ID

40154

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 medical conditions of the patient. It has to be filled in for screening.

Link

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

Keywords

  1. 3/16/20 3/16/20 - Christian Arras
  2. 3/17/20 3/17/20 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

March 17, 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

Medical conditions

  1. StudyEvent: ODM
    1. Medical conditions
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
Medical conditions
Description

Medical conditions

Alias
UMLS CUI-1
C0012634
Does the subject have any current or past cancer or non-cancer related medical conditions?
Description

If Yes, specify below:

Data type

text

Alias
UMLS CUI [1]
C0012634
Medical conditions entry
Description

Medical conditions entry

Alias
UMLS CUI-1
C0012634
Sequence number
Description

hidden/not required

Data type

text

Alias
UMLS CUI [1]
C2348184
Specific condition
Description

Specific condition

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Modified term
Description

hidden/not required

Data type

text

Alias
UMLS CUI [1]
C2826302
Status
Description

Status of Disease

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Medical condition classification code
Description

Medical condition, classification code

Data type

text

Alias
UMLS CUI [1,1]
C0008902
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0012634
Toxicity code
Description

Toxicity code

Data type

text

Alias
UMLS CUI [1,1]
C0040539
UMLS CUI [1,2]
C0805701

Similar models

Medical conditions

  1. StudyEvent: ODM
    1. Medical conditions
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
Medical conditions
C0012634 (UMLS CUI-1)
Item
Does the subject have any current or past cancer or non-cancer related medical conditions?
text
C0012634 (UMLS CUI [1])
Code List
Does the subject have any current or past cancer or non-cancer related medical conditions?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Medical conditions entry
C0012634 (UMLS CUI-1)
Sequence number
Item
Sequence number
text
C2348184 (UMLS CUI [1])
Specific condition
Item
Specific condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
reported term
Item
Modified term
text
C2826302 (UMLS CUI [1])
Item
Status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Status
CL Item
current (1)
CL Item
past (2)
Item
Medical condition classification code
text
C0008902 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
Code List
Medical condition classification code
CL Item
Cancer related (24)
CL Item
toxicities related to previous therapy (29)
CL Item
Other (general) (OT)
Item
Toxicity code
text
C0040539 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Code List
Toxicity code
CL Item
Grade 1 (1)
CL Item
Grade 2  (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
not applicable (X)

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