Informatie:
Fout:
ID
15851
Beschrijving
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
Trefwoorden
Versies (1)
- 16-06-16 16-06-16 -
Geüploaded op
16 juni 2016
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Eligibility Prostate Cancer NCT02344017
Eligibility Prostate Cancer NCT02344017
- StudyEvent: Eligibility
Similar models
Eligibility Prostate Cancer NCT02344017
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
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])
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])
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])
C0013230 (UMLS CUI [1,2])
pituitary dysfunction | Dysfunction adrenal
Item
history of pituitary or adrenal dysfunction.
boolean
C0281947 (UMLS CUI [1])
C0549609 (UMLS CUI [2])
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])
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])
C2826293 (UMLS CUI [1,2])
Prolonged QTc interval
Item
prolonged qtc interval
boolean
C1560305 (UMLS CUI [1])