ID

41731

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 documents any repeating Pharmacokinetics Blood measurements.

Link

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

Keywords

  1. 1/9/21 1/9/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 9, 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

Pharmacokinetics Repeat

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 ID
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Pharmacokinetics Repeat
Description

Pharmacokinetics Repeat

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0205341
sequence number
Description

Pharmacokinetics, sequence number

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C2348184
week number
Description

Pharmacokinetics, week number

Data type

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0439230
UMLS CUI [1,3]
C0237753
actual date/time
Description

Pharmacokinetics, actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1264639

Similar models

Pharmacokinetics Repeat

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 ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item Group
Pharmacokinetics Repeat
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
Pharmacokinetics, sequence number
Item
sequence number
text
C0031328 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item
week number
text
C0031328 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Code List
week number
CL Item
week 1 (1)
CL Item
week 2 (2)
CL Item
week 3 (3)
Pharmacokinetics, actual date/time
Item
actual date/time
datetime
C0031328 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])

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