ID

42693

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 logs and repeats.

Länk

https://clinicaltrials.gov/ct2/show/NCT00821054

Nyckelord

Versioner (2)
  1. 2020-07-04 2020-07-04 - Christian Arras
  2. 2021-09-17 2021-09-17 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

17 september 2021

DOI

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Licens

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

Engelsk

Logs and Repeats

1 Formulär  
  1. StudyEvent: ODM
    1. Logs and Repeats
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Beskrivning

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Beskrivning

Date is the start of the study for this subject.

Datatyp

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Adverse Event/concomitant medication/repeat assessment check question
Beskrivning

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
Are there any IP diary data to be entered for this subject?
Beskrivning

investigational product/experimental drug diary

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0376660
Did the subject experience any non-serious adverse events during the study?
Beskrivning

non-serious adverse Event during study

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Did the subject experience any serious adverse events during the study?
Beskrivning

serious adverse events during study

Datatyp

text

Alias
UMLS CUI [1,1]
C0347984
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C1519255
Were any concomitant medications taken by the subject during the study?
Beskrivning

concomitant medications during the study

Datatyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Were any repeat vital signs recorded?
Beskrivning

repeat vital signs

Datatyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0205341
Were any repeat ECGs performed?
Beskrivning

repeat ECG performed

Datatyp

text

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C2826672
Were any repeat ECG measurements abnormal - clinically signifcant?
Beskrivning

repeat ECG abnormal, clinically significant

Datatyp

text

Alias
UMLS CUI [1,1]
C0205341
UMLS CUI [1,2]
C0522055
UMLS CUI [1,3]
C2985739
Were any repeat ECOG assessments performed?
Beskrivning

repeat ECOG performance status

Datatyp

text

Alias
UMLS CUI [1,1]
C1520224
UMLS CUI [1,2]
C0205341
Were any repeat echocardiogram or multigated acquisition results recorded?
Beskrivning

repeat echocardiogram or multigated acquisition

Datatyp

text

Alias
UMLS CUI [1,1]
C0013516
UMLS CUI [1,2]
C0205341
UMLS CUI [2,1]
C0521317
UMLS CUI [2,2]
C0205341
Were any repeat Chemistry Lab samples taken?
Beskrivning

repeat chemistry laboratory samples

Datatyp

text

Alias
UMLS CUI [1,1]
C0151339
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0370003
Were any repeat Haematology Lab samples taken?
Beskrivning

repeat Haematologic lab samples taken

Datatyp

text

Alias
UMLS CUI [1,1]
C0475367
UMLS CUI [1,2]
C0205341
Were any repeat PK blood samples taken?
Beskrivning

repeat pharmacokinetic blood samples taken

Datatyp

text

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0205341
UMLS CUI [1,3]
C0031328
Were there any liver events for this subject?
Beskrivning

liver events

Datatyp

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
Were any lapatinib doses taken after the Week 3 Date/Date of Decision to Withdraw and prior to the start of dosing in the EGF111767 study?
Beskrivning

lapatinib dose taken after treatment period, withdraw, before start of dosing in the study

Datatyp

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
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Similar models

Logs and Repeats

1 Formulär
  1. StudyEvent: ODM
    1. Logs and Repeats
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Adverse Event/concomitant medication/repeat assessment check question
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
Item
Are there any IP diary data to be entered for this subject?
text
C0304229 (UMLS CUI [1,1])
C0376660 (UMLS CUI [1,2])
Are there any IP diary data to be entered for this subject?
Code List
Are there any IP diary data to be entered for this subject?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any non-serious adverse events during the study?
text
C1518404 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
non-serious adverse Event during study
Code List
Did the subject experience any non-serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject experience any serious adverse events during the study?
text
C0347984 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
serious adverse events during study
Code List
Did the subject experience any serious adverse events during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any concomitant medications taken by the subject during the study?
text
C2347852 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
concomitant medications during the study
Code List
Were any concomitant medications taken by the subject during the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat vital signs recorded?
text
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
repeat vital signs
Code List
Were any repeat vital signs recorded?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat ECGs performed?
text
C0205341 (UMLS CUI [1,1])
C2826672 (UMLS CUI [1,2])
ECG performed
Code List
Were any repeat ECGs performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat ECG measurements abnormal - clinically signifcant?
text
C0205341 (UMLS CUI [1,1])
C0522055 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
repeat ECG abnormal, clinically significant
Code List
Were any repeat ECG measurements abnormal - clinically signifcant?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat ECOG assessments performed?
text
C1520224 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat ECOG assessments performed?
Code List
Were any repeat ECOG assessments performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat echocardiogram or multigated acquisition results recorded?
text
C0013516 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0521317 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
repeat echocardiogram or multigated acquisition
Code List
Were any repeat echocardiogram or multigated acquisition results recorded?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat Chemistry Lab samples taken?
text
C0151339 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
repeat Clinical Chemistry Laboratory procedure
Code List
Were any repeat Chemistry Lab samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat Haematology Lab samples taken?
text
C0475367 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
repeat Haematologic test
Code List
Were any repeat Haematology Lab samples taken?
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any repeat PK blood samples taken?
text
C1277698 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
repeat pharmacokinetic blood samples
Code List
Were any repeat PK blood samples taken?
CL Item
Yes (Y)
CL Item
No (N)
liver events
Item
Were there any liver events for this subject?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Were any lapatinib doses taken after the Week 3 Date/Date of Decision to Withdraw and prior to the start of dosing in the EGF111767 study?
text
C1506770 (UMLS CUI [1,1])
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])
lapatinib dose taken after week three date of visit, withdraw, before start of dosing in the study
Code List
Were any lapatinib doses taken after the Week 3 Date/Date of Decision to Withdraw and prior to the start of dosing in the EGF111767 study?
CL Item
Yes (Y)
CL Item
No (N)
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