statistical analyses for this end point

    Secondary: Progression-Free Survival in Brain Metastasis (PFS-BM)

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    End point title
    		 Progression-Free Survival in Brain Metastasis (PFS-BM)
    End point description
    Progression-Free Survival in Brain Metastasis (PFS-BM) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) per Response Assessment in Neuro-Oncology—Brain Metastases (RANO-BM) in brain metastases or death from any cause. The PD will also be determined by the investigator's assessments.
    End point type
    Secondary
    End point timeframe
    Through study completion, an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    92
    86
    Units: Months
        median (confidence interval 95%)
    3.9 (2.6 to 4.3)
    3.3 (1.9 to 3.7)
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (Overall)

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    End point title
    		 Progression-Free Survival (Overall)
    End point description
    Progression-free survival (CNS and peripheral) is defined as the time from the date of randomization to the earliest evidence of documented PD in either the CNS or peripheral (using RANO-BM) or death from any cause. The PD will be determined by both the investigator's and the central imaging facility assessments. The same statistical methods that were used for PFS and PFS-BM will be used for PFS (Overall).
    End point type
    Secondary
    End point timeframe
    Through study completion, an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    92
    86
    Units: Months
        median (confidence interval 95%)
    2.1 (1.9 to 3.7)
    1.9 (1.8 to 2.0)
    No statistical analyses for this end point

    Secondary: Objective Response Rates (ORR) at the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC)

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    End point title
    		 Objective Response Rates (ORR) at the NKTR-102 Treatment and the Treatment of Physician's Choice (TPC)
    End point description
    Objective Response Rate (ORR) will be defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR) (RECIST for lesions outside the Central Nervous System (CNS); RANO-BM for CNS lesions) based upon the best response as assessed by the central imaging facility. As a secondary analysis, ORR will be calculated based on the Investigator assessment of response.
    End point type
    Secondary
    End point timeframe
    Through study completion, an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    83
    73
    Units: Participants
        Objective Response Rate (CR+PR)
    4
    2
        Stable Disease
    16
    5
        Progressive Disease
    38
    32
        Not Evaluable
    18
    30
        Missing
    7
    4
    No statistical analyses for this end point

    Secondary: Clinical Benefit Rate (CBR)

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    End point title
    		 Clinical Benefit Rate (CBR)
    End point description
    Clinical Benefit Rate will be defined as the proportion of patients having a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for at least 4 months (≥ 120 days). The SD duration of 4 months is selected to reflect the shorter life expectancy of study population. CBR will be calculated based on both the central imaging facility assessment of response, progression and stability of disease, as well as the investigator's assessment of these parameters.
    End point type
    Secondary
    End point timeframe
    For at least 4 months, with an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    92
    86
    Units: Participants
        Complete Response
    0
    0
        Partial Response
    6
    6
        Stable Disease >= 120 days
    17
    5
        Clinical Benefit Rate
    23
    11
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR)

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    End point title
    		 Duration of Response (DoR)
    End point description
    Duration of response (DoR) outside the CNS will be defined as the time from first documented CR or PR until the earliest evidence of disease progression per RECIST v1.1 or death from any cause. DoR will be calculated based on the central imaging facility assessment of response and progression as well as the investigator's assessment of response and progression.
    End point type
    Secondary
    End point timeframe
    Through study completion, an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    83
    73
    Units: Months
        median (inter-quartile range (Q1-Q3))
    7.4 (7.3 to 16.4)
    3.5 (3.5 to 3.5)
    No statistical analyses for this end point

    Secondary: Compare Health-Related Quality of Life (HRQoL) Using the European Organisation for Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) Module With the Brain Neoplasms 20-question (BN-20) Subscale.

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    End point title
    		 Compare Health-Related Quality of Life (HRQoL) Using the European Organisation for Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) Module With the Brain Neoplasms 20-question (BN-20) Subscale.
    End point description
    The EORTC QLQ-BN20 Scale has a series of 20 questions each of which involve reporting a scale from 1-4. It is an increasing scale where a score of one indicates "not at all" while a score of four indicates "very much". The minimum score is 20 and the maximum score is 80. The higher the score the worse the outcome.
    End point type
    Secondary
    End point timeframe
    Through study completion, an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    44
    35
    Units: Change in QLQ-C30 Score
        arithmetic mean (standard error)
    -12.29 ( 20.928 )
    -8.06 ( 21.888 )
    No statistical analyses for this end point

    Secondary: Compare Health-Related Quality of Life (HRQoL) Using the the EuroQoL 5D (EQ-5D-5L™)

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    End point title
    		 Compare Health-Related Quality of Life (HRQoL) Using the the EuroQoL 5D (EQ-5D-5L™)
    End point description
    The EQ-5D-5L scale is used to measure health by having a patient answer a series of questions. There are a series of 5 questions each of which is scaled from a score of 4-20 in increasing increments of 4. The scale is numbered from 0 to 100 where 100 means the beast health you can imagine and 0 means the worst health.
    End point type
    Secondary
    End point timeframe
    Through study completion, an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    92
    86
    Units: Change in EuroQol 5D Score
        arithmetic mean (standard error)
    -6.00 ( 20.482 )
    -4.90 ( 20.112 )
    No statistical analyses for this end point

    Secondary: Compare Health-Related Quality of Life (HRQoL) Using the Brief Fatigue Inventory (BFI)

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    End point title
    		 Compare Health-Related Quality of Life (HRQoL) Using the Brief Fatigue Inventory (BFI)
    End point description
    The Brief Fatigue Inventory scale utilizes a series of 4 questions. The first three are scored with a scale from 1-10. The fourth question has 6 six sub components each of which are scored with a scale of 1-10. For every scale, a score of 0 indicates no fatigue/interference where a score of 10 indicates as bad as you can imagine. A patient's score can range from 0 to 100 where 0 indicates the best outcome and 100 indicates the worst.
    End point type
    Secondary
    End point timeframe
    Through study completion, an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    92
    86
    Units: Change in BFI Score
        arithmetic mean (standard deviation)
    0.89 ( 1.924 )
    1.15 ( 2.004 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3

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    End point title
    		 Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3
    End point description
    The number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3
    End point type
    Secondary
    End point timeframe
    Through study completion, an expected average of 1 year
    End point values
    		 NKTR-102 Treatment of Physician's Choice (TPC)
    Number of subjects analysed
    90
    77
    Units: Particpants
    90
    76
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse event data was collected over the entire course of the study or approximately 2 years and 8 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    NKTR-102
    Reporting group description
    		 -

    Reporting group title
    TREATMENT OF PHYSICIAN’S CHOICE
    Reporting group description
    		 -

    Serious adverse events
    		 NKTR-102 TREATMENT OF PHYSICIAN’S CHOICE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 90 (36.67%)
    24 / 77 (31.17%)
         number of deaths (all causes)
    60
    57
         number of deaths resulting from adverse events
    Vascular disorders
    Deep Vein Thrombosis Grade 4
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Generalized Physical Health Deterioration Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalized Physical Health Deterioration Grade 5
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthenia Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue Grade 2
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    9 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea Grade 2
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnea Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax Grade 2
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional State Grade 2
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional State Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Status Changes Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination Grade 4
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip Fracture Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Tamponade Grade 4
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Fine motor skill dysfunction Grade 2
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Edema Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy Grade 2
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoesthesia Grade 2
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia Grade 2
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure Grade 2
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Epilepticus Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia Grade 4
         subjects affected / exposed
    3 / 90 (3.33%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    10 / 10
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia Grade 4
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile Neutropenia Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic Normocystic Anemia Grade 4
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Blindness Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhea Grade 3
         subjects affected / exposed
    5 / 90 (5.56%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    5 / 12
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea Grade 2
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    26 / 30
    11 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Grade 2
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Grade 3
         subjects affected / exposed
    3 / 90 (3.33%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting Grade 2
         subjects affected / exposed
    3 / 90 (3.33%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    4 / 19
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic Colitis Grade 4
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Esophagitis Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Grade 2
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Function Abnormal Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinemia Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    2 / 77 (2.60%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Failure Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Groin Pain Grade 2
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological Fracture Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Spasm Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacteremia Grade 4
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eschericia Sepsis Grade 4
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Esophageal Candidiasis Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyoderma Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Related Infection Grade 4
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Related Sepsis Grade 4
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza Grade 4
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Grade 5
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung Infection Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic Sepsis Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Gastroenteritis
         subjects affected / exposed
    1 / 90 (1.11%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to Thrive Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration Grade 3
         subjects affected / exposed
    2 / 90 (2.22%)
    0 / 77 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcemia Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatremia Grade 3
         subjects affected / exposed
    1 / 90 (1.11%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased Appetite Grade 2
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased Appetite Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain Grade 3
         subjects affected / exposed
    0 / 90 (0.00%)
    1 / 77 (1.30%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 NKTR-102 TREATMENT OF PHYSICIAN’S CHOICE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    90 / 90 (100.00%)
    76 / 77 (98.70%)
    Investigations
    Neutrophil Count Decreased
         subjects affected / exposed
    6 / 90 (6.67%)
    10 / 77 (12.99%)
         occurrences all number
    9
    14
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    5 / 90 (5.56%)
    9 / 77 (11.69%)
         occurrences all number
    6
    13
    Weight Decreased
         subjects affected / exposed
    13 / 90 (14.44%)
    1 / 77 (1.30%)
         occurrences all number
    15
    1
    Alanine Aminotransferase Increased
         subjects affected / exposed
    2 / 90 (2.22%)
    9 / 77 (11.69%)
         occurrences all number
    3
    13
    Platelet Count Decreased
         subjects affected / exposed
    3 / 90 (3.33%)
    4 / 77 (5.19%)
         occurrences all number
    5
    10
    White blood cell count decreased
         subjects affected / exposed
    2 / 90 (2.22%)
    4 / 77 (5.19%)
         occurrences all number
    3
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 90 (20.00%)
    9 / 77 (11.69%)
         occurrences all number
    26
    11
    Dizziness
         subjects affected / exposed
    9 / 90 (10.00%)
    4 / 77 (5.19%)
         occurrences all number
    15
    8
    Neuropathy Peripheral
         subjects affected / exposed
    3 / 90 (3.33%)
    9 / 77 (11.69%)
         occurrences all number
    3
    13
    Dysgeusia
         subjects affected / exposed
    7 / 90 (7.78%)
    2 / 77 (2.60%)
         occurrences all number
    10
    5
    Seizure
         subjects affected / exposed
    2 / 90 (2.22%)
    4 / 77 (5.19%)
         occurrences all number
    8
    17
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    36 / 90 (40.00%)
    26 / 77 (33.77%)
         occurrences all number
    43
    31
    Asthenia
         subjects affected / exposed
    28 / 90 (31.11%)
    16 / 77 (20.78%)
         occurrences all number
    29
    27
    Pyrexia
         subjects affected / exposed
    6 / 90 (6.67%)
    7 / 77 (9.09%)
         occurrences all number
    9
    9
    Oedema Peripheral
         subjects affected / exposed
    6 / 90 (6.67%)
    5 / 77 (6.49%)
         occurrences all number
    12
    8
    Pain
         subjects affected / exposed
    5 / 90 (5.56%)
    4 / 77 (5.19%)
         occurrences all number
    6
    4
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    17 / 90 (18.89%)
    18 / 77 (23.38%)
         occurrences all number
    35
    28
    Anemia
         subjects affected / exposed
    11 / 90 (12.22%)
    17 / 77 (22.08%)
         occurrences all number
    14
    21
    Thrombocytopenia
         subjects affected / exposed
    5 / 90 (5.56%)
    5 / 77 (6.49%)
         occurrences all number
    11
    7
    Leukopenia
         subjects affected / exposed
    5 / 90 (5.56%)
    3 / 77 (3.90%)
         occurrences all number
    6
    4
    Eye disorders
    Vision Blurred
         subjects affected / exposed
    10 / 90 (11.11%)
    2 / 77 (2.60%)
         occurrences all number
    10
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    54 / 90 (60.00%)
    31 / 77 (40.26%)
         occurrences all number
    60
    36
    Diarrhea
         subjects affected / exposed
    66 / 90 (73.33%)
    15 / 77 (19.48%)
         occurrences all number
    195
    18
    Vomiting
         subjects affected / exposed
    34 / 90 (37.78%)
    17 / 77 (22.08%)
         occurrences all number
    65
    24
    Constipation
         subjects affected / exposed
    24 / 90 (26.67%)
    20 / 77 (25.97%)
         occurrences all number
    40
    21
    Abdominal Pain
         subjects affected / exposed
    19 / 90 (21.11%)
    11 / 77 (14.29%)
         occurrences all number
    30
    17
    Upper Abdominal Pain
         subjects affected / exposed
    6 / 90 (6.67%)
    3 / 77 (3.90%)
         occurrences all number
    9
    3
    Stomatitis
         subjects affected / exposed
    4 / 90 (4.44%)
    5 / 77 (6.49%)
         occurrences all number
    12
    6
    Abdominal Distension
         subjects affected / exposed
    7 / 90 (7.78%)
    1 / 77 (1.30%)
         occurrences all number
    15
    4
    Flatulence
         subjects affected / exposed
    5 / 90 (5.56%)
    1 / 77 (1.30%)
         occurrences all number
    7
    4
    Dyspepsia
         subjects affected / exposed
    5 / 90 (5.56%)
    0 / 77 (0.00%)
         occurrences all number
    5
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    11 / 90 (12.22%)
    14 / 77 (18.18%)
         occurrences all number
    21
    19
    Cough
         subjects affected / exposed
    9 / 90 (10.00%)
    7 / 77 (9.09%)
         occurrences all number
    13
    8
    Oropharyngeal Pain
         subjects affected / exposed
    5 / 90 (5.56%)
    1 / 77 (1.30%)
         occurrences all number
    6
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    10 / 90 (11.11%)
    9 / 77 (11.69%)
         occurrences all number
    16
    9
    Pruritus
         subjects affected / exposed
    6 / 90 (6.67%)
    4 / 77 (5.19%)
         occurrences all number
    8
    4
    Rash
         subjects affected / exposed
    3 / 90 (3.33%)
    5 / 77 (6.49%)
         occurrences all number
    5
    7
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    8 / 90 (8.89%)
    5 / 77 (6.49%)
         occurrences all number
    9
    5
    Anxiety
         subjects affected / exposed
    2 / 90 (2.22%)
    6 / 77 (7.79%)
         occurrences all number
    8
    8
    Depression
         subjects affected / exposed
    6 / 90 (6.67%)
    2 / 77 (2.60%)
         occurrences all number
    7
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 90 (5.56%)
    9 / 77 (11.69%)
         occurrences all number
    5
    12
    Pain in Extremity
         subjects affected / exposed
    6 / 90 (6.67%)
    8 / 77 (10.39%)
         occurrences all number
    7
    10
    Back pain
         subjects affected / exposed
    5 / 90 (5.56%)
    7 / 77 (9.09%)
         occurrences all number
    6
    9
    Muscle Spasms
         subjects affected / exposed
    8 / 90 (8.89%)
    2 / 77 (2.60%)
         occurrences all number
    8
    3
    Myalgia
         subjects affected / exposed
    2 / 90 (2.22%)
    8 / 77 (10.39%)
         occurrences all number
    3
    10
    Muscle Weakness
         subjects affected / exposed
    5 / 90 (5.56%)
    3 / 77 (3.90%)
         occurrences all number
    6
    4
    Bone Pain
         subjects affected / exposed
    5 / 90 (5.56%)
    1 / 77 (1.30%)
         occurrences all number
    5
    2
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 90 (0.00%)
    4 / 77 (5.19%)
         occurrences all number
    0
    8
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    8 / 90 (8.89%)
    3 / 77 (3.90%)
         occurrences all number
    6
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    33 / 90 (36.67%)
    14 / 77 (18.18%)
         occurrences all number
    41
    21
    Hypokalemia
         subjects affected / exposed
    16 / 90 (17.78%)
    4 / 77 (5.19%)
         occurrences all number
    34
    13
    Dehydration
         subjects affected / exposed
    9 / 90 (10.00%)
    1 / 77 (1.30%)
         occurrences all number
    13
    3
    Hypocalcemia
         subjects affected / exposed
    8 / 90 (8.89%)
    1 / 77 (1.30%)
         occurrences all number
    18
    2
    Hypoalbuminemia
         subjects affected / exposed
    5 / 90 (5.56%)
    1 / 77 (1.30%)
         occurrences all number
    14
    2

    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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