ID
42287
Beschreibung
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
Stichworte
Versionen (2)
- 04.05.21 04.05.21 -
- 04.05.21 04.05.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
4. Mai 2021
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY 4.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
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)
Beschreibung
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Beschreibung
Investigator
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Date for which these reference ranges became effective
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0011008
Beschreibung
Laboratory Name
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Laboratory Address
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1442065
- UMLS CUI [1,2]
- C0022877
Beschreibung
Reference range gender
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0883335
- UMLS CUI [1,2]
- C0079399
Beschreibung
Age range
Datentyp
text
Maßeinheiten
- Years
Alias
- UMLS CUI [1,1]
- C0001779
- UMLS CUI [1,2]
- C1514721
Beschreibung
Laboratory Reference Ranges
Alias
- UMLS CUI-1
- C0883335
Beschreibung
Test - Haematology
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beschreibung
Test - Blood Chemistry
Datentyp
integer
Alias
- UMLS CUI [1]
- C0525044
Beschreibung
Unit
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Low Reference Value
Datentyp
float
Alias
- UMLS CUI [1]
- C1272773
Beschreibung
High Reference Value
Datentyp
float
Alias
- UMLS CUI [1]
- C1299400
Beschreibung
Concomitant Medication - Continued
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Trade Name Preferred
Datentyp
text
Alias
- UMLS CUI [1]
- C2360065
Beschreibung
(e.g. 500mg)
Datentyp
text
Alias
- UMLS CUI [1]
- C2348070
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Medical Condition
Datentyp
text
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Medication Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Medication End Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826744
Beschreibung
Medication Continuing
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beschreibung
Adverse Experiences (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Adverse Experiences (Non-serious)
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Adverse Experience
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Adverse Experience Onset Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2985916
- UMLS CUI [2]
- C2697889
Beschreibung
If ongoing please leave blank
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beschreibung
If patient died, STOP: go to SAE section and follow instructions given there
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
Experience Course
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0750729
Beschreibung
If Intermittent Course, record number of episodes
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0205267
- UMLS CUI [1,3]
- C4086638
Beschreibung
Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826262
Beschreibung
Action Taken with Respect to Investigational Drug
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826626
Beschreibung
Relationship to Investigational Drug
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
If 'Yes' record details in the Concomitant Medication section
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0087111
Beschreibung
Was patient withdrawn due to this specific AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1518404
Beschreibung
Investigator's Signature (Adverse Experience)
Alias
- UMLS CUI-1
- C2346576
- UMLS CUI-2
- C0877248
Ähnliche Modelle
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])