Breast Cancer
Conditions
Brief summary
This open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and Karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer.
Interventions
DRUGBevacizumab
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
DRUGPaclitaxel
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
DRUGDocetaxel
Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician. Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease * Participant who in the Investigator's opinion requires combination therapy for their disease * Life expectancy of greater than or equal to (\>/=)12 weeks
Exclusion criteria
* Previous chemotherapy for metastatic breast cancer * Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain) * Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in FACT-B Score at Cycle 3 | Baseline, Cycle 3 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 5 | Baseline, Cycle 5 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 6 | Baseline, Cycle 6 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 7 | Baseline, Cycle 7 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 8 | Baseline, Cycle 8 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score At Cycle 9 | Baseline, Cycle 9 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 10 | Baseline, Cycle 10 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 11 | Baseline, Cycle 11 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 12 | Baseline, Cycle 12 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 13 | Baseline, Cycle 13 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 14 | Baseline, Cycle 14 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 15 | Baseline, Cycle 15 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 16 | Baseline, Cycle 16 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 17 | Baseline, Cycle 17 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 18 | Baseline, Cycle 18 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 20 | Baseline, Cycle 20 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 21 | Baseline, Cycle 21 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 22 | Baseline, Cycle 22 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 23 | Baseline, Cycle 23 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 24 | Baseline, Cycle 24 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 25 | Baseline, Cycle 25 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 26 | Baseline, Cycle 26 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 27 | Baseline, Cycle 27 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 28 | Baseline, Cycle 28 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 29 | Baseline, Cycle 29 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 30 | Baseline, Cycle 30 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 32 | Baseline, Cycle 32 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 36 | Baseline, Cycle 36 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 37 | Baseline, Cycle 37 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 39 | Baseline, Cycle 39 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 42 | Baseline, Cycle 42 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 44 | Baseline, Cycle 44 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 46 | Baseline, Cycle 46 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at End of Study | Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2 | Baseline, Cycle 2 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3 | Baseline, Cycle 3 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4 | Baseline, Cycle 4 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5 | Baseline, Cycle 5 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6 | Baseline, Cycle 6 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7 | Baseline, Cycle 7 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8 | Baseline, Cycle 8 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9 | Baseline, Cycle 9 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10 | Baseline, Cycle 10 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11 | Baseline, Cycle 11 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12 | Baseline, Cycle 12 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13 | Baseline, Cycle 13 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14 | Baseline, Cycle 14 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15 | Baseline, Cycle 15 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16 | Baseline, Cycle 16 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17 | Baseline, Cycle 17 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18 | Baseline, Cycle 18 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20 | Baseline, Cycle 20 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21 | Baseline, Cycle 21 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22 | Baseline, Cycle 22 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23 | Baseline, Cycle 23 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24 | Baseline, Cycle 24 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25 | Baseline, Cycle 25 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26 | Baseline, Cycle 26 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27 | Baseline, Cycle 27 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28 | Baseline, Cycle 28 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29 | Baseline, Cycle 29 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30 | Baseline, Cycle 30 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32 | Baseline, Cycle 32 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36 | Baseline, Cycle 36 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37 | Baseline, Cycle 37 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39 | Baseline, Cycle 39 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40 | Baseline, Cycle 40 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42 | Baseline, Cycle 42 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44 | Baseline, Cycle 44 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46 | Baseline, Cycle 46 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study | Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2 | Baseline, Cycle 2 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 3 | Baseline, Cycle 3 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 4 | Baseline, Cycle 4 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 5 | Baseline, Cycle 5 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 6 | Baseline, Cycle 6 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 7 | Baseline, Cycle 7 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 8 | Baseline, Cycle 8 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 9 | Baseline, Cycle 9 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 10 | Baseline, Cycle 10 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 11 | Baseline, Cycle 11 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 12 | Baseline, Cycle 12 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 13 | Baseline, Cycle 13 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 14 | Baseline, Cycle 14 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 15 | Baseline, Cycle 15 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 16 | Baseline, Cycle 16 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 17 | Baseline, Cycle 17 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 18 | Baseline, Cycle 18 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 20 | Baseline, Cycle 20 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 21 | Baseline, Cycle 21 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 22 | Baseline, Cycle 22 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 23 | Baseline, Cycle 23 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 24 | Baseline, Cycle 24 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 25 | Baseline, Cycle 25 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 26 | Baseline, Cycle 26 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 27 | Baseline, Cycle 27 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 28 | Baseline, Cycle 28 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 29 | Baseline, Cycle 29 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 30 | Baseline, Cycle 30 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 32 | Baseline, Cycle 32 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 36 | Baseline, Cycle 36 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 37 | Baseline, Cycle 37 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 39 | Baseline, Cycle 39 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 40 | Baseline, Cycle 40 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 42 | Baseline, Cycle 42 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 44 | Baseline, Cycle 44 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at Cycle 46 | Baseline, Cycle 46 (Cycle length=2 and 3 weeks) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in EQ-5D-VAS Score at End of Study | Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months) | EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 | Baseline, Cycle 2 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in FACT-B Score at Cycle 4 | Baseline, Cycle 4 (Cycle length=2 and 3 weeks) | FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Progression | Baseline up to disease progression (overall approximately 5 years and 9 months) | 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. |
| Time to Disease Progression | Baseline up to disease progression (overall approximately 5 years and 9 months) | Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Disease progression was defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. |
| Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months) | Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease). Higher score means higher ability to perform daily tasks. |
| Percentage of Participants Who Died Due to Any Cause | Baseline up to death (overall approximately 5 years and 9 months) | — |
| Overall Survival | Baseline up to death (overall approximately 5 years and 9 months) | 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. |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 53 participants were screened; 49 participants were eligible for the study and assigned to study treatment
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab 10 mg/kg Q2W 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. | 36 |
| Bevacizumab 15 mg/kg Q3W 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. | 13 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 35 | 11 |
Baseline characteristics
| Characteristic | Bevacizumab 10 mg/kg Q2W | Bevacizumab 15 mg/kg Q3W | Total |
|---|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 14.74 | 58.4 years STANDARD_DEVIATION 9.22 | 54.2 years STANDARD_DEVIATION 13.64 |
| Sex: Female, Male Female | 36 Participants | 13 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 36 | 13 / 13 |
| serious Total, serious adverse events | 15 / 36 | 7 / 13 |
Outcome results
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10 | 0.0253 units on a scale | Standard Deviation 0.32169 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10 | -0.0540 units on a scale | Standard Deviation 0.2499 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11 | 0.0018 units on a scale | Standard Deviation 0.20907 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12 | 0.0997 units on a scale | Standard Deviation 0.35679 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12 | -0.0520 units on a scale | — |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13 | -0.0930 units on a scale | Standard Deviation 0.13152 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14 | 0.0620 units on a scale | Standard Deviation 0.11033 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14 | -0.3320 units on a scale | — |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15 | 0.0175 units on a scale | Standard Deviation 0.19021 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16 | 0.0060 units on a scale | Standard Deviation 0.21806 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17 | 0.1057 units on a scale | Standard Deviation 0.17756 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18 | 0.0970 units on a scale | Standard Deviation 0.01414 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18 | -0.1570 units on a scale | — |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20 | 0.1035 units on a scale | Standard Deviation 0.1967 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21 | 0.2955 units on a scale | Standard Deviation 0.26658 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21 | -0.1570 units on a scale | — |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22 | 0.0710 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23 | 0.0625 units on a scale | Standard Deviation 0.06293 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23 | -0.2280 units on a scale | — |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24 | 0.0540 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25 | -0.3320 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26 | 0.0180 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27 | 0.0540 units on a scale |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27 | -0.3320 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28 | -0.2610 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29 | -0.0860 units on a scale |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29 | -0.2610 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3 | 0.1920 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30 | 0.0540 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32 | -0.2610 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36 | -0.2610 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37 | -0.2610 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39 | -0.2610 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4 | -0.0105 units on a scale | Standard Deviation 0.28263 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4 | -0.0906 units on a scale | Standard Deviation 0.06661 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 40.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40 | -0.2610 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42 | -0.2610 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44 | -0.3320 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46 | -0.3320 units on a scale |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5 | -0.1164 units on a scale | Standard Deviation 0.10045 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5 | 0.2280 units on a scale | — |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6 | 0.0474 units on a scale | Standard Deviation 0.23827 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6 | -0.0735 units on a scale | Standard Deviation 0.24131 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7 | -0.0331 units on a scale | Standard Deviation 0.18865 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8 | 0.0627 units on a scale | Standard Deviation 0.23917 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8 | -0.0523 units on a scale | Standard Deviation 0.0525 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9 | -0.1904 units on a scale | Standard Deviation 0.24194 |
Primary
Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study | -0.1344 units on a scale | Standard Deviation 0.20511 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study | -0.1178 units on a scale | Standard Deviation 0.14225 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 10
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 10 | 6.0 mm | Standard Deviation 21.91 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 10 | 14.0 mm | Standard Deviation 32.79 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 11
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 11 | 2.0 mm | Standard Deviation 24.14 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 11 | 40.0 mm | — |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 12
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 12 | 13.7 mm | Standard Deviation 24.19 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 12 | 60.0 mm | — |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 13
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 13 | -3.0 mm | Standard Deviation 2.83 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 14
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 14 | -5.0 mm | Standard Deviation 20 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 14 | 9.0 mm | — |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 15
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 15 | 5.0 mm | Standard Deviation 7.07 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 16
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 16 | 7.3 mm | Standard Deviation 37.87 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 17
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 17 | 30.0 mm | Standard Deviation 25 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 18
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 18 | 9.5 mm | Standard Deviation 55.86 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 18 | 10.0 mm | — |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 20
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 20 | 15.0 mm | Standard Deviation 31.36 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 21
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 21 | 27.5 mm | Standard Deviation 31.82 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 21 | 8.0 mm | — |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 22
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 22 | 52.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 23
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 23 | 23.5 mm | Standard Deviation 47.38 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 23 | 10.0 mm | — |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 24
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 24 | -20.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 25
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 25 | 9.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 26
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 26 | -20.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 27
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 27 | -20.0 mm |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 27 | 10.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 28
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 28 | 9.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 29
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 29 | -20.0 mm |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 29 | 10.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 3
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 3 | 20.0 mm | Standard Deviation 26.46 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 30
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 30 | -20.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 32
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 32 | 9.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 36
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 36 | 8.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 37
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 37 | 8.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 39
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 39 | 8.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 4
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 4 | -1.9 mm | Standard Deviation 18.23 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 4 | 3.3 mm | Standard Deviation 29.27 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 40
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 40.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 40 | 5.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 42
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 42 | 7.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 44
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 44 | 13.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 46
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 46 | 14.0 mm |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 5
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 5 | -8.2 mm | Standard Deviation 17.57 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 5 | 7.0 mm | Standard Deviation 46.67 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 6
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 6 | 9.8 mm | Standard Deviation 22 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 6 | 21.4 mm | Standard Deviation 35.69 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 7
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 7 | -3.6 mm | Standard Deviation 12.1 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 7 | -9.0 mm | — |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 8
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 8 | 11.0 mm | Standard Deviation 27.6 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 8 | 35.0 mm | Standard Deviation 22.91 |
Primary
Change From Baseline in EQ-5D-VAS Score at Cycle 9
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at Cycle 9 | -5.8 mm | Standard Deviation 15.43 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at Cycle 9 | 27.5 mm | Standard Deviation 45.96 |
Primary
Change From Baseline in EQ-5D-VAS Score at End of Study
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D-VAS Score at End of Study | -2.7 mm | Standard Deviation 13.17 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D-VAS Score at End of Study | -1.4 mm | Standard Deviation 22.34 |
Primary
Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline and 'Number Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2 | Baseline | 64.8 mm | Standard Deviation 24.34 |
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2 | Change at Cycle 2 | -1.0 mm | Standard Deviation 18.59 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2 | Baseline | 60.3 mm | Standard Deviation 26.96 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2 | Change at Cycle 2 | -8.3 mm | Standard Deviation 19.41 |
Primary
Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline and 'Number Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2 | Baseline | 0.6391 units on a scale | Standard Deviation 0.25595 |
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2 | Change at Cycle 2 | 0.1090 units on a scale | Standard Deviation 0.23563 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2 | Baseline | 0.8152 units on a scale | Standard Deviation 0.12211 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2 | Change at Cycle 2 | -0.2074 units on a scale | Standard Deviation 0.19784 |
Primary
Change From Baseline in FACT-B Score at Cycle 10
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 10.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 10 | 2.71 units on a scale | Standard Deviation 20.075 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 10 | 4.61 units on a scale | Standard Deviation 13.968 |
Primary
Change From Baseline in FACT-B Score at Cycle 11
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 11.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 11 | 6.67 units on a scale | Standard Deviation 11.889 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 11 | 8.17 units on a scale | — |
Primary
Change From Baseline in FACT-B Score at Cycle 12
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 12 | 9.22 units on a scale | Standard Deviation 8.72 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 12 | 21.89 units on a scale | — |
Primary
Change From Baseline in FACT-B Score at Cycle 13
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 13.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 13 | -8.00 units on a scale | Standard Deviation 9.899 |
Primary
Change From Baseline in FACT-B Score at Cycle 14
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 14.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 14 | 6.83 units on a scale | Standard Deviation 5.897 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 14 | 2.33 units on a scale | — |
Primary
Change From Baseline in FACT-B Score at Cycle 15
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 15.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 15 | -6.67 units on a scale | Standard Deviation 8.25 |
Primary
Change From Baseline in FACT-B Score at Cycle 16
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 16.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 16 | 11.83 units on a scale | Standard Deviation 12.79 |
Primary
Change From Baseline in FACT-B Score at Cycle 17
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 17.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 17 | 22.63 units on a scale | Standard Deviation 13.157 |
Primary
Change From Baseline in FACT-B Score at Cycle 18
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 18 | 10.28 units on a scale | Standard Deviation 19.878 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 18 | 5.33 units on a scale | — |
Primary
Change From Baseline in FACT-B Score at Cycle 20
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 20.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 20 | 20.06 units on a scale | Standard Deviation 12.787 |
Primary
Change From Baseline in FACT-B Score at Cycle 21
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 21.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 21 | 25.75 units on a scale | Standard Deviation 5.303 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 21 | 10.33 units on a scale | — |
Primary
Change From Baseline in FACT-B Score at Cycle 22
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 22.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 22 | 13.67 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 23
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 23.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 23 | 9.67 units on a scale | Standard Deviation 20.742 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 23 | 7.33 units on a scale | — |
Primary
Change From Baseline in FACT-B Score at Cycle 24
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 24.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 24 | 6.00 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 25
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 25.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 25 | 11.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 26
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 26.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 26 | 3.22 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 27
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 27.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 27 | -26.78 units on a scale |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 27 | 12.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 28
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 28.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 28 | 16.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 29
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 29.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 29 | -3.00 units on a scale |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 29 | 9.78 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 3
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 3 | 14.56 units on a scale | Standard Deviation 13.961 |
Primary
Change From Baseline in FACT-B Score at Cycle 30
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 30.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 30 | -3.11 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 32
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 32.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 32 | 10.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 36
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 36.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 36 | 3.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 37
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 37.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 37 | 5.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 39
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 39.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 39 | 9.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 4
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 4 | 1.29 units on a scale | Standard Deviation 16.304 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 4 | 0.09 units on a scale | Standard Deviation 12.275 |
Primary
Change From Baseline in FACT-B Score at Cycle 42
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 42.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 42 | 10.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 44
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 44.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 44 | 11.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 46
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 46.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 46 | 13.33 units on a scale |
Primary
Change From Baseline in FACT-B Score at Cycle 5
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 5.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 5 | -10.77 units on a scale | Standard Deviation 11.677 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 5 | 4.50 units on a scale | Standard Deviation 27.577 |
Primary
Change From Baseline in FACT-B Score at Cycle 6
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 6 | 9.47 units on a scale | Standard Deviation 16.356 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 6 | 10.08 units on a scale | Standard Deviation 21.868 |
Primary
Change From Baseline in FACT-B Score at Cycle 7
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 7.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 7 | -6.24 units on a scale | Standard Deviation 13.22 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 7 | 1.83 units on a scale | — |
Primary
Change From Baseline in FACT-B Score at Cycle 8
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at Cycle 8 | 15.01 units on a scale | Standard Deviation 9.805 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at Cycle 8 | 15.44 units on a scale | Standard Deviation 19.979 |
Primary
Change From Baseline in FACT-B Score At Cycle 9
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at Cycle 9.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score At Cycle 9 | -2.43 units on a scale | Standard Deviation 7.762 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score At Cycle 9 | 7.00 units on a scale | — |
Primary
Change From Baseline in FACT-B Score at End of Study
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
Population: ITT analysis population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants who completed the questionnaire at Baseline as well as at End of Study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in FACT-B Score at End of Study | -10.33 units on a scale | Standard Deviation 13.509 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in FACT-B Score at End of Study | -1.01 units on a scale | Standard Deviation 9.343 |
Primary
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
Time frame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
Population: Intent-to-treat (ITT) analysis population included all participants who received at least 1 dose of all study medication (taxane and bevacizumab). 'Overall Number of Participants Analyzed'=participants who completed the questionnaire at Baseline; 'Number Analyzed'=participants who completed the questionnaire at Baseline and at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 | Baseline | 98.3 units on a scale | Standard Deviation 21.342 |
| Bevacizumab 10 mg/kg Q2W | Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 | Change at Cycle 2 | 5.83 units on a scale | Standard Deviation 17.027 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 | Baseline | 102.21 units on a scale | Standard Deviation 21.036 |
| Bevacizumab 15 mg/kg Q3W | Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2 | Change at Cycle 2 | -2.48 units on a scale | Standard Deviation 14.697 |
Secondary
Overall Survival
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.
Time frame: Baseline up to death (overall approximately 5 years and 9 months)
Population: ITT analysis population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Overall Survival | 11.6 months |
| Bevacizumab 15 mg/kg Q3W | Overall Survival | 18.9 months |
Secondary
Percentage of Participants By Karnofsky Performance Status Scale Scores
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease). Higher score means higher ability to perform daily tasks.
Time frame: Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
Population: ITT analysis population. Here, 'Number Analyzed' signifies the number of participants who underwent Karnofsky Performance Status Scale Score assessment at specified time points for different arms, respectively. Data is not reported for Cycles 35, 41, 44 as no participant was evaluable at these time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 80% | 37.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 70% | 9.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 80% | 27.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 90% | 30.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 100% | 30.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 60% | 6.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 70% | 6.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 80% | 26.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 90% | 32.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 100% | 29.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 60% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 70% | 13.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 80% | 23.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 90% | 35.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 100% | 29.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 3, 70% | 4.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 3, 80% | 43.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 3, 90% | 32.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 3, 100% | 21.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 60% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 70% | 8.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 80% | 29.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 90% | 42.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 100% | 21.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 60% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 70% | 5.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 60% | 3.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 90% | 42.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 100% | 16.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 6, 80% | 33.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 6, 90% | 47.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 6, 100% | 20.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 7, 80% | 14.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 7, 90% | 64.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 7, 100% | 21.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 8, 70% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 8, 80% | 20.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 8, 90% | 60.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 8, 100% | 20.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 60% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 70% | 10.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 80% | 10.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 90% | 60.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 100% | 20.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 10, 70% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 10, 80% | 9.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 10, 90% | 73.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 10, 100% | 18.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 11, 70% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 11, 80% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 11, 90% | 80.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 11, 100% | 20.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 12, 70% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 12, 80% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 12, 90% | 80.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 12, 100% | 20.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 13, 90% | 88.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 13, 100% | 13.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 14, 80% | 13.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 14, 90% | 75.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 14, 100% | 13.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 15, 80% | 14.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 15, 90% | 71.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 15, 100% | 14.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 16, 80% | 25.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 16, 90% | 75.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 16, 100% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 17, 90% | 75.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 17, 100% | 25.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 18, 90% | 75.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 18, 100% | 25.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 19, 90% | 75.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 19, 100% | 25.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 20, 80% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 20, 90% | 75.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 20, 100% | 25.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 21, 90% | 50.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 21, 100% | 50.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 22, 90% | 50.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 22, 100% | 50.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 23, 90% | 67.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 23, 100% | 33.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 24, 90% | 67.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 24, 100% | 33.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 25, 90% | 67.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 25, 100% | 33.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 26, 90% | 75.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 26, 100% | 25.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 27, 90% | 50.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 27, 100% | 50.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 28, 90% | 100.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 28, 100% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 29, 90% | 100.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 30, 80% | 100.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 50% | 5.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 60% | 0.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 70% | 16.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 80% | 32.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 90% | 42.0 percentage of participants |
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 100% | 5.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 39, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 11, 90% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 23, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 11, 100% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 40, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 12, 70% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 24, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 12, 80% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 42, 100% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 12, 90% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 24, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 12, 100% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 43, 100% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 60% | 8.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 13, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 70% | 8.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 25, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 80% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 13, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 90% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 45, 100% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Baseline, 100% | 33.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 14, 80% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 60% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 25, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 70% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 14, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 80% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 46, 100% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 90% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 14, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 1, 100% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 26, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 60% | 10.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 15, 80% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 70% | 30.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 47, 100% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 80% | 20.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 15, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 90% | 30.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 26, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 2, 100% | 10.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 15, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 3, 70% | 30.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 90% | 38.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 3, 80% | 30.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 16, 80% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 3, 90% | 30.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 27, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 3, 100% | 10.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 16, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 60% | 13.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 50% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 70% | 13.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 16, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 80% | 38.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 27, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 90% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 17, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 4, 100% | 13.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 80% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 60% | 11.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 17, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 70% | 11.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 28, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 80% | 33.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 18, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 90% | 33.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 60% | 13.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 5, 100% | 11.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 18, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 6, 80% | 50.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 28, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 6, 90% | 38.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 19, 90% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 6, 100% | 13.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 7, 80% | 43.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 19, 100% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 7, 90% | 29.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | End of Study, 70% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 7, 100% | 29.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 20, 80% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 8, 70% | 14.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 31, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 8, 80% | 29.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 20, 90% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 8, 90% | 43.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 32, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 8, 100% | 14.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 20, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 60% | 17.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 33, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 70% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 21, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 80% | 17.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 34, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 90% | 50.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 21, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 9, 100% | 17.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 36, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 10, 70% | 20.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 22, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 10, 80% | 40.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 37, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 10, 90% | 20.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 22, 100% | 0.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 10, 100% | 20.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 38, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 11, 70% | 25.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 23, 90% | 100.0 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants By Karnofsky Performance Status Scale Scores | Cycle 11, 80% | 25.0 percentage of participants |
Secondary
Percentage of Participants Who Died Due to Any Cause
Time frame: Baseline up to death (overall approximately 5 years and 9 months)
Population: ITT analysis population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants Who Died Due to Any Cause | 97.1 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants Who Died Due to Any Cause | 84.6 percentage of participants |
Secondary
Percentage of Participants With Disease Progression
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.
Time frame: Baseline up to disease progression (overall approximately 5 years and 9 months)
Population: ITT analysis population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Percentage of Participants With Disease Progression | 74.3 percentage of participants |
| Bevacizumab 15 mg/kg Q3W | Percentage of Participants With Disease Progression | 69.2 percentage of participants |
Secondary
Time to Disease Progression
Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Disease progression was defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Time frame: Baseline up to disease progression (overall approximately 5 years and 9 months)
Population: ITT analysis population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab 10 mg/kg Q2W | Time to Disease Progression | 6.7 months |
| Bevacizumab 15 mg/kg Q3W | Time to Disease Progression | 7.9 months |