A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (BATMAN)
25 de agosto de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
49
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bangor, Reino Unido, LL57 2PD
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Cottingham, Reino Unido, HU16 5JG
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Exeter, Reino Unido, EX2 5DW
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Grimsby, Reino Unido, DN33 2BA
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Harrogate, Reino Unido, HG2 8AY
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Plymouth, Reino Unido, PL6 8DH
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Portsmouth, Reino Unido, PO6 3LY
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Preston, Reino Unido, PR2 9HT
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Somerset, Reino Unido, TA1 5DA
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Wolverhampton, Reino Unido, WV10 0QP
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Otros nombres:
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.
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Experimental: 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.
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Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
Otros nombres:
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
Periodo de tiempo: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 3
Periodo de tiempo: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 4
Periodo de tiempo: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 5
Periodo de tiempo: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 6
Periodo de tiempo: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 7
Periodo de tiempo: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 8
Periodo de tiempo: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score At Cycle 9
Periodo de tiempo: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 10
Periodo de tiempo: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 11
Periodo de tiempo: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 12
Periodo de tiempo: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 13
Periodo de tiempo: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 14
Periodo de tiempo: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 15
Periodo de tiempo: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 16
Periodo de tiempo: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 17
Periodo de tiempo: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 18
Periodo de tiempo: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 20
Periodo de tiempo: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 21
Periodo de tiempo: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 22
Periodo de tiempo: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 23
Periodo de tiempo: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 24
Periodo de tiempo: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 25
Periodo de tiempo: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 26
Periodo de tiempo: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 27
Periodo de tiempo: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 28
Periodo de tiempo: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 29
Periodo de tiempo: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 30
Periodo de tiempo: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 32
Periodo de tiempo: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 36
Periodo de tiempo: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 37
Periodo de tiempo: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 39
Periodo de tiempo: 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.
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Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 42
Periodo de tiempo: 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.
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Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 44
Periodo de tiempo: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 46
Periodo de tiempo: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at End of Study
Periodo de tiempo: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
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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.
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Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
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Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
Periodo de tiempo: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3
Periodo de tiempo: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4
Periodo de tiempo: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5
Periodo de tiempo: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6
Periodo de tiempo: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7
Periodo de tiempo: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8
Periodo de tiempo: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9
Periodo de tiempo: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10
Periodo de tiempo: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11
Periodo de tiempo: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12
Periodo de tiempo: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13
Periodo de tiempo: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14
Periodo de tiempo: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15
Periodo de tiempo: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16
Periodo de tiempo: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17
Periodo de tiempo: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18
Periodo de tiempo: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20
Periodo de tiempo: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21
Periodo de tiempo: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22
Periodo de tiempo: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23
Periodo de tiempo: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24
Periodo de tiempo: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25
Periodo de tiempo: 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.
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Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
|
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26
Periodo de tiempo: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
|
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27
Periodo de tiempo: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28
Periodo de tiempo: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
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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)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29
Periodo de tiempo: 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.
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Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30
Periodo de tiempo: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
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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.
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Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32
Periodo de tiempo: 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.
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Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
|
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
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Change From Baseline in EQ-5D-VAS Score at Cycle 5
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Who Died Due to Any Cause
Periodo de tiempo: Baseline up to death (overall approximately 5 years and 9 months)
|
Baseline up to death (overall approximately 5 years and 9 months)
|
|
|
Overall Survival
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2010
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
16 de marzo de 2010
Primero enviado que cumplió con los criterios de control de calidad
25 de marzo de 2010
Publicado por primera vez (Estimar)
26 de marzo de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
25 de agosto de 2017
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de la piel
- Neoplasias
- Neoplasias por sitio
- Enfermedades de los senos
- Neoplasias de mama
- Neoplasias mamarias triple negativas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Docetaxel
- Paclitaxel
- Bevacizumab
Otros números de identificación del estudio
- ML22780
- 2009-014279-37
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .