ID

40271

Beschrijving

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 echocardiogram or multigated acquisition. It has to be filled in once for the Screening visit. Repeat measurements as often as necessary in logs and repeats.

Link

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

Trefwoorden

Versies (2)
  1. 26-03-20 26-03-20 - Christian Arras
  2. 26-03-20 26-03-20 - Christian Arras
Houder van rechten

GlaxoSmithKline

Geüploaded op

26 maart 2020

DOI

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Licentie

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

Engels

Echocardiogram or multigated acquisition

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschrijving

Date of Visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit type
Beschrijving

Visit type

Datatype

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Echocardiogram or Multigated Acquisition (ECHO/MUGA)
Beschrijving

Echocardiogram or Multigated Acquisition (ECHO/MUGA)

Alias
UMLS CUI-1
C0013516
UMLS CUI-2
C0521317
Date and Time of scan
Beschrijving

Date and Time of scan

Datatype

partialDatetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013516
Name of Institution that performed the scan
Beschrijving

Name of Institution that performed the scan

Datatype

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0441633
Scan Type
Beschrijving

Scan Type

Datatype

integer

Alias
UMLS CUI [1]
C0449523
Ejection fraction range lower limit
Beschrijving

Ejection fraction range lower limit

Datatype

text

Alias
UMLS CUI [1,1]
C2700378
UMLS CUI [1,2]
C1518030
Left ventricula ejection fraction (LVEF)
Beschrijving

LVEF

Datatype

text

Alias
UMLS CUI [1]
C0428772
Result of Scan
Beschrijving

Result of Scan

Datatype

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0013516
Please specify not clinically significant abnormalities:
Beschrijving

Specify not clinically significant abnormalities

Datatype

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C1273937
UMLS CUI [1,4]
C1521902
Please specify clinically significant abnormalities
Beschrijving

Specify clinically significant abnormalities

Datatype

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [1,3]
C1521902
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Similar models

Echocardiogram or multigated acquisition

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Screen (Screen)
CL Item
Logs/Repeats (Logs/Rpts)
Item Group
Echocardiogram or Multigated Acquisition (ECHO/MUGA)
C0013516 (UMLS CUI-1)
C0521317 (UMLS CUI-2)
Date and Time of scan
Item
Date and Time of scan
partialDatetime
C0011008 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Name of Institution that performed the scan
Item
Name of Institution that performed the scan
text
C1301943 (UMLS CUI [1,1])
C0441633 (UMLS CUI [1,2])
Item
Scan Type
integer
C0449523 (UMLS CUI [1])
Scan Type
Code List
Scan Type
CL Item
MUGA (1)
CL Item
ECHO (2)
Ejection fraction range lower limit
Item
Ejection fraction range lower limit
text
C2700378 (UMLS CUI [1,1])
C1518030 (UMLS CUI [1,2])
LVEF
Item
Left ventricula ejection fraction (LVEF)
text
C0428772 (UMLS CUI [1])
Item
Result of Scan
text
C1274040 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Result of Scan
Code List
Result of Scan
CL Item
Normal (1)
CL Item
Abnormal, not Clinically Significant, Specify details (3)
CL Item
Abnormal, Clinically Significant, Specify details  (4)
Specify not clinically significant abnormalities
Item
Please specify not clinically significant abnormalities:
text
C1704258 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1273937 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Specify clinically significant abnormalities
Item
Please specify clinically significant abnormalities
text
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Terug naar het begin van de pagina 

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