ID
42258
Description
Study ID: 104864/410 Clinical Study ID: 104864/410 Study Title: A randomised open-label multicentre Phase II study to evaluate the safety and efficacy of intravenous topotecan given with either cisplatin or etoposide every 21 days as first-line therapy in patients with extensive-disease (ED) small-cell lung cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Study Indication: Lung Cancer
Keywords
Versions (1)
- 4/21/21 4/21/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 21, 2021
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)
Laboratory Tests - Haematology; Blood Chemistry; Urinalysis
- StudyEvent: ODM
Description
Laboratory Tests - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Day 1 not required
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C1514873
Description
Sample Date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Sample Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Description
Laboratory Name
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Haematology Test
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Haematology Value
Data type
text
Alias
- UMLS CUI [1]
- C0474523
Description
Are there clinically significant abnormal laboratory values?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0474523
- UMLS CUI [1,3]
- C1704258
Description
Laboratory Tests - Blood Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0005774
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Day 1 not required
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C1514873
Description
Sample Date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Sample Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Description
Laboratory Name
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Blood Chemistry Test
Data type
integer
Alias
- UMLS CUI [1]
- C0525044
Description
Blood Chemistry Value
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
Description
Serum Beta HCG
Data type
integer
Alias
- UMLS CUI [1]
- C2348195
Description
Are there clinically significant abnormal laboratory values?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0005774
- UMLS CUI [1,3]
- C1704258
Description
Laboratory Tests - Urinalysis
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0042014
Description
Visit
Data type
integer
Alias
- UMLS CUI [1]
- C0545082
Description
Sample Date
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Laboratory Name
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Urinalysis Test
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0430370
Description
Urinalysis Value
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
Description
Was microscopy performed?
Data type
boolean
Alias
- UMLS CUI [1]
- C0430397
Description
Microscopy
Data type
text
Alias
- UMLS CUI [1]
- C0430397
Description
Microscopy Result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0587081
Description
If "Yes" record the findings and/or diagnosis in the Adverse Experience section.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0438215
Similar models
Laboratory Tests - Haematology; Blood Chemistry; Urinalysis
- StudyEvent: ODM
C0474523 (UMLS CUI-2)
C1514873 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0005774 (UMLS CUI-2)
C1514873 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0005774 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C0042014 (UMLS CUI-2)
C0587081 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,2])