Information:
Fel:
ID
38096
Beskrivning
Lean Body Mass as a Determinant of Docetaxel Pharmacokinetics and Toxicity; ODM derived from: https://clinicaltrials.gov/show/NCT01621425
Länk
https://clinicaltrials.gov/show/NCT01621425
Nyckelord
Versioner (1)
- 2019-09-17 2019-09-17 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
17 september 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01621425
Eligibility Breast Cancer NCT01621425
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT01621425
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
subject is at least 18
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
subject is able and willing to sign the informed consent form prior to screening evaluations
boolean
C0021430 (UMLS CUI [1])
Gender | Breast Carcinoma | docetaxel | TAC Regimen | Secondary malignant neoplasm of prostate Castration Resistance | Other Coding
Item
female subject diagnosed with breast carcinoma and will receive docetaxel treatment according to standard hospital protocol (tac regimen) or male subject diagnosed with metastatic castration-resistant prostate carcinoma and will receive docetaxel treatment according to standard hospital protocol (prodoc regimen)
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
C1883257 (UMLS CUI [4])
C0347001 (UMLS CUI [5,1])
C4329620 (UMLS CUI [5,2])
C3846158 (UMLS CUI [6])
C0678222 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
C1883257 (UMLS CUI [4])
C0347001 (UMLS CUI [5,1])
C4329620 (UMLS CUI [5,2])
C3846158 (UMLS CUI [6])
Life Expectancy
Item
subject has a live expectancy of 12 weeks or greater
boolean
C0023671 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophile count (anc) > 1.5 x 10e9/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100 x 10e9/l
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤ 2 x uln
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin level < 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Docetaxel
Item
docetaxel treatment within the last year
boolean
C0246415 (UMLS CUI [1])
Liver Dysfunction Moderate | Liver Dysfunction Severe | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
moderate or severe liver impairment; [alat and/or asat ≥ 1.5 uln] and [af ≥ 2.5 uln]
boolean
C0086565 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
C0205081 (UMLS CUI [1,2])
C0086565 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0151905 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
Pharmacotherapy | Dietary Supplements | CYP3A4 Inhibitors | CYP3A4 Inducers
Item
current therapy with any drug, dietary supplements, or other compounds, or have been used in the last 2 weeks prior to the first docetaxel administration, known to inhibit or induce cyp3a4.
boolean
C0013216 (UMLS CUI [1])
C0242295 (UMLS CUI [2])
C3850053 (UMLS CUI [3])
C3850041 (UMLS CUI [4])
C0242295 (UMLS CUI [2])
C3850053 (UMLS CUI [3])
C3850041 (UMLS CUI [4])
Study Protocol Comprehension Unable
Item
inability to understand the nature and extent of the study and the procedures required
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])