ID

31667

Beskrivning

An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001; ODM derived from: https://clinicaltrials.gov/show/NCT01664728

Länk

https://clinicaltrials.gov/show/NCT01664728

Nyckelord

Versioner (1)
  1. 2018-09-18 2018-09-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 september 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Neoplasms NCT01664728

Engelsk

Eligibility Prostate Neoplasms NCT01664728

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
completed 12 cycles of abiraterone acetate under study cou-aa-001
Beskrivning

Abiraterone acetate Course Quantity Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2607886
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0205197
last dose of abiraterone acetate within 14 days prior to treatment in this study
Beskrivning

Abiraterone acetate Dose Last Recently

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2607886
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C0332185
demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment
Beskrivning

Abiraterone acetate | Benefit Due to Therapeutic procedure Continuous

Datatyp

boolean

Alias
UMLS CUI [1]
C2607886
UMLS CUI [2,1]
C0814225
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C0549178
serum potassium level >=3.5 mmol/l
Beskrivning

Serum potassium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0302353
eastern cooperative oncology group performance status of <3 (karnofsky performance status >=30%)
Beskrivning

ECOG performance status | Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
agrees to protocol-defined use of effective contraception
Beskrivning

Contraceptive methods Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Beskrivning

Comorbidity Serious | Comorbidity Uncontrolled | Exception Malignant Neoplasms | 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]
C1705847
UMLS CUI [3,2]
C0006826
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
uncontrolled hypertension
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
abnormal liver function
Beskrivning

Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
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 (patients 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 prior to enrollment and after consultation with a cardiologist to insure that the disease is stable)
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
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]
C0004153
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C3495795
condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Beskrivning

Condition At risk Patient safety | Condition Interferes with Research results | Condition Interferes with Study Subject Participation Status | Social situation At risk Patient safety | Social situation Interferes with Research results | Social situation Interferes with Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C1113679
UMLS CUI [5,1]
C0748872
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0683954
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
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Similar models

Eligibility Prostate Neoplasms NCT01664728

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Abiraterone acetate Course Quantity Completed
Item
completed 12 cycles of abiraterone acetate under study cou-aa-001
boolean
C2607886 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Abiraterone acetate Dose Last Recently
Item
last dose of abiraterone acetate within 14 days prior to treatment in this study
boolean
C2607886 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
Abiraterone acetate | Benefit Due to Therapeutic procedure Continuous
Item
demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment
boolean
C2607886 (UMLS CUI [1])
C0814225 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C0549178 (UMLS CUI [2,4])
Serum potassium measurement
Item
serum potassium level >=3.5 mmol/l
boolean
C0302353 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group performance status of <3 (karnofsky performance status >=30%)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Contraceptive methods Study Protocol
Item
agrees to protocol-defined use of effective contraception
boolean
C0700589 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Comorbidity Serious | Comorbidity Uncontrolled | Exception Malignant Neoplasms | 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])
C1705847 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Liver Dysfunction
Item
abnormal liver function
boolean
C0086565 (UMLS CUI [1])
Heart Disease Significant | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Heart Disease New York Heart Association Classification | Atherosclerosis Requirement Coronary Artery Bypass Surgery | Atherosclerosis Requirement Peripheral artery bypass
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 (patients 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 prior to enrollment and after consultation with a cardiologist to insure that the disease is stable)
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
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])
C0004153 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C3495795 (UMLS CUI [7,3])
Condition At risk Patient safety | Condition Interferes with Research results | Condition Interferes with Study Subject Participation Status | Social situation At risk Patient safety | Social situation Interferes with Research results | Social situation Interferes with Study Subject Participation Status
Item
condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
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