ID
40268
Beskrivning
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 contains the survey of the vital signs once at the screening, study visit at day-1, weeks 1-3 and the follow-up visit and if required as often as needed for logs/repeats. Week 3 assessments can be used as Follow-up assessments for subjects who have completed the 24 hour PK blood draw at the Week 3 visit and are proceeding into the continuing study EGF111767. If this applies, do NOT reenter the same data twice; leave a form comment instead.
Länk
https://clinicaltrials.gov/ct2/show/NCT00821054
Nyckelord
Versioner (2)
- 2020-03-26 2020-03-26 - Christian Arras
- 2020-03-26 2020-03-26 - Christian Arras
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
26 mars 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054
Vital Signs
- StudyEvent: ODM
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Date in time
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
only to be filled in at Visits Week 1 to 3
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
Beskrivning
only to be filled in at screening visit
Datatyp
float
Måttenheter
- cm
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
only to be filled in at screening visit
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Systolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- bpm
Alias
- UMLS CUI [1]
- C0018810
Similar models
Vital Signs
- StudyEvent: ODM
C3469597 (UMLS CUI [1,2])