Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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

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

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Open-Label Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the First-Line Treatment of Patients With Advanced Triple Negative Breast Cancer

    Summary
    EudraCT number
    		 2009-014279-37
    Trial protocol
    		 GB  
    Global end of trial date
    02 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2017
    First version publication date
    04 Jan 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ML22780
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01094184
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.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
    05 Aug 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the tolerability and safety profile of bevacizumab when combined with taxane monotherapy (weekly paclitaxel) as first line treatment of participants with triple-negative metastatic breast cancer.
    Protection of trial subjects
    The study was conducted in accordance with the principles of the “Declaration of Helsinki” and Good Clinical Practice (GCP). Approval from the Independent Ethics Committee/Institutional Review Board (IEC/IRB) was obtained before study start and was documented in a letter to the Investigator specifying the date on which the committee met and granted the approval. The Sponsor also obtained approval from the relevant Competent Authority prior to starting the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Mar 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    37
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 53 participants were screened; 49 participants were eligible for the study and assigned to study treatment.

    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
    		 Bevacizumab 10 mg/kg Q2W
    Arm description
    		 Participants received bevacizumab at a dose of 10 milligram per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab 10 mg/kg Q2W
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab was administered at a dose of 10 mg/kg Q2W as intravenous infusion.

    Arm title
    		 Bevacizumab 15 mg/kg Q3W
    Arm description
    		 Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bevacizumab 15 mg/kg Q3W
    Investigational medicinal product code
    Other name
    Avastin
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bevacizumab was administered at a dose of 15 mg/kg Q3W as intravenous infusion.

    Number of subjects in period 1
    		Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Started
    36
    13
    Completed
    1
    2
    Not completed
    35
    11
         Death
    35
    11

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Bevacizumab 10 mg/kg Q2W
    Reporting group description
    		 Participants received bevacizumab at a dose of 10 milligram per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

    Reporting group title
    Bevacizumab 15 mg/kg Q3W
    Reporting group description
    		 Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

    Reporting group values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W Total
    Number of subjects
    		 36 13 49
    Age categorical
    Units: Subjects
    Age continuous
    Safety analysis population included all participants who received at least one dose of study medication (taxane [paclitaxel/ docetaxel] or bevacizumab).
    Units: years
        arithmetic mean (standard deviation)
    		 52.8 ± 14.74 58.4 ± 9.22 -
    Gender categorical
    Safety analysis population
    Units: Subjects
        Female
    		 36 13 49
        Male
    		 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Bevacizumab 10 mg/kg Q2W
    Reporting group description
    		 Participants received bevacizumab at a dose of 10 milligram per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

    Reporting group title
    Bevacizumab 15 mg/kg Q3W
    Reporting group description
    		 Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

    Primary: Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2

    		 Close Top of page
    End point title
    		 Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 [1]
    End point description
    FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL. Intent-to-treat (ITT) analysis population included all participants who received at least one dose of all study medication (taxane and bevacizumab). Here, 'Number of subject analysed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
    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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    31
    12
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=31,12)
    98.3 ± 21.342
    102.21 ± 21.036
        Change at Cycle 2 (n=25,6)
    5.83 ± 17.027
    -2.48 ± 14.697
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 3

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 3 [2]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subject analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
    Notes
    [2] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [3]
    3
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    14.56 ± 13.961
    Notes
    [3] - No participant was evaluable in the indicated arm for this outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 4

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 4 [4]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subject analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
    Notes
    [4] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    20
    6
    Units: units on a scale
        arithmetic mean (standard deviation)
    1.29 ± 16.304
    0.09 ± 12.275
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 5

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 5 [5]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    2
    Units: units on a scale
        arithmetic mean (standard deviation)
    -10.77 ± 11.677
    4.5 ± 27.577
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 6

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 6 [6]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
    Notes
    [6] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    6
    7
    Units: units on a scale
        arithmetic mean (standard deviation)
    9.47 ± 16.356
    10.08 ± 21.868
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 7

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 7 [7]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    7
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    -6.24 ± 13.22
    1.83 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 8

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 8 [8]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    4
    4
    Units: units on a scale
        arithmetic mean (standard deviation)
    15.01 ± 9.805
    15.44 ± 19.979
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 9

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 9 [9]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    -2.43 ± 7.762
    7 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 10

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 10 [10]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
    Notes
    [10] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    4
    5
    Units: units on a scale
        arithmetic mean (standard deviation)
    2.71 ± 20.075
    4.61 ± 13.968
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 11

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 11 [11]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
    Notes
    [11] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    6.67 ± 11.889
    8.17 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 12

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 12 [12]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
    Notes
    [12] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    9.22 ± 8.72
    21.89 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 13

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 13 [13]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
    Notes
    [13] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    0 [14]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -8 ± 9.899
    ±
    Notes
    [14] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 14

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 14 [15]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
    Notes
    [15] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    4
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    6.83 ± 5.897
    2.33 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 15

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 15 [16]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
    Notes
    [16] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    0 [17]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -6.67 ± 8.25
    ±
    Notes
    [17] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 16

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 16 [18]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
    Notes
    [18] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    0 [19]
    Units: units on a scale
        arithmetic mean (standard deviation)
    11.83 ± 12.79
    ±
    Notes
    [19] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 17

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 17 [20]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
    Notes
    [20] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    0 [21]
    Units: units on a scale
        arithmetic mean (standard deviation)
    22.63 ± 13.157
    ±
    Notes
    [21] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 18

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 18 [22]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
    Notes
    [22] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    10.28 ± 19.878
    5.33 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 20

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 20 [23]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
    Notes
    [23] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    0 [24]
    Units: units on a scale
        arithmetic mean (standard deviation)
    20.06 ± 12.787
    ±
    Notes
    [24] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 21

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 21 [25]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
    Notes
    [25] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    25.75 ± 5.303
    10.33 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 22

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 22 [26]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
    Notes
    [26] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [27]
    Units: units on a scale
        arithmetic mean (standard deviation)
    13.67 ± 99999
    ±
    Notes
    [27] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 23

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 23 [28]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
    Notes
    [28] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    9.67 ± 20.742
    7.33 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 24

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 24 [29]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
    Notes
    [29] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [30]
    Units: units on a scale
        arithmetic mean (standard deviation)
    6 ± 99999
    ±
    Notes
    [30] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 25

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 25 [31]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
    Notes
    [31] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [32]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    11.33 ± 99999
    Notes
    [32] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 26

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 26 [33]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
    Notes
    [33] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [34]
    Units: units on a scale
        arithmetic mean (standard deviation)
    3.22 ± 99999
    ±
    Notes
    [34] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 27

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 27 [35]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
    Notes
    [35] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    -26.78 ± 99999
    12.33 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 28

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 28 [36]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
    Notes
    [36] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [37]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    16.33 ± 99999
    Notes
    [37] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 29

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 29 [38]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
    Notes
    [38] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3 ± 99999
    9.78 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 30

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 30 [39]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
    Notes
    [39] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [40]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -3.11 ± 99999
    ±
    Notes
    [40] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 32

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 32 [41]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
    Notes
    [41] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [42]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    10.33 ± 99999
    Notes
    [42] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 36

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 36 [43]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
    Notes
    [43] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [44]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    3.33 ± 99999
    Notes
    [44] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 37

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 37 [45]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
    Notes
    [45] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [46]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    5.33 ± 99999
    Notes
    [46] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 39

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 39 [47]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
    Notes
    [47] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [48]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    9.33 ± 99999
    Notes
    [48] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 42

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 42 [49]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
    Notes
    [49] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [50]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    10.33 ± 99999
    Notes
    [50] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 44

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 44 [51]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
    Notes
    [51] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [52]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    11.33 ± 99999
    Notes
    [52] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score at Cycle 46

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score at Cycle 46 [53]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
    Notes
    [53] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [54]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    13.33 ± 99999
    Notes
    [54] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in FACT-B Score At End of Study

    		 Close Top of page
    End point title
    		 Change From Baseline in FACT-B Score At End of Study [55]
    End point description
    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, End of study (4-6 weeks after the last bevacizumab administration) (maximum up to 5 years and 9 months)
    Notes
    [55] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    14
    7
    Units: units on a scale
        arithmetic mean (standard deviation)
    -10.33 ± 13.509
    -1.01 ± 9.343
    No statistical analyses for this end point

    Primary: Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2

    		 Close Top of page
    End point title
    		 Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2 [56]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
    Notes
    [56] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    31
    10
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline (n=31,10)
    0.6391 ± 0.25595
    0.8152 ± 0.12211
        Change at Cycle 2 (n=25,5)
    0.109 ± 0.23563
    -0.2074 ± 0.19784
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3 [57]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
    Notes
    [57] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [58]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    0.192 ± 99999
    Notes
    [58] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4 [59]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
    Notes
    [59] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    20
    5
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.0105 ± 0.28263
    -0.0906 ± 0.06661
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5 [60]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
    Notes
    [60] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.1164 ± 0.10045
    0.228 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6 [61]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
    Notes
    [61] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    6
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.0474 ± 0.23827
    -0.0735 ± 0.24131
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7 [62]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
    Notes
    [62] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    7
    0 [63]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.0331 ± 0.18865
    ±
    Notes
    [63] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8 [64]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
    Notes
    [64] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    6
    3
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.0627 ± 0.23917
    -0.0523 ± 0.0525
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9 [65]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
    Notes
    [65] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    0 [66]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.1904 ± 0.24194
    ±
    Notes
    [66] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10 [67]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
    Notes
    [67] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    4
    3
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.0253 ± 0.32169
    -0.054 ± 0.2499
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11 [68]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
    Notes
    [68] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    0 [69]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.0018 ± 0.20907
    ±
    Notes
    [69] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12 [70]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
    Notes
    [70] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.0997 ± 0.35679
    -0.052 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13 [71]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
    Notes
    [71] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    0 [72]
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.093 ± 0.13152
    ±
    Notes
    [72] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14 [73]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
    Notes
    [73] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    4
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.062 ± 0.11033
    -0.332 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15 [74]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
    Notes
    [74] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    0 [75]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.0175 ± 0.19021
    ±
    Notes
    [75] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16 [76]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
    Notes
    [76] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    0 [77]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.006 ± 0.21806
    ±
    Notes
    [77] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17 [78]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
    Notes
    [78] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    0 [79]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.1057 ± 0.17756
    ±
    Notes
    [79] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18 [80]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure."99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
    Notes
    [80] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.097 ± 0.01414
    -0.157 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20 [81]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
    Notes
    [81] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    4
    0 [82]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.1035 ± 0.1967
    ±
    Notes
    [82] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21 [83]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
    Notes
    [83] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.2955 ± 0.26658
    -0.157 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22 [84]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
    Notes
    [84] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [85]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.071 ± 99999
    ±
    Notes
    [85] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23 [86]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
    Notes
    [86] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.0625 ± 0.06293
    -0.228 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24 [87]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
    Notes
    [87] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [88]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.054 ± 99999
    ±
    Notes
    [88] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25 [89]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
    Notes
    [89] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [90]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.332 ± 99999
    Notes
    [90] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26 [91]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
    Notes
    [91] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [92]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.018 ± 99999
    ±
    Notes
    [92] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27 [93]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
    Notes
    [93] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.054 ± 99999
    -0.332 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28 [94]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
    Notes
    [94] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [95]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.261 ± 99999
    Notes
    [95] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29 [96]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
    Notes
    [96] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.086 ± 99999
    -0.261 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30 [97]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
    Notes
    [97] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [98]
    Units: units on a scale
        arithmetic mean (standard deviation)
    0.054 ± 99999
    ±
    Notes
    [98] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32 [99]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
    Notes
    [99] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [100]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.261 ± 99999
    Notes
    [100] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36 [101]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
    Notes
    [101] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [102]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.261 ± 99999
    Notes
    [102] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37 [103]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
    Notes
    [103] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [104]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.261 ± 99999
    Notes
    [104] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39 [105]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
    Notes
    [105] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [106]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.261 ± 99999
    Notes
    [106] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40 [107]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
    Notes
    [107] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [108]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.261 ± 99999
    Notes
    [108] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42 [109]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
    Notes
    [109] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [110]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.261 ± 99999
    Notes
    [110] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44 [111]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
    Notes
    [111] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [112]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.332 ± 99999
    Notes
    [112] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46 [113]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
    Notes
    [113] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [114]
    1
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    -0.332 ± 99999
    Notes
    [114] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study [115]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, End of study (4-6 weeks after the last bevacizumab administration) (maximum up to 5 years and 9 months)
    Notes
    [115] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    14
    5
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.1344 ± 0.20511
    -0.1178 ± 0.14225
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Score at Cycle 2

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Score at Cycle 2 [116]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
    Notes
    [116] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    30
    12
    Units: mm
    arithmetic mean (standard deviation)
        Baseline (n=30,12)
    64.8 ± 24.34
    60.3 ± 26.96
        Change at Cycle 2 (n=23,6)
    -1 ± 18.59
    -8.3 ± 19.41
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 3

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 3 [117]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
    Notes
    [117] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [118]
    3
    Units: mm
        arithmetic mean (standard deviation)
    ±
    20 ± 26.46
    Notes
    [118] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 4

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 4 [119]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
    Notes
    [119] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    19
    6
    Units: mm
        arithmetic mean (standard deviation)
    -1.9 ± 18.23
    3.3 ± 29.27
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 5

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 5 [120]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
    Notes
    [120] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    2
    Units: mm
        arithmetic mean (standard deviation)
    -8.2 ± 17.57
    7 ± 46.67
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 6

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 6 [121]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
    Notes
    [121] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    6
    7
    Units: mm
        arithmetic mean (standard deviation)
    9.8 ± 22
    21.4 ± 35.69
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 7

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 7 [122]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
    Notes
    [122] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    1
    Units: mm
        arithmetic mean (standard deviation)
    -3.6 ± 12.1
    -9 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 8

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 8 [123]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
    Notes
    [123] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    3
    Units: mm
        arithmetic mean (standard deviation)
    11 ± 27.6
    35 ± 22.91
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 9

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 9 [124]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
    Notes
    [124] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    2
    Units: mm
        arithmetic mean (standard deviation)
    -5.8 ± 15.43
    27.5 ± 45.96
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 10

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 10 [125]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
    Notes
    [125] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    4
    5
    Units: mm
        arithmetic mean (standard deviation)
    6 ± 21.91
    14 ± 32.79
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 11

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 11 [126]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
    Notes
    [126] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    5
    1
    Units: mm
        arithmetic mean (standard deviation)
    2 ± 24.14
    40 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 12

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 12 [127]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
    Notes
    [127] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    1
    Units: mm
        arithmetic mean (standard deviation)
    13.7 ± 24.19
    60 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 13

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 13 [128]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
    Notes
    [128] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    0 [129]
    Units: mm
        arithmetic mean (standard deviation)
    -3 ± 2.83
    ±
    Notes
    [129] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 14

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 14 [130]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
    Notes
    [130] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    1
    Units: mm
        arithmetic mean (standard deviation)
    -5 ± 20
    9 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 15

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 15 [131]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
    Notes
    [131] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    0 [132]
    Units: mm
        arithmetic mean (standard deviation)
    5 ± 7.07
    ±
    Notes
    [132] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 16

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 16 [133]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
    Notes
    [133] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    0 [134]
    Units: mm
        arithmetic mean (standard deviation)
    7.3 ± 37.87
    ±
    Notes
    [134] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 17

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 17 [135]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
    Notes
    [135] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    3
    0 [136]
    Units: mm
        arithmetic mean (standard deviation)
    30 ± 25
    ±
    Notes
    [136] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 18

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 18 [137]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
    Notes
    [137] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    1
    Units: mm
        arithmetic mean (standard deviation)
    9.5 ± 55.86
    10 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 20

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 20 [138]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
    Notes
    [138] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    4
    0 [139]
    Units: mm
        arithmetic mean (standard deviation)
    15 ± 31.36
    ±
    Notes
    [139] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 21

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 21 [140]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
    Notes
    [140] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    1
    Units: mm
        arithmetic mean (standard deviation)
    27.5 ± 31.82
    8 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 22

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 22 [141]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
    Notes
    [141] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [142]
    Units: mm
        arithmetic mean (standard deviation)
    52 ± 99999
    ±
    Notes
    [142] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 23

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 23 [143]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
    Notes
    [143] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    2
    1
    Units: mm
        arithmetic mean (standard deviation)
    23.5 ± 47.38
    10 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 24

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 24 [144]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
    Notes
    [144] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [145]
    Units: mm
        arithmetic mean (standard deviation)
    -20 ± 99999
    ±
    Notes
    [145] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 25

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 25 [146]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
    Notes
    [146] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [147]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    9 ± 99999
    Notes
    [147] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 26

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 26 [148]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
    Notes
    [148] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [149]
    Units: mm
        arithmetic mean (standard deviation)
    -20 ± 99999
    ±
    Notes
    [149] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 27

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 27 [150]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
    Notes
    [150] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    1
    Units: mm
        arithmetic mean (standard deviation)
    -20 ± 99999
    10 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 28

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 28 [151]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
    Notes
    [151] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [152]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    9 ± 99999
    Notes
    [152] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 29

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 29 [153]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
    Notes
    [153] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    1
    Units: mm
        arithmetic mean (standard deviation)
    -20 ± 99999
    10 ± 99999
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 30

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 30 [154]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
    Notes
    [154] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    1
    0 [155]
    Units: mm
        arithmetic mean (standard deviation)
    -20 ± 99999
    ±
    Notes
    [155] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 32

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 32 [156]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
    Notes
    [156] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [157]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    9 ± 99999
    Notes
    [157] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 36

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 36 [158]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
    Notes
    [158] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [159]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    8 ± 99999
    Notes
    [159] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 37

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 37 [160]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
    Notes
    [160] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [161]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    8 ± 99999
    Notes
    [161] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 39

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 39 [162]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
    Notes
    [162] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [163]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    8 ± 99999
    Notes
    [163] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 40

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 40 [164]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
    Notes
    [164] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [165]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    5 ± 99999
    Notes
    [165] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 42

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 42 [166]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
    Notes
    [166] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [167]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    7 ± 99999
    Notes
    [167] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 44

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 44 [168]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
    Notes
    [168] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [169]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    13 ± 99999
    Notes
    [169] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at Cycle 46

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at Cycle 46 [170]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
    Notes
    [170] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    0 [171]
    1
    Units: mm
        arithmetic mean (standard deviation)
    ±
    14 ± 99999
    Notes
    [171] - No participant was evaluable in this arm for the indicated outcome measure.
    No statistical analyses for this end point

    Primary: Change From Baseline in EQ-5D-VAS Score at End of Study

    		 Close Top of page
    End point title
    		 Change From Baseline in EQ-5D-VAS Score at End of Study [172]
    End point description
    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, End of study (4-6 weeks after the last bevacizumab administration) (maximum up to 5 years and 9 months)
    Notes
    [172] - 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: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups.
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    12
    7
    Units: mm
        arithmetic mean (standard deviation)
    -2.7 ± 13.17
    -1.4 ± 22.34
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Died Due to Any Cause

    		 Close Top of page
    End point title
    		 Percentage of Participants Who Died Due to Any Cause
    End point description
    ITT analysis population
    End point type
    Secondary
    End point timeframe
    Baseline up to death (overall approximately 5 years and 9 months)
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    35
    13
    Units: percentage of participants
        number (not applicable)
    97.1
    84.6
    No statistical analyses for this end point

    Secondary: Overall Survival

    		 Close Top of page
    End point title
    		 Overall Survival
    End point description
    Overall survival was defined as the time from start of taxane plus bevacizumab therapy to death due to any cause. Overall survival was calculated in months as (date of death from any cause - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants for whom no death was captured on the clinical database were censored at the last date they were known to be alive. ITT analysis population.
    End point type
    Secondary
    End point timeframe
    Baseline up to death (overall approximately 5 years and 9 months)
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    35
    13
    Units: months
        median (confidence interval 95%)
    11.6 (8.5 to 16.9)
    18.9 (12.8 to 33.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Disease Progression

    		 Close Top of page
    End point title
    		 Percentage of Participants With Disease Progression
    End point description
    Disease progression was defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 mm of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. ITT analysis population.
    End point type
    Secondary
    End point timeframe
    Baseline up to disease progression (overall approximately 5 years and 9 months)
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    35
    13
    Units: percentage of participants
        number (not applicable)
    74.3
    69.2
    No statistical analyses for this end point

    Secondary: Time to Disease Progression

    		 Close Top of page
    End point title
    		 Time to Disease Progression
    End point description
    Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Disease progression was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. ITT analysis population.
    End point type
    Secondary
    End point timeframe
    Baseline up to disease progression (overall approximately 5 years and 9 months)
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    35
    13
    Units: months
        median (confidence interval 95%)
    6.7 (4.5 to 14.1)
    7.9 (3.2 to 9.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants by Karnofsky Performance Status Scale Scores

    		 Close Top of page
    End point title
    		 Percentage of Participants by Karnofsky Performance Status Scale Scores
    End point description
    Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease). Higher score means higher ability to perform daily tasks. Percentage of participants with different level scores is reported. ITT analysis population. Here, 'Number of subjects analysed' signifies overall number of participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time points for different arms, respectively. No data reported for Cycles 35, 41, 44 as no participant was evaluable at these time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
    End point values
    		 Bevacizumab 10 mg/kg Q2W Bevacizumab 15 mg/kg Q3W
    Number of subjects analysed
    35
    13
    Units: percentage of participants
    number (not applicable)
        Baseline, 60% (n=33,12)
    3
    8
        Baseline, 70% (n=33,12)
    9
    8
        Baseline, 80% (n=33,12)
    27
    25
        Baseline, 90% (n=33,12)
    30
    25
        Baseline, 100% (n=33,12)
    30
    33
        Cycle 1, 60% (n=31,12)
    6
    0
        Cycle 1, 70% (n=31,12)
    6
    25
        Cycle 1, 80% (n=31,12)
    26
    25
        Cycle 1, 90% (n=31,12)
    32
    25
        Cycle 1, 100% (n=31,12)
    29
    25
        Cycle 2, 60% (n=31,10)
    0
    10
        Cycle 2, 70% (n=31,10)
    13
    30
        Cycle 2, 80% (n=31,10)
    23
    20
        Cycle 2, 90% (n=31,10)
    35
    30
        Cycle 2, 100% (n=31,10)
    29
    10
        Cycle 3, 70% (n=28,10)
    4
    30
        Cycle 3, 80% (n=28,10)
    43
    30
        Cycle 3, 90% (n=28,10)
    32
    30
        Cycle 3, 100% (n=28,10)
    21
    10
        Cycle 4, 60% (n=24,8)
    0
    13
        Cycle 4, 70% (n=24,8)
    8
    13
        Cycle 4, 80% (n=24,8)
    29
    38
        Cycle 4, 90% (n=24,8)
    42
    25
        Cycle 4, 100% (n=24,8)
    21
    13
        Cycle 5, 60% (n=19,9)
    0
    11
        Cycle 5, 70% (n=19,9)
    5
    11
        Cycle 5, 80% (n=19,9)
    37
    33
        Cycle 5, 90% (n=19,9)
    42
    33
        Cycle 5, 100% (n=19,9)
    16
    11
        Cycle 6, 80% (n=15,8)
    33
    50
        Cycle 6, 90% (n=15,8)
    47
    38
        Cycle 6, 100% (n=15,8)
    20
    13
        Cycle 7, 80% (n=14,7)
    14
    43
        Cycle 7, 90% (n=14,7)
    64
    29
        Cycle 7, 100% (n=14,7)
    21
    29
        Cycle 8, 70% (n=10,7)
    0
    14
        Cycle 8, 80% (n=10,7)
    20
    29
        Cycle 8, 90% (n=10,7)
    60
    43
        Cycle 8, 100% (n=10,7)
    20
    14
        Cycle 9, 60% (n=10,6)
    0
    17
        Cycle 9, 70% (n=10,6)
    10
    0
        Cycle 9, 80% (n=10,6)
    10
    17
        Cycle 9, 90% (n=10,6)
    60
    50
        Cycle 9, 100% (n=10,6)
    20
    17
        Cycle 10, 70% (n=11,5)
    0
    20
        Cycle 10, 80% (n=11,5)
    9
    40
        Cycle 10, 90% (n=11,5)
    73
    20
        Cycle 10, 100% (n=11,5)
    18
    20
        Cycle 11, 70% (n=10,4)
    0
    25
        Cycle 11, 80% (n=10,4)
    0
    25
        Cycle 11, 90% (n=10,4)
    80
    25
        Cycle 11, 100% (n=10,4)
    20
    25
        Cycle 12, 70% (n=10,4)
    0
    25
        Cycle 12, 80% (n=10,4)
    0
    25
        Cycle 12, 90% (n=10,4)
    80
    25
        Cycle 12, 100% (n=10,4)
    20
    25
        Cycle 13, 90% (n=8,2)
    88
    100
        Cycle 13, 100% (n=8,2)
    13
    0
        Cycle 14, 80% (n=8,1)
    13
    0
        Cycle 14, 90% (n=8,1)
    75
    100
        Cycle 14, 100% (n=8,1)
    13
    0
        Cycle 15, 80% (n=7,1)
    14
    0
        Cycle 15, 90% (n=7,1)
    71
    100
        Cycle 15, 100% (n=7,1)
    14
    0
        Cycle 16, 80% (n=4,1)
    25
    0
        Cycle 16, 90% (n=4,1)
    75
    100
        Cycle 16, 100% (n=4,1)
    0
    0
        Cycle 17, 90% (n=4,1)
    75
    100
        Cycle 17, 100% (n=4,1)
    25
    0
        Cycle 18, 90% (n=4,1)
    75
    100
        Cycle 18, 100% (n=4,1)
    25
    0
        Cycle 19, 90% (n=4,1)
    75
    0
        Cycle 19, 100% (n=4,1)
    25
    100
        Cycle 20, 80% (n=4,1)
    0
    100
        Cycle 20, 90% (n=4,1)
    75
    0
        Cycle 20, 100% (n=4,1)
    25
    0
        Cycle 21, 90% (n=4,1)
    50
    100
        Cycle 21, 100% (n=4,1)
    50
    0
        Cycle 22, 90% (n=2,1)
    50
    100
        Cycle 22, 100% (n=2,1)
    50
    0
        Cycle 23, 90% (n=3,1)
    67
    100
        Cycle 23, 100% (n=3,1)
    33
    0
        Cycle 24, 90% (n=3,1)
    67
    100
        Cycle 24, 100% (n=3,1)
    33
    0
        Cycle 25, 90% (n=3,1)
    67
    100
        Cycle 25, 100% (n=3,1)
    33
    0
        Cycle 26, 90% (n=4,1)
    75
    100
        Cycle 26, 100% (n=4,1)
    25
    0
        Cycle 27, 90% (n=2,1)
    50
    100
        Cycle 27, 100% (n=2,1)
    50
    0
        Cycle 28, 90% (n=1,1)
    100
    100
        Cycle 28, 100% (n=1,1)
    0
    0
        Cycle 29, 90% (n=1,0)
    100
    0
        Cycle 30, 80% (n=1,0)
    100
    0
        Cycle 31, 90% (n=0,1)
    0
    100
        Cycle 32, 90% (n=0,1)
    0
    100
        Cycle 33, 90% (n=0,1)
    0
    100
        Cycle 34, 90% (n=0,1)
    0
    100
        Cycle 36, 90% (n=0,1)
    0
    100
        Cycle 37, 90% (n=0,1)
    0
    100
        Cycle 38, 90% (n=0,1)
    0
    100
        Cycle 39, 90% (n=0,1)
    0
    100
        Cycle 40, 90% (n=0,1)
    0
    100
        Cycle 42, 100% (n=0,1)
    0
    100
        Cycle 43, 100% (n=0,1)
    0
    100
        Cycle 45, 100% (n=0,1)
    0
    100
        Cycle 46, 100% (n=0,1)
    0
    100
        Cycle 47, 100% (n=0,1)
    0
    100
        End of Study, 50% (n=19,8)
    5
    0
        End of Study, 60% (n=19,8)
    0
    13
        End of Study, 70% (n=19,8)
    16
    25
        End of Study, 80% (n=19,8)
    32
    25
        End of Study, 90% (n=19,8)
    42
    38
        End of Study, 100% (n=19,8)
    5
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
    Adverse event reporting additional description
    Treatment-emergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Bevacizumab 15 mg/kg Q3W
    Reporting group description
    		 Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

    Reporting group title
    Bevacizumab 10 mg/kg Q2W
    Reporting group description
    		 Participants received bevacizumab at a dose of 10 mg/kg Q2W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

    Serious adverse events
    		 Bevacizumab 15 mg/kg Q3W Bevacizumab 10 mg/kg Q2W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 13 (53.85%)
    15 / 36 (41.67%)
         number of deaths (all causes)
    11
    35
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lung
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Catheter site dermatitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum perforation
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Facial paralysis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Device related infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Postoperative wound infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 36 (2.78%)
         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: 5%
    Non-serious adverse events
    		 Bevacizumab 15 mg/kg Q3W Bevacizumab 10 mg/kg Q2W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 13 (100.00%)
    35 / 36 (97.22%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Hot flush
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Hypertension
         subjects affected / exposed
    4 / 13 (30.77%)
    9 / 36 (25.00%)
         occurrences all number
    4
    11
    Hypotension
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Lymphoedema
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Phlebitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Catheter site inflammation
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 36 (0.00%)
         occurrences all number
    4
    0
    Chills
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    9 / 13 (69.23%)
    26 / 36 (72.22%)
         occurrences all number
    11
    28
    Oedema peripheral
         subjects affected / exposed
    2 / 13 (15.38%)
    3 / 36 (8.33%)
         occurrences all number
    2
    4
    Pyrexia
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Mucosal inflammation
         subjects affected / exposed
    2 / 13 (15.38%)
    11 / 36 (30.56%)
         occurrences all number
    3
    12
    Pain
         subjects affected / exposed
    3 / 13 (23.08%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    Ulcer
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Vulvovaginal dryness
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    3 / 13 (23.08%)
    9 / 36 (25.00%)
         occurrences all number
    3
    10
    Cough
         subjects affected / exposed
    4 / 13 (30.77%)
    10 / 36 (27.78%)
         occurrences all number
    4
    11
    Hiccups
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Epistaxis
         subjects affected / exposed
    4 / 13 (30.77%)
    14 / 36 (38.89%)
         occurrences all number
    5
    15
    Nasal congestion
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Rhinalgia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Insomnia
         subjects affected / exposed
    1 / 13 (7.69%)
    4 / 36 (11.11%)
         occurrences all number
    1
    4
    Mood altered
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Depression
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 13 (7.69%)
    3 / 36 (8.33%)
         occurrences all number
    1
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Neutrophil count decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Weight increased
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 36 (5.56%)
         occurrences all number
    1
    4
    Weight decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    5 / 36 (13.89%)
         occurrences all number
    0
    5
    White blood cells urine positive
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    8
    White blood cell count decreased
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3
    Ligament sprain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Wound decomposition
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Headache
         subjects affected / exposed
    3 / 13 (23.08%)
    11 / 36 (30.56%)
         occurrences all number
    4
    12
    Dysgeusia
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Neuralgia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Lethargy
         subjects affected / exposed
    2 / 13 (15.38%)
    5 / 36 (13.89%)
         occurrences all number
    2
    5
    Paraesthesia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3
    Syncope
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    8 / 13 (61.54%)
    17 / 36 (47.22%)
         occurrences all number
    11
    23
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    Tremor
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Neutropenia
         subjects affected / exposed
    3 / 13 (23.08%)
    2 / 36 (5.56%)
         occurrences all number
    4
    3
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Eye irritation
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Eye pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Hyphaema
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Eyelid ptosis
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Vision blurred
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Lacrimation increased
         subjects affected / exposed
    3 / 13 (23.08%)
    0 / 36 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 13 (38.46%)
    14 / 36 (38.89%)
         occurrences all number
    5
    15
    Abdominal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Diarrhoea
         subjects affected / exposed
    5 / 13 (38.46%)
    11 / 36 (30.56%)
         occurrences all number
    11
    11
    Dyspepsia
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 36 (5.56%)
         occurrences all number
    2
    3
    Mouth ulceration
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Dry mouth
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Oral pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    4 / 13 (30.77%)
    13 / 36 (36.11%)
         occurrences all number
    6
    17
    Toothache
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Stomatitis
         subjects affected / exposed
    3 / 13 (23.08%)
    4 / 36 (11.11%)
         occurrences all number
    3
    4
    Vomiting
         subjects affected / exposed
    1 / 13 (7.69%)
    5 / 36 (13.89%)
         occurrences all number
    2
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 13 (23.08%)
    11 / 36 (30.56%)
         occurrences all number
    4
    11
    Dermatitis acneiform
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Dry skin
         subjects affected / exposed
    1 / 13 (7.69%)
    7 / 36 (19.44%)
         occurrences all number
    1
    8
    Nail disorder
         subjects affected / exposed
    3 / 13 (23.08%)
    4 / 36 (11.11%)
         occurrences all number
    3
    4
    Dermatitis allergic
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Onycholysis
         subjects affected / exposed
    2 / 13 (15.38%)
    6 / 36 (16.67%)
         occurrences all number
    2
    6
    Onychomadesis
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 36 (5.56%)
         occurrences all number
    2
    2
    Pruritus
         subjects affected / exposed
    3 / 13 (23.08%)
    3 / 36 (8.33%)
         occurrences all number
    3
    3
    Rash maculo-papular
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3
    Rash
         subjects affected / exposed
    4 / 13 (30.77%)
    6 / 36 (16.67%)
         occurrences all number
    6
    8
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    2 / 13 (15.38%)
    3 / 36 (8.33%)
         occurrences all number
    9
    6
    Haematuria
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 13 (7.69%)
    6 / 36 (16.67%)
         occurrences all number
    1
    8
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Back pain
         subjects affected / exposed
    1 / 13 (7.69%)
    5 / 36 (13.89%)
         occurrences all number
    1
    5
    Bone pain
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Myalgia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Pain in extremity
         subjects affected / exposed
    1 / 13 (7.69%)
    5 / 36 (13.89%)
         occurrences all number
    1
    6
    Infections and infestations
    Catheter site infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Device related infection
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Fungal infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Herpes simplex
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 13 (23.08%)
    2 / 36 (5.56%)
         occurrences all number
    3
    2
    Nail infection
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 13 (15.38%)
    5 / 36 (13.89%)
         occurrences all number
    3
    6
    Paronychia
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Oral herpes
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    Tooth abscess
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 36 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Urinary tract infection
         subjects affected / exposed
    3 / 13 (23.08%)
    8 / 36 (22.22%)
         occurrences all number
    3
    12
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 13 (15.38%)
    1 / 36 (2.78%)
         occurrences all number
    2
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Feb 2011
    Docetaxel was removed as a treatment combination option, following the decision by the European Medicines Agency (EMA) to follow the recommendation of the Committee for Medicinal Products for Human Use (CHMP) to remove docetaxel from the Avastin product licence.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 03:43:06 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA