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    Clinical Trial Results:
    A Single-arm Open-label International Multi-center Study Of The Efficacy And Safety Of Sunitinib Malate (SU011248, Sutent (Registered)) In Patients With Progressive Advanced Metastatic Well-differentiated Unresectable Pancreatic Neuroendocrine Tumors

    Summary
    EudraCT number
    2011-004363-74
    Trial protocol
    CZ   NL   HU   ES   BE   PT   PL   SK   EE   IT  
    Global end of trial date
    26 Jul 2018

    Results information
    Results version number
    v2(current)
    This version publication date
    31 Jul 2019
    First version publication date
    26 Mar 2017
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    A6181202
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01525550
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 800-718-1021, 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
    13 Dec 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To confirm sunitinib treatment effect on progression-free survival (PFS) per investigator assessment in subjects with advanced/metastatic, well-differentiated, unresectable, pancreatic neuroendocrine tumors per Response Evaluation Criteria in Solid Tumors (RECIST 1.0).
    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 Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Jun 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    China: 31
    Country: Number of subjects enrolled
    Czech Republic: 10
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Hungary: 5
    Country: Number of subjects enrolled
    India: 2
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Japan: 4
    Country: Number of subjects enrolled
    Norway: 6
    Country: Number of subjects enrolled
    Romania: 12
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    South Africa: 3
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United States: 4
    Worldwide total number of subjects
    106
    EEA total number of subjects
    58
    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)
    92
    From 65 to 84 years
    14
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted for a total of 106 subjects between 6 June 2012 and 26 July 2018. "End of treatment” for outcome measures of ECOG-PS, EORTC QLQ-C30 and EORTC QLQ-GI NET 21 was up to “primary completion date” (PCD) only.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Sunitinib: Treatment Naive Cohort
    Arm description
    Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive subjects.
    Arm type
    Experimental

    Investigational medicinal product name
    Sunitinib 37.5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle.

    Arm title
    Sunitinib: Later-Line Cohort
    Arm description
    Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (subjects who developed progressive disease on or after prior systemic therapy).
    Arm type
    Experimental

    Investigational medicinal product name
    Sunitinib 37.5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle.

    Number of subjects in period 1
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Started
    61
    45
    Completed
    0
    0
    Not completed
    61
    45
         Death
    19
    28
         Unspecified
    -
    4
         Consent withdrawn by subject
    4
    -
         Sponsor Decision
    30
    11
         Lost to follow-up
    8
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sunitinib: Treatment Naive Cohort
    Reporting group description
    Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive subjects.

    Reporting group title
    Sunitinib: Later-Line Cohort
    Reporting group description
    Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (subjects who developed progressive disease on or after prior systemic therapy).

    Reporting group values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort Total
    Number of subjects
    61 45 106
    Age categorical
    Units: Subjects
        18-64 years
    53 39 92
        65-84 years
    8 6 14
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    55.4 ± 8.9 53.5 ± 9.1 -
    Gender, Male/Female
    Units: Subjects
        Female
    31 12 43
        Male
    30 33 63

    End points

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    End points reporting groups
    Reporting group title
    Sunitinib: Treatment Naive Cohort
    Reporting group description
    Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive subjects.

    Reporting group title
    Sunitinib: Later-Line Cohort
    Reporting group description
    Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (subjects who developed progressive disease on or after prior systemic therapy).

    Primary: Progression-Free Survival (PFS): Investigator Assessment

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    End point title
    Progression-Free Survival (PFS): Investigator Assessment [1]
    End point description
    Investigator assessed PFS was defined as time (in months) from date of enrollment in study to date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the subject was censored at date of subject’s last progression-free tumor assessment prior to study cut-off date. Progression as per RECIST version 1.0 criteria was defined as: greater than or equal to (>=) 20 percent increase in sum of longest diameter (LD) of target lesions taking as a reference smallest sum of the LD recorded since treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. FAS included all subjects who were enrolled into study regardless of whether subjects received study drug or not.
    End point type
    Primary
    End point timeframe
    Baseline until disease progression or death due to any cause (up to 1226 days)
    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 statistics were planned for this endpoint
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: months
        median (confidence interval 95%)
    13.2 (7.4 to 16.8)
    13.0 (9.2 to 20.4)
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment

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    End point title
    Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment
    End point description
    IRR assessed PFS was defined as the time (in months) from the date of enrollment in study until the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the subject was censored at the date of the subject’s last progression-free tumor assessment prior to the study cut-off date. Progression as per RECIST 1.0 criteria was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.
    End point type
    Secondary
    End point timeframe
    Baseline until disease progression or death due to any cause (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: months
        median (confidence interval 95%)
    11.1 (5.5 to 16.7)
    9.5 (7.4 to 18.4)
    No statistical analyses for this end point

    Secondary: Time to Tumor Progression (TTP): Investigator Assessment

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    End point title
    Time to Tumor Progression (TTP): Investigator Assessment
    End point description
    Investigator assessed TTP was defined as the time (in months) from the date of enrollment in study until the date of first documentation of objective tumor progression. TTP calculated as (first event date minus date of enrollment plus 1)/30.4. Progression as per RECIST 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. FAS included all subjects who were enrolled into the study regardless of whether they received study drug or not.
    End point type
    Secondary
    End point timeframe
    Baseline until first documented tumor progression (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: months
        median (confidence interval 95%)
    14.8 (7.5 to 16.8)
    14.5 (9.2 to 20.4)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    Overall Survival (OS)
    End point description
    OS was defined as the time (in months) from date of enrollment in study to the date of death due to any cause. If death was not observed, the subject was censored at the earliest of the last date the subject was known to be alive or the study cut-off date. Here, "99999" for median and confidence interval (CI) signifies data not available (NA) due to the less number of participants who had event. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.
    End point type
    Secondary
    End point timeframe
    Baseline until death or study cut-off (up to 1939 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: Months
        median (confidence interval 95%)
    99999 (41.7 to 99999)
    37.9 (22.9 to 56.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Objective Response (OR): Investigator Assessment

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    End point title
    Percentage of Subjects With Objective Response (OR): Investigator Assessment
    End point description
    Investigator assessed OR in subjects was defined as having a complete response (CR) or partial response (PR) according to RECIST 1.0 and sustained for at least 4 weeks. CR was defined as disappearance of all target and non-target lesions. PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Percentage of subjects with investigator assessed OR were reported. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.
    End point type
    Secondary
    End point timeframe
    Baseline until disease progression or death due to any cause (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: percentage of subjects
        number (confidence interval 95%)
    21.3 (11.9 to 33.7)
    28.9 (16.4 to 44.3)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR): Investigator Assessment

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    End point title
    Duration of Response (DOR): Investigator Assessment
    End point description
    Investigator assessed DOR was defined as time (in months) from date of first documented objective tumor response (CR or PR) that was subsequently confirmed to first documented objective tumor progression or death due to any cause, whichever occurred first according to RECIST 1.0 and sustained for at least 4 weeks, confirmed by repeat tumor assessments. CR: disappearance of all target and non-target lesions. PR: >=30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD. Progression as per RECIST version 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. Here, "99999" for CI signifies data not available (NA) due to the less number of subjects who had event. Subset of FAS which included all subjects who had response.
    End point type
    Secondary
    End point timeframe
    Baseline until disease progression or death due to any cause (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    13
    13
    Units: months
        median (confidence interval 95%)
    19.1 (10.1 to 99999)
    14.7 (5.5 to 21.9)
    No statistical analyses for this end point

    Secondary: Time to Tumor Response (TTR): Investigator Assessment

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    End point title
    Time to Tumor Response (TTR): Investigator Assessment
    End point description
    Investigator assessed TTR was defined as the time (in months) from date of enrollment in study until date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. As per RECIST 1.0, CR was defined as disappearance of all target and non-target lesions and PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Subset of FAS which included all subjects who had response.
    End point type
    Secondary
    End point timeframe
    Baseline until first documented objective tumor response (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    13
    13
    Units: months
        median (full range (min-max))
    3.8 (1.0 to 11.1)
    3.8 (1.0 to 9.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Objective Response: Independent Radiological Review (IRR) Assessment

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    End point title
    Percentage of Subjects With Objective Response: Independent Radiological Review (IRR) Assessment
    End point description
    IRR assessed OR in subjects was defined as having a CR or PR according to Choi criteria and sustained for at least 4 weeks. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on Computed tomography (CT) with no new lesions and no obvious progression of non-measurable disease. Percentage of subjects with objective response were reported in this endpoint. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.
    End point type
    Secondary
    End point timeframe
    Baseline until disease progression or death due to any cause (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: percentage of subjects
        number (confidence interval 95%)
    52.5 (39.3 to 65.4)
    55.6 (40.0 to 70.4)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR): Independent Radiological Review (IRR) Assessment

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    End point title
    Duration of Response (DOR): Independent Radiological Review (IRR) Assessment
    End point description
    IRR assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR) that was subsequently confirmed to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease. Here, "99999" for median and CI signifies data not available (NA) due to the small number of subjects who encountered tumor progression or death. Subset of FAS which included all subjects who had response.
    End point type
    Secondary
    End point timeframe
    Baseline until disease progression or death due to any cause (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    32
    25
    Units: months
        number (confidence interval 95%)
    99999 (17.8 to 99999)
    19.2 (15.7 to 35.9)
    No statistical analyses for this end point

    Secondary: Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment

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    End point title
    Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment
    End point description
    IRR assessed TTR was defined as the time (in months) from date of enrollment in study until first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of response. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease. Subset of FAS which included all subjects who had response.
    End point type
    Secondary
    End point timeframe
    Baseline until first documented objective tumor response (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    32
    25
    Units: months
        median (full range (min-max))
    1.0 (0.8 to 7.3)
    1.0 (0.9 to 3.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Chromogranin A (CgA) Response

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    End point title
    Percentage of Subjects With Chromogranin A (CgA) Response
    End point description
    CgA response in subjects was defined as having confirmed CgA CR or CgA PR, relative to the population with an elevated baseline CgA value in the blood. CgA CR was defined as decrease from a high baseline value of CgA in the blood to one that fell within the normal range. CgA PR was defined as a decrease of greater than or equal to 50 percent from a high baseline value of CgA. Normal baseline value of CgA in blood was 39.0 ng/mL. Confirmed responses were those that persisted for at least 4 weeks after initial documentation of response. Blood levels of CgA were assessed and percentage of subjects with CgA response were reported. FAS included all subjects who were enrolled into the study regardless of whether subjects received study drug or not.
    End point type
    Secondary
    End point timeframe
    Baseline until CgA response or death due to any cause (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: percentage of subjects
        number (confidence interval 95%)
    16.4 (9.6 to 32.5)
    11.1 (4.0 to 25.6)
    No statistical analyses for this end point

    Secondary: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

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    End point title
    Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
    End point description
    EORTC QLQ-C30: cancer-specific instrument with 30 questions to assess subject quality of life (QOL).First 28 questions used for evaluating 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, vomiting, pain)and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Questions assessed on 4-point scale(1=not at all, 2=a little, 3=quite a bit, 4=very much), high score=high level of problem.Last 2 questions used for evaluating global health status/QOL. Each question was assessed on 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning. Here, "99999" for mean and standard deviation signifies data not available (NA) as none of subjects were evaluable in given group at this time point. FAS population and 'n' signifies those subjects who were evaluable at specified time point for each arm.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: units on a scale
    arithmetic mean (standard deviation)
        Global health status:Cycle 1 (n=61,43)
    71.31 ± 21.111
    66.09 ± 20.282
        Global health status: Cycle 2 (n=56,41)
    69.94 ± 19.311
    65.45 ± 20.880
        Global health status: Cycle 3 (n=55,40)
    70.30 ± 21.502
    60.83 ± 26.768
        Global health status: Cycle 4 (n=50,38)
    70.00 ± 21.429
    61.84 ± 25.010
        Global health status: Cycle 5 (n=47,34)
    69.15 ± 19.421
    65.93 ± 24.306
        Global health status: Cycle 6 (n=43,31)
    68.41 ± 18.053
    65.32 ± 20.310
        Global health status: Cycle 7 (n=39,29)
    68.38 ± 21.132
    61.21 ± 24.016
        Global health status: Cycle 8 (n=37,25)
    70.05 ± 17.062
    65.33 ± 20.649
        Global health status: Cycle 9 (n=35,26)
    66.90 ± 20.058
    65.71 ± 20.045
        Global health status: Cycle 10 (n=35,23)
    68.10 ± 20.561
    63.04 ± 18.434
        Global health status: Cycle 11 (n=35,24)
    63.81 ± 21.384
    66.67 ± 19.812
        Global health status: Cycle 12 (n=35,22)
    65.71 ± 22.395
    64.77 ± 22.848
        Global health status: Cycle 13 (n=34,21)
    67.89 ± 20.733
    66.67 ± 19.365
        Global health status: Cycle 14 (n=31,19)
    68.28 ± 20.797
    57.89 ± 18.937
        Global health status: Cycle 15 (n=30,17)
    66.67 ± 22.318
    64.71 ± 21.757
        Global health status: Cycle 16 (n=27,16)
    64.51 ± 21.005
    67.19 ± 17.339
        Global health status: Cycle 17 (n=22,15)
    62.50 ± 23.110
    67.78 ± 15.706
        Global health status: Cycle 18 (n=17,14)
    58.33 ± 24.826
    70.83 ± 18.125
        Global health status: Cycle 19 (n=12,14)
    54.86 ± 24.736
    66.67 ± 20.672
        Global health status: Cycle 20 (n=11,13)
    55.30 ± 25.893
    64.74 ± 17.398
        Global health status: Cycle 21 (n=11,12)
    55.30 ± 23.650
    65.28 ± 18.407
        Global health status: Cycle 22 (n=11,11)
    56.06 ± 23.889
    62.88 ± 27.224
        Global health status: Cycle 23 (n=11,10)
    56.82 ± 24.386
    59.17 ± 20.953
        Global health status: Cycle 24 (n=10,10)
    50.00 ± 23.570
    60.83 ± 19.265
        Global health status: Cycle 25 (n=10,8)
    51.67 ± 19.954
    61.46 ± 16.022
        Global health status: Cycle 26 (n=7,7)
    50.00 ± 20.972
    65.48 ± 13.968
        Global health status: Cycle 27 (n=6,8)
    41.67 ± 12.910
    61.46 ± 17.216
        Global health status: Cycle 28 (n=7,8)
    44.05 ± 20.813
    61.46 ± 16.022
        Global health status: Cycle 29 (n=5,7)
    56.67 ± 19.003
    63.10 ± 16.567
        Global health status: Cycle 30 (n=4,7)
    52.08 ± 21.916
    64.29 ± 14.996
        Global health status: Cycle 31 (n=2,7)
    58.33 ± 11.785
    60.71 ± 20.813
        Global health status: Cycle 32 (n=3,6)
    61.11 ± 19.245
    59.72 ± 15.290
        Global health status: Cycle 33 (n=3,6)
    61.11 ± 12.729
    55.56 ± 22.771
        Global health status: Cycle 34 (n=3,6)
    58.33 ± 25.000
    55.56 ± 20.861
        Global health status: Cycle 35 (n=2,6)
    66.67 ± 23.570
    61.11 ± 13.608
        Global health status: Cycle 36 (n=1,5)
    83.33 ± 99999
    58.33 ± 16.667
        Global health status: Cycle 37 (n=1,4)
    83.33 ± 99999
    58.33 ± 21.517
        Global health status: Cycle 38 (n=0,4)
    99999 ± 99999
    58.33 ± 21.517
        Global health status: Cycle 39 (n=1,3)
    83.33 ± 99999
    50.00 ± 16.667
        Global health status: Cycle 40 (n=1,3)
    83.33 ± 99999
    50.00 ± 16.667
        Global health status: Cycle 41 (n=0,3)
    99999 ± 99999
    50.00 ± 16.667
        Global health status: Cycle 42 (n=0,2)
    99999 ± 99999
    45.83 ± 5.893
        Global health status: Cycle 43 (n=0,1)
    99999 ± 99999
    50.00 ± 99999
        Global health status: EOT (n=33,30)
    60.10 ± 22.318
    50.00 ± 22.210
        Physical Functioning: Cycle 1 (n=61,44)
    90.38 ± 14.733
    86.93 ± 12.677
        Physical Functioning: Cycle 2 (n=57,42)
    89.71 ± 10.988
    86.51 ± 13.929
        Physical Functioning: Cycle 3 (n=55,40)
    88.73 ± 12.886
    85.00 ± 17.263
        Physical Functioning: Cycle 4 (n=50,38)
    89.07 ± 10.412
    83.68 ± 16.958
        Physical Functioning: Cycle 5 (n=47,34)
    88.23 ± 11.311
    87.06 ± 17.519
        Physical Functioning: Cycle 6 (n=43,31)
    87.91 ± 11.293
    83.44 ± 18.924
        Physical Functioning: Cycle 7 (n=39,29)
    86.24 ± 12.891
    84.14 ± 15.473
        Physical Functioning: Cycle 8 (n=37,25)
    85.23 ± 12.486
    88.27 ± 11.102
        Physical Functioning: Cycle 9 (n=35,26)
    84.00 ± 13.255
    87.18 ± 14.474
        Physical Functioning: Cycle 10 (n=35,23)
    86.67 ± 11.771
    87.25 ± 15.943
        Physical Functioning: Cycle 11 (n=35,24)
    84.19 ± 12.944
    90.83 ± 10.552
        Physical Functioning: Cycle 12 (n=35,22)
    84.38 ± 15.419
    88.48 ± 11.489
        Physical Functioning: Cycle 13 (n=34,21)
    87.45 ± 11.808
    89.52 ± 10.016
        Physical Functioning: Cycle 14 (n=31,19)
    86.67 ± 12.996
    86.67 ± 10.423
        Physical Functioning: Cycle 15 (n=30,17)
    85.33 ± 11.534
    89.02 ± 11.041
        Physical Functioning: Cycle 16 (n=27,16)
    83.70 ± 18.053
    89.58 ± 10.319
        Physical Functioning: Cycle 17 (n=22,15)
    82.42 ± 16.657
    88.00 ± 9.155
        Physical Functioning: Cycle 18 (n=17,14)
    82.35 ± 18.248
    90.95 ± 8.516
        Physical Functioning: Cycle 19 (n=12,14)
    75.00 ± 22.406
    89.52 ± 9.324
        Physical Functioning: Cycle 20 (n=11,13)
    74.55 ± 20.181
    89.74 ± 8.439
        Physical Functioning: Cycle 21 (n=11,12)
    75.15 ± 17.911
    90.00 ± 7.785
        Physical Functioning: Cycle 22 (n=11,11)
    77.58 ± 22.563
    81.82 ± 24.782
        Physical Functioning: Cycle 23 (n=11,10)
    77.73 ± 18.170
    82.67 ± 14.470
        Physical Functioning: Cycle 24 (n=10,10)
    72.67 ± 22.760
    82.67 ± 14.807
        Physical Functioning: Cycle 25 (n=10,8)
    74.67 ± 23.685
    89.17 ± 10.653
        Physical Functioning: Cycle 26 (n=7,7)
    66.67 ± 25.531
    83.81 ± 13.801
        Physical Functioning: Cycle 27 (n=6,8)
    62.22 ± 27.217
    85.83 ± 12.051
        Physical Functioning: Cycle 28 (n=7,8)
    69.52 ± 21.381
    87.50 ± 11.513
        Physical Functioning: Cycle 29 (n=6,7)
    80.00 ± 10.328
    83.81 ± 15.803
        Physical Functioning: Cycle 30 (n=5,7)
    84.00 ± 3.651
    84.76 ± 11.362
        Physical Functioning: Cycle 31 (n=3,7)
    77.78 ± 10.184
    85.71 ± 13.569
        Physical Functioning: Cycle 32 (n=3,6)
    84.44 ± 3.849
    82.22 ± 10.037
        Physical Functioning: Cycle 33 (n=3,6)
    73.33 ± 6.667
    83.33 ± 10.954
        Physical Functioning: Cycle 34 (n=3,6)
    64.44 ± 21.430
    80.00 ± 12.649
        Physical Functioning: Cycle 35 (n=2,6)
    70.00 ± 23.570
    78.89 ± 12.939
        Physical Functioning: Cycle 36 (n=1,5)
    86.67 ± 99999
    80.00 ± 9.428
        Physical Functioning: Cycle 37 (n=1,4)
    86.67 ± 99999
    76.67 ± 3.849
        Physical Functioning: Cycle 38 (n=0,4)
    99999 ± 99999
    75.00 ± 6.383
        Physical Functioning: Cycle 39 (n=1,3)
    86.67 ± 99999
    77.78 ± 3.849
        Physical Functioning: Cycle 40 (n=1,3)
    93.33 ± 99999
    71.11 ± 10.184
        Physical Functioning: Cycle 41 (n=0,3)
    99999 ± 99999
    77.78 ± 10.184
        Physical Functioning: Cycle 42 (n=0,2)
    99999 ± 99999
    80.00 ± 0.000
        Physical Functioning: Cycle 43 (n=0,1)
    99999 ± 99999
    80.00 ± 99999
        Physical Functioning: EOT(n=33,30)
    76.16 ± 23.454
    78.00 ± 19.191
        Role Functioning: Cycle 1 (n=60,44)
    88.33 ± 20.424
    85.61 ± 18.880
        Role Functioning: Cycle 2 (n=57,42)
    85.67 ± 17.089
    80.56 ± 25.214
        Role Functioning: Cycle 3 (n=55,40)
    85.15 ± 18.613
    80.83 ± 25.473
        Role Functioning: Cycle 4 (n=50,38)
    84.67 ± 17.444
    80.26 ± 23.841
        Role Functioning: Cycle 5 (n=47,34)
    85.82 ± 19.343
    82.35 ± 23.904
        Role Functioning: Cycle 6 (n=43,31)
    86.05 ± 16.639
    79.57 ± 25.353
        Role Functioning: Cycle 7 (n=39,29)
    83.33 ± 21.965
    81.03 ± 24.285
        Role Functioning: Cycle 8 (n=37,25)
    80.63 ± 19.049
    85.33 ± 16.887
        Role Functioning: Cycle 9 (n=35,26)
    76.19 ± 22.968
    80.77 ± 22.945
        Role Functioning: Cycle 10 (n=35,23)
    82.86 ± 18.737
    83.33 ± 23.028
        Role Functioning: Cycle 11 (n=35,24)
    79.52 ± 22.537
    86.11 ± 18.822
        Role Functioning: Cycle 12 (n=35,22)
    79.52 ± 20.246
    84.85 ± 19.182
        Role Functioning: Cycle 13 (n=34,21)
    82.35 ± 19.219
    84.13 ± 17.059
        Role Functioning: Cycle 14 (n=31,19)
    81.72 ± 20.346
    79.82 ± 19.704
        Role Functioning: Cycle 15 (n=30,17)
    77.22 ± 22.946
    77.45 ± 22.777
        Role Functioning: Cycle 16 (n=27,16)
    77.16 ± 24.956
    84.38 ± 15.478
        Role Functioning: Cycle 17 (n=22,15)
    74.24 ± 24.520
    82.22 ± 17.213
        Role Functioning: Cycle 18 (n=17,14)
    75.49 ± 28.332
    84.52 ± 16.621
        Role Functioning: Cycle 19 (n=12,14)
    66.67 ± 26.591
    79.76 ± 20.856
        Role Functioning: Cycle 20 (n=11,13)
    69.70 ± 27.707
    80.77 ± 19.059
        Role Functioning: Cycle 21 (n=11,12)
    68.18 ± 27.340
    79.17 ± 23.704
        Role Functioning: Cycle 22 (n=11,11)
    68.18 ± 29.302
    71.21 ± 29.899
        Role Functioning: Cycle 23 (n=11,10)
    63.64 ± 30.567
    71.67 ± 24.907
        Role Functioning: Cycle 24 (n=10,10)
    60.00 ± 27.442
    76.67 ± 22.498
        Role Functioning: Cycle 25 (n=10,8)
    58.33 ± 30.682
    77.08 ± 23.465
        Role Functioning: Cycle 26 (n=7,7)
    57.14 ± 30.211
    83.33 ± 16.667
        Role Functioning: Cycle 27 (n=6,8)
    58.33 ± 36.132
    77.08 ± 23.465
        Role Functioning: Cycle 28 (n=7,8)
    59.52 ± 18.898
    79.17 ± 24.801
        Role Functioning: Cycle 29 (n=6,7)
    75.00 ± 13.944
    78.57 ± 24.934
        Role Functioning: Cycle 30 (n=5,7)
    90.00 ± 14.907
    76.19 ± 25.198
        Role Functioning: Cycle 31 (n=3,7)
    83.33 ± 16.667
    78.57 ± 24.934
        Role Functioning: Cycle 32 (n=3,6)
    94.44 ± 9.623
    77.78 ± 20.184
        Role Functioning: Cycle 33 (n=3,6)
    88.89 ± 19.245
    72.22 ± 25.092
        Role Functioning: Cycle 34 (n=3,6)
    72.22 ± 34.694
    69.44 ± 30.581
        Role Functioning: Cycle 35 (n=2,6)
    75.00 ± 35.355
    72.22 ± 25.092
        Role Functioning: Cycle 36 (n=1,5)
    100.00 ± 99999
    73.33 ± 19.003
        Role Functioning: Cycle 37 (n=1,4)
    66.67 ± 99999
    70.83 ± 28.464
        Role Functioning: Cycle 38 (n=0,4)
    99999 ± 99999
    66.67 ± 27.217
        Role Functioning: Cycle 39 (n=1,3)
    100.00 ± 99999
    55.56 ± 19.245
        Role Functioning: Cycle 40 (n=1,3)
    100.00 ± 99999
    55.56 ± 9.623
        Role Functioning: Cycle 41 (n=0,3)
    99999 ± 99999
    55.56 ± 19.245
        Role Functioning: Cycle 42 (n=0,2)
    99999 ± 99999
    66.67 ± 0.000
        Role Functioning: Cycle 43 (n=0,1)
    99999 ± 99999
    66.67 ± 99999
        Role Functioning: EOT (n=33,30)
    70.71 ± 26.031
    65.56 ± 36.075
        Emotional Functioning: Cycle 1 (n=61,43)
    80.19 ± 18.644
    76.23 ± 18.238
        Emotional Functioning: Cycle 2 (n=57,41)
    84.31 ± 17.619
    77.64 ± 17.021
        Emotional Functioning: Cycle 3 (n=55,40)
    82.53 ± 18.792
    73.96 ± 24.401
        Emotional Functioning: Cycle 4 (n=50,38)
    82.67 ± 16.906
    77.41 ± 22.167
        Emotional Functioning: Cycle 5 (n=47,34)
    82.09 ± 18.632
    79.66 ± 21.141
        Emotional Functioning: Cycle 6 (n=43,31)
    82.17 ± 17.871
    73.92 ± 24.696
        Emotional Functioning: Cycle 7 (n=39,29)
    80.56 ± 21.059
    73.56 ± 26.075
        Emotional Functioning: Cycle 8 (n=37,25)
    80.63 ± 21.877
    76.00 ± 18.991
        Emotional Functioning: Cycle 9 (n=35,26)
    80.24 ± 19.812
    76.92 ± 18.304
        Emotional Functioning: Cycle 10 (n=35,23)
    81.27 ± 19.818
    76.45 ± 21.998
        Emotional Functioning: Cycle 11 (n=35,24)
    79.76 ± 19.311
    75.46 ± 20.587
        Emotional Functioning: Cycle 12 (n=35,22)
    78.10 ± 23.052
    75.76 ± 22.700
        Emotional Functioning: Cycle 13 (n=34,21)
    77.45 ± 22.429
    77.38 ± 19.211
        Emotional Functioning: Cycle 14 (n=31,19)
    78.49 ± 20.387
    75.00 ± 24.375
        Emotional Functioning: Cycle 15 (n=30,17)
    80.00 ± 21.173
    74.51 ± 23.839
        Emotional Functioning: Cycle 16 (n=27,16)
    82.10 ± 22.133
    75.00 ± 24.343
        Emotional Functioning: Cycle 17 (n=22,15)
    79.92 ± 23.522
    79.44 ± 19.382
        Emotional Functioning: Cycle 18 (n=17,14)
    78.92 ± 23.592
    76.19 ± 25.499
        Emotional Functioning: Cycle 19 (n=12,14)
    73.61 ± 28.611
    73.81 ± 25.288
        Emotional Functioning: Cycle 20 (n=11,13)
    71.21 ± 29.666
    78.85 ± 25.823
        Emotional Functioning: Cycle 21 (n=11,12)
    76.52 ± 28.824
    75.00 ± 25.624
        Emotional Functioning: Cycle 22 (n=11,11)
    75.76 ± 30.834
    78.03 ± 22.445
        Emotional Functioning: Cycle 23 (n=11,10)
    74.24 ± 30.834
    75.00 ± 27.778
        Emotional Functioning: Cycle 24 (n=10,10)
    71.67 ± 28.921
    76.67 ± 22.153
        Emotional Functioning: Cycle 25 (n=10,8)
    65.83 ± 33.206
    66.67 ± 29.881
        Emotional Functioning: Cycle 26 (n=7,7)
    71.43 ± 34.979
    77.38 ± 17.156
        Emotional Functioning: Cycle 27 (n=6,8)
    56.94 ± 32.667
    68.75 ± 29.124
        Emotional Functioning: Cycle 28 (n=7,8)
    65.48 ± 34.166
    68.75 ± 29.463
        Emotional Functioning: Cycle 29 (n=5,7)
    68.33 ± 29.698
    71.43 ± 31.127
        Emotional Functioning: Cycle 30 (n=4,7)
    72.92 ± 29.950
    70.24 ± 31.497
        Emotional Functioning: Cycle 31 (n=2,7)
    45.83 ± 17.678
    72.62 ± 26.227
        Emotional Functioning: Cycle 32 (n=3,6)
    69.44 ± 29.266
    69.44 ± 33.610
        Emotional Functioning: Cycle 33 (n=3,6)
    77.78 ± 19.245
    70.83 ± 27.764
        Emotional Functioning: Cycle 34 (n=3,6)
    66.67 ± 33.333
    66.67 ± 34.561
        Emotional Functioning: Cycle 35 (n=2,6)
    83.33 ± 23.570
    68.06 ± 33.918
        Emotional Functioning: Cycle 36 (n=1,5)
    100.00 ± 99999
    71.67 ± 31.513
        Emotional Functioning: Cycle 37 (n=1,4)
    100.00 ± 99999
    77.08 ± 35.600
        Emotional Functioning: Cycle 38 (n=0,4)
    99999 ± 99999
    70.83 ± 42.219
        Emotional Functioning: Cycle 39 (n=1,3)
    100.00 ± 99999
    63.89 ± 48.829
        Emotional Functioning: Cycle 40(n=1,3)
    100.00 ± 99999
    66.67 ± 38.188
        Emotional Functioning: Cycle 41(n=0,3)
    99999 ± 99999
    58.33 ± 41.667
        Emotional Functioning: Cycle 42(n=0,2)
    99999 ± 99999
    54.17 ± 64.818
        Emotional Functioning: Cycle 43(n=0,1)
    99999 ± 99999
    100.00 ± 99999
        Emotional Functioning: EOT (n=33,30)
    67.17 ± 23.748
    66.94 ± 27.024
        Cognitive Functioning: Cycle 1 (n=61,43)
    90.16 ± 15.329
    88.76 ± 15.310
        Cognitive Functioning: Cycle 2 (n=57,41)
    88.89 ± 15.537
    89.43 ± 13.310
        Cognitive Functioning: Cycle 3 (n=55,40)
    89.09 ± 15.119
    87.50 ± 19.882
        Cognitive Functioning: Cycle 4 (n=50,38)
    89.67 ± 12.993
    87.72 ± 15.346
        Cognitive Functioning: Cycle 5 (n=47,34)
    88.65 ± 15.583
    85.29 ± 22.385
        Cognitive Functioning: Cycle 6 (n=43,31)
    89.53 ± 15.006
    82.80 ± 25.993
        Cognitive Functioning: Cycle 7 (n=39,29)
    89.74 ± 14.618
    85.06 ± 20.091
        Cognitive Functioning: Cycle 8 (n=37,25)
    87.39 ± 13.836
    83.33 ± 21.517
        Cognitive Functioning: Cycle 9 (n=35,26)
    88.10 ± 16.455
    85.26 ± 20.181
        Cognitive Functioning: Cycle 10 (n=35,23)
    88.10 ± 13.750
    83.33 ± 21.320
        Cognitive Functioning: Cycle 11 (n=35,24)
    86.67 ± 16.068
    86.11 ± 17.492
        Cognitive Functioning: Cycle 12 (n=35,22)
    86.67 ± 13.886
    86.36 ± 18.993
        Cognitive Functioning: Cycle 13 (n=34,21)
    87.25 ± 15.922
    85.71 ± 19.211
        Cognitive Functioning: Cycle 14 (n=31,19)
    88.71 ± 13.185
    77.19 ± 22.368
        Cognitive Functioning: Cycle 15 (n=30,17)
    88.33 ± 12.495
    80.39 ± 27.154
        Cognitive Functioning: Cycle 16 (n=27,16)
    88.27 ± 12.067
    80.21 ± 24.509
        Cognitive Functioning: Cycle 17 (n=22,15)
    89.39 ± 12.112
    84.44 ± 20.380
        Cognitive Functioning: Cycle 18 (n=17,14)
    88.24 ± 14.148
    79.76 ± 24.615
        Cognitive Functioning: Cycle 19 (n=12,14)
    88.89 ± 12.975
    78.57 ± 24.832
        Cognitive Functioning: Cycle 20 (n=11,13)
    90.91 ± 11.459
    82.05 ± 24.964
        Cognitive Functioning: Cycle 21 (n=11,12)
    89.39 ± 11.237
    76.39 ± 26.071
        Cognitive Functioning: Cycle 22 (n=11,11)
    86.36 ± 12.513
    81.82 ± 20.350
        Cognitive Functioning: Cycle 23 (n=11,10)
    84.85 ± 11.677
    76.67 ± 27.442
        Cognitive Functioning: Cycle 24 (n=10,10)
    85.00 ± 16.574
    81.67 ± 19.954
        Cognitive Functioning: Cycle 25 (n=10,8)
    81.67 ± 18.342
    75.00 ± 25.198
        Cognitive Functioning: Cycle 26(n=7,7)
    85.71 ± 20.250
    85.71 ± 17.817
        Cognitive Functioning: Cycle 27(n=6,8)
    75.00 ± 20.412
    77.08 ± 25.099
        Cognitive Functioning: Cycle 28(n=7,8)
    76.19 ± 18.898
    72.92 ± 29.463
        Cognitive Functioning: Cycle 29(n=5,7)
    76.67 ± 14.907
    78.57 ± 26.726
        Cognitive Functioning: Cycle 30(n=4,7)
    75.00 ± 16.667
    76.19 ± 31.706
        Cognitive Functioning: Cycle 31(n=2,7)
    83.33 ± 23.570
    73.81 ± 31.706
        Cognitive Functioning: Cycle 32(n=3,6)
    83.33 ± 16.667
    69.44 ± 32.347
        Cognitive Functioning: Cycle 33(n=3,6)
    88.89 ± 19.245
    69.44 ± 26.701
        Cognitive Functioning: Cycle 34(n=3,6)
    77.78 ± 9.623
    66.67 ± 34.960
        Cognitive Functioning: Cycle 35(n=2,6)
    100.00 ± 0.000
    75.00 ± 27.386
        Cognitive Functioning: Cycle 36(n=1,5)
    100.00 ± 99999
    73.33 ± 34.561
        Cognitive Functioning: Cycle 37(n=1,4)
    100.00 ± 99999
    75.00 ± 39.675
        Cognitive Functioning: Cycle 38(n=0,4)
    99999 ± 99999
    70.83 ± 47.871
        Cognitive Functioning: Cycle 39(n=1,3)
    100.00 ± 99999
    72.22 ± 34.694
        Cognitive Functioning: Cycle 40(n=1,3)
    83.33 ± 99999
    61.11 ± 34.694
        Cognitive Functioning: Cycle 41(n=0,3)
    99999 ± 99999
    61.11 ± 41.944
        Cognitive Functioning: Cycle 42(n=0,2)
    99999 ± 99999
    50.00 ± 70.711
        Cognitive Functioning: Cycle 43(n=0,1)
    99999 ± 99999
    100.00 ± 99999
        Cognitive Functioning: EOT (n=33,30)
    83.33 ± 17.180
    78.33 ± 23.631
        Social Functioning: Cycle 1 (n=61,43)
    80.87 ± 23.734
    79.46 ± 25.675
        Social Functioning: Cycle 2 (n=57,41)
    83.04 ± 20.288
    82.93 ± 20.578
        Social Functioning: Cycle 3 (n=55,40)
    79.09 ± 23.399
    77.08 ± 26.335
        Social Functioning: Cycle 4 (n=50,38)
    81.67 ± 21.626
    79.82 ± 25.160
        Social Functioning: Cycle 5 (n=47,34)
    80.85 ± 21.697
    79.41 ± 26.291
        Social Functioning: Cycle 6 (n=43,31)
    80.23 ± 28.232
    77.42 ± 28.398
        Social Functioning: Cycle 7 (n=39,29)
    80.34 ± 22.579
    83.91 ± 27.271
        Social Functioning: Cycle 8 (n=37,25)
    78.83 ± 21.748
    80.00 ± 25.909
        Social Functioning: Cycle 9 (n=35,26)
    77.62 ± 24.234
    82.05 ± 23.534
        Social Functioning: Cycle 10 (n=35,23)
    81.43 ± 20.119
    76.81 ± 26.939
        Social Functioning: Cycle 11 (n=35,24)
    76.19 ± 23.321
    81.25 ± 26.151
        Social Functioning: Cycle 12 (n=35,22)
    75.71 ± 25.030
    81.82 ± 27.172
        Social Functioning: Cycle 13 (n=34,21)
    77.94 ± 25.859
    84.92 ± 21.670
        Social Functioning: Cycle 14 (n=31,19)
    81.18 ± 20.968
    79.82 ± 29.700
        Social Functioning: Cycle 15 (n=30,17)
    76.67 ± 19.865
    74.51 ± 31.797
        Social Functioning: Cycle 16 (n=27,16)
    75.93 ± 24.167
    77.08 ± 25.000
        Social Functioning: Cycle 17 (n=22,15)
    75.00 ± 25.066
    75.56 ± 25.871
        Social Functioning: Cycle 18 (n=17,14)
    76.47 ± 27.041
    82.14 ± 28.090
        Social Functioning: Cycle 19 (n=12,14)
    72.22 ± 24.958
    77.38 ± 26.640
        Social Functioning: Cycle 20 (n=11,13)
    75.76 ± 30.151
    83.33 ± 21.517
        Social Functioning: Cycle 21 (n=11,12)
    71.21 ± 28.955
    81.94 ± 26.071
        Social Functioning: Cycle 22 (n=11,11)
    69.70 ± 33.181
    75.76 ± 30.151
        Social Functioning: Cycle 23 (n=11,10)
    71.21 ± 30.814
    78.33 ± 31.476
        Social Functioning: Cycle 24 (n=10,10)
    63.33 ± 32.203
    76.67 ± 30.631
        Social Functioning: Cycle 25 (n=10,8)
    70.00 ± 39.126
    66.67 ± 34.503
        Social Functioning: Cycle 26 (n=7,7)
    61.90 ± 34.311
    88.10 ± 15.853
        Social Functioning: Cycle 27 (n=6,8)
    58.33 ± 32.914
    70.83 ± 33.034
        Social Functioning: Cycle 28 (n=7,8)
    73.81 ± 38.318
    77.08 ± 28.084
        Social Functioning: Cycle 29 (n=5,7)
    80.00 ± 18.257
    71.43 ± 34.311
        Social Functioning: Cycle 30 (n=4,7)
    75.00 ± 31.914
    69.05 ± 36.551
        Social Functioning: Cycle 31 (n=2,7)
    66.67 ± 47.140
    71.43 ± 35.635
        Social Functioning: Cycle 32 (n=3,6)
    77.78 ± 19.245
    66.67 ± 36.515
        Social Functioning: Cycle 33 (n=3,6)
    66.67 ± 0.000
    69.44 ± 30.581
        Social Functioning: Cycle 34 (n=3,6)
    66.67 ± 0.000
    63.89 ± 37.143
        Social Functioning: Cycle 35 (n=2,6)
    66.67 ± 23.570
    72.22 ± 37.515
        Social Functioning: Cycle 36 (n=1,5)
    100.00 ± 99999
    53.33 ± 36.132
        Social Functioning: Cycle 37 (n=1,4)
    66.67 ± 99999
    58.33 ± 41.944
        Social Functioning: Cycle 38 (n=0,4)
    99999 ± 99999
    66.67 ± 36.004
        Social Functioning: Cycle 39 (n=1,3)
    100.00 ± 99999
    44.44 ± 38.490
        Social Functioning: Cycle 40 (n=1,3)
    66.67 ± 99999
    61.11 ± 38.490
        Social Functioning: Cycle 41 (n=0,3)
    99999 ± 99999
    44.44 ± 25.459
        Social Functioning: Cycle 42 (n=0,2)
    99999 ± 99999
    41.67 ± 35.355
        Social Functioning: Cycle 43 (n=0,1)
    99999 ± 99999
    66.67 ± 99999
        Social Functioning: EOT (n=33,30)
    73.74 ± 25.355
    65.00 ± 29.148
        Fatigue: Cycle 1 (n=61,44)
    21.49 ± 20.374
    29.42 ± 17.835
        Fatigue: Cycle 2 (n=57,42)
    24.37 ± 17.995
    29.10 ± 19.001
        Fatigue: Cycle 3 (n=55,40)
    26.46 ± 19.303
    30.28 ± 22.644
        Fatigue: Cycle 4 (n=50,38)
    24.00 ± 18.424
    29.53 ± 24.133
        Fatigue: Cycle 5 (n=47,34)
    26.00 ± 17.069
    27.61 ± 23.865
        Fatigue: Cycle 6 (n=43,31)
    25.32 ± 17.029
    29.93 ± 25.526
        Fatigue: Cycle 7 (n=39,29)
    26.78 ± 21.284
    28.35 ± 24.232
        Fatigue: Cycle 8 (n=37,25)
    27.63 ± 17.297
    23.11 ± 18.681
        Fatigue: Cycle 9 (n=35,26)
    26.35 ± 20.182
    22.22 ± 20.608
        Fatigue: Cycle 10 (n=35,23)
    26.03 ± 19.975
    24.64 ± 23.914
        Fatigue: Cycle 11 (n=35,24)
    27.94 ± 18.548
    22.45 ± 20.624
        Fatigue: Cycle 12 (n=35,22)
    26.35 ± 20.001
    22.22 ± 23.256
        Fatigue: Cycle 13 (n=34,21)
    25.16 ± 19.012
    18.52 ± 15.045
        Fatigue: Cycle 14 (n=31,19)
    24.73 ± 19.183
    24.56 ± 20.813
        Fatigue: Cycle 15 (n=30,17)
    24.07 ± 20.443
    24.84 ± 24.066
        Fatigue: Cycle 16 (n=27,16)
    27.16 ± 23.937
    22.92 ± 17.902
        Fatigue: Cycle 17 (n=22,15)
    28.28 ± 22.150
    18.52 ± 18.144
        Fatigue: Cycle 18 (n=17,14)
    26.80 ± 22.243
    22.22 ± 17.433
        Fatigue: Cycle 19 (n=12,14)
    34.26 ± 31.944
    23.02 ± 20.191
        Fatigue: Cycle 20 (n=11,13)
    34.34 ± 26.036
    22.22 ± 18.144
        Fatigue: Cycle 21 (n=11,12)
    34.34 ± 32.377
    28.70 ± 21.429
        Fatigue: Cycle 22 (n=11,11)
    31.31 ± 28.029
    30.30 ± 27.707
        Fatigue: Cycle 23 (n=11,10)
    39.39 ± 28.702
    28.89 ± 25.229
        Fatigue: Cycle 24 (n=10,10)
    36.67 ± 32.309
    28.89 ± 26.294
        Fatigue: Cycle 25 (n=10,8)
    40.00 ± 30.180
    27.78 ± 21.414
        Fatigue: Cycle 26 (n=7,7)
    44.44 ± 27.962
    22.22 ± 14.344
        Fatigue: Cycle 27 (n=6,8)
    50.00 ± 30.429
    26.39 ± 22.954
        Fatigue: Cycle 28 (n=7,8)
    42.86 ± 28.276
    30.56 ± 26.394
        Fatigue: Cycle 29 (n=6,7)
    35.19 ± 23.744
    28.57 ± 21.138
        Fatigue: Cycle 30 (n=5,7)
    24.44 ± 18.257
    31.75 ± 27.539
        Fatigue: Cycle 31 (n=3,7)
    22.22 ± 29.397
    31.75 ± 29.696
        Fatigue: Cycle 32 (n=3,6)
    18.52 ± 23.130
    35.19 ± 12.989
        Fatigue: Cycle 33 (n=3,6)
    22.22 ± 29.397
    40.74 ± 20.688
        Fatigue: Cycle 34 (n=3,6)
    37.04 ± 35.717
    40.74 ± 16.728
        Fatigue: Cycle 35 (n=2,6)
    33.33 ± 47.140
    35.19 ± 16.355
        Fatigue: Cycle 36 (n=1,5)
    0.00 ± 99999
    40.00 ± 14.907
        Fatigue: Cycle 37 (n=1,4)
    0.00 ± 99999
    36.11 ± 21.033
        Fatigue: Cycle 38 (n=0,4)
    99999 ± 99999
    44.44 ± 27.217
        Fatigue: Cycle 39 (n=1,3)
    0.00 ± 99999
    51.85 ± 33.945
        Fatigue: Cycle 40 (n=1,3)
    0.00 ± 99999
    59.26 ± 33.945
        Fatigue: Cycle 41 (n=0,3)
    99999 ± 99999
    48.15 ± 23.130
        Fatigue: Cycle 42 (n=0,2)
    99999 ± 99999
    44.44 ± 31.427
        Fatigue: Cycle 43 (n=0,1)
    99999 ± 99999
    22.22 ± 99999
        Fatigue: EOT (n=33,30)
    33.00 ± 23.812
    40.56 ± 28.632
        Nausea and Vomiting: Cycle 1 (n=61,44)
    6.56 ± 13.010
    7.95 ± 17.420
        Nausea and Vomiting: Cycle 2 (n=57,42)
    7.31 ± 12.206
    7.14 ± 9.123
        Nausea and Vomiting: Cycle 3 (n=55,40)
    7.27 ± 12.735
    12.08 ± 19.967
        Nausea and Vomiting: Cycle 4 (n=50,38)
    8.00 ± 13.569
    4.39 ± 9.238
        Nausea and Vomiting: Cycle 5 (n=47,34)
    6.38 ± 12.794
    8.33 ± 14.935
        Nausea and Vomiting: Cycle 6 (n=43,31)
    6.98 ± 12.189
    6.99 ± 11.200
        Nausea and Vomiting: Cycle 7 (n=39,29)
    6.41 ± 12.458
    6.90 ± 15.117
        Nausea and Vomiting: Cycle 8 (n=37,25)
    7.66 ± 15.513
    3.33 ± 6.804
        Nausea and Vomiting: Cycle 9 (n=35,26)
    9.05 ± 14.766
    4.49 ± 10.064
        Nausea and Vomiting: Cycle 10 (n=35,23)
    5.71 ± 12.088
    4.35 ± 9.014
        Nausea and Vomiting: Cycle 11 (n=35,24)
    4.76 ± 10.362
    4.86 ± 9.167
        Nausea and Vomiting: Cycle 12 (n=35,22)
    4.76 ± 11.835
    6.06 ± 8.206
        Nausea and Vomiting: Cycle 13 (n=34,21)
    3.43 ± 8.970
    2.38 ± 5.976
        Nausea and Vomiting: Cycle 14 (n=31,19)
    5.38 ± 9.988
    6.14 ± 12.681
        Nausea and Vomiting: Cycle 15 (n=30,17)
    7.22 ± 12.132
    5.88 ± 16.605
        Nausea and Vomiting: Cycle 16 (n=27,16)
    4.32 ± 9.906
    3.13 ± 9.065
        Nausea and Vomiting: Cycle 17 (n=22,15)
    3.03 ± 8.351
    4.44 ± 9.894
        Nausea and Vomiting: Cycle 18 (n=17,14)
    4.90 ± 11.433
    1.19 ± 4.454
        Nausea and Vomiting: Cycle 19 (n=12,14)
    4.17 ± 10.360
    4.76 ± 12.105
        Nausea and Vomiting: Cycle 20 (n=11,13)
    6.06 ± 15.407
    1.28 ± 4.623
        Nausea and Vomiting: Cycle 21 (n=11,12)
    4.55 ± 15.076
    6.94 ± 19.408
        Nausea and Vomiting: Cycle 22 (n=11,11)
    4.55 ± 15.076
    9.09 ± 30.151
        Nausea and Vomiting: Cycle 23 (n=11,10)
    6.06 ± 15.407
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 24 (n=10,10)
    6.67 ± 11.653
    3.33 ± 7.027
        Nausea and Vomiting: Cycle 25 (n=10,8)
    8.33 ± 14.164
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 26 (n=7,7)
    7.14 ± 8.909
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 27 (n=6,8)
    11.11 ± 20.184
    4.17 ± 11.785
        Nausea and Vomiting: Cycle 28 (n=7,8)
    9.52 ± 18.898
    2.08 ± 5.893
        Nausea and Vomiting: Cycle 29 (n=6,7)
    2.78 ± 6.804
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 30 (n=5,7)
    0.00 ± 0.000
    2.38 ± 6.299
        Nausea and Vomiting: Cycle 31 (n=3,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 32 (n=3,6)
    5.56 ± 9.623
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 33 (n=3,6)
    22.22 ± 38.490
    2.78 ± 6.804
        Nausea and Vomiting: Cycle 34 (n=3,6)
    22.22 ± 38.490
    8.33 ± 13.944
        Nausea and Vomiting: Cycle 35 (n=2,6)
    16.67 ± 23.570
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 36 (n=1,5)
    0.00 ± 99999
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 37 (n=1,4)
    0.00 ± 99999
    4.17 ± 8.333
        Nausea and Vomiting: Cycle 38 (n=0,4)
    99999 ± 99999
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 39 (n=1,3)
    0.00 ± 99999
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 40 (n=1,3)
    0.00 ± 99999
    11.11 ± 19.245
        Nausea and Vomiting: Cycle 41 (n=0,3)
    99999 ± 99999
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 42 (n=0,2)
    99999 ± 99999
    0.00 ± 0.000
        Nausea and Vomiting: Cycle 43 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Nausea and Vomiting: EOT (n=33,30)
    16.16 ± 21.844
    12.78 ± 20.846
        Pain: Cycle 1 (n=61,44)
    16.39 ± 20.067
    18.18 ± 18.958
        Pain: Cycle 2 (n=57,42)
    16.67 ± 18.094
    19.05 ± 20.353
        Pain: Cycle 3 (n=55,40)
    15.76 ± 18.542
    22.50 ± 27.099
        Pain: Cycle 4 (n=50,38)
    14.00 ± 15.922
    23.25 ± 24.056
        Pain: Cycle 5 (n=47,34)
    15.96 ± 16.651
    18.14 ± 22.235
        Pain: Cycle 6 (n=43,31)
    15.89 ± 17.041
    20.43 ± 26.073
        Pain: Cycle 7 (n=39,29)
    20.09 ± 21.690
    22.99 ± 22.893
        Pain: Cycle 8 (n=37,25)
    17.57 ± 17.099
    14.67 ± 16.887
        Pain: Cycle 9 (n=35,26)
    20.48 ± 19.838
    19.87 ± 19.447
        Pain: Cycle 10 (n=35,23)
    19.52 ± 22.682
    18.84 ± 22.079
        Pain: Cycle 11 (n=35,24)
    19.05 ± 19.446
    13.89 ± 18.169
        Pain: Cycle 12 (n=35,22)
    20.48 ± 22.172
    16.67 ± 17.817
        Pain: Cycle 13 (n=34,21)
    17.16 ± 15.616
    15.87 ± 20.053
        Pain: Cycle 14 (n=31,19)
    14.52 ± 17.074
    21.05 ± 19.909
        Pain: Cycle 15 (n=30,17)
    15.00 ± 23.305
    21.57 ± 24.127
        Pain: Cycle 16 (n=27,16)
    17.28 ± 21.917
    15.63 ± 14.232
        Pain: Cycle 17 (n=22,15)
    18.94 ± 23.171
    15.56 ± 17.213
        Pain: Cycle 18 (n=17,14)
    16.67 ± 22.048
    10.71 ± 16.803
        Pain: Cycle 19 (n=12,14)
    26.39 ± 27.941
    13.10 ± 16.249
        Pain: Cycle 20 (n=11,13)
    25.76 ± 27.247
    12.82 ± 15.447
        Pain: Cycle 21 (n=11,12)
    25.76 ± 29.215
    16.67 ± 21.320
        Pain: Cycle 22 (n=11,11)
    18.18 ± 26.304
    21.21 ± 21.201
        Pain: Cycle 23 (n=11,10)
    21.21 ± 27.979
    15.00 ± 22.839
        Pain: Cycle 24 (n=10,10)
    28.33 ± 26.117
    20.00 ± 24.595
        Pain: Cycle 25 (n=10,8)
    26.67 ± 30.631
    16.67 ± 19.920
        Pain: Cycle 26 (n=7,7)
    38.10 ± 40.500
    16.67 ± 19.245
        Pain: Cycle 27 (n=6,8)
    47.22 ± 35.616
    20.83 ± 21.362
        Pain: Cycle 28 (n=7,8)
    35.71 ± 33.923
    22.92 ± 25.099
        Pain: Cycle 29 (n=6,7)
    19.44 ± 19.484
    23.81 ± 26.972
        Pain: Cycle 30 (n=5,7)
    20.00 ± 21.731
    19.05 ± 24.398
        Pain: Cycle 31 (n=3,7)
    16.67 ± 28.868
    26.19 ± 23.288
        Pain: Cycle 32 (n=3,6)
    16.67 ± 28.868
    27.78 ± 31.032
        Pain: Cycle 33 (n=3,6)
    16.67 ± 28.868
    25.00 ± 25.276
        Pain: Cycle 34 (n=3,6)
    22.22 ± 38.490
    27.78 ± 25.092
        Pain: Cycle 35 (n=2,6)
    25.00 ± 35.355
    22.22 ± 13.608
        Pain: Cycle 36 (n=1,5)
    0.00 ± 99999
    20.00 ± 13.944
        Pain: Cycle 37 (n=1,4)
    16.67 ± 99999
    29.17 ± 28.464
        Pain: Cycle 38 (n=0,4)
    99999 ± 99999
    29.17 ± 28.464
        Pain: Cycle 39 (n=1,3)
    0.00 ± 99999
    38.89 ± 25.459
        Pain: Cycle 40 (n=1,3)
    0.00 ± 99999
    44.44 ± 19.245
        Pain: Cycle 41 (n=0,3)
    99999 ± 99999
    55.56 ± 41.944
        Pain: Cycle 42 (n=0,2)
    99999 ± 99999
    33.33 ± 47.140
        Pain: Cycle 43 (n=0,1)
    99999 ± 99999
    33.33 ± 99999
        Pain: EOT (n=33,30)
    23.74 ± 25.695
    33.89 ± 32.009
        Dyspnoea: Cycle 1 (n=60,44)
    5.00 ± 12.003
    7.58 ± 15.854
        Dyspnoea: Cycle 2 (n=57,42)
    7.02 ± 15.088
    8.73 ± 18.123
        Dyspnoea: Cycle 3 (n=55,40)
    6.06 ± 12.975
    9.17 ± 21.334
        Dyspnoea: Cycle 4 (n=50,38)
    6.00 ± 12.936
    13.16 ± 21.280
        Dyspnoea: Cycle 5 (n=47,34)
    5.67 ± 14.445
    10.78 ± 22.801
        Dyspnoea: Cycle 6 (n=43,31)
    6.98 ± 15.530
    10.75 ± 24.925
        Dyspnoea: Cycle 7 (n=39,29)
    11.11 ± 22.076
    10.34 ± 20.125
        Dyspnoea: Cycle 8 (n=37,25)
    15.32 ± 21.652
    6.67 ± 13.608
        Dyspnoea: Cycle 9 (n=35,26)
    9.52 ± 20.725
    5.13 ± 12.265
        Dyspnoea: Cycle 10 (n=35,23)
    9.52 ± 15.278
    10.14 ± 21.165
        Dyspnoea: Cycle 11 (n=35,24)
    5.71 ± 12.746
    9.72 ± 15.477
        Dyspnoea: Cycle 12 (n=35,22)
    8.57 ± 14.781
    6.06 ± 13.159
        Dyspnoea: Cycle 13 (n=34,21)
    10.78 ± 15.829
    12.70 ± 19.653
        Dyspnoea: Cycle 14 (n=31,19)
    9.68 ± 15.380
    8.77 ± 15.080
        Dyspnoea: Cycle 15 (n=30,17)
    8.89 ± 14.993
    9.80 ± 15.656
        Dyspnoea: Cycle 16 (n=27,16)
    6.17 ± 13.195
    6.25 ± 13.437
        Dyspnoea: Cycle 17 (n=22,15)
    10.61 ± 15.891
    6.67 ± 13.801
        Dyspnoea: Cycle 18 (n=17,14)
    7.84 ± 14.575
    4.76 ± 12.105
        Dyspnoea: Cycle 19 (n=12,14)
    13.89 ± 17.164
    4.76 ± 12.105
        Dyspnoea: Cycle 20 (n=11,13)
    6.06 ± 13.484
    5.13 ± 12.518
        Dyspnoea: Cycle 21 (n=11,12)
    12.12 ± 16.817
    8.33 ± 15.076
        Dyspnoea: Cycle 22 (n=11,11)
    9.09 ± 15.570
    9.09 ± 15.570
        Dyspnoea: Cycle 23 (n=11,10)
    6.06 ± 13.484
    13.33 ± 17.213
        Dyspnoea: Cycle 24 (n=10,10)
    6.67 ± 14.055
    13.33 ± 17.213
        Dyspnoea: Cycle 25 (n=10,8)
    13.33 ± 23.307
    8.33 ± 15.430
        Dyspnoea: Cycle 26 (n=7,7)
    9.52 ± 16.265
    9.52 ± 16.265
        Dyspnoea: Cycle 27 (n=6,8)
    11.11 ± 27.217
    8.33 ± 15.430
        Dyspnoea: Cycle 28 (n=7,8)
    19.05 ± 17.817
    12.50 ± 17.252
        Dyspnoea: Cycle 29 (n=6,7)
    11.11 ± 27.217
    19.05 ± 17.817
        Dyspnoea: Cycle 30 (n=5,7)
    6.67 ± 14.907
    14.29 ± 17.817
        Dyspnoea: Cycle 31 (n=3,7)
    0.00 ± 0.000
    9.52 ± 16.265
        Dyspnoea: Cycle 32 (n=3,6)
    11.11 ± 19.245
    16.67 ± 27.889
        Dyspnoea: Cycle 33 (n=3,6)
    22.22 ± 38.490
    11.11 ± 17.213
        Dyspnoea: Cycle 34 (n=3,6)
    11.11 ± 19.245
    16.67 ± 27.889
        Dyspnoea: Cycle 35 (n=2,6)
    16.67 ± 23.570
    11.11 ± 17.213
        Dyspnoea: Cycle 36 (n=1,5)
    0.00 ± 99999
    26.67 ± 27.889
        Dyspnoea: Cycle 37 (n=1,4)
    0.00 ± 99999
    8.33 ± 16.667
        Dyspnoea: Cycle 38 (n=0,4)
    99999 ± 99999
    8.33 ± 16.667
        Dyspnoea: Cycle 39 (n=1,3)
    0.00 ± 99999
    0.00 ± 0.000
        Dyspnoea: Cycle 40 (n=1,3)
    0.00 ± 99999
    0.00 ± 0.000
        Dyspnoea: Cycle 41 (n=0,3)
    99999 ± 99999
    0.00 ± 0.000
        Dyspnoea: Cycle 42 (n=0,2)
    99999 ± 99999
    16.67 ± 23.570
        Dyspnoea: Cycle 43 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Dyspnoea: EOT (n=33,30)
    14.14 ± 16.730
    13.33 ± 24.132
        Insomnia: Cycle 1 (n=61,44)
    13.11 ± 20.438
    25.76 ± 27.715
        Insomnia: Cycle 2 (n=57,42)
    9.36 ± 16.372
    19.84 ± 23.350
        Insomnia: Cycle 3 (n=55,40)
    12.12 ± 17.408
    26.67 ± 26.366
        Insomnia: Cycle 4 (n=50,38)
    11.33 ± 19.760
    24.56 ± 27.601
        Insomnia: Cycle 5 (n=47,34)
    9.22 ± 19.289
    17.65 ± 26.253
        Insomnia: Cycle 6 (n=43,31)
    10.85 ± 18.857
    20.43 ± 26.774
        Insomnia: Cycle 7 (n=39,29)
    9.40 ± 18.651
    21.84 ± 28.558
        Insomnia: Cycle 8 (n=37,25)
    10.81 ± 20.867
    21.33 ± 21.257
        Insomnia: Cycle 9 (n=35,26)
    11.43 ± 19.708
    20.51 ± 23.242
        Insomnia: Cycle 10 (n=35,23)
    12.38 ± 18.232
    21.74 ± 21.576
        Insomnia: Cycle 11 (n=35,24)
    12.38 ± 18.232
    22.22 ± 27.217
        Insomnia: Cycle 12 (n=35,22)
    6.67 ± 15.760
    22.73 ± 27.958
        Insomnia: Cycle 13 (n=34,21)
    9.80 ± 15.417
    23.81 ± 21.455
        Insomnia: Cycle 14 (n=31,19)
    8.60 ± 17.144
    22.81 ± 19.413
        Insomnia: Cycle 15 (n=29,17)
    9.20 ± 17.586
    25.49 ± 25.082
        Insomnia: Cycle 16 (n=27,16)
    9.88 ± 20.286
    25.00 ± 28.545
        Insomnia: Cycle 17 (n=22,15)
    6.06 ± 16.703
    22.22 ± 24.125
        Insomnia: Cycle 18 (n=17,14)
    11.76 ± 16.420
    23.81 ± 24.209
        Insomnia: Cycle 19 (n=12,14)
    13.89 ± 22.285
    23.81 ± 24.209
        Insomnia: Cycle 20 (n=11,13)
    9.09 ± 15.570
    25.64 ± 24.167
        Insomnia: Cycle 21 (n=11,12)
    18.18 ± 22.918
    30.56 ± 26.432
        Insomnia: Cycle 22 (n=11,11)
    15.15 ± 22.918
    30.30 ± 27.707
        Insomnia: Cycle 23 (n=11,10)
    15.15 ± 17.408
    30.00 ± 33.148
        Insomnia: Cycle 24 (n=10,10)
    10.00 ± 22.498
    33.33 ± 27.217
        Insomnia: Cycle 25 (n=10,8)
    23.33 ± 27.442
    29.17 ± 27.817
        Insomnia: Cycle 26 (n=7,7)
    9.52 ± 16.265
    23.81 ± 25.198
        Insomnia: Cycle 27 (n=6,8)
    27.78 ± 38.968
    33.33 ± 25.198
        Insomnia: Cycle 28 (n=7,8)
    23.81 ± 25.198
    25.00 ± 29.547
        Insomnia: Cycle 29 (n=6,7)
    22.22 ± 27.217
    38.10 ± 35.635
        Insomnia: Cycle 30 (n=5,7)
    6.67 ± 14.907
    28.57 ± 29.991
        Insomnia: Cycle 31 (n=3,7)
    11.11 ± 19.245
    19.05 ± 26.227
        Insomnia: Cycle 32 (n=3,6)
    22.22 ± 19.245
    27.78 ± 25.092
        Insomnia: Cycle 33 (n=3,6)
    22.22 ± 19.245
    22.22 ± 27.217
        Insomnia: Cycle 34 (n=3,6)
    22.22 ± 38.490
    27.78 ± 25.092
        Insomnia: Cycle 35 (n=2,6)
    16.67 ± 23.570
    27.78 ± 25.092
        Insomnia: Cycle 36 (n=1,5)
    0.00 ± 99999
    26.67 ± 27.889
        Insomnia: Cycle 37 (n=1,4)
    0.00 ± 99999
    16.67 ± 19.245
        Insomnia: Cycle 38 (n=0,4)
    99999 ± 99999
    33.33 ± 27.217
        Insomnia: Cycle 39 (n=1,3)
    0.00 ± 99999
    22.22 ± 19.245
        Insomnia: Cycle 40 (n=1,3)
    0.00 ± 99999
    33.33 ± 0.000
        Insomnia: Cycle 41 (n=0,3)
    99999 ± 99999
    22.22 ± 19.245
        Insomnia: Cycle 42 (n=0,2)
    99999 ± 99999
    16.67 ± 23.570
        Insomnia: Cycle 43 (n=0,1)
    99999 ± 99999
    33.33 ± 99999
        Insomnia: EOT (n=33,30)
    16.16 ± 26.512
    25.56 ± 33.543
        Appetite Loss: Cycle 1 (n=61,44)
    12.57 ± 21.225
    15.91 ± 23.282
        Appetite Loss: Cycle 2 (n=57,42)
    16.96 ± 21.009
    18.25 ± 22.333
        Appetite Loss: Cycle 3 (n=55,40)
    13.94 ± 18.912
    20.83 ± 28.929
        Appetite Loss: Cycle 4 (n=50,38)
    14.00 ± 24.365
    16.67 ± 26.565
        Appetite Loss: Cycle 5 (n=47,34)
    10.64 ± 20.974
    15.69 ± 28.704
        Appetite Loss: Cycle 6 (n=43,31)
    10.85 ± 20.212
    18.28 ± 30.839
        Appetite Loss: Cycle 7 (n=39,29)
    14.53 ± 22.679
    14.94 ± 28.986
        Appetite Loss: Cycle 8 (n=37,25)
    16.22 ± 25.606
    14.67 ± 25.604
        Appetite Loss: Cycle 9 (n=35,26)
    14.29 ± 18.587
    14.10 ± 26.954
        Appetite Loss: Cycle 10 (n=35,23)
    13.33 ± 21.693
    17.39 ± 28.194
        Appetite Loss: Cycle 11 (n=35,24)
    15.24 ± 21.907
    8.33 ± 22.522
        Appetite Loss: Cycle 12 (n=35,22)
    13.33 ± 25.820
    12.12 ± 24.224
        Appetite Loss: Cycle 13 (n=34,21)
    13.73 ± 21.893
    7.94 ± 14.548
        Appetite Loss: Cycle 14 (n=31,19)
    10.75 ± 21.751
    10.53 ± 19.413
        Appetite Loss: Cycle 15 (n=30,17)
    13.33 ± 24.132
    15.69 ± 29.149
        Appetite Loss: Cycle 16 (n=27,16)
    13.58 ± 23.130
    8.33 ± 19.245
        Appetite Loss: Cycle 17 (n=22,15)
    10.61 ± 23.874
    6.67 ± 18.687
        Appetite Loss: Cycle 18 (n=17,14)
    17.65 ± 29.149
    9.52 ± 20.375
        Appetite Loss: Cycle 19 (n=12,14)
    19.44 ± 33.207
    9.52 ± 27.514
        Appetite Loss: Cycle 20 (n=11,13)
    21.21 ± 34.230
    5.13 ± 12.518
        Appetite Loss: Cycle 21 (n=11,12)
    21.21 ± 34.230
    16.67 ± 22.473
        Appetite Loss: Cycle 22 (n=11,11)
    18.18 ± 31.140
    15.15 ± 22.918
        Appetite Loss: Cycle 23 (n=11,10)
    18.18 ± 31.140
    10.00 ± 22.498
        Appetite Loss: Cycle 24 (n=10,10)
    23.33 ± 35.312
    13.33 ± 23.307
        Appetite Loss: Cycle 25 (n=10,8)
    23.33 ± 41.722
    8.33 ± 23.570
        Appetite Loss: Cycle 26 (n=7,7)
    38.10 ± 48.795
    4.76 ± 12.599
        Appetite Loss: Cycle 27 (n=6,8)
    33.33 ± 42.164
    12.50 ± 35.355
        Appetite Loss: Cycle 28 (n=7,8)
    28.57 ± 40.500
    16.67 ± 35.635
        Appetite Loss: Cycle 29 (n=6,7)
    11.11 ± 27.217
    4.76 ± 12.599
        Appetite Loss: Cycle 30 (n=5,7)
    0.00 ± 0.000
    4.76 ± 12.599
        Appetite Loss: Cycle 31 (n=3,7)
    0.00 ± 0.000
    9.52 ± 25.198
        Appetite Loss: Cycle 32 (n=3,6)
    11.11 ± 19.245
    16.67 ± 27.889
        Appetite Loss: Cycle 33 (n=3,6)
    22.22 ± 38.490
    16.67 ± 27.889
        Appetite Loss: Cycle 34 (n=3,6)
    33.33 ± 57.735
    27.78 ± 32.773
        Appetite Loss: Cycle 35 (n=2,6)
    33.33 ± 47.140
    11.11 ± 27.217
        Appetite Loss: Cycle 36 (n=1,5)
    0.00 ± 99999
    0.00 ± 0.000
        Appetite Loss: Cycle 37 (n=1,4)
    0.00 ± 99999
    16.67 ± 19.245
        Appetite Loss: Cycle 38 (n=0,4)
    99999 ± 99999
    16.67 ± 19.245
        Appetite Loss: Cycle 39 (n=1,3)
    0.00 ± 99999
    11.11 ± 19.245
        Appetite Loss: Cycle 40 (n=1,3)
    0.00 ± 99999
    11.11 ± 19.245
        Appetite Loss: Cycle 41 (n=0,3)
    99999 ± 99999
    22.22 ± 38.490
        Appetite Loss: Cycle 42 (n=0,2)
    99999 ± 99999
    16.67 ± 23.570
        Appetite Loss: Cycle 43 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Appetite Loss: EOT (n=33,30)
    27.27 ± 34.816
    26.67 ± 32.044
        Constipation: Cycle 1 (n=61,44)
    7.10 ± 17.336
    9.09 ± 18.135
        Constipation: Cycle 2 (n=57,42)
    3.51 ± 10.321
    13.49 ± 26.605
        Constipation: Cycle 3 (n=55,40)
    7.27 ± 15.303
    4.17 ± 13.477
        Constipation: Cycle 4 (n=50,38)
    6.67 ± 15.058
    5.26 ± 12.318
        Constipation: Cycle 5 (n=47,34)
    3.55 ± 12.499
    2.94 ± 12.627
        Constipation: Cycle 6 (n=43,31)
    3.88 ± 10.812
    2.15 ± 8.324
        Constipation: Cycle 7 (n=39,29)
    3.42 ± 10.245
    5.75 ± 17.970
        Constipation: Cycle 8 (n=37,25)
    3.60 ± 13.109
    4.00 ± 14.657
        Constipation: Cycle 9 (n=35,26)
    6.67 ± 15.760
    3.85 ± 14.382
        Constipation: Cycle 10 (n=35,23)
    2.86 ± 9.468
    5.80 ± 16.368
        Constipation: Cycle 11 (n=35,24)
    3.81 ± 13.459
    2.78 ± 9.411
        Constipation: Cycle 12 (n=35,22)
    5.71 ± 12.746
    4.55 ± 11.708
        Constipation: Cycle 13 (n=34,21)
    2.94 ± 9.597
    1.59 ± 7.274
        Constipation: Cycle 14 (n=31,19)
    1.08 ± 5.987
    3.51 ± 10.510
        Constipation: Cycle 15 (n=30,17)
    2.22 ± 8.457
    3.92 ± 16.169
        Constipation: Cycle 16 (n=27,16)
    2.47 ± 8.896
    6.25 ± 13.437
        Constipation: Cycle 17 (n=22,15)
    6.06 ± 13.159
    2.22 ± 8.607
        Constipation: Cycle 18 (n=17,14)
    3.92 ± 11.070
    4.76 ± 12.105
        Constipation: Cycle 19 (n=12,14)
    0.00 ± 0.000
    9.52 ± 20.375
        Constipation: Cycle 20 (n=11,13)
    0.00 ± 0.000
    0.00 ± 0.000
        Constipation: Cycle 21 (n=11,12)
    0.00 ± 0.000
    2.78 ± 9.623
        Constipation: Cycle 22 (n=11,11)
    0.00 ± 0.000
    12.12 ± 30.814
        Constipation: Cycle 23 (n=11,10)
    0.00 ± 0.000
    3.33 ± 10.541
        Constipation: Cycle 24 (n=10,10)
    0.00 ± 0.000
    6.67 ± 14.055
        Constipation: Cycle 25 (n=10,8)
    3.33 ± 10.541
    0.00 ± 0.000
        Constipation: Cycle 26 (n=7,7)
    0.00 ± 0.000
    4.76 ± 12.599
        Constipation: Cycle 27 (n=6,8)
    5.56 ± 13.608
    4.17 ± 11.785
        Constipation: Cycle 28 (n=7,8)
    4.76 ± 12.599
    4.17 ± 11.785
        Constipation: Cycle 29 (n=5,7)
    0.00 ± 0.000
    4.76 ± 12.599
        Constipation: Cycle 30 (n=4,7)
    0.00 ± 0.000
    4.76 ± 12.599
        Constipation: Cycle 31 (n=2,7)
    0.00 ± 0.000
    4.76 ± 12.599
        Constipation: Cycle 32 (n=3,6)
    0.00 ± 0.000
    0.00 ± 0.000
        Constipation: Cycle 33 (n=3,6)
    0.00 ± 0.000
    5.56 ± 13.608
        Constipation: Cycle 34 (n=3,6)
    0.00 ± 0.000
    5.56 ± 13.608
        Constipation: Cycle 35 (n=2,6)
    0.00 ± 0.000
    5.56 ± 13.608
        Constipation: Cycle 36 (n=1,5)
    0.00 ± 99999
    13.33 ± 29.814
        Constipation: Cycle 37 (n=1,4)
    0.00 ± 99999
    0.00 ± 0.000
        Constipation: Cycle 38 (n=0,4)
    99999 ± 99999
    0.00 ± 0.000
        Constipation: Cycle 39 (n=1,3)
    0.00 ± 99999
    11.11 ± 19.245
        Constipation: Cycle 40 (n=1,3)
    0.00 ± 99999
    0.00 ± 0.000
        Constipation: Cycle 41 (n=0,3)
    99999 ± 99999
    0.00 ± 0.000
        Constipation: Cycle 42 (n=0,2)
    99999 ± 99999
    0.00 ± 0.000
        Constipation: Cycle 43 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Constipation: EOT (n=33,30)
    10.10 ± 19.516
    3.33 ± 10.171
        Diarrhoea: Cycle 1 (n=61,43)
    14.21 ± 22.327
    11.63 ± 17.644
        Diarrhoea: Cycle 2 (n=57,41)
    18.13 ± 26.027
    17.07 ± 25.951
        Diarrhoea: Cycle 3 (n=55,40)
    16.36 ± 24.740
    24.17 ± 25.021
        Diarrhoea: Cycle 4 (n=50,38)
    22.00 ± 27.446
    15.79 ± 21.556
        Diarrhoea: Cycle 5 (n=47,34)
    22.70 ± 26.105
    21.57 ± 23.039
        Diarrhoea: Cycle 6 (n=43,31)
    24.03 ± 29.390
    22.58 ± 21.751
        Diarrhoea: Cycle 7 (n=39,29)
    29.06 ± 27.762
    25.29 ± 29.080
        Diarrhoea: Cycle 8 (n=37,25)
    26.13 ± 27.369
    20.00 ± 28.868
        Diarrhoea: Cycle 9 (n=35,26)
    30.48 ± 30.648
    29.49 ± 33.102
        Diarrhoea: Cycle 10 (n=35,23)
    24.76 ± 26.000
    27.54 ± 29.563
        Diarrhoea: Cycle 11 (n=35,24)
    23.81 ± 25.012
    23.61 ± 23.008
        Diarrhoea: Cycle 12 (n=35,22)
    21.90 ± 22.785
    18.18 ± 22.366
        Diarrhoea: Cycle 13 (n=34,21)
    21.57 ± 21.528
    19.05 ± 27.021
        Diarrhoea: Cycle 14 (n=31,19)
    23.66 ± 23.084
    19.30 ± 20.233
        Diarrhoea: Cycle 15 (n=30,17)
    21.11 ± 23.947
    25.49 ± 22.140
        Diarrhoea: Cycle 16 (n=27,16)
    18.52 ± 25.036
    20.83 ± 20.638
        Diarrhoea: Cycle 17 (n=22,15)
    21.21 ± 19.370
    15.56 ± 24.774
        Diarrhoea: Cycle 18 (n=17,14)
    25.49 ± 27.712
    19.05 ± 25.198
        Diarrhoea: Cycle 19 (n=12,14)
    13.89 ± 17.164
    19.05 ± 21.540
        Diarrhoea: Cycle 20 (n=11,13)
    27.27 ± 20.101
    23.08 ± 25.036
        Diarrhoea: Cycle 21 (n=11,12)
    33.33 ± 29.814
    25.00 ± 28.868
        Diarrhoea: Cycle 22 (n=11,11)
    18.18 ± 31.140
    21.21 ± 26.968
        Diarrhoea: Cycle 23 (n=11,10)
    24.24 ± 33.635
    26.67 ± 30.631
        Diarrhoea: Cycle 24 (n=10,10)
    23.33 ± 22.498
    23.33 ± 31.623
        Diarrhoea: Cycle 25 (n=10,8)
    16.67 ± 17.568
    29.17 ± 27.817
        Diarrhoea: Cycle 26 (n=7,7)
    19.05 ± 26.227
    28.57 ± 29.991
        Diarrhoea: Cycle 27 (n=6,8)
    22.22 ± 17.213
    37.50 ± 33.034
        Diarrhoea: Cycle 28 (n=7,8)
    14.29 ± 17.817
    29.17 ± 27.817
        Diarrhoea: Cycle 29 (n=5,7)
    0.00 ± 0.000
    28.57 ± 29.991
        Diarrhoea: Cycle 30 (n=4,7)
    0.00 ± 0.000
    38.10 ± 23.002
        Diarrhoea: Cycle 31 (n=2,7)
    0.00 ± 0.000
    33.33 ± 27.217
        Diarrhoea: Cycle 32 (n=3,6)
    22.22 ± 19.245
    50.00 ± 27.889
        Diarrhoea: Cycle 33 (n=3,6)
    11.11 ± 19.245
    50.00 ± 27.889
        Diarrhoea: Cycle 34 (n=3,6)
    33.33 ± 33.333
    44.44 ± 27.217
        Diarrhoea: Cycle 35 (n=2,6)
    16.67 ± 23.570
    38.89 ± 32.773
        Diarrhoea: Cycle 36 (n=1,5)
    0.00 ± 99999
    40.00 ± 43.461
        Diarrhoea: Cycle 37 (n=1,4)
    0.00 ± 99999
    25.00 ± 31.914
        Diarrhoea: Cycle 38 (n=0,4)
    99999 ± 99999
    41.67 ± 31.914
        Diarrhoea: Cycle 39 (n=1,3)
    0.00 ± 99999
    33.33 ± 33.333
        Diarrhoea: Cycle 40 (n=1,3)
    0.00 ± 99999
    44.44 ± 38.490
        Diarrhoea: Cycle 41 (n=0,3)
    99999 ± 99999
    44.44 ± 38.490
        Diarrhoea: Cycle 42 (n=0,2)
    99999 ± 99999
    50.00 ± 23.570
        Diarrhoea: Cycle 43 (n=0,1)
    99999 ± 99999
    66.67 ± 99999
        Diarrhoea: EOT (n=33,30)
    24.24 ± 29.194
    17.78 ± 24.343
        Financial Difficulties: Cycle 1 (n=61,43)
    25.68 ± 35.691
    31.01 ± 33.646
        Financial Difficulties: Cycle 2 (n=57,41)
    23.39 ± 28.843
    21.95 ± 26.468
        Financial Difficulties: Cycle 3 (n=55,40)
    23.03 ± 30.002
    30.00 ± 34.427
        Financial Difficulties: Cycle 4 (n=50,38)
    24.00 ± 30.147
    28.95 ± 27.037
        Financial Difficulties: Cycle 5 (n=47,34)
    26.24 ± 34.005
    25.49 ± 29.654
        Financial Difficulties: Cycle 6 (n=43,31)
    27.13 ± 35.078
    26.88 ± 31.528
        Financial Difficulties: Cycle 7 (n=39,29)
    29.06 ± 31.696
    27.59 ± 32.206
        Financial Difficulties: Cycle 8 (n=37,25)
    30.63 ± 32.753
    25.33 ± 29.313
        Financial Difficulties: Cycle 9 (n=35,26)
    22.86 ± 28.892
    20.51 ± 29.929
        Financial Difficulties: Cycle 10 (n=35,23)
    25.71 ± 28.105
    24.64 ± 30.513
        Financial Difficulties: Cycle 11 (n=35,24)
    26.67 ± 27.771
    23.61 ± 28.622
        Financial Difficulties: Cycle 12 (n=35,22)
    26.67 ± 30.033
    19.70 ± 26.546
        Financial Difficulties: Cycle 13 (n=34,21)
    23.53 ± 27.864
    19.05 ± 30.861
        Financial Difficulties: Cycle 14 (n=31,19)
    23.66 ± 28.795
    17.54 ± 28.040
        Financial Difficulties: Cycle 15 (n=30,17)
    21.11 ± 22.289
    19.61 ± 29.009
        Financial Difficulties: Cycle 16 (n=27,16)
    22.22 ± 22.646
    18.75 ± 29.736
        Financial Difficulties: Cycle 17 (n=22,15)
    19.70 ± 24.471
    15.56 ± 27.794
        Financial Difficulties: Cycle 18 (n=17,14)
    17.65 ± 29.149
    16.67 ± 21.681
        Financial Difficulties: Cycle 19 (n=12,14)
    22.22 ± 32.824
    14.29 ± 17.118
        Financial Difficulties: Cycle 20 (n=11,13)
    15.15 ± 22.918
    15.38 ± 29.235
        Financial Difficulties: Cycle 21 (n=11, 12)
    24.24 ± 33.635
    16.67 ± 30.151
        Financial Difficulties: Cycle 22 (n=11, 11)
    18.18 ± 27.340
    15.15 ± 22.918
        Financial Difficulties: Cycle 23 (n=11, 10)
    15.15 ± 22.918
    20.00 ± 32.203
        Financial Difficulties: Cycle 24 (n=10, 10)
    20.00 ± 28.109
    16.67 ± 32.394
        Financial Difficulties: Cycle 25 (n=10, 8)
    16.67 ± 28.328
    29.17 ± 37.533
        Financial Difficulties: Cycle 26 (n=7, 7)
    23.81 ± 31.706
    28.57 ± 40.500
        Financial Difficulties: Cycle 27 (n=6, 8)
    16.67 ± 27.889
    20.83 ± 35.355
        Financial Difficulties: Cycle 28 (n=7, 8)
    19.05 ± 26.227
    20.83 ± 35.355
        Financial Difficulties: Cycle 29 (n=5, 7)
    13.33 ± 29.814
    19.05 ± 37.796
        Financial Difficulties: Cycle 30 (n=4, 7)
    16.67 ± 33.333
    19.05 ± 37.796
        Financial Difficulties: Cycle 31 (n=2, 7)
    33.33 ± 47.140
    19.05 ± 37.796
        Financial Difficulties: Cycle 32 (n=3, 6)
    22.22 ± 38.490
    22.22 ± 40.369
        Financial Difficulties: Cycle 33 (n=3, 6)
    33.33 ± 33.333
    22.22 ± 40.369
        Financial Difficulties: Cycle 34 (n=3, 6)
    22.22 ± 19.245
    22.22 ± 40.369
        Financial Difficulties: Cycle 35 (n=2, 6)
    50.00 ± 23.570
    22.22 ± 40.369
        Financial Difficulties: Cycle 36 (n=1, 5)
    0.00 ± 99999
    20.00 ± 44.721
        Financial Difficulties: Cycle 37 (n=1, 4)
    33.33 ± 99999
    8.33 ± 16.667
        Financial Difficulties: Cycle 38 (n=0, 4)A
    99999 ± 99999
    8.33 ± 16.667
        Financial Difficulties: Cycle 39 (n=1, 3)
    0.00 ± 99999
    11.11 ± 19.245
        Financial Difficulties: Cycle 40 (n=1, 3)
    33.33 ± 99999
    11.11 ± 19.245
        Financial Difficulties: Cycle 41 (n=0, 3)
    99999 ± 99999
    22.22 ± 19.245
        Financial Difficulties: Cycle 42 (n=0, 2)
    99999 ± 99999
    0.00 ± 0.000
        Financial Difficulties: Cycle 43 (n=0, 1)
    99999 ± 99999
    0.00 ± 99999
        Financial Difficulties: EOT (n=33, 30)
    30.30 ± 29.302
    23.33 ± 26.479
    No statistical analyses for this end point

    Secondary: Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)

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    End point title
    Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
    End point description
    EORTC QLQ-GI-NET 21 was a 21-item questionnaire. These 21 questions assesses endocrine symptoms, gastrointestinal (G.I.) symptoms, treatment related symptoms, social functioning, disease related worries, muscle/bone pain, sexual function, information/communication function and body image. Each item was answered on a 4-point scale: 1 =not at all, 2 =a little, 3 =quite a bit, 4 =very much; where higher scores indicated more severe symptoms/problems. Scores averaged, transformed to 0-100 scale; higher score=more severe symptoms. Here, "99999" for mean and standard deviation signifies data not available (NA) as none of the subjects were evaluable in the given group at this time point. FAS population and 'n' signifies those subjects who were evaluable at specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: units on a scale
    arithmetic mean (standard deviation)
        Endocrine Symptoms: Cycle 1 (n=61,44)
    9.47 ± 14.746
    15.66 ± 20.378
        Endocrine Symptoms: Cycle 2 (n=57,41)
    9.94 ± 14.347
    14.91 ± 16.407
        Endocrine Symptoms: Cycle 3 (n=55,40)
    14.75 ± 20.066
    11.67 ± 14.443
        Endocrine Symptoms: Cycle 4 (n=50,37)
    12.67 ± 15.227
    12.31 ± 14.531
        Endocrine Symptoms: Cycle 5 (n=47,33)
    12.29 ± 13.752
    8.08 ± 12.507
        Endocrine Symptoms: Cycle 6 (n=43,31)
    13.18 ± 16.490
    9.32 ± 13.788
        Endocrine Symptoms: Cycle 7 (n=39,29)
    12.82 ± 14.315
    12.07 ± 16.538
        Endocrine Symptoms: Cycle 8 (n=37,25)
    13.81 ± 18.408
    10.67 ± 14.515
        Endocrine Symptoms: Cycle 9 (n=35,26)
    10.16 ± 14.851
    11.11 ± 14.741
        Endocrine Symptoms: Cycle 10 (n=35,23)
    10.16 ± 13.304
    14.01 ± 18.416
        Endocrine Symptoms: Cycle 11 (n=35,24)
    13.02 ± 16.934
    13.43 ± 19.653
        Endocrine Symptoms: Cycle 12 (n=35,22)
    12.06 ± 16.693
    11.62 ± 17.644
        Endocrine Symptoms: Cycle 13 (n=34,21)
    10.46 ± 14.459
    11.64 ± 15.899
        Endocrine Symptoms: Cycle 14 (n=31,19)
    12.19 ± 16.815
    14.62 ± 18.538
        Endocrine Symptoms: Cycle 15 (n=30,17)
    13.33 ± 18.082
    15.69 ± 18.864
        Endocrine Symptoms: Cycle 16 (n=27,16)
    10.70 ± 16.155
    9.03 ± 11.631
        Endocrine Symptoms: Cycle 17 (n=22,15)
    12.12 ± 18.753
    8.89 ± 10.457
        Endocrine Symptoms: Cycle 18 (n=17,14)
    11.11 ± 18.840
    11.90 ± 14.756
        Endocrine Symptoms: Cycle 19 (n=12,14)
    14.81 ± 21.364
    6.35 ± 11.293
        Endocrine Symptoms: Cycle 20 (n=11,13)
    15.15 ± 20.045
    11.11 ± 17.568
        Endocrine Symptoms: Cycle 21 (n=11,12)
    20.20 ± 20.975
    9.26 ± 12.385
        Endocrine Symptoms: Cycle 22 (n=11,11)
    14.14 ± 19.303
    16.16 ± 21.294
        Endocrine Symptoms: Cycle 23 (n=11,10)
    18.18 ± 15.131
    13.33 ± 16.397
        Endocrine Symptoms: Cycle 24 (n=10,10)
    22.22 ± 31.427
    13.33 ± 14.628
        Endocrine Symptoms: Cycle 25 (n=10,8)
    16.67 ± 23.570
    8.33 ± 12.944
        Endocrine Symptoms: Cycle 26 (n=7,7)
    22.22 ± 27.962
    7.94 ± 13.929
        Endocrine Symptoms: Cycle 27 (n=6,8)
    22.22 ± 28.109
    9.72 ± 12.511
        Endocrine Symptoms: Cycle 28 (n=7,8)
    19.05 ± 29.197
    12.50 ± 18.245
        Endocrine Symptoms: Cycle 29 (n=6,7)
    12.96 ± 12.989
    11.11 ± 12.830
        Endocrine Symptoms: Cycle 30 (n=5,7)
    8.89 ± 9.296
    14.29 ± 13.929
        Endocrine Symptoms: Cycle 31 (n=3,7)
    14.81 ± 6.415
    12.70 ± 11.878
        Endocrine Symptoms: Cycle 32 (n=3,6)
    7.41 ± 12.830
    14.81 ± 13.456
        Endocrine Symptoms: Cycle 33 (n=3,6)
    11.11 ± 0.000
    16.67 ± 11.653
        Endocrine Symptoms: Cycle 34 (n=3,6)
    18.52 ± 6.415
    20.37 ± 23.744
        Endocrine Symptoms: Cycle 35 (n=2,6)
    22.22 ± 0.000
    16.67 ± 16.851
        Endocrine Symptoms: Cycle 36 (n=1,5)
    22.22 ± 99999
    17.78 ± 18.592
        Endocrine Symptoms: Cycle 37 (n=1,4)
    22.22 ± 99999
    5.56 ± 11.111
        Endocrine Symptoms: Cycle 38 (n=0,4)
    99999 ± 99999
    8.33 ± 10.638
        Endocrine Symptoms: Cycle 39 (n=1,3)
    22.22 ± 99999
    11.11 ± 11.111
        Endocrine Symptoms: Cycle 40 (n=1,3)
    22.22 ± 99999
    11.11 ± 11.111
        Endocrine Symptoms: Cycle 41 (n=0,3)
    99999 ± 99999
    11.11 ± 11.111
        Endocrine Symptoms: Cycle 42 (n=0,2)
    99999 ± 99999
    0.00 ± 0.000
        Endocrine Symptoms: Cycle 43 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Endocrine Symptoms: EOT (n=33,29)
    13.80 ± 15.474
    11.11 ± 16.534
        Gastrointestinal Symptoms: Cycle 1 (n=61,44)
    15.41 ± 14.633
    15.30 ± 13.301
        Gastrointestinal Symptoms: Cycle 2 (n=57,41)
    17.66 ± 14.057
    17.72 ± 13.631
        Gastrointestinal Symptoms: Cycle 3 (n=55,40)
    20.24 ± 17.543
    19.50 ± 16.702
        Gastrointestinal Symptoms: Cycle 4 (n=50,38)
    19.47 ± 16.814
    19.30 ± 17.315
        Gastrointestinal Symptoms: Cycle 5 (n=47,33)
    15.18 ± 13.528
    21.01 ± 17.569
        Gastrointestinal Symptoms: Cycle 6 (n=43,31)
    18.76 ± 16.982
    21.51 ± 20.273
        Gastrointestinal Symptoms: Cycle 7 (n=39,29)
    18.63 ± 19.114
    20.23 ± 18.728
        Gastrointestinal Symptoms: Cycle 8 (n=37,25)
    20.72 ± 19.359
    19.47 ± 15.743
        Gastrointestinal Symptoms: Cycle 9 (n=35,26)
    18.86 ± 18.040
    19.49 ± 17.681
        Gastrointestinal Symptoms: Cycle 10 (n=35,23)
    18.38 ± 17.916
    19.78 ± 18.315
        Gastrointestinal Symptoms: Cycle 11 (n=35,24)
    18.86 ± 15.295
    16.94 ± 17.360
        Gastrointestinal Symptoms: Cycle 12 (n=35,22)
    18.86 ± 18.040
    18.79 ± 20.741
        Gastrointestinal Symptoms: Cycle 13 (n=34,21)
    18.04 ± 17.641
    14.60 ± 13.600
        Gastrointestinal Symptoms: Cycle 14 (n=31,19)
    18.06 ± 18.871
    16.49 ± 13.943
        Gastrointestinal Symptoms: Cycle 15 (n=30,17)
    19.56 ± 17.934
    22.35 ± 22.966
        Gastrointestinal Symptoms: Cycle 16 (n=27,16)
    17.53 ± 17.458
    17.50 ± 14.782
        Gastrointestinal Symptoms: Cycle 17 (n=22,15)
    18.18 ± 19.099
    13.78 ± 12.206
        Gastrointestinal Symptoms: Cycle 18 (n=17,14)
    24.31 ± 20.942
    15.71 ± 12.433
        Gastrointestinal Symptoms: Cycle 19 (n=12,14)
    23.89 ± 21.360
    20.48 ± 20.500
        Gastrointestinal Symptoms: Cycle 20 (n=11,13)
    25.45 ± 22.473
    16.41 ± 15.303
        Gastrointestinal Symptoms: Cycle 21 (n=11,12)
    29.09 ± 22.759
    17.22 ± 16.927
        Gastrointestinal Symptoms: Cycle 22 (n=11,11)
    23.03 ± 21.574
    18.18 ± 18.641
        Gastrointestinal Symptoms: Cycle 23 (n=11,10)
    27.27 ± 26.408
    20.00 ± 18.856
        Gastrointestinal Symptoms: Cycle 24 (n=10,10)
    26.00 ± 20.476
    21.33 ± 18.539
        Gastrointestinal Symptoms: Cycle 25 (n=10,8)
    24.67 ± 19.386
    23.33 ± 17.090
        Gastrointestinal Symptoms: Cycle 26 (n=7,7)
    30.48 ± 17.152
    20.95 ± 15.601
        Gastrointestinal Symptoms: Cycle 27 (n=6,8)
    34.44 ± 28.415
    25.83 ± 20.912
        Gastrointestinal Symptoms: Cycle 28 (n=7,8)
    28.57 ± 23.637
    23.96 ± 20.967
        Gastrointestinal Symptoms: Cycle 29 (n=6,7)
    22.22 ± 5.443
    28.57 ± 17.090
        Gastrointestinal Symptoms: Cycle 30 (n=5,7)
    18.67 ± 15.202
    21.90 ± 17.518
        Gastrointestinal Symptoms: Cycle 31 (n=3,7)
    24.44 ± 26.943
    22.86 ± 19.572
        Gastrointestinal Symptoms: Cycle 32 (n=3,6)
    22.22 ± 27.756
    27.78 ± 19.052
        Gastrointestinal Symptoms: Cycle 33 (n=3,6)
    26.67 ± 35.277
    23.33 ± 17.256
        Gastrointestinal Symptoms: Cycle 34 (n=3,6)
    20.00 ± 29.059
    28.89 ± 15.587
        Gastrointestinal Symptoms: Cycle 35 (n=2,6)
    23.33 ± 32.998
    20.00 ± 15.202
        Gastrointestinal Symptoms: Cycle 36 (n=1,5)
    0.00 ± 99999
    17.33 ± 15.348
        Gastrointestinal Symptoms: Cycle 37 (n=1,4)
    0.00 ± 99999
    21.67 ± 13.744
        Gastrointestinal Symptoms: Cycle 38 (n=0,4)
    99999 ± 99999
    27.92 ± 20.520
        Gastrointestinal Symptoms: Cycle 39 (n=1,3)
    6.67 ± 99999
    31.11 ± 19.245
        Gastrointestinal Symptoms: Cycle 40 (n=1,3)
    0.00 ± 99999
    26.67 ± 17.638
        Gastrointestinal Symptoms: Cycle 41 (n=0,3)
    99999 ± 99999
    35.56 ± 21.430
        Gastrointestinal Symptoms: Cycle 42 (n=0,2)
    99999 ± 99999
    33.33 ± 18.856
        Gastrointestinal Symptoms: Cycle 43 (n=0,1)
    99999 ± 99999
    20.00 ± 99999
        Gastrointestinal Symptoms:EOT (n=33,29)
    23.23 ± 18.568
    18.85 ± 19.766
        Treatment Related Symptoms: Cycle 1 (n=19,13)
    12.57 ± 14.797
    16.24 ± 19.038
        Treatment Related Symptoms: Cycle 2 (n=56,36)
    14.48 ± 11.686
    16.20 ± 14.141
        Treatment Related Symptoms: Cycle 3 (n=49,39)
    15.42 ± 12.280
    17.09 ± 18.574
        Treatment Related Symptoms: Cycle 4 (n=45,36)
    17.53 ± 15.622
    13.89 ± 16.074
        Treatment Related Symptoms: Cycle 5 (n=45,31)
    15.06 ± 11.522
    14.52 ± 15.361
        Treatment Related Symptoms: Cycle 6 (n=41,30)
    15.45 ± 13.293
    15.00 ± 17.577
        Treatment Related Symptoms: Cycle 7 (n=37,27)
    18.77 ± 16.216
    15.84 ± 17.207
        Treatment Related Symptoms: Cycle 8 (n=35,24)
    20.48 ± 19.930
    14.12 ± 17.870
        Treatment Related Symptoms: Cycle 9 (n=32,23)
    18.23 ± 15.917
    14.01 ± 17.558
        Treatment Related Symptoms: Cycle 10 (n=33,23)
    15.99 ± 15.760
    16.91 ± 17.446
        Treatment Related Symptoms: Cycle 11 (n=35,24)
    16.83 ± 16.196
    15.05 ± 21.453
        Treatment Related Symptoms: Cycle 12 (n=34,21)
    16.01 ± 18.989
    11.11 ± 13.494
        Treatment Related Symptoms: Cycle 13 (n=32,19)
    15.45 ± 12.441
    7.89 ± 8.942
        Treatment Related Symptoms: Cycle 14 (n=29,19)
    13.60 ± 12.386
    11.70 ± 13.968
        Treatment Related Symptoms: Cycle 15 (n=28,16)
    15.48 ± 12.950
    8.68 ± 12.664
        Treatment Related Symptoms: Cycle 16 (n=25,15)
    13.78 ± 13.714
    10.74 ± 14.467
        Treatment Related Symptoms: Cycle 17 (n=21,15)
    14.81 ± 15.941
    7.41 ± 8.572
        Treatment Related Symptoms: Cycle 18 (n=16,14)
    17.71 ± 16.999
    10.71 ± 11.828
        Treatment Related Symptoms: Cycle 19 (n=10,14)
    20.00 ± 17.013
    12.30 ± 13.287
        Treatment Related Symptoms: Cycle 20 (n=10,12)
    18.33 ± 17.382
    9.72 ± 11.392
        Treatment Related Symptoms: Cycle 21 (n=11,12)
    18.18 ± 18.608
    14.81 ± 14.279
        Treatment Related Symptoms: Cycle 22 (n=10,11)
    24.44 ± 22.253
    12.63 ± 12.691
        Treatment Related Symptoms: Cycle 23 (n=10,10)
    22.22 ± 23.570
    13.89 ± 13.671
        Treatment Related Symptoms: Cycle 24 (n=9,10)
    22.84 ± 24.602
    11.67 ± 13.969
        Treatment Related Symptoms: Cycle 25 (n=8,8)
    21.53 ± 21.504
    15.28 ± 14.164
        Treatment Related Symptoms: Cycle 26 (n=7,7)
    26.19 ± 21.448
    12.70 ± 11.437
        Treatment Related Symptoms: Cycle 27 (n=6,8)
    37.96 ± 16.636
    19.44 ± 18.306
        Treatment Related Symptoms: Cycle 28 (n=5,8)
    35.56 ± 21.009
    17.36 ± 15.555
        Treatment Related Symptoms: Cycle 29 (n=4,7)
    16.67 ± 4.536
    15.87 ± 12.184
        Treatment Related Symptoms: Cycle 30 (n=3,7)
    20.37 ± 3.208
    15.87 ± 14.138
        Treatment Related Symptoms: Cycle 31 (n=3,7)
    22.22 ± 11.111
    20.63 ± 17.484
        Treatment Related Symptoms: Cycle 32 (n=3,6)
    16.67 ± 5.556
    20.37 ± 7.590
        Treatment Related Symptoms: Cycle 33 (n=3,6)
    22.22 ± 11.111
    20.37 ± 7.590
        Treatment Related Symptoms: Cycle 34 (n=3,6)
    27.78 ± 9.623
    20.37 ± 12.989
        Treatment Related Symptoms: Cycle 35 (n=2,6)
    11.11 ± 15.713
    17.59 ± 11.340
        Treatment Related Symptoms: Cycle 36 (n=1,5)
    16.67 ± 99999
    25.56 ± 7.454
        Treatment Related Symptoms: Cycle 37 (n=1,4)
    16.67 ± 99999
    26.39 ± 8.333
        Treatment Related Symptoms: Cycle 38 (n=0,3)
    99999 ± 99999
    22.22 ± 11.111
        Treatment Related Symptoms: Cycle 39 (n=1,3)
    0.00 ± 99999
    29.63 ± 6.415
        Treatment Related Symptoms: Cycle 40 (n=1,3)
    0.00 ± 99999
    25.93 ± 6.415
        Treatment Related Symptoms: Cycle 41 (n=0,3)
    99999 ± 99999
    24.07 ± 8.486
        Treatment Related Symptoms: Cycle 42 (n=0,2)
    99999 ± 99999
    27.78 ± 7.857
        Treatment Related Symptoms: Cycle 43 (n=0,1)
    99999 ± 99999
    33.33 ± 99999
        Treatment Related Symptoms: EOT (n=29,27)
    24.33 ± 20.542
    20.78 ± 24.969
        Social Functioning: Cycle 1 (n=61,44)
    35.34 ± 22.907
    31.06 ± 20.132
        Social Functioning: Cycle 2 (n=57,41)
    30.99 ± 21.490
    29.81 ± 22.695
        Social Functioning: Cycle 3 (n=55,40)
    29.49 ± 20.534
    30.00 ± 25.061
        Social Functioning: Cycle 4 (n=50,38)
    27.00 ± 19.441
    26.17 ± 22.331
        Social Functioning: Cycle 5 (n=47,33)
    27.90 ± 19.087
    24.24 ± 22.473
        Social Functioning: Cycle 6 (n=43,31)
    25.71 ± 21.138
    28.32 ± 23.101
        Social Functioning: Cycle 7 (n=39,29)
    29.06 ± 20.171
    27.20 ± 26.157
        Social Functioning: Cycle 8 (n=37,25)
    30.63 ± 20.015
    27.11 ± 20.051
        Social Functioning: Cycle 9 (n=35,26)
    29.84 ± 27.715
    23.08 ± 19.607
        Social Functioning: Cycle 10 (n=35,23)
    28.89 ± 22.579
    24.64 ± 24.835
        Social Functioning: Cycle 11 (n=35,24)
    29.21 ± 21.573
    24.07 ± 22.383
        Social Functioning: Cycle 12 (n=35,22)
    28.25 ± 24.454
    23.74 ± 22.562
        Social Functioning: Cycle 13 (n=34,21)
    24.84 ± 23.380
    23.81 ± 23.382
        Social Functioning: Cycle 14 (n=31,19)
    27.96 ± 20.056
    25.73 ± 24.018
        Social Functioning: Cycle 15 (n=30,17)
    28.52 ± 20.149
    28.76 ± 28.070
        Social Functioning: Cycle 16 (n=27,16)
    27.16 ± 20.286
    27.78 ± 23.307
        Social Functioning: Cycle 17 (n=22,15)
    28.79 ± 21.320
    23.70 ± 22.564
        Social Functioning: Cycle 18 (n=17,14)
    29.41 ± 26.040
    26.98 ± 21.666
        Social Functioning: Cycle 19 (n=12,14)
    29.63 ± 25.219
    28.57 ± 22.943
        Social Functioning: Cycle 20 (n=11,13)
    31.82 ± 28.119
    29.06 ± 28.160
        Social Functioning: Cycle 21 (n=11,12)
    35.35 ± 30.151
    24.07 ± 23.130
        Social Functioning: Cycle 22 (n=11,11)
    31.31 ± 28.029
    27.27 ± 24.527
        Social Functioning: Cycle 23 (n=11,10)
    30.30 ± 28.149
    26.67 ± 27.317
        Social Functioning: Cycle 24 (n=10,10)
    38.89 ± 28.328
    24.44 ± 24.456
        Social Functioning: Cycle 25 (n=10,8)
    35.56 ± 27.116
    31.94 ± 26.184
        Social Functioning: Cycle 26 (n=7,7)
    46.03 ± 28.276
    22.22 ± 11.111
        Social Functioning: Cycle 27 (n=6,8)
    51.85 ± 28.689
    33.33 ± 28.483
        Social Functioning: Cycle 28 (n=7,8)
    46.03 ± 33.597
    31.94 ± 29.360
        Social Functioning: Cycle 29 (n=6,7)
    35.19 ± 25.740
    28.57 ± 27.857
        Social Functioning: Cycle 30 (n=5,7)
    35.56 ± 26.527
    30.16 ± 29.893
        Social Functioning: Cycle 31 (n=3,7)
    44.44 ± 22.222
    30.16 ± 29.197
        Social Functioning: Cycle 32 (n=3,6)
    33.33 ± 11.111
    31.48 ± 30.965
        Social Functioning: Cycle 33 (n=3,6)
    40.74 ± 23.130
    40.74 ± 31.164
        Social Functioning: Cycle 34 (n=3,6)
    44.44 ± 22.222
    35.19 ± 29.327
        Social Functioning: Cycle 35 (n=2,6)
    38.89 ± 23.570
    33.33 ± 24.343
        Social Functioning: Cycle 36 (n=1,5)
    22.22 ± 99999
    31.11 ± 27.666
        Social Functioning: Cycle 37 (n=1,4)
    22.22 ± 99999
    30.56 ± 39.933
        Social Functioning: Cycle 38 (n=0,4)
    99999 ± 99999
    41.67 ± 41.944
        Social Functioning: Cycle 39 (n=1,3)
    33.33 ± 99999
    51.85 ± 44.905
        Social Functioning: Cycle 40 (n=1,3)
    11.11 ± 99999
    42.59 ± 36.991
        Social Functioning: Cycle 41 (n=0,3)
    99999 ± 99999
    44.44 ± 40.062
        Social Functioning: Cycle 42 (n=0,2)
    99999 ± 99999
    38.89 ± 39.284
        Social Functioning: Cycle 43 (n=0,1)
    99999 ± 99999
    11.11 ± 99999
        Social Functioning: EOT (n=33,29)
    39.73 ± 25.914
    41.38 ± 26.874
        Disease Related Worries: Cycle 1 (n=61,43)
    49.27 ± 26.381
    42.89 ± 23.108
        Disease Related Worries: Cycle 2 (n=57,41)
    38.01 ± 24.550
    36.04 ± 24.942
        Disease Related Worries: Cycle 3 (n=55,40)
    36.46 ± 23.074
    34.58 ± 23.853
        Disease Related Worries: Cycle 4 (n=50,38)
    31.89 ± 22.075
    33.19 ± 23.904
        Disease Related Worries: Cycle 5 (n=47,33)
    37.12 ± 25.619
    30.64 ± 22.742
        Disease Related Worries: Cycle 6 (n=43,31)
    36.43 ± 25.148
    34.05 ± 25.000
        Disease Related Worries: Cycle 7 (n=39,29)
    39.32 ± 24.825
    32.18 ± 26.618
        Disease Related Worries: Cycle 8 (n=37,25)
    38.29 ± 25.653
    32.00 ± 22.753
        Disease Related Worries: Cycle 9 (n=35,26)
    35.71 ± 31.116
    32.05 ± 22.072
        Disease Related Worries: Cycle 10 (n=35,23)
    37.30 ± 26.458
    28.02 ± 26.563
        Disease Related Worries: Cycle 11 (n=35,24)
    35.87 ± 25.292
    27.78 ± 22.700
        Disease Related Worries: Cycle 12 (n=35,22)
    35.56 ± 28.621
    29.29 ± 25.325
        Disease Related Worries: Cycle 13 (n=34,21)
    34.64 ± 27.046
    30.16 ± 24.881
        Disease Related Worries: Cycle 14 (n=31,19)
    32.97 ± 22.312
    31.87 ± 22.055
        Disease Related Worries: Cycle 15 (n=30,17)
    34.44 ± 25.160
    33.66 ± 27.250
        Disease Related Worries: Cycle 16 (n=27,16)
    34.16 ± 25.022
    37.85 ± 23.589
        Disease Related Worries: Cycle 17 (n=22,15)
    29.80 ± 22.059
    34.07 ± 27.043
        Disease Related Worries: Cycle 18 (n=17,14)
    30.07 ± 28.805
    32.14 ± 27.232
        Disease Related Worries: Cycle 19 (n=12,14)
    37.50 ± 29.504
    31.75 ± 28.862
        Disease Related Worries: Cycle 20 (n=11,13)
    40.40 ± 32.687
    29.91 ± 31.877
        Disease Related Worries: Cycle 21 (n=11,12)
    39.90 ± 30.512
    27.78 ± 30.887
        Disease Related Worries: Cycle 22 (n=11,11)
    33.33 ± 31.032
    30.30 ± 34.816
        Disease Related Worries: Cycle 23 (n=11,10)
    36.36 ± 35.168
    26.11 ± 29.403
        Disease Related Worries: Cycle 24 (n=10,10)
    41.11 ± 32.309
    27.78 ± 28.328
        Disease Related Worries: Cycle 25 (n=10,8)
    38.33 ± 32.547
    38.89 ± 31.983
        Disease Related Worries: Cycle 26 (n=7,7)
    42.86 ± 33.597
    31.75 ± 33.597
        Disease Related Worries: Cycle 27 (n=6,8)
    52.78 ± 40.023
    34.72 ± 28.133
        Disease Related Worries: Cycle 28 (n=7,8)
    50.79 ± 38.946
    40.28 ± 39.368
        Disease Related Worries: Cycle 29 (n=6,7)
    37.96 ± 35.210
    38.10 ± 35.635
        Disease Related Worries: Cycle 30 (n=5,7)
    35.56 ± 38.809
    34.92 ± 29.696
        Disease Related Worries: Cycle 31 (n=3,7)
    48.15 ± 46.259
    36.51 ± 32.530
        Disease Related Worries: Cycle 32 (n=3,6)
    25.93 ± 23.130
    37.04 ± 38.276
        Disease Related Worries: Cycle 33 (n=3,6)
    51.85 ± 42.066
    35.19 ± 36.118
        Disease Related Worries: Cycle 34 (n=3,6)
    55.56 ± 40.062
    35.19 ± 36.796
        Disease Related Worries: Cycle 35 (n=2,6)
    16.67 ± 23.570
    35.19 ± 34.006
        Disease Related Worries: Cycle 36 (n=1,5)
    0.00 ± 99999
    31.11 ± 36.345
        Disease Related Worries: Cycle 37 (n=1,4)
    0.00 ± 99999
    22.22 ± 31.427
        Disease Related Worries: Cycle 38 (n=0,4)
    99999 ± 99999
    33.33 ± 45.361
        Disease Related Worries: Cycle 39 (n=1,3)
    0.00 ± 99999
    44.44 ± 50.918
        Disease Related Worries: Cycle 40 (n=1,3)
    0.00 ± 99999
    37.04 ± 35.717
        Disease Related Worries: Cycle 41 (n=0,3)
    99999 ± 99999
    44.44 ± 50.918
        Disease Related Worries: Cycle 42 (n=0,2)
    99999 ± 99999
    50.00 ± 54.997
        Disease Related Worries: Cycle 43 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Disease Related Worries: EOT (n=33,29)
    50.84 ± 27.079
    41.38 ± 30.123
        Muscle/Bone Pain Symptom: Cycle 1 (n=59,44)
    13.56 ± 20.640
    13.64 ± 20.734
        Muscle/Bone Pain Symptom: Cycle 2 (n=57,41)
    20.47 ± 24.197
    17.89 ± 23.685
        Muscle/Bone Pain Symptom: Cycle 3 (n=55,40)
    16.36 ± 19.108
    23.33 ± 24.108
        Muscle/Bone Pain Symptom: Cycle 4 (n=50,38)
    16.00 ± 20.471
    21.93 ± 26.024
        Muscle/Bone Pain Symptom: Cycle 5 (n=47,33)
    17.02 ± 18.221
    22.22 ± 27.217
        Muscle/Bone Pain Symptom: Cycle 6 (n=43,31)
    18.60 ± 20.959
    20.43 ± 23.847
        Muscle/Bone Pain Symptom: Cycle 7 (n=39,29)
    20.51 ± 22.446
    21.84 ± 29.915
        Muscle/Bone Pain Symptom: Cycle 8 (n=37,25)
    20.72 ± 22.705
    20.00 ± 23.570
        Muscle/Bone Pain Symptom: Cycle 9 (n=35,26)
    16.19 ± 18.737
    20.51 ± 21.243
        Muscle/Bone Pain Symptom: Cycle 10 (n=35,23)
    20.00 ± 25.820
    24.64 ± 28.810
        Muscle/Bone Pain Symptom: Cycle 11 (n=35,24)
    21.90 ± 25.492
    22.22 ± 25.380
        Muscle/Bone Pain Symptom: Cycle 12 (n=35,22)
    20.95 ± 26.918
    19.70 ± 24.471
        Muscle/Bone Pain Symptom: Cycle 13 (n=34,21)
    20.59 ± 24.638
    23.81 ± 28.172
        Muscle/Bone Pain Symptom: Cycle 14 (n=31,19)
    12.90 ± 22.240
    22.81 ± 27.336
        Muscle/Bone Pain Symptom: Cycle 15 (n=29,17)
    11.49 ± 18.422
    25.49 ± 32.338
        Muscle/Bone Pain Symptom: Cycle 16 (n=27,16)
    19.75 ± 24.909
    16.67 ± 24.343
        Muscle/Bone Pain Symptom: Cycle 17 (n=22,15)
    22.73 ± 25.996
    15.56 ± 24.774
        Muscle/Bone Pain Symptom: Cycle 18 (n=17,14)
    15.69 ± 20.809
    14.29 ± 25.198
        Muscle/Bone Pain Symptom: Cycle 19 (n=12,14)
    25.00 ± 20.719
    16.67 ± 25.318
        Muscle/Bone Pain Symptom: Cycle 20 (n=11,13)
    27.27 ± 25.025
    12.82 ± 21.681
        Muscle/Bone Pain Symptom: Cycle 21 (n=11,12)
    21.21 ± 22.473
    13.89 ± 22.285
        Muscle/Bone Pain Symptom: Cycle 22 (n=11,11)
    15.15 ± 22.918
    24.24 ± 26.208
        Muscle/Bone Pain Symptom: Cycle 23 (n=11,10)
    21.21 ± 26.968
    23.33 ± 22.498
        Muscle/Bone Pain Symptom: Cycle 24 (n=10,10)
    20.00 ± 23.307
    30.00 ± 29.187
        Muscle/Bone Pain Symptom: Cycle 25 (n=10,8)
    23.33 ± 27.442
    33.33 ± 30.861
        Muscle/Bone Pain Symptom: Cycle 26 (n=7,7)
    33.33 ± 27.217
    28.57 ± 29.991
        Muscle/Bone Pain Symptom: Cycle 27 (n=6,8)
    50.00 ± 18.257
    29.17 ± 27.817
        Muscle/Bone Pain Symptom: Cycle 28 (n=7,8)
    38.10 ± 23.002
    33.33 ± 35.635
        Muscle/Bone Pain Symptom: Cycle 29 (n=6,7)
    22.22 ± 27.217
    33.33 ± 27.217
        Muscle/Bone Pain Symptom: Cycle 30 (n=5,7)
    26.67 ± 27.889
    28.57 ± 35.635
        Muscle/Bone Pain Symptom: Cycle 31 (n=3,7)
    22.22 ± 38.490
    38.10 ± 29.991
        Muscle/Bone Pain Symptom: Cycle 32 (n=3,6)
    22.22 ± 38.490
    38.89 ± 13.608
        Muscle/Bone Pain Symptom: Cycle 33 (n=3,6)
    33.33 ± 33.333
    33.33 ± 29.814
        Muscle/Bone Pain Symptom: Cycle 34 (n=3,6)
    11.11 ± 19.245
    44.44 ± 17.213
        Muscle/Bone Pain Symptom: Cycle 35 (n=2,6)
    33.33 ± 47.140
    38.89 ± 13.608
        Muscle/Bone Pain Symptom: Cycle 36 (n=1,5)
    0.00 ± 99999
    53.33 ± 18.257
        Muscle/Bone Pain Symptom: Cycle 37 (n=1,4)
    0.00 ± 99999
    50.00 ± 19.245
        Muscle/Bone Pain Symptom: Cycle 38 (n=0,4)
    99999 ± 99999
    58.33 ± 16.667
        Muscle/Bone Pain Symptom: Cycle 39 (n=1,3)
    0.00 ± 99999
    44.44 ± 19.245
        Muscle/Bone Pain Symptom: Cycle 40 (n=1,3)
    33.33 ± 99999
    55.56 ± 19.245
        Muscle/Bone Pain Symptom: Cycle 41 (n=0,3)
    99999 ± 99999
    55.56 ± 19.245
        Muscle/Bone Pain Symptom: Cycle 42 (n=0,2)
    99999 ± 99999
    50.00 ± 23.570
        Muscle/Bone Pain Symptom: Cycle 43 (n=0,1)
    99999 ± 99999
    66.67 ± 99999
        Muscle/Bone Pain Symptom: EOT (n=33,29)
    25.25 ± 27.677
    26.44 ± 30.052
        Sexual Function: Cycle 1 (n=34,29)
    22.55 ± 31.485
    34.48 ± 35.054
        Sexual Function: Cycle 2 (n=43,30)
    17.83 ± 25.561
    30.00 ± 30.763
        Sexual Function: Cycle 3 (n=39,29)
    17.95 ± 25.185
    36.78 ± 32.544
        Sexual Function: Cycle 4 (n=34,27)
    18.63 ± 24.878
    22.22 ± 30.662
        Sexual Function: Cycle 5 (n=32,27)
    18.75 ± 25.312
    28.40 ± 35.450
        Sexual Function: Cycle 6 (n=30,23)
    14.44 ± 20.869
    31.88 ± 35.503
        Sexual Function: Cycle 7 (n=28,23)
    19.05 ± 24.727
    30.43 ± 37.488
        Sexual Function: Cycle 8 (n=26,16)
    23.08 ± 27.919
    27.08 ± 27.806
        Sexual Function: Cycle 9 (n=25,19)
    13.33 ± 27.217
    28.07 ± 31.940
        Sexual Function: Cycle 10 (n=25,16)
    17.33 ± 29.059
    27.08 ± 32.702
        Sexual Function: Cycle 11 (n=25,16)
    16.00 ± 25.676
    20.83 ± 26.874
        Sexual Function: Cycle 12 (n=26,14)
    20.51 ± 29.929
    19.05 ± 25.198
        Sexual Function: Cycle 13 (n=24,15)
    16.67 ± 26.006
    22.22 ± 32.530
        Sexual Function: Cycle 14 (n=25,14)
    20.00 ± 27.217
    26.19 ± 26.726
        Sexual Function: Cycle 15 (n=21,12)
    17.46 ± 27.119
    19.44 ± 26.432
        Sexual Function: Cycle 16 (n=19,13)
    22.81 ± 33.431
    25.64 ± 27.735
        Sexual Function: Cycle 17 (n=15,12)
    20.00 ± 27.603
    22.22 ± 25.950
        Sexual Function: Cycle 18 (n=12,11)
    22.22 ± 21.711
    18.18 ± 27.340
        Sexual Function: Cycle 19 (n=7,10)
    19.05 ± 26.227
    20.00 ± 28.109
        Sexual Function: Cycle 20 (n=8,10)
    25.00 ± 29.547
    13.33 ± 23.307
        Sexual Function: Cycle 21 (n=7,9)
    23.81 ± 25.198
    14.81 ± 24.216
        Sexual Function: Cycle 22 (n=8,9)
    33.33 ± 30.861
    14.81 ± 24.216
        Sexual Function: Cycle 23 (n=7,8)
    23.81 ± 31.706
    20.83 ± 24.801
        Sexual Function: Cycle 24 (n=5,8)
    26.67 ± 27.889
    16.67 ± 25.198
        Sexual Function: Cycle 25 (n=5,6)
    26.67 ± 36.515
    16.67 ± 27.889
        Sexual Function: Cycle 26 (n=4,6)
    25.00 ± 31.914
    16.67 ± 27.889
        Sexual Function: Cycle 27 (n=1,6)
    33.33 ± 99999
    16.67 ± 27.889
        Sexual Function: Cycle 28 (n=3,6)
    33.33 ± 33.333
    16.67 ± 27.889
        Sexual Function: Cycle 29 (n=1,6)
    33.33 ± 99999
    16.67 ± 27.889
        Sexual Function: Cycle 30 (n=1,6)
    33.33 ± 99999
    16.67 ± 27.889
        Sexual Function: Cycle 31 (n=1,6)
    33.33 ± 99999
    16.67 ± 27.889
        Sexual Function: Cycle 32 (n=3,5)
    22.22 ± 38.490
    20.00 ± 29.814
        Sexual Function: Cycle 33 (n=1,5)
    33.33 ± 99999
    20.00 ± 29.814
        Sexual Function: Cycle 34 (n=1,5)
    33.33 ± 99999
    33.33 ± 33.333
        Sexual Function: Cycle 35 (n=1,5)
    33.33 ± 99999
    20.00 ± 29.814
        Sexual Function: Cycle 36 (n=1,4)
    0.00 ± 99999
    25.00 ± 31.914
        Sexual Function: Cycle 37 (n=1,3)
    0.00 ± 99999
    33.33 ± 33.333
        Sexual Function: Cycle 38 (n=0,3)
    99999 ± 99999
    33.33 ± 33.333
        Sexual Function: Cycle 39 (n=1,2)
    33.33 ± 99999
    16.67 ± 23.570
        Sexual Function: Cycle 40 (n=1,2)
    66.67 ± 99999
    0.00 ± 0.000
        Sexual Function: Cycle 41 (n=0,2)
    99999 ± 99999
    16.67 ± 23.570
        Sexual Function: Cycle 42 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Sexual Function: Cycle 43 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Sexual Function: EOT (n=22,19)
    25.76 ± 27.084
    49.12 ± 37.463
        Information/Communication: Cycle 1 (n=61,44)
    8.74 ± 21.860
    6.82 ± 15.384
        Information/Communication: Cycle 2 (n=57,41)
    5.85 ± 12.791
    5.69 ± 14.724
        Information/Communication: Cycle 3 (n=55,40)
    5.45 ± 14.001
    5.00 ± 14.222
        Information/Communication: Cycle 4 (n=50,38)
    4.67 ± 11.684
    5.26 ± 12.318
        Information/Communication: Cycle 5 (n=47,33)
    3.55 ± 10.389
    7.07 ± 18.177
        Information/Communication: Cycle 6 (n=43,31)
    4.65 ± 11.687
    5.38 ± 15.146
        Information/Communication: Cycle 7 (n=39,29)
    6.84 ± 13.636
    9.20 ± 23.395
        Information/Communication: Cycle 8 (n=37,25)
    8.11 ± 16.491
    5.33 ± 15.753
        Information/Communication: Cycle 9 (n=35,26)
    5.71 ± 12.746
    3.85 ± 10.860
        Information/Communication: Cycle 10 (n=35,23)
    8.57 ± 16.848
    7.25 ± 17.281
        Information/Communication: Cycle 11 (n=35,24)
    7.62 ± 18.232
    5.56 ± 16.051
        Information/Communication: Cycle 12 (n=35,22)
    10.48 ± 22.537
    1.52 ± 7.107
        Information/Communication: Cycle 13 (n=34,21)
    3.92 ± 10.901
    4.76 ± 11.952
        Information/Communication: Cycle 14 (n=31,19)
    6.45 ± 13.387
    3.51 ± 10.510
        Information/Communication: Cycle 15 (n=30,17)
    4.44 ± 11.525
    7.84 ± 18.743
        Information/Communication: Cycle 16 (n=27,16)
    2.47 ± 8.896
    8.33 ± 14.907
        Information/Communication: Cycle 17 (n=22,15)
    4.55 ± 11.708
    2.22 ± 8.607
        Information/Communication: Cycle 18 (n=17,14)
    7.84 ± 14.575
    7.14 ± 19.298
        Information/Communication: Cycle 19 (n=12, 14)
    0.00 ± 0.000
    2.38 ± 8.909
        Information/Communication: Cycle 20 (n=11,13)
    3.03 ± 10.050
    2.56 ± 9.245
        Information/Communication: Cycle 21 (n=11,12)
    6.06 ± 13.484
    2.78 ± 9.623
        Information/Communication: Cycle 22 (n=11,11)
    6.06 ± 13.484
    3.03 ± 10.050
        Information/Communication: Cycle 23 (n=11,10)
    9.09 ± 21.556
    3.33 ± 10.541
        Information/Communication: Cycle 24 (n=10,10)
    10.00 ± 22.498
    3.33 ± 10.541
        Information/Communication: Cycle 25 (n=10,8)
    6.67 ± 14.055
    4.17 ± 11.785
        Information/Communication: Cycle 26 (n=6,7)
    11.11 ± 17.213
    4.76 ± 12.599
        Information/Communication: Cycle 27 (n=6,8)
    0.00 ± 0.000
    4.17 ± 11.785
        Information/Communication: Cycle 28 (n=7,8)
    9.52 ± 16.265
    4.17 ± 11.785
        Information/Communication: Cycle 29 (n=6,7)
    5.56 ± 13.608
    4.76 ± 12.599
        Information/Communication: Cycle 30 (n=5,7)
    0.00 ± 0.000
    4.76 ± 12.599
        Information/Communication: Cycle 31 (n=3,7)
    0.00 ± 0.000
    4.76 ± 12.599
        Information/Communication: Cycle 32 (n=3,6)
    0.00 ± 0.000
    5.56 ± 13.608
        Information/Communication: Cycle 33 (n=3,6)
    11.11 ± 19.245
    0.00 ± 0.000
        Information/Communication: Cycle 34 (n=3,6)
    11.11 ± 19.245
    5.56 ± 13.608
        Information/Communication: Cycle 35 (n=2,6)
    0.00 ± 0.000
    5.56 ± 13.608
        Information/Communication: Cycle 36 (n=1,5)
    0.00 ± 99999
    0.00 ± 0.000
        Information/Communication: Cycle 37 (n=1,4)
    0.00 ± 99999
    0.00 ± 0.000
        Information/Communication: Cycle 38 (n=0,4)
    99999 ± 99999
    8.33 ± 16.667
        Information/Communication: Cycle 39 (n=1,3)
    0.00 ± 99999
    11.11 ± 19.245
        Information/Communication: Cycle 40 (n=1,3)
    0.00 ± 99999
    11.11 ± 19.245
        Information/Communication: Cycle 41 (n=0,3)
    99999 ± 99999
    11.11 ± 19.245
        Information/Communication: Cycle 42 (n=0,2)
    99999 ± 99999
    0.00 ± 0.000
        Information/Communication: Cycle 43 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Information/Communication: EOT (n=33,29)
    10.10 ± 19.516
    5.75 ± 20.057
        Body Image: Cycle 1 (n=60,44)
    21.67 ± 32.950
    24.24 ± 24.234
        Body Image: Cycle 2 (n=57,41)
    12.87 ± 19.674
    15.45 ± 25.925
        Body Image: Cycle 3 (n=52,40)
    10.90 ± 21.614
    19.17 ± 31.020
        Body Image: Cycle 4 (n=49,38)
    10.88 ± 17.197
    16.67 ± 24.199
        Body Image: Cycle 5 (n=46,33)
    8.70 ± 17.826
    15.15 ± 25.126
        Body Image: Cycle 6 (n=42,30)
    11.90 ± 21.866
    21.11 ± 29.664
        Body Image: Cycle 7 (n=38,28)
    14.91 ± 25.347
    21.43 ± 31.706
        Body Image: Cycle 8 (n=37,24)
    13.51 ± 24.164
    15.28 ± 24.035
        Body Image: Cycle 9 (n=35,25)
    14.29 ± 28.337
    14.67 ± 23.727
        Body Image: Cycle 10 (n=34,23)
    13.73 ± 24.779
    18.84 ± 26.258
        Body Image: Cycle 11 (n=35,24)
    12.38 ± 19.944
    15.28 ± 24.035
        Body Image: Cycle 12 (n=35,22)
    10.48 ± 21.038
    9.09 ± 23.417
        Body Image: Cycle 13 (n=34,21)
    7.84 ± 20.199
    7.94 ± 17.965
        Body Image: Cycle 14 (n=31,19)
    12.90 ± 23.847
    7.02 ± 13.962
        Body Image: Cycle 15 (n=29,17)
    9.20 ± 21.633
    9.80 ± 19.596
        Body Image: Cycle 16 (n=27,16)
    16.05 ± 28.300
    10.42 ± 23.472
        Body Image: Cycle 17 (n=22,15)
    12.12 ± 26.318
    8.89 ± 15.258
        Body Image: Cycle 18 (n=17,14)
    15.69 ± 31.441
    7.14 ± 14.194
        Body Image: Cycle 19 (n=12,14)
    11.11 ± 25.950
    2.38 ± 8.909
        Body Image: Cycle 20 (n=11,12)
    9.09 ± 30.151
    8.33 ± 15.076
        Body Image: Cycle 21 (n=11,12)
    9.09 ± 30.151
    2.78 ± 9.623
        Body Image: Cycle 22 (n=11,11)
    15.15 ± 31.140
    6.06 ± 13.484
        Body Image: Cycle 23 (n=11,10)
    9.09 ± 21.556
    6.67 ± 14.055
        Body Image: Cycle 24 (n=10,10)
    16.67 ± 36.004
    3.33 ± 10.541
        Body Image: Cycle 25 (n=10,8)
    16.67 ± 36.004
    8.33 ± 15.430
        Body Image: Cycle 26 (n=7,7)
    23.81 ± 41.786
    4.76 ± 12.599
        Body Image: Cycle 27 (n=6,8)
    22.22 ± 40.369
    4.17 ± 11.785
        Body Image: Cycle 28 (n=6,8)
    22.22 ± 40.369
    12.50 ± 17.252
        Body Image: Cycle 29 (n=6,7)
    11.11 ± 27.217
    0.00 ± 0.000
        Body Image: Cycle 30 (n=5,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Body Image: Cycle 31 (n=3,7)
    0.00 ± 0.000
    0.00 ± 0.000
        Body Image: Cycle 32 (n=3,6)
    0.00 ± 0.000
    0.00 ± 0.000
        Body Image: Cycle 33 (n=3,6)
    0.00 ± 0.000
    5.56 ± 13.608
        Body Image: Cycle 34 (n=3,6)
    22.22 ± 38.490
    5.56 ± 13.608
        Body Image: Cycle 35 (n=2,6)
    16.67 ± 23.570
    11.11 ± 17.213
        Body Image: Cycle 36 (n=1,5)
    0.00 ± 99999
    0.00 ± 0.000
        Body Image: Cycle 37 (n=1,4)
    0.00 ± 99999
    8.33 ± 16.667
        Body Image: Cycle 38 (n=0,4)
    99999 ± 99999
    8.33 ± 16.667
        Body Image: Cycle 39 (n=1,3)
    0.00 ± 99999
    22.22 ± 38.490
        Body Image: Cycle 40 (n=1,3)
    0.00 ± 99999
    0.00 ± 0.000
        Body Image: Cycle 41 (n=0,3)
    99999 ± 99999
    11.11 ± 19.245
        Body Image: Cycle 42 (n=0,2)
    99999 ± 99999
    0.00 ± 0.000
        Body Image: Cycle 43 (n=0,1)
    99999 ± 99999
    0.00 ± 99999
        Body Image: EOT (n=33,29)
    23.23 ± 32.792
    18.39 ± 31.605
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Soluble Protein Biomarker (sKIT)

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    End point title
    Plasma Concentration of Soluble Protein Biomarker (sKIT)
    End point description
    sKIT analysis set included all enrolled subjects who received at least 1 dose of study drug and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment. Here, "99999" for mean and standard deviation signifies data not available (NA) as none of the subjects were evaluable in the given group at specified time point. Here, 'n' signifies those subjects who were evaluable at specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 3 and every 2 cycles thereafter (Cycle 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43), End of Treatment (up to 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    58
    45
    Units: picogram per milliliter (pcg/mL)
    arithmetic mean (standard deviation)
        Cycle1/Day1 (n =58, 45)
    58218.8 ± 18406.35
    62267.7 ± 17298.53
        Cycle1/Day15 (n =58, 44)
    51614.2 ± 18638.21
    48946.4 ± 15189.15
        Cycle2/Day1 (n= 56, 44)
    37705.1 ± 14128.27
    40334.8 ± 14304.02
        Cycle3/Day1 (n =52, 41)
    26939.9 ± 10839.77
    30224.0 ± 13709.28
        Cycle5/Day1 (n= 46, 35)
    20596.1 ± 7331.69
    23892.6 ± 11355.85
        Cycle7/Day1 (n =38, 29)
    18222.9 ± 8010.89
    19786.4 ± 10564.09
        Cycle9/Day1 (n =32, 24)
    17677.0 ± 6179.43
    19761.3 ± 12429.49
        Cycle11/Day1 (n =33, 23)
    16689.8 ± 7452.02
    21091.1 ± 13222.55
        Cycle13/Day1 (n =30, 20)
    16657.7 ± 8876.97
    18103.0 ± 7763.15
        Cycle15/Day1 (n =28, 14)
    15675.0 ± 6591.98
    16222.5 ± 4939.29
        Cycle17/Day1 (n =21, 15)
    15705.5 ± 5665.32
    15769.0 ± 7628.43
        Cycle19/Day1 (n =12, 13)
    14600.0 ± 4537.41
    15811.2 ± 7297.71
        Cycle21/Day1 (n =11, 10)
    14809.5 ± 4395.74
    15577.0 ± 5782.28
        Cycle23/Day1 (n =11, 8)
    13332.3 ± 3670.43
    12238.8 ± 4252.01
        Cycle25/Day1 (n =10, 7)
    13674.0 ± 5440.63
    13112.1 ± 5057.35
        Cycle27/Day1 (n =5, 8)
    12616.0 ± 3513.31
    16553.1 ± 8092.47
        Cycle29/Day1 (n =4, 7)
    13638.8 ± 3555.38
    16261.4 ± 10057.56
        Cycle31/Day1 (n =2, 6)
    9567.5 ± 1644.02
    10950.8 ± 4149.34
        Cycle33/Day1 (n =2, 6)
    9440.0 ± 1541.49
    10590.0 ± 4008.65
        Cycle35/Day1 (n =1, 6)
    11255.0 ± 99999
    10241.7 ± 2748.91
        Cycle37/Day1 (n =0, 4)
    99999 ± 99999
    9038.8 ± 3243.45
        Cycle39/Day1 (n =0, 2)
    99999 ± 99999
    8672.5 ± 477.30
        Cycle41/Day1 (n =0, 3)
    99999 ± 99999
    7023.3 ± 1849.00
        Cycle43/Day1 (n =0, 1)
    99999 ± 99999
    9360.0 ± 99999
        EOT (n= 30, 28)
    21680.3 ± 10358.35
    22605.5 ± 10953.00
    No statistical analyses for this end point

    Secondary: Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and its Metabolite SU012662

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    End point title
    Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and its Metabolite SU012662
    End point description
    Ctrough is the plasma concentration of sunitinib prior to study drug administration (lowest level at which a drug is present in the body). Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters. Here, 'n' signifies those subjects who were evaluable at specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: nanogram per milliliter (ng/mL)
    arithmetic mean (standard deviation)
        Sunitinib: Cycle1/Day15 (n =60, 44)
    52.78 ± 27.361
    41.93 ± 21.707
        Sunitinib: Cycle2/Day1 (n =57, 44)
    42.68 ± 20.320
    38.38 ± 22.765
        Sunitinib: Cycle3/Day1 (n =54, 41)
    41.79 ± 21.517
    38.49 ± 18.750
        Sunitinib: Cycle5/Day1 (n =48, 35)
    35.57 ± 15.221
    33.60 ± 15.010
        SU012662: Cycle1/Day15 (n =60, 44)
    18.03 ± 11.169
    14.26 ± 9.264
        SU012662: Cycle2/Day1 (n =57, 44)
    15.94 ± 9.059
    12.53 ± 8.000
        SU012662: Cycle3/Day1 (n =54, 41)
    15.85 ± 9.444
    13.64 ± 6.983
        SU012662: Cycle5/Day1 (n =48, 35)
    12.78 ± 6.375
    12.61 ± 6.735
    No statistical analyses for this end point

    Secondary: Dose-Corrected Trough Plasma Concentration of Sunitinib and its Metabolite SU012662

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    End point title
    Dose-Corrected Trough Plasma Concentration of Sunitinib and its Metabolite SU012662
    End point description
    Dose-corrected plasma trough concentration is calculated as: trough plasma concentration*(intended dose divided by actual dose). Intended dose was defined as the starting dose in the study and actual dose was defined as the last dose which the subject had received over the last 10 consecutive days prior sampling. SU012662 is the metabolite of sunitininb. PK population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters. Here, 'n' signifies those subjects who were evaluable at specified time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: ng/mL
    arithmetic mean (standard deviation)
        Sunitinib: Cycle1/Day15 (n =59, 40)
    52.66 ± 27.136
    43.38 ± 21.520
        Sunitinib: Cycle2/Day1 (n =55, 36)
    42.89 ± 20.607
    39.52 ± 19.833
        Sunitinib: Cycle3/Day1 (n =49, 39)
    44.99 ± 23.031
    38.56 ± 18.375
        Sunitinib: Cycle5/Day1 (n =43, 35)
    42.49 ± 16.769
    33.27 ± 16.733
        SU012662: Cycle1/Day15 (n =59, 40)
    18.14 ± 11.059
    14.79 ± 9.436
        SU012662: Cycle2/Day1 (n =55, 36)
    16.01 ± 9.132
    13.09 ± 7.684
        SU012662: Cycle3/Day1 (n =49, 39)
    17.37 ± 10.233
    14.22 ± 7.085
        SU012662: Cycle5/Day1 (n =43, 35)
    15.35 ± 6.882
    12.53 ± 6.914
    No statistical analyses for this end point

    Secondary: Area Under the Curve (AUC24) of Sunitinib and its Metabolite SU012662

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    End point title
    Area Under the Curve (AUC24) of Sunitinib and its Metabolite SU012662
    End point description
    Area under the plasma concentration-time profile from time zero (pre-dose) to 24 hours post-dose. SU012662 is the metabolite of sunitininb.
    End point type
    Secondary
    End point timeframe
    Pre-dose (0 hour) and at multiple time points (up to 24 hours) post dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: (nanogram*hour) per milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [2] - Data for this secondary endpoint is not available and shall be posted in April 2017.
    [3] - Data for this secondary endpoint is not available and shall be posted in April 2017.
    No statistical analyses for this end point

    Secondary: Oral Clearance (CL/F) of Sunitinib and its Metabolite SU012662

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    End point title
    Oral Clearance (CL/F) of Sunitinib and its Metabolite SU012662
    End point description
    Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
    End point type
    Secondary
    End point timeframe
    Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: milliliter per minute
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [4] - Data for this secondary endpoint is not available and shall be posted in April 2017.
    [5] - Data for this secondary endpoint is not available and shall be posted in April 2017.
    No statistical analyses for this end point

    Secondary: Half Maximal Effective Concentration (EC50) of Sunitinib

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    End point title
    Half Maximal Effective Concentration (EC50) of Sunitinib
    End point description
    Concentration of sunitinib in plasma at which 50 percent of the maximum effect was observed.
    End point type
    Secondary
    End point timeframe
    Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: milligram per milliliter
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [6] - Data for this secondary endpoint is not available and shall be posted in April 2017.
    [7] - Data for this secondary endpoint is not available and shall be posted in April 2017.
    No statistical analyses for this end point

    Secondary: 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 a subject 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 are events between first dose of study drug and up to 1939 days that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to 1939 days
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: subjects
        AEs
    59
    45
        SAEs
    17
    12
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
    End point description
    Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. 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 were events between first dose of study drug and up to 1939 days that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to 1939 days
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: subjects
        AEs
    57
    44
        SAEs
    9
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs) According to Severity

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    End point title
    Number of Subjects With Adverse Events (AEs) According to Severity
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death. Safety analysis set included all subjects who received at least 1 dose of study medication. Here, "number of subjects analyzed" signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to 1939 days
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    59
    45
    Units: subjects
        Grade 1
    4
    5
        Grade 2
    9
    9
        Grade 3
    38
    23
        Grade 4
    6
    6
        Grade 5
    2
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Laboratory Abnormalities

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    End point title
    Number of Subjects With Clinically Significant Laboratory Abnormalities
    End point description
    Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein), miscellaneous (pregnancy test, Chromogranin A). Clinically significant laboratory abnormalities were identified by the Investigator. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to 1939 days
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: subjects
    30
    22
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change From Baseline in Vital Signs Abnormalities

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    End point title
    Number of Subjects With Change From Baseline in Vital Signs Abnormalities
    End point description
    Criteria for change in vital signs were defined as: >=20 mmHg or >=40 mmHg or >=60 mmHg increase from baseline in systolic blood pressure (SBP); >=10 mmHg or >=20 mmHg or >=30 mmHg increase from baseline in diastolic blood pressure (DBP); increase of >=1.1 degree Celsius in baseline body temperature (temp.) if the baseline temperature is >36.8 degree Celsius. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to 1939 days
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: subjects
        SBP: increase from baseline >=20
    31
    23
        SBP: increase from baseline >=40
    6
    9
        SBP: increase from baseline >=60
    3
    3
        DBP: increase from baseline >=10
    41
    35
        DBP: increase from baseline >=20
    15
    19
        DBP: increase from baseline >=30
    6
    6
        Temp.: increase from baseline >=1.1 degree Celsius
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Increase From Baseline in Corrected QT Interval (QTc)

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    End point title
    Number of Subjects With Increase From Baseline in Corrected QT Interval (QTc)
    End point description
    QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF). Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to 1939 days
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: subjects
        QTcB
    0
    0
        QTcF
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change From Baseline in Physical Examinations Findings

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    End point title
    Number of Subjects With Change From Baseline in Physical Examinations Findings
    End point description
    Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to 1939 days
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: subjects
    23
    19
    No statistical analyses for this end point

    Secondary: Number of Subjects With Change From Baseline in Body Weight

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    End point title
    Number of Subjects With Change From Baseline in Body Weight
    End point description
    Subjects with increase of >=5 percent and decrease of >=5 percent from baseline in body weight were reported in this outcome measure. Safety analysis set included all subjects who received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline up to 1939 days
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: subjects
        Increase of >=5 percent
    27
    9
        Decrease of >=5 percent
    18
    15
    No statistical analyses for this end point

    Secondary: Number of Subjects With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)

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    End point title
    Number of Subjects With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
    End point description
    ECOG-PS is used to assess how disease affects daily living abilities of subject and measured on 6-point scale ranging from 0-5 (0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work; 2= ambulatory for more than 50% of waking hours and capable of all self-care but unable to carry out any work activities; 3= capable of limited self-care, confined to bed or chair >50% of waking hours; 4= completely disabled, not capable of any self-care, totally confined to bed or chair; 5= dead. Higher score=greater functional impairment. Only those ECOG-PS categories, in which at least one subject had data at any indicated time point were reported in this outcome measure. Subject with not reported (NR) category did not provided any ECOG performance status. Safety analysis set and 'n' signifies those subjects who were evaluable at specified time point for each arm.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)
    End point values
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Number of subjects analysed
    61
    45
    Units: subjects
        Cycle 1/Day 1: ECOG-PS =0 (n=61,45)
    37
    25
        Cycle 1/Day 1: ECOG-PS =1 (n=61,45)
    15
    14
        Cycle 1/Day 1: ECOG-PS =NR (n=61,45)
    9
    6
        Cycle 2/Day 1: ECOG-PS =0 (n=59,44)
    37
    30
        Cycle 2/Day 1: ECOG-PS =1 (n=59,44)
    19
    13
        Cycle 2/Day 1: ECOG-PS =NR (n=59,44)
    3
    1
        Cycle 3/Day 1: ECOG-PS =0 (n=56,41)
    37
    29
        Cycle 3/Day 1: ECOG-PS =1 (n=56,41)
    17
    10
        Cycle 3/Day 1: ECOG-PS =2 (n=56,41)
    0
    1
        Cycle 3/Day 1: ECOG-PS =3 (n=56,41)
    0
    1
        Cycle 3/Day 1: ECOG-PS =NR (n=56,41)
    2
    0
        Cycle 4/Day 1: ECOG-PS =0 (n=51,39)
    34
    25
        Cycle 4/Day 1: ECOG-PS =1 (n=51,39)
    15
    13
        Cycle 4/Day 1: ECOG-PS =NR (n=51,39)
    2
    1
        Cycle 5/Day 1: ECOG-PS =0 (n=48,35)
    34
    23
        Cycle 5/Day 1: ECOG-PS =1 (n=48,35)
    13
    11
        Cycle 5/Day 1: ECOG-PS =2 (n=48,35)
    1
    1
        Cycle 6/Day 1: ECOG-PS =0 (n=43,31)
    30
    21
        Cycle 6/Day 1: ECOG-PS =1 (n=43,31)
    13
    9
        Cycle 6/Day 1: ECOG-PS =2 (n=43,31)
    0
    1
        Cycle 7/Day 1: ECOG-PS =0 (n=40,29)
    27
    21
        Cycle 7/Day 1: ECOG-PS =1 (n=40,29)
    13
    7
        Cycle 7/Day 1: ECOG-PS =2 (n=40,29)
    0
    1
        Cycle 8/Day 1: ECOG-PS =0 (n=37,26)
    24
    20
        Cycle 8/Day 1: ECOG-PS =1 (n=37,26)
    13
    6
        Cycle 9/Day 1: ECOG-PS =0 (n=35,26)
    24
    20
        Cycle 9/Day 1: ECOG-PS =1 (n=35,26)
    11
    6
        Cycle 10/Day 1: ECOG-PS =0 (n=35,25)
    22
    18
        Cycle 10/Day 1: ECOG-PS =1 (n=35,25)
    13
    6
        Cycle 10/Day 1: ECOG-PS =NR (n=35,25)
    0
    1
        Cycle 11/Day 1: ECOG-PS =0 (n=35,24)
    22
    18
        Cycle 11/Day 1: ECOG-PS =1 (n=35,24)
    13
    6
        Cycle 12/Day 1: ECOG-PS =0 (n=35,22)
    22
    16
        Cycle 12/Day 1: ECOG-PS =1 (n=35,22)
    13
    6
        Cycle 13/Day 1: ECOG-PS =0 (n=34,21)
    21
    15
        Cycle 13/Day 1: ECOG-PS =1 (n=34,21)
    13
    6
        Cycle 14/Day 1: ECOG-PS =0 (n=31,20)
    19
    12
        Cycle 14/Day 1: ECOG-PS =1 (n=31,20)
    11
    6
        Cycle 14/Day 1: ECOG-PS =NR (n=31,20)
    1
    2
        Cycle 15/Day 1: ECOG-PS =0 (n=30,17)
    20
    13
        Cycle 15/Day 1: ECOG-PS =1 (n=30,17)
    10
    4
        Cycle 16/Day 1: ECOG-PS =0 (n=27,16)
    16
    13
        Cycle 16/Day 1: ECOG-PS =1 (n=27,16)
    10
    3
        Cycle 16/Day 1: ECOG-PS =NR (n=27,16)
    1
    0
        Cycle 17/Day 1: ECOG-PS =0 (n=22,15)
    15
    13
        Cycle 17/Day 1: ECOG-PS =1 (n=22,15)
    6
    2
        Cycle 17/Day 1: ECOG-PS =NR (n=22,15)
    1
    0
        Cycle 18/Day 1: ECOG-PS =0 (n=17,14)
    10
    12
        Cycle 18/Day 1: ECOG-PS =1 (n=17,14)
    5
    1
        Cycle 18/Day 1: ECOG-PS =NR (n=17,14)
    2
    1
        Cycle 19/Day 1: ECOG-PS =0 (n=12,14)
    8
    12
        Cycle 19/Day 1: ECOG-PS =1 (n=12,14)
    3
    1
        Cycle 19/Day 1: ECOG-PS =2 (n=12,14)
    1
    0
        Cycle 19/Day 1: ECOG-PS =NR (n=12,14)
    0
    1
        Cycle 20/Day 1: ECOG-PS =0 (n=12,13)
    8
    11
        Cycle 20/Day 1: ECOG-PS =1 (n=12,13)
    2
    1
        Cycle 20/Day 1: ECOG-PS =2 (n=12,13)
    1
    0
        Cycle 20/Day 1: ECOG-PS =NR (n=12,13)
    1
    1
        Cycle 21/Day 1: ECOG-PS =0 (n=11,12)
    7
    9
        Cycle 21/Day 1: ECOG-PS =1 (n=11,12)
    4
    2
        Cycle 21/Day 1: ECOG-PS =NR (n=11,12)
    0
    1
        Cycle 22/Day 1: ECOG-PS =0 (n=11,11)
    8
    8
        Cycle 22/Day 1: ECOG-PS =1 (n=11,11)
    3
    1
        Cycle 22/Day 1: ECOG-PS =3 (n=11,11)
    0
    1
        Cycle 22/Day 1: ECOG-PS =NR (n=11,11)
    0
    1
        Cycle 23/Day 1: ECOG-PS =0 (n=11,10)
    8
    7
        Cycle 23/Day 1: ECOG-PS =1 (n=11,10)
    2
    2
        Cycle 23/Day 1: ECOG-PS =NR (n=11,10)
    1
    1
        Cycle 24/Day 1: ECOG-PS =0 (n=10,10)
    9
    7
        Cycle 24/Day 1: ECOG-PS =1 (n=10,10)
    0
    2
        Cycle 24/Day 1: ECOG-PS =2 (n=10,10)
    1
    0
        Cycle 24/Day 1: ECOG-PS =NR (n=10,10)
    0
    1
        Cycle 25/Day 1: ECOG-PS =0 (n=10,8)
    8
    6
        Cycle 25/Day 1: ECOG-PS =1 (n=10,8)
    1
    1
        Cycle 25/Day 1: ECOG-PS =2 (n=10,8)
    1
    0
        Cycle 25/Day 1: ECOG-PS =NR (n=10,8)
    0
    1
        Cycle 26/Day 1: ECOG-PS =0 (n=7,8)
    5
    7
        Cycle 26/Day 1: ECOG-PS =1 (n=7,8)
    1
    1
        Cycle 26/Day 1: ECOG-PS =2 (n=7,8)
    1
    0
        Cycle 27/Day 1: ECOG-PS =0 (n=7,8)
    4
    7
        Cycle 27/Day 1: ECOG-PS =1 (n=7,8)
    1
    1
        Cycle 27/Day 1: ECOG-PS =2 (n=7,8)
    1
    0
        Cycle 27/Day 1: ECOG-PS =NR (n=7,8)
    1
    0
        Cycle 28/Day 1: ECOG-PS =0 (n=7,8)
    5
    6
        Cycle 28/Day 1: ECOG-PS =1 (n=7,8)
    1
    1
        Cycle 28/Day 1: ECOG-PS =2 (n=7,8)
    1
    0
        Cycle 28/Day 1: ECOG-PS =NR (n=7,8)
    0
    1
        Cycle 29/Day 1: ECOG-PS =0 (n=6,7)
    5
    6
        Cycle 29/Day 1: ECOG-PS =1 (n=6,7)
    1
    0
        Cycle 29/Day 1: ECOG-PS =NR (n=6,7)
    0
    1
        Cycle 30/Day 1: ECOG-PS =0 (n=5,7)
    5
    6
        Cycle 30/Day 1: ECOG-PS =NR (n=5,7)
    0
    1
        Cycle 31/Day 1: ECOG-PS =0 (n=3,7)
    2
    5
        Cycle 31/Day 1: ECOG-PS =1 (n=3,7)
    1
    1
        Cycle 31/Day 1: ECOG-PS =NR (n=3,7)
    0
    1
        Cycle 32/Day 1: ECOG-PS =0 (n=3,6)
    3
    5
        Cycle 32/Day 1: ECOG-PS =NR (n=3,6)
    0
    1
        Cycle 33/Day 1: ECOG-PS =0 (n=3,6)
    2
    4
        Cycle 33/Day 1: ECOG-PS =1 (n=3,6)
    1
    1
        Cycle 33/Day 1: ECOG-PS =NR (n=3,6)
    0
    1
        Cycle 34/Day 1: ECOG-PS =0 (n=3,6)
    3
    4
        Cycle 34/Day 1: ECOG-PS =1 (n=3,6)
    0
    1
        Cycle 34/Day 1: ECOG-PS =NR (n=3,6)
    0
    1
        Cycle 35/Day 1: ECOG-PS =0 (n=2,6)
    2
    4
        Cycle 35/Day 1: ECOG-PS =1 (n=2,6)
    0
    1
        Cycle 35/Day 1: ECOG-PS =NR (n=2,6)
    0
    1
        Cycle 36/Day 1: ECOG-PS =0 (n=1,5)
    1
    3
        Cycle 36/Day 1: ECOG-PS =1 (n=1,5)
    0
    1
        Cycle 36/Day 1: ECOG-PS =NR (n=1,5)
    0
    1
        Cycle 37/Day 1: ECOG-PS =0 (n=1,4)
    1
    2
        Cycle 37/Day 1: ECOG-PS =1 (n=1,4)
    0
    1
        Cycle 37/Day 1: ECOG-PS =NR (n=1,4)
    0
    1
        Cycle 38/Day 1: ECOG-PS =0 (n=1,4)
    1
    3
        Cycle 38/Day 1: ECOG-PS =1 (n=1,4)
    0
    1
        Cycle 39/Day 1: ECOG-PS =0 (n=1,3)
    1
    1
        Cycle 39/Day 1: ECOG-PS =1 (n=1,3)
    0
    2
        Cycle 40/Day 1: ECOG-PS =0 (n=1,3)
    0
    1
        Cycle 40/Day 1: ECOG-PS =1 (n=1,3)
    1
    2
        Cycle 41/Day 1: ECOG-PS =0 (n=0,3)
    0
    1
        Cycle 41/Day 1: ECOG-PS =1 (n=0,3)
    0
    1
        Cycle 41/Day 1: ECOG-PS =NR (n=0,3)
    0
    1
        Cycle 42/Day 1: ECOG-PS =1 (n=0,2)
    0
    2
        Cycle 43/Day 1: ECOG-PS =1 (n=0,1)
    0
    1
        EOT: ECOG-PS =0 (n=43,38)
    20
    14
        EOT: ECOG-PS =1 (n=43,38)
    13
    12
        EOT: ECOG-PS =2 (n=43,38)
    0
    4
        EOT: ECOG-PS =3 (n=43,38)
    1
    1
        EOT: ECOG-PS =NR (n=43,38)
    9
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 1939 days
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Sunitinib: Treatment Naive Cohort
    Reporting group description
    Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.

    Reporting group title
    Sunitinib: Later-Line Cohort
    Reporting group description
    Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 64 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).

    Serious adverse events
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 61 (27.87%)
    12 / 45 (26.67%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    2 / 61 (3.28%)
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 45 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypercalcaemia
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urosepsis
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peritonitis bacterial
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Sunitinib: Treatment Naive Cohort Sunitinib: Later-Line Cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 61 (96.72%)
    45 / 45 (100.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 45 (2.22%)
         occurrences all number
    3
    1
    Flushing
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    Haemorrhage
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Hot flush
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Hypertension
         subjects affected / exposed
    16 / 61 (26.23%)
    13 / 45 (28.89%)
         occurrences all number
    39
    27
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Tooth extraction
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Paraneoplastic syndrome
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Hypersensitivity
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    11 / 61 (18.03%)
    7 / 45 (15.56%)
         occurrences all number
    24
    27
    Chest pain
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Discomfort
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Face oedema
         subjects affected / exposed
    3 / 61 (4.92%)
    1 / 45 (2.22%)
         occurrences all number
    4
    1
    Facial pain
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    20 / 61 (32.79%)
    13 / 45 (28.89%)
         occurrences all number
    42
    19
    Feeling cold
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Gait disturbance
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    2
    General physical health deterioration
         subjects affected / exposed
    0 / 61 (0.00%)
    2 / 45 (4.44%)
         occurrences all number
    0
    2
    Hyperpyrexia
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Malaise
         subjects affected / exposed
    2 / 61 (3.28%)
    1 / 45 (2.22%)
         occurrences all number
    4
    1
    Mucosal inflammation
         subjects affected / exposed
    6 / 61 (9.84%)
    5 / 45 (11.11%)
         occurrences all number
    6
    8
    Mucous membrane disorder
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Oedema
         subjects affected / exposed
    5 / 61 (8.20%)
    2 / 45 (4.44%)
         occurrences all number
    6
    2
    Oedema peripheral
         subjects affected / exposed
    5 / 61 (8.20%)
    3 / 45 (6.67%)
         occurrences all number
    7
    4
    Pain
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 45 (6.67%)
         occurrences all number
    1
    4
    Pyrexia
         subjects affected / exposed
    6 / 61 (9.84%)
    8 / 45 (17.78%)
         occurrences all number
    7
    11
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 61 (3.28%)
    2 / 45 (4.44%)
         occurrences all number
    2
    3
    Depressed mood
         subjects affected / exposed
    1 / 61 (1.64%)
    1 / 45 (2.22%)
         occurrences all number
    1
    1
    Hallucination
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 61 (0.00%)
    3 / 45 (6.67%)
         occurrences all number
    0
    4
    Reproductive system and breast disorders
    Genital erythema
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Menstruation irregular
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Penile erythema
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    4
    Perineal pain
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Vaginal inflammation
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 45 (0.00%)
         occurrences all number
    6
    0
    Vulvovaginal inflammation
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 45 (0.00%)
         occurrences all number
    6
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Fall
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Limb injury
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Overdose
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Skin abrasion
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Skin wound
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Sunburn
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Wound
         subjects affected / exposed
    0 / 61 (0.00%)
    1 / 45 (2.22%)
         occurrences all number
    0
    1
    Chillblains
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 61 (4.92%)
    8 / 45 (17.78%)
         occurrences all number
    6
    10
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 61 (8.20%)
    7 / 45 (15.56%)
         occurrences all number
    9
    13
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 61 (3.28%)
    3 / 45 (6.67%)
         occurrences all number
    5
    3
    Blood bilirubin increased
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 45 (6.67%)
         occurrences all number
    2
    3
    Blood chloride decreased
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blood chromogranin A increased
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 61 (1.64%)
    3 / 45 (6.67%)
         occurrences all number
    1
    4
    Blood folate decreased
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blood glucose increased
         subjects affected / exposed
    2 / 61 (3.28%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    Blood iron decreased
         subjects affected / exposed
    1 / 61 (1.64%)
    0 / 45 (0.00%)
         occurrences all number
    1
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 61 (1.64%)
    0