ID
40269
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 data entry for the electrocardiogram surveys. It has to be filled in once for Screening, Visit day-1, and week 1-3. 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. Repeat measurements as often as necessary in logs and repeats.
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
ECG
- StudyEvent: ODM
Description
ECG
Alias
- UMLS CUI-1
- C1623258
Description
Date and Time of ECG
Data type
text
Alias
- UMLS CUI [1]
- C2826846
Description
Heart rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
PR Intervall
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS complex duration
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT intervall
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C4072785
Description
not required/read-only
Data type
text
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1882512
Description
not required/read-only
Data type
text
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1882513
Description
Complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE
Data type
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1274040
Similar models
ECG
- StudyEvent: ODM
C4072785 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])