A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (BATMAN)
2017년 8월 25일 업데이트: Hoffmann-La Roche
Open-Label Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the First-Line Treatment of Patients With Advanced Triple Negative Breast Cancer
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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (실제)
등록
49
단계
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Bangor, 영국, LL57 2PD
-
Cottingham, 영국, HU16 5JG
-
Exeter, 영국, EX2 5DW
-
Grimsby, 영국, DN33 2BA
-
Harrogate, 영국, HG2 8AY
-
Plymouth, 영국, PL6 8DH
-
Portsmouth, 영국, PO6 3LY
-
Preston, 영국, PR2 9HT
-
Somerset, 영국, TA1 5DA
-
Wolverhampton, 영국, WV10 0QP
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Bevacizumab 10 mg/kg Q2W
Participants will receive bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
|
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
다른 이름들:
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
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.
|
|
실험적: Bevacizumab 15 mg/kg Q3W
Participants will receive 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.
|
Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
다른 이름들:
Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
기간: 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.
|
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 3
기간: 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.
|
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 4
기간: 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.
|
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 5
기간: 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.
|
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 6
기간: 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.
|
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 7
기간: 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.
|
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 8
기간: 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.
|
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score At Cycle 9
기간: 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.
|
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 10
기간: 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.
|
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 11
기간: 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.
|
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 12
기간: 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.
|
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 13
기간: 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.
|
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 14
기간: 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.
|
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 15
기간: 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.
|
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 16
기간: 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.
|
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 17
기간: 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.
|
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 18
기간: 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.
|
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 20
기간: 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.
|
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 21
기간: 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.
|
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 22
기간: 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.
|
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 23
기간: 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.
|
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 24
기간: 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.
|
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 25
기간: 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.
|
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 26
기간: 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.
|
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 27
기간: 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.
|
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 28
기간: 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.
|
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 29
기간: 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.
|
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 30
기간: 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.
|
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 32
기간: 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.
|
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 36
기간: 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.
|
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 37
기간: 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.
|
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 39
기간: 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.
|
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 42
기간: 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.
|
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 44
기간: 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.
|
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at Cycle 46
기간: 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.
|
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in FACT-B Score at End of Study
기간: 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.
|
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
|
Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
기간: 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.
|
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3
기간: 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.
|
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4
기간: 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.
|
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5
기간: 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.
|
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6
기간: 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.
|
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7
기간: 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.
|
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8
기간: 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.
|
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9
기간: 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.
|
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10
기간: 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.
|
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11
기간: 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.
|
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12
기간: 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.
|
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13
기간: 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.
|
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14
기간: 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.
|
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15
기간: 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.
|
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16
기간: 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.
|
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17
기간: 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.
|
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18
기간: 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.
|
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20
기간: 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.
|
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21
기간: 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.
|
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22
기간: 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.
|
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23
기간: 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.
|
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24
기간: 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.
|
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25
기간: 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.
|
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26
기간: 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.
|
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27
기간: 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.
|
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28
기간: 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.
|
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29
기간: 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.
|
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30
기간: 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.
|
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32
기간: 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.
|
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36
기간: 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.
|
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37
기간: 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.
|
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39
기간: 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.
|
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40
기간: 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.
|
Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42
기간: 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.
|
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44
기간: 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.
|
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46
기간: 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.
|
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study
기간: 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.
|
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
|
Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2
기간: 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.
|
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 3
기간: 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.
|
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 4
기간: 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.
|
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 5
기간: 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.
|
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 6
기간: 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.
|
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 7
기간: 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.
|
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 8
기간: 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.
|
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 9
기간: 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.
|
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 10
기간: 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.
|
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 11
기간: 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.
|
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 12
기간: 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.
|
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 13
기간: 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.
|
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 14
기간: 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.
|
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 15
기간: 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.
|
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 16
기간: 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.
|
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 17
기간: 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.
|
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 18
기간: 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.
|
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 20
기간: 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.
|
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 21
기간: 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.
|
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 22
기간: 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.
|
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 23
기간: 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.
|
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 24
기간: 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.
|
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 25
기간: 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.
|
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 26
기간: 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.
|
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 27
기간: 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.
|
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 28
기간: 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.
|
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 29
기간: 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.
|
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 30
기간: 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.
|
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 32
기간: 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.
|
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 36
기간: 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.
|
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 37
기간: 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.
|
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 39
기간: 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.
|
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 40
기간: 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.
|
Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 42
기간: 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.
|
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 44
기간: 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.
|
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at Cycle 46
기간: 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.
|
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
|
|
Change From Baseline in EQ-5D-VAS Score at End of Study
기간: 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.
|
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants Who Died Due to Any Cause
기간: Baseline up to death (overall approximately 5 years and 9 months)
|
Baseline up to death (overall approximately 5 years and 9 months)
|
|
|
Overall Survival
기간: 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.
|
Baseline up to death (overall approximately 5 years and 9 months)
|
|
Percentage of Participants With Disease Progression
기간: 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.
|
Baseline up to disease progression (overall approximately 5 years and 9 months)
|
|
Time to Disease Progression
기간: 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.
|
Baseline up to disease progression (overall approximately 5 years and 9 months)
|
|
Percentage of Participants By Karnofsky Performance Status Scale Scores
기간: 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.
|
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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
연구 시작
2010년 3월 1일
기본 완료 (실제)
기본 완료
2015년 12월 1일
연구 완료 (실제)
연구 완료
2015년 12월 1일
연구 등록 날짜
최초 제출
최초 제출
2010년 3월 16일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2010년 3월 25일
처음 게시됨 (추정)
처음 게시됨
2010년 3월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2018년 3월 22일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2017년 8월 25일
마지막으로 확인됨
마지막으로 확인됨
2017년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- ML22780
- 2009-014279-37
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .