ID

31674

Beskrivning

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT00638690

Länk

https://clinicaltrials.gov/show/NCT00638690

Nyckelord

Versioner (1)
  1. 2018-09-19 2018-09-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 september 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Prostatic Neoplasms NCT00638690

Engelsk

Eligibility Prostatic Neoplasms NCT00638690

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
metastatic castration-resistant prostate cancer progression after one or two prior cytotoxic chemotherapies
Beskrivning

Hormone refractory prostate cancer | Disease Progression metastatic | Status post Cytotoxic Chemotherapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C1328504
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0677881
UMLS CUI [3,3]
C1265611
at least one chemotherapy must have contained docetaxel
Beskrivning

Chemotherapy Quantity Containing Docetaxel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0246415
eastern cooperative oncology group (ecog) performance status <= 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
medical or surgical castration with testosterone < 50 ng/dl
Beskrivning

Medical Castration | Male Castration | Testosterone measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C1513054
UMLS CUI [2]
C0007347
UMLS CUI [3]
C0523912
adequate bone marrow, hepatic and renal function
Beskrivning

Bone Marrow function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
potassium >= 3.5 mmol/l
Beskrivning

Serum potassium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0302353
able to swallow the study drug whole as a tablet
Beskrivning

Able to swallow Investigational New Drug Tablet

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0039225
informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
more than two prior cytotoxic chemotherapy regimens
Beskrivning

Cytotoxic Chemotherapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
prior ketoconazole for prostate cancer
Beskrivning

Ketoconazole Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C0600139
prior abiraterone acetate or other cyp17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
Beskrivning

Abiraterone acetate | CYP17 Inhibitor | Investigational New Drugs Targeting Androgen Receptor | Relationship Therapeutic procedure Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2607886
UMLS CUI [2]
C3160096
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0034786
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0600139
uncontrolled hypertension
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
active or symptomatic viral hepatitis or chronic liver disease
Beskrivning

Viral hepatitis | Viral hepatitis Symptomatic | Chronic liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0042721
UMLS CUI [2,1]
C0042721
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0341439
history of pituitary or adrenal dysfunction
Beskrivning

Pituitary dysfunction | Dysfunction adrenal

Datatyp

boolean

Alias
UMLS CUI [1]
C0281947
UMLS CUI [2]
C0549609
clinically significant heart disease
Beskrivning

Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
other malignancy
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
known brain metastasis
Beskrivning

Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
gi disorder affecting absorption
Beskrivning

Gastrointestinal Disease Affecting Absorption

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0237442
not willing to use contraception
Beskrivning

Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
Tillbaka till toppen

Similar models

Eligibility Prostatic Neoplasms NCT00638690

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Hormone refractory prostate cancer | Disease Progression metastatic | Status post Cytotoxic Chemotherapy Quantity
Item
metastatic castration-resistant prostate cancer progression after one or two prior cytotoxic chemotherapies
boolean
C1328504 (UMLS CUI [1])
C0242656 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0677881 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Chemotherapy Quantity Containing Docetaxel
Item
at least one chemotherapy must have contained docetaxel
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0246415 (UMLS CUI [1,4])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status <= 2
boolean
C1520224 (UMLS CUI [1])
Medical Castration | Male Castration | Testosterone measurement
Item
medical or surgical castration with testosterone < 50 ng/dl
boolean
C1513054 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
C0523912 (UMLS CUI [3])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, hepatic and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Serum potassium measurement
Item
potassium >= 3.5 mmol/l
boolean
C0302353 (UMLS CUI [1])
Able to swallow Investigational New Drug Tablet
Item
able to swallow the study drug whole as a tablet
boolean
C2712086 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cytotoxic Chemotherapy Quantity
Item
more than two prior cytotoxic chemotherapy regimens
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Ketoconazole Prostate carcinoma
Item
prior ketoconazole for prostate cancer
boolean
C0022625 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Abiraterone acetate | CYP17 Inhibitor | Investigational New Drugs Targeting Androgen Receptor | Relationship Therapeutic procedure Prostate carcinoma
Item
prior abiraterone acetate or other cyp17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer
boolean
C2607886 (UMLS CUI [1])
C3160096 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0034786 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0600139 (UMLS CUI [4,3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Viral hepatitis | Viral hepatitis Symptomatic | Chronic liver disease
Item
active or symptomatic viral hepatitis or chronic liver disease
boolean
C0042721 (UMLS CUI [1])
C0042721 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0341439 (UMLS CUI [3])
Pituitary dysfunction | Dysfunction adrenal
Item
history of pituitary or adrenal dysfunction
boolean
C0281947 (UMLS CUI [1])
C0549609 (UMLS CUI [2])
Heart Disease
Item
clinically significant heart disease
boolean
C0018799 (UMLS CUI [1])
Cancer Other
Item
other malignancy
boolean
C1707251 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastasis
boolean
C0220650 (UMLS CUI [1])
Gastrointestinal Disease Affecting Absorption
Item
gi disorder affecting absorption
boolean
C0017178 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
Contraceptive methods Unwilling
Item
not willing to use contraception
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial