ID
42693
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 logs and repeats.
Link
https://clinicaltrials.gov/ct2/show/NCT00821054
Keywords
Versions (2)
- 7/4/20 7/4/20 - Christian Arras
- 9/17/21 9/17/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 17, 2021
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
Logs and Repeats
- StudyEvent: ODM
Description
Date of Visit/Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Description
Adverse Event/concomitant medication/repeat assessment check question
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0205341
- UMLS CUI-4
- C0220825
Description
investigational product/experimental drug diary
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0376660
Description
non-serious adverse Event during study
Data type
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
serious adverse events during study
Data type
text
Alias
- UMLS CUI [1,1]
- C0347984
- UMLS CUI [1,2]
- C0008976
- UMLS CUI [1,3]
- C1519255
Description
concomitant medications during the study
Data type
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
repeat vital signs
Data type
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Description
repeat ECG performed
Data type
text
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C2826672
Description
repeat ECG abnormal, clinically significant
Data type
text
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0522055
- UMLS CUI [1,3]
- C2985739
Description
repeat ECOG performance status
Data type
text
Alias
- UMLS CUI [1,1]
- C1520224
- UMLS CUI [1,2]
- C0205341
Description
repeat echocardiogram or multigated acquisition
Data type
text
Alias
- UMLS CUI [1,1]
- C0013516
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [2,1]
- C0521317
- UMLS CUI [2,2]
- C0205341
Description
repeat chemistry laboratory samples
Data type
text
Alias
- UMLS CUI [1,1]
- C0151339
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0370003
Description
repeat Haematologic lab samples taken
Data type
text
Alias
- UMLS CUI [1,1]
- C0475367
- UMLS CUI [1,2]
- C0205341
Description
repeat pharmacokinetic blood samples taken
Data type
text
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0205341
- UMLS CUI [1,3]
- C0031328
Description
liver events
Data type
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
Description
lapatinib dose taken after treatment period, withdraw, before start of dosing in the study
Data type
text
Alias
- UMLS CUI [1,1]
- C1506770
- UMLS CUI [1,2]
- C2347804
- UMLS CUI [1,3]
- C1548614
- UMLS CUI [1,4]
- C0087111
- UMLS CUI [2,1]
- C1506770
- UMLS CUI [2,2]
- C1548614
- UMLS CUI [2,3]
- C2349954
- UMLS CUI [3,1]
- C1506770
- UMLS CUI [3,2]
- C0087111
- UMLS CUI [3,3]
- C0332152
- UMLS CUI [3,4]
- C2347804
Similar models
Logs and Repeats
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [2])
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0376660 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C2826672 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C0205341 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C1548614 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C1506770 (UMLS CUI [2,1])
C1548614 (UMLS CUI [2,2])
C2349954 (UMLS CUI [2,3])
C1506770 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
C2347804 (UMLS CUI [3,4])