ID
42287
Beschrijving
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
Trefwoorden
Versies (2)
- 04-05-21 04-05-21 -
- 04-05-21 04-05-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 mei 2021
DOI
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Licentie
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)
Beschrijving
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Beschrijving
Investigator
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Date for which these reference ranges became effective
Datatype
date
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0011008
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C3258037
Beschrijving
Laboratory Address
Datatype
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschrijving
Reference range gender
Datatype
text
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0079399
Beschrijving
Age range
Datatype
text
Maateenheden
- Years
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Beschrijving
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Beschrijving
Test - Haematology
Datatype
integer
Alias
- UMLS CUI [1]
- C0018941
Beschrijving
Test - Blood Chemistry
Datatype
integer
Alias
- UMLS CUI [1]
- C0525044
Beschrijving
Unit
Datatype
text
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Low Reference Value
Datatype
float
Alias
- UMLS CUI [1]
- C1272773
Beschrijving
High Reference Value
Datatype
float
Alias
- UMLS CUI [1]
- C1299400
Beschrijving
Concomitant Medication - Continued
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Trade Name Preferred
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
(e.g. 500mg)
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Medical Condition
Datatype
text
Alias
- UMLS CUI [1]
- C0012634
Beschrijving
Medication Start Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826734
Beschrijving
Medication End Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826744
Beschrijving
Medication Continuing
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beschrijving
Adverse Experiences (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Adverse Experiences (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Beschrijving
Adverse Experience
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Adverse Experience Onset Date and Time
Datatype
datetime
Alias
- UMLS CUI [1]
- C2985916
- UMLS CUI [2]
- C2697889
Beschrijving
If ongoing please leave blank
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschrijving
If patient died, STOP: go to SAE section and follow instructions given there
Datatype
integer
Alias
- UMLS CUI [1]
- C1705586
Beschrijving
Experience Course
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschrijving
If Intermittent Course, record number of episodes
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0205267
- UMLS CUI [1,3]
- C4086638
Beschrijving
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening
Datatype
integer
Alias
- UMLS CUI [1]
- C2826262
Beschrijving
Action Taken with Respect to Investigational Drug
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
Relationship to Investigational Drug
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschrijving
If 'Yes' record details in the Concomitant Medication section
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschrijving
Was patient withdrawn due to this specific AE?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beschrijving
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])