ID

40269

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 data entry for the electrocardiogram surveys. It has to be filled in once for Screening, Visit day-1, and week 1-3. 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. Repeat measurements as often as necessary in logs and repeats.

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

  1. StudyEvent: ODM
    1. ECG
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
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
Date and Time of ECG
Description

Date and Time of ECG

Data type

text

Alias
UMLS CUI [1]
C2826846
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR Intervall
Description

PR Intervall

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS duration
Description

QRS complex duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT intervall
Description

Uncorrected QT intervall

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C4072785
msec
QTc - Bazett's Correction
Description

not required/read-only

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C1882512
msec
QTc - Fridericia's Correction
Description

not required/read-only

Data type

text

Measurement units
  • msec
Alias
UMLS CUI [1]
C1882513
msec
Result of the ECG
Description

Complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE

Data type

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C1274040

Similar models

  1. StudyEvent: ODM
    1. ECG
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
Week 1 (Week 1)
CL Item
Week2 (Week 2)
CL Item
Week 3 (Week 3)
CL Item
Logs/Repeats (Logs/Rpts)
Item Group
ECG
C1623258 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
text
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Intervall
Item
PR Intervall
float
C0429087 (UMLS CUI [1])
QRS complex duration
Item
QRS duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT intervall
Item
Uncorrected QT intervall
float
C1287082 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
QTc - Bazett's Correction Formula
Item
QTc - Bazett's Correction
text
C1882512 (UMLS CUI [1])
QTc - Fridericia's Correction
Item
QTc - Fridericia's Correction
text
C1882513 (UMLS CUI [1])
Item
Result of the ECG
integer
C1623258 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No results (Not available) (4)

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