ID
42258
Beschrijving
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
Trefwoorden
Versies (1)
- 21-04-21 21-04-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
21 april 2021
DOI
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Licentie
Creative Commons BY 4.0
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Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)
Laboratory Tests - Haematology; Blood Chemistry; Urinalysis
- StudyEvent: ODM
Beschrijving
Laboratory Tests - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Day 1 not required
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C1514873
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Haematology Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
Haematology Value
Datatype
text
Alias
- UMLS CUI [1]
- C0474523
Beschrijving
Are there clinically significant abnormal laboratory values?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0474523
- UMLS CUI [1,3]
- C1704258
Beschrijving
Laboratory Tests - Blood Chemistry
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C0005774
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Day 1 not required
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C1514873
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Blood Chemistry Test
Datatype
integer
Alias
- UMLS CUI [1]
- C0525044
Beschrijving
Blood Chemistry Value
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
Beschrijving
Serum Beta HCG
Datatype
integer
Alias
- UMLS CUI [1]
- C2348195
Beschrijving
Are there clinically significant abnormal laboratory values?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0005774
- UMLS CUI [1,3]
- C1704258
Beschrijving
Laboratory Tests - Urinalysis
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0042014
Beschrijving
Visit
Datatype
integer
Alias
- UMLS CUI [1]
- C0545082
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Urinalysis Test
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0430370
Beschrijving
Urinalysis Value
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
Beschrijving
Was microscopy performed?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
Microscopy
Datatype
text
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
Microscopy Result
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0587081
Beschrijving
If "Yes" record the findings and/or diagnosis in the Adverse Experience section.
Datatype
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])