ID

41228

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 information about the Meal. It has to be filled in once for each week 1, week 2 and week 3.

Link

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

Keywords

Versions (1)
  1. 7/20/20 7/20/20 - Christian Arras
Copyright Holder

GlaxoSmithKline

Uploaded on

July 20, 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

English

Meal

1 forms  
  1. StudyEvent: ODM
    1. Meal
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit type
Description

Visit type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Dosing date/time
Description

Dosing date/time

Alias
UMLS CUI-1
C0178602
UMLS CUI-2
C1264639
Dosing date/time
Description

read only/not required

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1264639
Last Meal on Day of Dosing at Clinic
Description

Last Meal on Day of Dosing at Clinic

Alias
UMLS CUI-1
C0578574
UMLS CUI-2
C0011008
UMLS CUI-3
C0178602
UMLS CUI-4
C0442592
Predose Meal Start Date and Time
Description

Must be at least 8 hours prior to dosing.

Data type

datetime

Alias
UMLS CUI [1,1]
C0578574
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0439565
Breakfast Meal on Day of Dosing at Clinic
Description

Breakfast Meal on Day of Dosing at Clinic

Alias
UMLS CUI-1
C2698559
UMLS CUI-2
C0439565
UMLS CUI-3
C0442592
Meal Start Date and Time
Description

Meal Beginning, Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C1998602
Meal type
Description

Meal type

Data type

integer

Alias
UMLS CUI [1,1]
C3842710
UMLS CUI [1,2]
C0332307
Indicate percent of meal consumed by patient
Description

Percent of eating a meal

Data type

integer

Alias
UMLS CUI [1,1]
C0439165
UMLS CUI [1,2]
C3842710
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Similar models

Meal

1 forms
  1. StudyEvent: ODM
    1. Meal
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Week 1 (Week 1)
CL Item
Week2 (Week 2)
CL Item
Week 3 (Week 3)
Item Group
Dosing date/time
C0178602 (UMLS CUI-1)
C1264639 (UMLS CUI-2)
Dosing date and time
Item
Dosing date/time
datetime
C0178602 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Last Meal on Day of Dosing at Clinic
C0578574 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
C0178602 (UMLS CUI-3)
C0442592 (UMLS CUI-4)
Last food intakte before Dosing, Date and Time
Item
Predose Meal Start Date and Time
datetime
C0578574 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Item Group
Breakfast Meal on Day of Dosing at Clinic
C2698559 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
C0442592 (UMLS CUI-3)
Meal Beginning, Date and Time
Item
Meal Start Date and Time
datetime
C1264639 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C1998602 (UMLS CUI [1,3])
Item
Meal type
integer
C3842710 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Meal type
Code List
Meal type
CL Item
Low-fat breakfast (12)
CL Item
High-fat breakfast (6)
Item
Indicate percent of meal consumed by patient
integer
C0439165 (UMLS CUI [1,1])
C3842710 (UMLS CUI [1,2])
Percent of eating a meal
Code List
Indicate percent of meal consumed by patient
CL Item
1 - 25% (1)
CL Item
26 - 50% (2)
CL Item
51 - 75% (3)
CL Item
76 - 100% (4)
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