ID

40268

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 survey of the vital signs once at the screening, study visit at day-1, weeks 1-3 and the follow-up visit and if required as often as needed for logs/repeats. Week 3 assessments can be used as Follow-up assessments for subjects who have completed the 24 hour PK blood draw at the Week 3 visit and are proceeding into the continuing study EGF111767. If this applies, do NOT reenter the same data twice; leave a form comment instead.

Link

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

Keywords

  1. 3/26/20 3/26/20 - Christian Arras
  2. 3/26/20 3/26/20 - Christian Arras
Copyright Holder

GlaxoSmithKline

Uploaded on

March 26, 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

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
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
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual Date
Description

Date in time

Data type

date

Alias
UMLS CUI [1]
C0011008
Time relative to dosing
Description

only to be filled in at Visits Week 1 to 3

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C3469597
Height
Description

only to be filled in at screening visit

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

only to be filled in at screening visit

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm

Similar models

Vital Signs

  1. StudyEvent: ODM
    1. Vital Signs
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])
Code List
Visit type
CL Item
Screen (Screen)
CL Item
Day-1 (Day-1)
CL Item
F/U (F/U)
CL Item
Week 1 (Week 1)
CL Item
Week2 (Week 2)
CL Item
Week 3 (Week 3)
CL Item
Logs/Repeats (Logs/Rpts)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date in time
Item
Actual Date
date
C0011008 (UMLS CUI [1])
Item
Time relative to dosing
integer
C0439564 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Code List
Time relative to dosing
CL Item
Predose (1)
CL Item
0.5 Hr post dose (2)
CL Item
1 Hr post dose (3)
CL Item
4 Hrs post dose (4)
CL Item
24 hrs post dose (5)
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])

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