ID
42249
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)
- 4/17/21 4/17/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 17, 2021
DOI
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License
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
Description
Toxicities related to previous Radiotherapy for SCLC
Alias
- UMLS CUI-1
- C0013221
- UMLS CUI-2
- C1522449
- UMLS CUI-3
- C0205156
- UMLS CUI-4
- C0149925
Description
If "Yes" please record the toxicity below with NCI Common Toxicity Grade.
Data type
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
Description
Toxicities related to previous Radiotherapy for SCLC
Alias
- UMLS CUI-1
- C0013221
- UMLS CUI-2
- C1522449
- UMLS CUI-3
- C0205156
- UMLS CUI-4
- C0149925
Description
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Description
Diagnostic Studies for Tumor Assessment
Alias
- UMLS CUI-1
- C0430022
- UMLS CUI-2
- C0008976
- UMLS CUI-3
- C0027651
- UMLS CUI-4
- C0220825
Description
Tumor Assessment
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C0220825
Description
Tumor Assessment Not Done
Data type
integer
Alias
- UMLS CUI [1,1]
- C0027651
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C1272696
Description
Date Assessment Performed
Data type
date
Alias
- UMLS CUI [1]
- C2985720
Description
Assessment Result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0220825
- UMLS CUI [1,2]
- C1274040
Description
Ongoing Medical Conditions Associated with SCLC
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0549178
- UMLS CUI-3
- C0149925
Description
Ongoing Medical Conditions Associated with SCLC
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0549178
- UMLS CUI-3
- C0149925
Description
Significant Medical/ Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
- UMLS CUI-3
- C0031809
Description
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"
Data type
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2,1]
- C0543467
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [3]
- C0149925
Description
Significant Medical/ Surgical History and Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
- UMLS CUI-3
- C0031809
Description
Diagnosis
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
NCI Grade
Data type
text
Alias
- UMLS CUI [1]
- C2826262
Description
Year of first diagnosis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0439234
- UMLS CUI [1,2]
- C0011900
Description
Condition Status
Data type
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])