Clinical Trial Results:
OpenLabel Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the FirstLine Treatment of Patients With Advanced Triple Negative Breast Cancer
Summary


EudraCT number 
200901427937 
Trial protocol 
GB 
Global end of trial date 
02 Dec 2015

Results information


Results version number 
v1(current) 
This version publication date 
04 Jan 2017

First version publication date 
04 Jan 2017

Other versions 
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information


Trial identification


Sponsor protocol code 
ML22780


Additional study identifiers


ISRCTN number 
  
US NCT number 
NCT01094184  
WHO universal trial number (UTN) 
  
Sponsors


Sponsor organisation name 
F. HoffmannLa Roche AG


Sponsor organisation address 
Grenzacherstrasse 124, Basel, Switzerland, CH4070


Public contact 
Roche Trial Information Hotline, F. HoffmannLa Roche AG, 41 61 6878333, global.trial_information@roche.com


Scientific contact 
Roche Trial Information Hotline, F. HoffmannLa Roche AG, 41 61 6878333, global.trial_information@roche.com


Paediatric regulatory details


Is trial part of an agreed paediatric investigation plan (PIP) 
No


Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? 
No


Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? 
No


Results analysis stage


Analysis stage 
Final


Date of interim/final analysis 
05 Aug 2016


Is this the analysis of the primary completion data? 
No


Global end of trial reached? 
Yes


Global end of trial date 
02 Dec 2015


Was the trial ended prematurely? 
No


General information about the trial


Main objective of the trial 
To assess the tolerability and safety profile of bevacizumab when combined with taxane monotherapy (weekly paclitaxel) as first line treatment of participants with triplenegative metastatic breast cancer.


Protection of trial subjects 
The study was conducted in accordance with the principles of the “Declaration of Helsinki” and Good Clinical Practice (GCP). Approval from the Independent Ethics Committee/Institutional Review Board (IEC/IRB) was obtained before study start and was documented in a letter to the Investigator specifying the date on which the committee met and granted the approval. The Sponsor also obtained approval from the relevant Competent Authority prior to starting the study.


Background therapy 
  
Evidence for comparator 
  
Actual start date of recruitment 
29 Mar 2010


Long term followup planned 
No


Independent data monitoring committee (IDMC) involvement? 
No


Population of trial subjects


Number of subjects enrolled per country 

Country: Number of subjects enrolled 
United Kingdom: 49


Worldwide total number of subjects 
49


EEA total number of subjects 
49


Number of subjects enrolled per age group 

In utero 
0


Preterm newborn  gestational age < 37 wk 
0


Newborns (027 days) 
0


Infants and toddlers (28 days23 months) 
0


Children (211 years) 
0


Adolescents (1217 years) 
0


Adults (1864 years) 
37


From 65 to 84 years 
12


85 years and over 
0



Recruitment


Recruitment details 
  
Preassignment


Screening details 
A total of 53 participants were screened; 49 participants were eligible for the study and assigned to study treatment.  
Period 1


Period 1 title 
Overall Study (overall period)


Is this the baseline period? 
Yes  
Allocation method 
Not applicable


Blinding used 
Not blinded  
Arms


Are arms mutually exclusive 
Yes


Arm title

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


Investigational medicinal product code 

Other name 
Avastin


Pharmaceutical forms 
Concentrate for solution for infusion


Routes of administration 
Intravenous use


Dosage and administration details 
Bevacizumab was administered at a dose of 10 mg/kg Q2W as intravenous infusion.


Arm title

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


Investigational medicinal product code 

Other name 
Avastin


Pharmaceutical forms 
Concentrate for solution for infusion


Routes of administration 
Intravenous use


Dosage and administration details 
Bevacizumab was administered at a dose of 15 mg/kg Q3W as intravenous infusion.





Baseline characteristics reporting groups


Reporting group title 
Bevacizumab 10 mg/kg Q2W


Reporting group description 
Participants received bevacizumab at a dose of 10 milligram per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.  
Reporting group title 
Bevacizumab 15 mg/kg Q3W


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



End points reporting groups


Reporting group title 
Bevacizumab 10 mg/kg Q2W


Reporting group description 
Participants received bevacizumab at a dose of 10 milligram per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.  
Reporting group title 
Bevacizumab 15 mg/kg Q3W


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


End point title 
Change From Baseline in Functional Assessment of Cancer TherapyBreast Cancer (FACTB) Score at Cycle 2 ^{[1]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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. Intenttotreat (ITT) analysis population included all participants who received at least one dose of all study medication (taxane and bevacizumab). Here, 'Number of subject analysed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.


End point type 
Primary


End point timeframe 
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)


Notes [1]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 3 ^{[2]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subject analysed' signifies the number of participants evaluable for this outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)


Notes [2]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



Notes [3]  No participant was evaluable in the indicated arm for this outcome measure. 

No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 4 ^{[4]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subject analysed' signifies the number of participants evaluable for this outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)


Notes [4]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 5 ^{[5]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0=‘Not at all’ to 4=‘Very much’. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)


Notes [5]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 6 ^{[6]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)


Notes [6]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 7 ^{[7]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)


Notes [7]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 8 ^{[8]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)


Notes [8]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 9 ^{[9]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)


Notes [9]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 10 ^{[10]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)


Notes [10]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 11 ^{[11]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)


Notes [11]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 12 ^{[12]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)


Notes [12]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 13 ^{[13]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)


Notes [13]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



Notes [14]  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 FACTB Score at Cycle 14 ^{[15]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure. "99999" in results indicate data could not be calculated because only 1 participant was evaluable in this arm for the indicated outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)


Notes [15]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



No statistical analyses for this end point 


End point title 
Change From Baseline in FACTB Score at Cycle 15 ^{[16]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. ITT analysis population. Here, 'Number of subjects analysed' signifies the number of participants evaluable for this outcome measure.


End point type 
Primary


End point timeframe 
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)


Notes [16]  No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Results were reported descriptively and were not planned to be analyzed for statistically significant differences between groups. 



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 FACTB Score at Cycle 16 ^{[18]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 17 ^{[20]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 18 ^{[22]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 20 ^{[23]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 21 ^{[25]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 22 ^{[26]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 23 ^{[28]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 24 ^{[29]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 25 ^{[31]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 26 ^{[33]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 27 ^{[35]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 28 ^{[36]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 29 ^{[38]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 30 ^{[39]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 32 ^{[41]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 36 ^{[43]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 37 ^{[45]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 39 ^{[47]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 42 ^{[49]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 44 ^{[51]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score at Cycle 46 ^{[53]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 FACTB Score At End of Study ^{[55]}  
End point description 
FACTB is used for assessment of healthrelated 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 singleitem 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 (46 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 (EQ5D)  Health State Questionnaire Score at Cycle 2 ^{[56]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 3 ^{[57]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 4 ^{[59]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 5 ^{[60]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 6 ^{[61]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 7 ^{[62]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 8 ^{[64]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 9 ^{[65]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 10 ^{[67]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 11 ^{[68]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 12 ^{[70]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 13 ^{[71]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 14 ^{[73]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 15 ^{[74]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 16 ^{[76]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 17 ^{[78]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 18 ^{[80]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 20 ^{[81]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 21 ^{[83]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 22 ^{[84]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 23 ^{[86]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 24 ^{[87]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 25 ^{[89]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 26 ^{[91]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 27 ^{[93]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 28 ^{[94]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 29 ^{[96]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 30 ^{[97]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 32 ^{[99]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 36 ^{[101]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 37 ^{[103]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 39 ^{[105]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 40 ^{[107]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 42 ^{[109]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 44 ^{[111]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at Cycle 46 ^{[113]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 EQ5D Health State Questionnaire Score at End of Study ^{[115]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, 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 (46 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 EQ5D  Visual Analog Scale (VAS) Score at Cycle 2 ^{[116]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 3 ^{[117]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 4 ^{[119]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 5 ^{[120]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 6 ^{[121]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 7 ^{[122]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 8 ^{[123]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 9 ^{[124]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 10 ^{[125]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 11 ^{[126]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 12 ^{[127]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 13 ^{[128]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 14 ^{[130]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 15 ^{[131]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 16 ^{[133]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 17 ^{[135]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 18 ^{[137]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 20 ^{[138]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 21 ^{[140]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 22 ^{[141]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 23 ^{[143]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 24 ^{[144]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 25 ^{[146]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 26 ^{[148]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 27 ^{[150]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 28 ^{[151]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 29 ^{[153]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 30 ^{[154]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 32 ^{[156]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 36 ^{[158]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 37 ^{[160]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 39 ^{[162]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 40 ^{[164]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 42 ^{[166]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 44 ^{[168]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at Cycle 46 ^{[170]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 EQ5DVAS Score at End of Study ^{[172]}  
End point description 
EQ5D: participant rated questionnaire to assess healthrelated 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 (46 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 followup 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 wellbeing and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease). Higher score means higher ability to perform daily tasks. Percentage of participants with different level scores is reported. ITT analysis population. Here, 'Number of subjects analysed' signifies overall number of participants evaluable for this outcome measure and 'n' signifies number of participants evaluable at specified time points for different arms, respectively. No data reported for Cycles 35, 41, 44 as no participant was evaluable at these time points.


End point type 
Secondary


End point timeframe 
Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (46 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)




No statistical analyses for this end point 


Adverse events information


Timeframe for reporting adverse events 
Day 1 up to 6 months after last dose (overall approximately 5 years and 9 months)


Adverse event reporting additional description 
Treatmentemergent are events between first dose of study drug and up to 6 months after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety analysis population.


Assessment type 
Nonsystematic  
Dictionary used for adverse event reporting


Dictionary name 
MedDRA  
Dictionary version 
18.1


Reporting groups


Reporting group title 
Bevacizumab 15 mg/kg Q3W


Reporting group description 
Participants received bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.  
Reporting group title 
Bevacizumab 10 mg/kg Q2W


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


Frequency threshold for reporting nonserious adverse events: 5%  
