ID
40139
Descripción
Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document is for documentation of demography, the randomization number and regimen at the screening visit.
Link
https://clinicaltrials.gov/ct2/show/NCT00821054
Palabras clave
Versiones (1)
- 16/3/20 16/3/20 - Christian Arras
Titular de derechos de autor
GlaxoSmithKline
Subido en
16 de marzo de 2020
DOI
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Licencia
Creative Commons BY-NC 4.0
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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054
Demography, Randomization, Regimen
- StudyEvent: ODM
Descripción
Demography
Alias
- UMLS CUI-1
- C0011298
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Sex
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
child-bearing potential
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3831118
Descripción
Ethnicity
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0015031
Descripción
Geographic ancestry
Alias
- UMLS CUI-1
- C3841890
Descripción
African American/African Heritage
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Descripción
American Indian or Alaskan Native
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1515945
Descripción
Asian - Central/South Asian Heritage
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Descripción
Asian - East Asian Heritage
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C4540996
Descripción
Asian - Japanese Heritage
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1556094
Descripción
Asian - South East Asian Heritage
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0238697
Descripción
Native Hawaiian or Other Pacific Islander
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1513907
Descripción
White - Arabic/North African Heritage
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Descripción
White - White/Caucasian/European Heritage
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0043157
Descripción
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Descripción
Ability to randomization
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
Descripción
Randomisation number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Descripción
Date of randomisation
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Descripción
Regimen
Alias
- UMLS CUI-1
- C1276413
Similar models
Demography, Randomization, Regimen
- StudyEvent: ODM
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [2])
C0085732 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])