ID
42096
Descripción
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
Palabras clave
Versiones (1)
- 8/4/21 8/4/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
8 de abril de 2021
DOI
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Licencia
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
Descripción
Demography
Alias
- UMLS CUI-1
- C0011298
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descripción
Height (cm)
Tipo de datos
float
Unidades de medida
- cm
Alias
- UMLS CUI [1]
- C0005890
Descripción
Height (in)
Tipo de datos
float
Unidades de medida
- in
Alias
- UMLS CUI [1]
- C0005890
Descripción
Temperature measurement site
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0489453
Descripción
Temperature Unit
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Descripción
Temperature
Tipo de datos
float
Alias
- UMLS CUI [1]
- C0005903
Descripción
After 5 Minutes Sitting
Tipo de datos
integer
Unidades de medida
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Descripción
After 5 Minutes Sitting
Tipo de datos
integer
Unidades de medida
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Descripción
Pulse
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Descripción
History of Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0007131
- UMLS CUI-2
- C0262926
Descripción
Date of the histological diagnosis of primary disease
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0679557
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C0277554
Descripción
Mark one box only If Limited Disease --> The patient is not eligible for the study
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0699749
Descripción
Previous Surgical Procedures for Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C0205156
- UMLS CUI-3
- C0007131
Descripción
Previous Surgical Procedures for Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0543467
- UMLS CUI-2
- C0205156
- UMLS CUI-3
- C0007131
Descripción
Previous Radiotherapy for Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0007131
- UMLS CUI-2
- C0279134
Descripción
If "Yes", please record details below, and answer the following question
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0007131
- UMLS CUI [1,2]
- C0279134
Descripción
Has the patient had cranial irridation for treatment of CNS metastases?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205918
- UMLS CUI [1,2]
- C3163632
- UMLS CUI [2]
- C0686377
Descripción
Has the patient had prophylactic cranial irridation?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1514496
Descripción
Has the patient had consolidation to primary site?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C3179017
- UMLS CUI [1,2]
- C0449695
Descripción
Has the patient had radiotherapy to other sites for palliation?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1522449
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [3]
- C0679251
Descripción
Previous Radiotherapy for Small Cell Lung Cancer
Alias
- UMLS CUI-1
- C0007131
- UMLS CUI-2
- C0279134
Descripción
Field Site
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1997599
Descripción
Cumulative Dose (x100 R)
Tipo de datos
float
Alias
- UMLS CUI [1]
- C2986497
Descripción
Radiation Start Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0808070
Descripción
Radiation End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1522449
- UMLS CUI [1,2]
- C0806020
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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
C0019994 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0277554 (UMLS CUI [2])
C0205156 (UMLS CUI-2)
C0007131 (UMLS CUI-3)
C0543467 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0205156 (UMLS CUI-2)
C0007131 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0279134 (UMLS CUI-2)
C0279134 (UMLS CUI [1,2])
C3163632 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2])
C0449695 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0679251 (UMLS CUI [3])
C0279134 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])