ID

41227

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 the Lapatinib Dosing information. 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

Lapatinib

1 forms  
  1. StudyEvent: ODM
    1. Lapatinib
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
Lapatinib Dosing
Description

Lapatinib Dosing

Alias
UMLS CUI-1
C1506770
UMLS CUI-2
C0178602
Did the subject fast at least 8 hours prior to dosing?
Description

Fasting prior to dosing

Data type

text

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C0439565
Date and time of Dose
Description

Date and time of Dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Actual Dose
Description

Actual Dose, Lapatinib

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C1506770
mg
Did the subject vomit within 4 hours after dosing?
Description

post-dose vomiting

Data type

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0439568
Treatment confirmation
Description

Treatment confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

correct treatment during dosing interval

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0178602
UMLS CUI [1,5]
C1272706
If incorrect treatment, please record reason:
Description

incorrect treatment, reason

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C3827420
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Similar models

Lapatinib

1 forms
  1. StudyEvent: ODM
    1. Lapatinib
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
Lapatinib Dosing
C1506770 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Item
Did the subject fast at least 8 hours prior to dosing?
text
C0015663 (UMLS CUI [1,1])
C0439565 (UMLS CUI [1,2])
recent fasting, pharmaceutical preparation
Code List
Did the subject fast at least 8 hours prior to dosing?
CL Item
Yes (Y)
CL Item
No (N)
Date and time of Dose
Item
Date and time of Dose
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Actual Dose, Lapatinib
Item
Actual Dose
float
C3174092 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
post-dose vomiting
Item
Did the subject vomit within 4 hours after dosing?
boolean
C0042963 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Item Group
Treatment confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
text
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
C1272706 (UMLS CUI [1,5])
correct treatment during dosing interval
Code List
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
CL Item
Yes (Y)
CL Item
No, record reason: (N)
incorrect treatment, reason
Item
If incorrect treatment, please record reason:
text
C0566251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
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