ID
40268
Description
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00821054
Keywords
Versions (2)
- 3/26/20 3/26/20 - Christian Arras
- 3/26/20 3/26/20 - Christian Arras
Copyright Holder
GlaxoSmithKline
Uploaded on
March 26, 2020
DOI
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License
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
Vital Signs
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Date in time
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
only to be filled in at Visits Week 1 to 3
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
Description
only to be filled in at screening visit
Data type
float
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
only to be filled in at screening visit
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Systolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Similar models
Vital Signs
- StudyEvent: ODM
C3469597 (UMLS CUI [1,2])
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