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ID
18329
Beschreibung
Rollover Study Of Lapatinib In Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00169533
Link
https://clinicaltrials.gov/show/NCT00169533
Stichworte
Versionen (2)
- 31.10.16 31.10.16 -
- 02.11.16 02.11.16 -
Hochgeladen am
31. Oktober 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Eligibility Neoplasms, Breast NCT00169533
Eligibility Neoplasms, Breast NCT00169533
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Neoplasms, Breast NCT00169533
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
lapatinib Clinical Trial participation | Therapeutic procedure | Combined Modality Therapy | Tumor status In complete remission | Tumor status partial response | Tumor status Stable Disease
Item
currently receiving clinical benefit as defined by cr, pr or sd from treatment with lapatinib through participation in a phase i study of lapatinib either as monotherapy or as part of a combination regimen.
boolean
C1506770 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0475752 (UMLS CUI [4,1])
C0677874 (UMLS CUI [4,2])
C0475752 (UMLS CUI [5,1])
C1521726 (UMLS CUI [5,2])
C0475752 (UMLS CUI [6,1])
C0677946 (UMLS CUI [6,2])
C0008976 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0475752 (UMLS CUI [4,1])
C0677874 (UMLS CUI [4,2])
C0475752 (UMLS CUI [5,1])
C1521726 (UMLS CUI [5,2])
C0475752 (UMLS CUI [6,1])
C0677946 (UMLS CUI [6,2])
Informed Consent
Item
ability to understand and provide written informed consent to participate in this trial.
boolean
C0021430 (UMLS CUI [1])
Gender
Item
is male or female.
boolean
C0079399 (UMLS CUI [1])
Gender | Contraceptive methods agreement
Item
female and male subjects agree to the protocol specific birth control measures
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0680240 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,1])
C0680240 (UMLS CUI [2,2])
lapatinib Discontinued Permanent | intolerance to lapatinib | lapatinib treatment failure
Item
permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.
boolean
C1506770 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C1506770 (UMLS CUI [2,2])
C1506770 (UMLS CUI [3,1])
C0162643 (UMLS CUI [3,2])
C1444662 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C1506770 (UMLS CUI [2,2])
C1506770 (UMLS CUI [3,1])
C0162643 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
is a pregnant or lactating female.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Medically unfit Related Clinical Trial | patient interview | Physical Examination | Screening procedure
Item
is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.
boolean
C3841806 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0220908 (UMLS CUI [4])
C0439849 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0220908 (UMLS CUI [4])
Illicit drug use
Item
currently receiving treatment with any medications listed on the prohibited medication list (see section 7.2).
boolean
C0281875 (UMLS CUI [1])
Heart failure | New York Heart Association Classification
Item
has class iii or iv heart failure as defined by the new york heart association (nyha) functional classification system.
boolean
C0018801 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C1275491 (UMLS CUI [2])
Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography
Item
has a left ventricular ejection fraction (lvef) < 40% based on muga or echo.
boolean
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
C0521317 (UMLS CUI [2])
C0013516 (UMLS CUI [3])