ID
42249
Descripción
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)
- 17/4/21 17/4/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
17 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)
Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination
Descripción
Toxicities related to previous Radiotherapy for SCLC
Alias
- UMLS CUI-1
- C0013221
- UMLS CUI-2
- C1522449
- UMLS CUI-3
- C0205156
- UMLS CUI-4
- C0149925
Descripción
If "Yes" please record the toxicity below with NCI Common Toxicity Grade.
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0013221
- UMLS CUI [1,2]
- C1609982
- UMLS CUI [2,1]
- C1522449
- UMLS CUI [2,2]
- C0205156
- UMLS CUI [3]
- C0149925
Descripción
Toxicities related to previous Radiotherapy for SCLC
Alias
- UMLS CUI-1
- C0013221
- UMLS CUI-2
- C1522449
- UMLS CUI-3
- C0205156
- UMLS CUI-4
- C0149925
Descripción
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Descripción
Diagnostic Studies for Tumor Assessment
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0027651
- UMLS CUI-4
- C0220825
Descripción
Tumor Assessment
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C0220825
Descripción
Tumor Assessment Not Done
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C1272696
Descripción
Date Assessment Performed
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985720
Descripción
Assessment Result
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C1274040
Descripción
Ongoing Medical Conditions Associated with SCLC
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0549178
- UMLS CUI-3
- C0149925
Descripción
Ongoing Medical Conditions Associated with SCLC
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0549178
- UMLS CUI-3
- C0149925
Descripción
Condition
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0012634
Descripción
NCL Toxicity Grade
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826262
Descripción
Year of first diagnosis
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439234
- UMLS CUI [1,2]
- C0011900
Descripción
Significant Medical/ Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
- UMLS CUI-3
- C0031809
Descripción
If "Yes" please provide diagnosis below, listing no more than one diagnosis per line. All signs and symptoms referring to a single diagnosis must be recorded on the same line with the diagnosis. Signs and symptoms without an associated diagnosis must be recorded on separate lines. Please record the associated NCI CTC toxicity grade. For events not covered by the NCI scale, record the maximum intensity based on the SB criteria (grade 1 - 4) presented in the Assessment of Intensity section of the protocol. If a diagnosis does not warrant a toxicity, please populate the box with "NA"
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [3]
- C0149925
Descripción
Significant Medical/ Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
- UMLS CUI-3
- C0031809
Descripción
Diagnosis
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011900
Descripción
NCI Grade
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826262
Descripción
Year of first diagnosis
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439234
- UMLS CUI [1,2]
- C0011900
Descripción
Condition Status
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C3176928
Similar models
Screening - Toxicities Related to Previous Radiotherapy for SCLC; 12-Lead Electrocardiogram; Diagnostic Studies for Tumor Assessment; Ongoing Medical Conditions Associated with SCLC; Significant Medical/Surgical History and Physical Examination
C1522449 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
C0149925 (UMLS CUI-4)
C1609982 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0149925 (UMLS CUI [3])
C1522449 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
C0149925 (UMLS CUI-4)
C0011008 (UMLS CUI [1,2])
C0008976 (UMLS CUI-2)
C0027651 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0220825 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C0549178 (UMLS CUI-2)
C0149925 (UMLS CUI-3)
C0549178 (UMLS CUI [1,2])
C0149925 (UMLS CUI [1,3])
C0549178 (UMLS CUI-2)
C0149925 (UMLS CUI-3)
C0011900 (UMLS CUI [1,2])
C0455610 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0543467 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0149925 (UMLS CUI [3])
C0455610 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
C0011900 (UMLS CUI [1,2])