ID
40139
Beschreibung
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
Stichworte
Versionen (1)
- 16.03.20 16.03.20 - Christian Arras
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
16. März 2020
DOI
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Lizenz
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
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
child-bearing potential
Datentyp
integer
Alias
- UMLS CUI [1]
- C3831118
Beschreibung
Ethnicity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Geographic ancestry
Alias
- UMLS CUI-1
- C3841890
Beschreibung
African American/African Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Beschreibung
American Indian or Alaskan Native
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1515945
Beschreibung
Asian - Central/South Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Beschreibung
Asian - East Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C4540996
Beschreibung
Asian - Japanese Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1556094
Beschreibung
Asian - South East Asian Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238697
Beschreibung
Native Hawaiian or Other Pacific Islander
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1513907
Beschreibung
White - Arabic/North African Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Beschreibung
White - White/Caucasian/European Heritage
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0043157
Beschreibung
Randomisation Number
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschreibung
Ability to randomization
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0085732
Beschreibung
Randomisation number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
Date of randomisation
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beschreibung
Regimen
Alias
- UMLS CUI-1
- C1276413
Ähnliche Modelle
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])