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
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Summary
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EudraCT number |
2009-014279-37 |
Trial protocol |
GB |
Global end of trial date |
02 Dec 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jan 2017
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First version publication date |
04 Jan 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ML22780
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01094184 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche AG
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4070
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Public contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.com
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Scientific contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 61 6878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
05 Aug 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Dec 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Mar 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 49
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Worldwide total number of subjects |
49
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EEA total number of subjects |
49
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
37
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From 65 to 84 years |
12
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
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Pre-assignment
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Screening details |
A total of 53 participants were screened; 49 participants were eligible for the study and assigned to study treatment. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
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Other name |
Avastin
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Bevacizumab was administered at a dose of 10 mg/kg Q2W as intravenous infusion.
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Arm title
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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
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Investigational medicinal product code |
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Other name |
Avastin
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Bevacizumab was administered at a dose of 15 mg/kg Q3W as intravenous infusion.
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Baseline characteristics reporting groups
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Reporting group title |
Bevacizumab 10 mg/kg Q2W
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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
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Bevacizumab 10 mg/kg Q2W
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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
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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. | ||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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| 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. |
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| Notes [3] - No participant was evaluable in the indicated arm for this outcome measure. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
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| 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. |
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| Notes [14] - No participant was evaluable in this arm for the indicated outcome measure. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
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| 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. |
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| No statistical analyses for this end point | |||||||||||||
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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.
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End point type |
Primary
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End point timeframe |
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
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| 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. |
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|
|||||||||||||
| Notes [17] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [19] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [21] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [24] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [27] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [30] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [32] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [34] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [37] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [40] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [42] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [44] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [46] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [48] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [50] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [52] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [54] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||
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. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [58] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [63] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [66] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [69] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [72] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [75] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [77] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [79] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [82] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [85] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [88] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [90] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [92] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [95] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [98] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [100] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [102] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [104] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [106] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [108] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [110] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [112] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [114] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||
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. |
|||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [118] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [129] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [132] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [134] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [136] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [139] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [142] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [145] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [147] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [149] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [152] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [155] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [157] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [159] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [161] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [163] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [165] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [167] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [169] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| Notes [171] - No participant was evaluable in this arm for the indicated outcome measure. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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. |
|||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
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)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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
|
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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)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
Adverse events information
|
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Timeframe for reporting adverse events |
Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)
|
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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.
|
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Bevacizumab 15 mg/kg Q3W
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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
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||