ID

22728

Beskrivning

An Safety and Efficacy Study of Abiraterone Acetate in Participants With Advanced Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00474383

Länk

https://clinicaltrials.gov/show/NCT00474383

Nyckelord

Versioner (1)
  1. 2017-06-11 2017-06-11 -
Uppladdad den

11 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Neoplasms NCT00474383

Engelsk

Eligibility Prostate Neoplasms NCT00474383

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma (cancer that begins in cells that line certain internal organs and that have secretory properties) of the prostate, but not with neuroendocrine differentiation or of small cell histology
Beskrivning

Adenocarcinoma of prostate | Neuroendocrine Differentiation Absent | Adenocarcinoma of prostate Non-small cell

Datatyp

boolean

Alias
UMLS CUI [1]
C0007112
UMLS CUI [2,1]
C1709218
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0007112
UMLS CUI [3,2]
C0445128
before chemotherapy for prostate cancer with regimen(s) containing paclitaxel or docetaxel
Beskrivning

Chemotherapy Prostate carcinoma | Paclitaxel | docetaxel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0144576
UMLS CUI [3]
C0246415
documented prostate-specific antigen (psa) progression according to psa working group eligibility criteria with a psa greater than 5 nanogram per milliliter (ng/ml)
Beskrivning

PSA Progression | Prostate specific antigen measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C4054264
UMLS CUI [2]
C0201544
ongoing androgen deprivation with serum testosterone level of less than 50 nanogram per deciliter (ng/dl)
Beskrivning

Androgen suppression | Serum testosterone measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1515985
UMLS CUI [2]
C0428413
eastern cooperative oncology group (ecog) performance status of less than or equal to 2 (karnofsky performance status greater than or equal 50 percentage)
Beskrivning

ECOG performance status | Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
active or uncontrolled autoimmune disease that may require corticosteroid therapy
Beskrivning

Autoimmune Disease | Autoimmune Disease Uncontrolled | Steroid therapy Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C0686904
serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Beskrivning

Comorbidity Serious | Comorbidity Uncontrolled | Communicable Disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
uncontrolled hypertension
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease (participants with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years before to enrollment and after consultation with a cardiologist to insure that the disease is stable)
Beskrivning

Heart Disease | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Heart Disease New York Heart Association Classification | Atherosclerosis Requirement Coronary Artery Bypass Surgery | Peripheral artery bypass Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018799
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0004153
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0010055
UMLS CUI [7,1]
C3495795
UMLS CUI [7,2]
C0686904
history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication
Beskrivning

Gastrointestinal Diseases Interfere with Absorption Investigational New Drugs | Gastrointestinal Surgical Procedure Extensive Interferes with Absorption Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0524722
UMLS CUI [2,2]
C0205231
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0237442
UMLS CUI [2,5]
C0013230
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Similar models

Eligibility Prostate Neoplasms NCT00474383

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate | Neuroendocrine Differentiation Absent | Adenocarcinoma of prostate Non-small cell
Item
histologically or cytologically confirmed adenocarcinoma (cancer that begins in cells that line certain internal organs and that have secretory properties) of the prostate, but not with neuroendocrine differentiation or of small cell histology
boolean
C0007112 (UMLS CUI [1])
C1709218 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0007112 (UMLS CUI [3,1])
C0445128 (UMLS CUI [3,2])
Chemotherapy Prostate carcinoma | Paclitaxel | docetaxel
Item
before chemotherapy for prostate cancer with regimen(s) containing paclitaxel or docetaxel
boolean
C0392920 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0144576 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
PSA Progression | Prostate specific antigen measurement
Item
documented prostate-specific antigen (psa) progression according to psa working group eligibility criteria with a psa greater than 5 nanogram per milliliter (ng/ml)
boolean
C4054264 (UMLS CUI [1])
C0201544 (UMLS CUI [2])
Androgen suppression | Serum testosterone measurement
Item
ongoing androgen deprivation with serum testosterone level of less than 50 nanogram per deciliter (ng/dl)
boolean
C1515985 (UMLS CUI [1])
C0428413 (UMLS CUI [2])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group (ecog) performance status of less than or equal to 2 (karnofsky performance status greater than or equal 50 percentage)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease | Autoimmune Disease Uncontrolled | Steroid therapy Patient need for
Item
active or uncontrolled autoimmune disease that may require corticosteroid therapy
boolean
C0004364 (UMLS CUI [1])
C0004364 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Comorbidity Serious | Comorbidity Uncontrolled | Communicable Disease Uncontrolled
Item
serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Heart Disease | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Heart Disease New York Heart Association Classification | Atherosclerosis Requirement Coronary Artery Bypass Surgery | Peripheral artery bypass Patient need for
Item
clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease (participants with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years before to enrollment and after consultation with a cardiologist to insure that the disease is stable)
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0018799 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0004153 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0010055 (UMLS CUI [6,3])
C3495795 (UMLS CUI [7,1])
C0686904 (UMLS CUI [7,2])
Gastrointestinal Diseases Interfere with Absorption Investigational New Drugs | Gastrointestinal Surgical Procedure Extensive Interferes with Absorption Investigational New Drugs
Item
history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0524722 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0237442 (UMLS CUI [2,4])
C0013230 (UMLS CUI [2,5])
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