A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (BATMAN)
25 agosto 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
49
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Bangor, Regno Unito, LL57 2PD
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Cottingham, Regno Unito, HU16 5JG
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Exeter, Regno Unito, EX2 5DW
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Grimsby, Regno Unito, DN33 2BA
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Harrogate, Regno Unito, HG2 8AY
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Plymouth, Regno Unito, PL6 8DH
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Portsmouth, Regno Unito, PO6 3LY
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Preston, Regno Unito, PR2 9HT
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Somerset, Regno Unito, TA1 5DA
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Wolverhampton, Regno Unito, WV10 0QP
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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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Sperimentale: 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.
Altri nomi:
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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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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
Lasso di tempo: 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
Lasso di tempo: 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.
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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
Lasso di tempo: 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)
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Change From Baseline in FACT-B Score at Cycle 17
Lasso di tempo: 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)
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Change From Baseline in FACT-B Score at Cycle 18
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 26
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 30
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
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Change From Baseline in FACT-B Score at Cycle 37
Lasso di tempo: 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)
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Change From Baseline in FACT-B Score at Cycle 39
Lasso di tempo: 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)
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Change From Baseline in FACT-B Score at Cycle 42
Lasso di tempo: 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)
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Change From Baseline in FACT-B Score at Cycle 44
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, Cycle 25 (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 25 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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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
Lasso di tempo: Baseline, Cycle 29 (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 29 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30
Lasso di tempo: 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
Lasso di tempo: Baseline, Cycle 32 (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 32 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36
Lasso di tempo: Baseline, Cycle 36 (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 36 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37
Lasso di tempo: Baseline, Cycle 37 (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 37 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39
Lasso di tempo: Baseline, Cycle 39 (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 39 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40
Lasso di tempo: Baseline, Cycle 40 (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 40 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42
Lasso di tempo: Baseline, Cycle 42 (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 42 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44
Lasso di tempo: Baseline, Cycle 44 (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 44 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46
Lasso di tempo: Baseline, Cycle 46 (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 46 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study
Lasso di tempo: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
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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, 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 EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2
Lasso di tempo: 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 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.
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Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D-VAS Score at Cycle 3
Lasso di tempo: 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 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.
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Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D-VAS Score at Cycle 4
Lasso di tempo: 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 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.
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Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
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Change From Baseline in EQ-5D-VAS Score at Cycle 5
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Who Died Due to Any Cause
Lasso di tempo: Baseline up to death (overall approximately 5 years and 9 months)
|
Baseline up to death (overall approximately 5 years and 9 months)
|
|
|
Overall Survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2010
Completamento primario (Effettivo)
1 dicembre 2015
Completamento dello studio (Effettivo)
1 dicembre 2015
Date di iscrizione allo studio
Primo inviato
16 marzo 2010
Primo inviato che soddisfa i criteri di controllo qualità
25 marzo 2010
Primo Inserito (Stima)
26 marzo 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 marzo 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 agosto 2017
Ultimo verificato
1 agosto 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie della pelle
- Neoplasie
- Neoplasie per sede
- Malattie del seno
- Neoplasie mammarie
- Neoplasie mammarie triplo negativo
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Docetaxel
- Paclitaxel
- Bevacizumab
Altri numeri di identificazione dello studio
- ML22780
- 2009-014279-37
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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