ID

41172

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 diary. This form is for dosing and meal data from the diary only. Go to visits Week 1 to Week 3 for Lapatinib and Meal data from clinic visits. This form has to be filled in for each week and each study day of the trial.

Link

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

Keywords

Versions (1)
  1. 7/4/20 7/4/20 - Christian Arras
Copyright Holder

GlaxoSmithKline

Uploaded on

July 4, 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 diary

1 forms  
  1. StudyEvent: ODM
    1. Lapatinib diary
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
Week number and study day
Description

Week number and study day

Alias
UMLS CUI-1
C0439230
UMLS CUI-2
C0449788
UMLS CUI-3
C2826182
Week Number
Description

Week number

Data type

integer

Alias
UMLS CUI [1,1]
C0439230
UMLS CUI [1,2]
C0449788
Study Day
Description

Study day

Data type

text

Alias
UMLS CUI [1]
C2826182
Predose Overnight Fast
Description

Predose Overnight Fast

Alias
UMLS CUI-1
C0439565
UMLS CUI-2
C0015663
UMLS CUI-3
C0439583
Date and Time of Last Meal
Description

Date and Time of Last Meal

Data type

datetime

Alias
UMLS CUI [1,1]
C0578574
UMLS CUI [1,2]
C0011008
Study Medication - 1250 mg of lapatinib
Description

Study Medication - 1250 mg of lapatinib

Alias
UMLS CUI-1
C1506770
UMLS CUI-2
C0178602
UMLS CUI-3
C0449788
Date and Time of Dose
Description

Date and Time of Dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C1264639
Number of Tablets taken
Description

Tablet dosage form, taken, count of entities

Data type

text

Alias
UMLS CUI [1,1]
C0039225
UMLS CUI [1,2]
C1883727
UMLS CUI [1,3]
C0449788
Postdose Fast
Description

Postdose Fast

Alias
UMLS CUI-1
C0439568
UMLS CUI-2
C0015663
Date and Time of next Meal
Description

Start Date and Time of next Meal

Data type

datetime

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1998602
UMLS CUI [1,3]
C0439568
UMLS CUI [2,1]
C1301880
UMLS CUI [2,2]
C1998602
UMLS CUI [2,3]
C0439568
Postdose Vomiting
Description

Postdose Vomiting

Alias
UMLS CUI-1
C0042963
UMLS CUI-2
C0439568
Did you vomit within the four hours after you took the study drug?
Description

Post-dose vomiting

Data type

text

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

Treatment Confirmation

Alias
UMLS CUI-1
C0750484
UMLS CUI-2
C0087111
If entire dose was missed, or less than 5 tablets were taken, enter reason:
Description

missed dose, tablet dosage form, reason

Data type

text

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0566251
UMLS CUI [2,1]
C0039225
UMLS CUI [2,2]
C0449788
UMLS CUI [2,3]
C1709043
UMLS CUI [2,4]
C0566251
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Similar models

Lapatinib diary

1 forms
  1. StudyEvent: ODM
    1. Lapatinib diary
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 Group
Week number and study day
C0439230 (UMLS CUI-1)
C0449788 (UMLS CUI-2)
C2826182 (UMLS CUI-3)
Item
Week Number
integer
C0439230 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Week number
Code List
Week Number
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
Item
Study Day
text
C2826182 (UMLS CUI [1])
Study day
Code List
Study Day
CL Item
Day1 (DAY 1 DOSE)
CL Item
Day2 (DAY 2 DOSE)
CL Item
Day3 (DAY 3 DOSE)
CL Item
Day4 (DAY 4 DOSE)
CL Item
Day5 (DAY 5 DOSE)
CL Item
Day6 (DAY 6 DOSE)
CL Item
Day7 (DAY 7 DOSE)
CL Item
Day8 (DAY 8 DOSE)
Item Group
Predose Overnight Fast
C0439565 (UMLS CUI-1)
C0015663 (UMLS CUI-2)
C0439583 (UMLS CUI-3)
Date and Time of Last Meal
Item
Date and Time of Last Meal
datetime
C0578574 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Study Medication - 1250 mg of lapatinib
C1506770 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0449788 (UMLS CUI-3)
Date and Time of Dose
Item
Date and Time of Dose
datetime
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Tablet dosage form, taken, count of entities
Item
Number of Tablets taken
text
C0039225 (UMLS CUI [1,1])
C1883727 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Item Group
Postdose Fast
C0439568 (UMLS CUI-1)
C0015663 (UMLS CUI-2)
Start Date and Time of next Meal
Item
Date and Time of next Meal
datetime
C0808070 (UMLS CUI [1,1])
C1998602 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
C1301880 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
C0439568 (UMLS CUI [2,3])
Item Group
Postdose Vomiting
C0042963 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Did you vomit within the four hours after you took the study drug?
text
C0042963 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Post-dose vomiting
Code List
Did you vomit within the four hours after you took the study drug?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Treatment Confirmation
C0750484 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
missed dose, tablet dosage form, reason
Item
If entire dose was missed, or less than 5 tablets were taken, enter reason:
text
C1709043 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0039225 (UMLS CUI [2,1])
C0449788 (UMLS CUI [2,2])
C1709043 (UMLS CUI [2,3])
C0566251 (UMLS CUI [2,4])
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