ID
42287
Beskrivning
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
Nyckelord
Versioner (2)
- 2021-05-04 2021-05-04 -
- 2021-05-04 2021-05-04 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
4 maj 2021
DOI
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Licens
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)
Beskrivning
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Beskrivning
Investigator
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Date for which these reference ranges became effective
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0011008
Beskrivning
Laboratory Name
Datatyp
text
Alias
- UMLS CUI [1]
- C3258037
Beskrivning
Laboratory Address
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beskrivning
Reference range gender
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0079399
Beskrivning
Age range
Datatyp
text
Måttenheter
- Years
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Beskrivning
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Beskrivning
Test - Haematology
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beskrivning
Test - Blood Chemistry
Datatyp
integer
Alias
- UMLS CUI [1]
- C0525044
Beskrivning
Unit
Datatyp
text
Alias
- UMLS CUI [1]
- C1519795
Beskrivning
Low Reference Value
Datatyp
float
Alias
- UMLS CUI [1]
- C1272773
Beskrivning
High Reference Value
Datatyp
float
Alias
- UMLS CUI [1]
- C1299400
Beskrivning
Concomitant Medication - Continued
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Trade Name Preferred
Datatyp
text
Alias
- UMLS CUI [1]
- C2360065
Beskrivning
(e.g. 500mg)
Datatyp
text
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Route
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Medical Condition
Datatyp
text
Alias
- UMLS CUI [1]
- C0012634
Beskrivning
Medication Start Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826734
Beskrivning
Medication End Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826744
Beskrivning
Medication Continuing
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beskrivning
Adverse Experiences (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Adverse Experiences (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Beskrivning
Adverse Experience
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Adverse Experience Onset Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2985916
- UMLS CUI [2]
- C2697889
Beskrivning
If ongoing please leave blank
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beskrivning
If patient died, STOP: go to SAE section and follow instructions given there
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
Experience Course
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beskrivning
If Intermittent Course, record number of episodes
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0205267
- UMLS CUI [1,3]
- C4086638
Beskrivning
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826262
Beskrivning
Action Taken with Respect to Investigational Drug
Datatyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beskrivning
Relationship to Investigational Drug
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beskrivning
If 'Yes' record details in the Concomitant Medication section
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beskrivning
Was patient withdrawn due to this specific AE?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beskrivning
Investigator's Signature (Adverse Experience)
Alias
- UMLS CUI-1
- C2346576
- UMLS CUI-2
- C0877248
Similar models
Laboratory Reference Ranges; Concomitant Medication; Adverse Experiences (Non-serious)
C0019994 (UMLS CUI [1,2])
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])