ID
42280
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)
- 4/29/21 4/29/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 29, 2021
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)
Module 2 - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG
Description
Serious Adverse Experiences
Alias
- UMLS CUI-1
- C1519255
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Temperature
Data type
float
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature
Data type
integer
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature site
Data type
integer
Alias
- UMLS CUI [1]
- C0489453
Description
After 5 Minutes Sitting
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
After 5 Minutes Sitting
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
After 5 Minutes Sitting
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Description
Mark the box if not required
Data type
integer
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1514873
Description
Date ECG performed
Data type
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0011008
Description
ECG result
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Similar models
Module 2 - Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG
C0019994 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])