ID

40271

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 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.

Länk

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

Nyckelord

Versioner (2)
  1. 2020-03-26 2020-03-26 - Christian Arras
  2. 2020-03-26 2020-03-26 - Christian Arras
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 mars 2020

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

Echocardiogram or multigated acquisition

1 Formulär  
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
Visit type
Beskrivning

Visit type

Datatyp

text

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

Echocardiogram or Multigated Acquisition (ECHO/MUGA)

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

Date and Time of scan

Datatyp

partialDatetime

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

Name of Institution that performed the scan

Datatyp

text

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

Scan Type

Datatyp

integer

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

Ejection fraction range lower limit

Datatyp

text

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

LVEF

Datatyp

text

Alias
UMLS CUI [1]
C0428772
Result of Scan
Beskrivning

Result of Scan

Datatyp

text

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

Specify not clinically significant abnormalities

Datatyp

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
Beskrivning

Specify clinically significant abnormalities

Datatyp

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 Formulär
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
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])
Tillbaka till toppen 

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