Informações:
Falhas:
ID
18376
Descrição
Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00359190
Link
https://clinicaltrials.gov/show/NCT00359190
Palavras-chave
Versões (1)
- 02/11/2016 02/11/2016 -
Transferido a
2 de novembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Neoplasms, Breast NCT00359190
Eligibility Neoplasms, Breast NCT00359190
- StudyEvent: Eligibility
Similar models
Eligibility Neoplasms, Breast NCT00359190
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Laboratory Results Acceptable
Item
clinical labs are within acceptable ranges.
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,2])
Therapy naive Breast Carcinoma | Tumor size | Biopsy
Item
a histologically confirmed, treatment-naive, breast tumor measuring 1 cm or greater that can be readily biopsied.
boolean
C0919936 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2])
C0005558 (UMLS CUI [3])
C0678222 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2])
C0005558 (UMLS CUI [3])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Gender | Inclusion criteria Study Protocol
Item
females must meet certain criteria specified in protocol.
boolean
C0079399 (UMLS CUI [1])
C1512693 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Able to swallow oral medication | oral medication Retain Ability
Item
ability to swallow and retain oral medication.
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C0175795 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Follow directions Ability
Item
ability to follow and understand directions.
boolean
C1720622 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
female who is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Medically unfit | patient interview | Physical Examination
Item
medically unfit by the doctor as a result of the medical interview or physicals.
boolean
C3841806 (UMLS CUI [1])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0683518 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Investigational New Drugs
Item
received treatment of an investigational drug within 4 weeks of study start.
boolean
C0013230 (UMLS CUI [1])
Illicit drug use Study Protocol
Item
currently receiving treatment with prohibited meds listed in protocol.
boolean
C0281875 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
major surgery
Item
had major surgery in previous 2 weeks.
boolean
C0679637 (UMLS CUI [1])
History of radiation therapy to chest Breast Carcinoma
Item
had prior radiation therapy to the chest to treat this incidence of breast cancer.
boolean
C4038799 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,2])
Hypersensitivity Pharmaceutical Preparations Related Investigational New Drugs | Idiosyncrasy Pharmaceutical Preparations Related Investigational New Drugs
Item
hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study med.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0231191 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0013227 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0231191 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Malabsorption Syndrome
Item
has a malabsorption syndrome.
boolean
C0024523 (UMLS CUI [1])