ID
42096
Beschrijving
lung 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)
- 08-04-21 08-04-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 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)
Module 1 - Screening (Demography; Vital Signs; History of Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Height (cm)
Datatype
float
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Height (in)
Datatype
float
Maateenheden
- in
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Temperature measurement site
Datatype
integer
Alias
- UMLS CUI [1]
- C0489453
Beschrijving
Temperature Unit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschrijving
Temperature
Datatype
float
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
After 5 Minutes Sitting
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschrijving
After 5 Minutes Sitting
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschrijving
Pulse
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
History of Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0007131
- UMLS CUI-2
- C0262926
Beschrijving
Date of the histological diagnosis of primary disease
Datatype
date
Alias
- UMLS CUI [1,1]
- C0679557
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C0277554
Beschrijving
Mark one box only If Limited Disease --> The patient is not eligible for the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0699749
Beschrijving
Previous Surgical Procedures for Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C0205156
- UMLS CUI-3
- C0007131
Beschrijving
Previous Surgical Procedures for Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C0205156
- UMLS CUI-3
- C0007131
Beschrijving
Previous Radiotherapy for Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0007131
- UMLS CUI-2
- C0279134
Beschrijving
If "Yes", please record details below, and answer the following question
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0007131
- UMLS CUI [1,2]
- C0279134
Beschrijving
Has the patient had cranial irridation for treatment of CNS metastases?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205918
- UMLS CUI [1,2]
- C3163632
- UMLS CUI [2]
- C0686377
Beschrijving
Has the patient had prophylactic cranial irridation?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1514496
Beschrijving
Has the patient had consolidation to primary site?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3179017
- UMLS CUI [1,2]
- C0449695
Beschrijving
Has the patient had radiotherapy to other sites for palliation?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1522449
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3]
- C0679251
Beschrijving
Previous Radiotherapy for Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0007131
- UMLS CUI-2
- C0279134
Beschrijving
Field Site
Datatype
text
Alias
- UMLS CUI [1]
- C1997599
Beschrijving
Cumulative Dose (x100 R)
Datatype
float
Alias
- UMLS CUI [1]
- C2986497
Beschrijving
Radiation Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0808070
Beschrijving
Radiation End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0806020
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