ID
42287
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 (2)
- 5/4/21 5/4/21 -
- 5/4/21 5/4/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 4, 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)
Laboratory Reference Ranges; Concomitant Medication; Adverse Experiences (Non-serious)
Description
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Description
Investigator
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Date for which these reference ranges became effective
Data type
date
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0011008
Description
Laboratory Name
Data type
text
Alias
- UMLS CUI [1]
- C3258037
Description
Laboratory Address
Data type
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Description
Reference range gender
Data type
text
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0079399
Description
Age range
Data type
text
Measurement units
- Years
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Description
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Description
Test - Haematology
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Test - Blood Chemistry
Data type
integer
Alias
- UMLS CUI [1]
- C0525044
Description
Unit
Data type
text
Alias
- UMLS CUI [1]
- C1519795
Description
Low Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C1272773
Description
High Reference Value
Data type
float
Alias
- UMLS CUI [1]
- C1299400
Description
Concomitant Medication - Continued
Alias
- UMLS CUI-1
- C2347852
Description
Trade Name Preferred
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
(e.g. 500mg)
Data type
text
Alias
- UMLS CUI [1]
- C2348070
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Medical Condition
Data type
text
Alias
- UMLS CUI [1]
- C0012634
Description
Medication Start Date
Data type
date
Alias
- UMLS CUI [1]
- C2826734
Description
Medication End Date
Data type
date
Alias
- UMLS CUI [1]
- C2826744
Description
Medication Continuing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Description
Adverse Experiences (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Description
Adverse Experiences (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Description
Adverse Experience
Data type
text
Alias
- UMLS CUI [1]
- C0877248
Description
Adverse Experience Onset Date and Time
Data type
datetime
Alias
- UMLS CUI [1]
- C2985916
- UMLS CUI [2]
- C2697889
Description
If ongoing please leave blank
Data type
datetime
Alias
- UMLS CUI [1]
- C2826793
Description
If patient died, STOP: go to SAE section and follow instructions given there
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
Experience Course
Data type
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Description
If Intermittent Course, record number of episodes
Data type
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0205267
- UMLS CUI [1,3]
- C4086638
Description
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening
Data type
integer
Alias
- UMLS CUI [1]
- C2826262
Description
Action Taken with Respect to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1]
- C2826626
Description
Relationship to Investigational Drug
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Description
If 'Yes' record details in the Concomitant Medication section
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Description
Was patient withdrawn due to this specific AE?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Description
Investigator's Signature (Adverse Experience)
Alias
- UMLS CUI-1
- C2346576
- UMLS CUI-2
- C0877248
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Laboratory Reference Ranges; Concomitant Medication; Adverse Experiences (Non-serious)
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C0750729 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0022877 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,2])
C1514721 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,2])
C2697889 (UMLS CUI [2])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,2])
C4086638 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])