ID

21860

Beskrivning

Salvage Therapy With Bevacizumab Plus Docetaxel and Cisplatin for Taiwanese Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01025349

Länk

https://clinicaltrials.gov/show/NCT01025349

Nyckelord

Versioner (1)
  1. 2017-05-04 2017-05-04 -
Uppladdad den

4 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT01025349

Engelsk

Eligibility Metastatic Breast Cancer NCT01025349

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
eastern cooperative oncology group (ecog) performance status (ps) 0-2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
normal left ventricular ejection fraction (lvef).
Beskrivning

Left ventricular ejection fraction Normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
age ≤ 65 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
at least one unidimensionally measurable lesion by imaging studies.
Beskrivning

Measurable Disease Linear Quantity Imaging study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1881134
ast/alt 2.5 uln (< 5 uln if liver metastases).
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0494165
serum bilirubin 3 uln, serum creatinine 1.5 uln.
Beskrivning

Serum total bilirubin measurement | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201976
urine dipstick of proteinuria <2+.
Beskrivning

Proteinuria Urine dipstick test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033687
UMLS CUI [1,2]
C0430370
women of childbearing potential must have a negative serum pregnancy test.
Beskrivning

Childbearing Potential Serum pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled hypertension (systolic blood pressure > 160 mm hg, diastolic blood pressure > 90 mm hg).
Beskrivning

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
prior exposure to bevacizumab.
Beskrivning

Bevacizumab Exposure to

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0796392
UMLS CUI [1,2]
C0332157
planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed), except bone metastasis.
Beskrivning

Therapeutic radiology procedure Planned Comorbidity | Prior radiation therapy Completed | Secondary malignant neoplasm of bone Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0153690
UMLS CUI [3,2]
C2828389
evidence of bleeding diathesis or coagulopathy.
Beskrivning

Bleeding tendency Evidence of | Blood Coagulation Disorder Evidence of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1458140
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0005779
UMLS CUI [2,2]
C0332120
clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure, serious cardiac arrhythmia requiring medication. stroke in the preceding six months.
Beskrivning

Cardiovascular Diseases | Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C1514873
UMLS CUI [6,4]
C0013227
evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of bevacizumab with chemotherapy.
Beskrivning

Disease Evidence of | Impaired metabolic functioning | Physical Examination | Laboratory Results | Medical contraindication Bevacizumab | Medical contraindication Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C4062541
UMLS CUI [3]
C0031809
UMLS CUI [4]
C1254595
UMLS CUI [5,1]
C1301624
UMLS CUI [5,2]
C0796392
UMLS CUI [6,1]
C1301624
UMLS CUI [6,2]
C0392920
ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
Beskrivning

Aspirin U/day | Pharmaceutical Preparations Predisposition Gastrointestinal ulceration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0220898
UMLS CUI [2,3]
C1963975
pregnancy (positive serum pregnancy test) and lactation. any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.
Beskrivning

Pregnancy Serum pregnancy test positive | Breast Feeding | Illness Serious Study Subject Participation Status Inappropriate | Illness Uncontrolled Study Subject Participation Status Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0430063
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205404
UMLS CUI [3,3]
C2348568
UMLS CUI [3,4]
C1548788
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C2348568
UMLS CUI [4,4]
C1548788
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Similar models

Eligibility Metastatic Breast Cancer NCT01025349

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status (ps) 0-2.
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction Normal
Item
normal left ventricular ejection fraction (lvef).
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Age
Item
age ≤ 65 years.
boolean
C0001779 (UMLS CUI [1])
Measurable Disease Linear Quantity Imaging study
Item
at least one unidimensionally measurable lesion by imaging studies.
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1881134 (UMLS CUI [1,4])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
ast/alt 2.5 uln (< 5 uln if liver metastases).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Serum total bilirubin measurement | Creatinine measurement, serum
Item
serum bilirubin 3 uln, serum creatinine 1.5 uln.
boolean
C1278039 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Proteinuria Urine dipstick test
Item
urine dipstick of proteinuria <2+.
boolean
C0033687 (UMLS CUI [1,1])
C0430370 (UMLS CUI [1,2])
Childbearing Potential Serum pregnancy test negative
Item
women of childbearing potential must have a negative serum pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (systolic blood pressure > 160 mm hg, diastolic blood pressure > 90 mm hg).
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Bevacizumab Exposure to
Item
prior exposure to bevacizumab.
boolean
C0796392 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Therapeutic radiology procedure Planned Comorbidity | Prior radiation therapy Completed | Secondary malignant neoplasm of bone Excluded
Item
planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed), except bone metastasis.
boolean
C1522449 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0153690 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
Bleeding tendency Evidence of | Blood Coagulation Disorder Evidence of
Item
evidence of bleeding diathesis or coagulopathy.
boolean
C1458140 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0005779 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Cardiovascular Diseases | Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations
Item
clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure, serious cardiac arrhythmia requiring medication. stroke in the preceding six months.
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0003811 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0013227 (UMLS CUI [6,4])
Disease Evidence of | Impaired metabolic functioning | Physical Examination | Laboratory Results | Medical contraindication Bevacizumab | Medical contraindication Chemotherapy
Item
evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of bevacizumab with chemotherapy.
boolean
C0012634 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C4062541 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C1254595 (UMLS CUI [4])
C1301624 (UMLS CUI [5,1])
C0796392 (UMLS CUI [5,2])
C1301624 (UMLS CUI [6,1])
C0392920 (UMLS CUI [6,2])
Aspirin U/day | Pharmaceutical Preparations Predisposition Gastrointestinal ulceration
Item
ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
boolean
C0004057 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0220898 (UMLS CUI [2,2])
C1963975 (UMLS CUI [2,3])
Pregnancy Serum pregnancy test positive | Breast Feeding | Illness Serious Study Subject Participation Status Inappropriate | Illness Uncontrolled Study Subject Participation Status Inappropriate
Item
pregnancy (positive serum pregnancy test) and lactation. any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.
boolean
C0032961 (UMLS CUI [1,1])
C0430063 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1548788 (UMLS CUI [3,4])
C0221423 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C1548788 (UMLS CUI [4,4])
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