ID

15851

Beschreibung

Safety and Pharmacokinetics of ODM-204 in Patients With Metastatic Castration-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02344017

Link

https://clinicaltrials.gov/show/NCT02344017

Stichworte

  1. 16.06.16 16.06.16 -
Hochgeladen am

16. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Prostate Cancer NCT02344017

Eligibility Prostate Cancer NCT02344017

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent (ic) obtained.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
male aged ≥ 18 years.
Beschreibung

Gender | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically or cytologically confirmed adenocarcinoma of prostate.
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
ongoing gnrh agonist or antagonist therapy, or after bilateral orchiectomy.
Beschreibung

Gonadotropin Releasing Hormone Receptor Agonist Therapeutic procedure | Gonadotropin Releasing Hormone Antagonist Therapeutic procedure | Male Castration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2267073
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C3537040
UMLS CUI [2,2]
C0087111
UMLS CUI [3]
C0007347
progressive metastatic disease
Beschreibung

Metastatic Neoplasm Progressive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2939420
UMLS CUI [1,2]
C0205329
adequate bone marrow, hepatic, and renal function
Beschreibung

Bone Marrow physiological aspects | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
acceptable and regular bowel movements without any gi disorder or procedure which may interfere with absorption of study treatment
Beschreibung

Defecation Regular | Gastrointestinal Diseases | Absorption | Therapies, Investigational

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011135
UMLS CUI [1,2]
C0205272
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0021826
UMLS CUI [4]
C0949266
ability to swallow study treatments
Beschreibung

Able to swallow Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0013230
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of pituitary or adrenal dysfunction.
Beschreibung

pituitary dysfunction | Dysfunction adrenal

Datentyp

boolean

Alias
UMLS CUI [1]
C0281947
UMLS CUI [2]
C0549609
known brain metastases.
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
Beschreibung

Communicable Diseases | medical condition | Medical contraindication Prednisone | Medical contraindication Adrenal Cortex Hormones

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C1699700
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0032952
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0001617
uncontrolled hypertension
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
clinically significant heart disease
Beschreibung

Heart Disease Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
prolonged qtc interval
Beschreibung

Prolonged QTc interval

Datentyp

boolean

Alias
UMLS CUI [1]
C1560305

Ähnliche Modelle

Eligibility Prostate Cancer NCT02344017

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
written informed consent (ic) obtained.
boolean
C0021430 (UMLS CUI [1])
Gender | Age
Item
male aged ≥ 18 years.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate
Item
histologically or cytologically confirmed adenocarcinoma of prostate.
boolean
C0007112 (UMLS CUI [1])
Gonadotropin Releasing Hormone Receptor Agonist Therapeutic procedure | Gonadotropin Releasing Hormone Antagonist Therapeutic procedure | Male Castration
Item
ongoing gnrh agonist or antagonist therapy, or after bilateral orchiectomy.
boolean
C2267073 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3537040 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0007347 (UMLS CUI [3])
Metastatic Neoplasm Progressive
Item
progressive metastatic disease
boolean
C2939420 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
Bone Marrow physiological aspects | 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])
Defecation Regular | Gastrointestinal Diseases | Absorption | Therapies, Investigational
Item
acceptable and regular bowel movements without any gi disorder or procedure which may interfere with absorption of study treatment
boolean
C0011135 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2])
C0021826 (UMLS CUI [3])
C0949266 (UMLS CUI [4])
Able to swallow Investigational New Drugs
Item
ability to swallow study treatments
boolean
C2712086 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
pituitary dysfunction | Dysfunction adrenal
Item
history of pituitary or adrenal dysfunction.
boolean
C0281947 (UMLS CUI [1])
C0549609 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
known brain metastases.
boolean
C0220650 (UMLS CUI [1])
Communicable Diseases | medical condition | Medical contraindication Prednisone | Medical contraindication Adrenal Cortex Hormones
Item
active infection or other medical condition that would make prednisone (corticosteroid) contraindicated.
boolean
C0009450 (UMLS CUI [1])
C1699700 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0032952 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0001617 (UMLS CUI [4,2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Heart Disease Clinical Significance
Item
clinically significant heart disease
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Prolonged QTc interval
Item
prolonged qtc interval
boolean
C1560305 (UMLS CUI [1])

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