ID

42275

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)
  1. 4/27/21 4/27/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 27, 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)

English

Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Serious Adverse Experiences
Description

Serious Adverse Experiences

Alias
UMLS CUI-1
C1519255
Has the patient had any serious adverse experiences during this course?
Description

Has the patient had any serious adverse experiences during this course?

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Temperature
Description

Temperature

Data type

float

Alias
UMLS CUI [1]
C0005903
Temperature
Description

Temperature

Data type

integer

Alias
UMLS CUI [1]
C0005903
Temperature site
Description

Temperature site

Data type

integer

Alias
UMLS CUI [1]
C0489453
Sitting Systolic Blood Pressure
Description

After 5 Minutes Sitting

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mm[Hg]
Diastolic Sitting Blood Pressure
Description

After 5 Minutes Sitting

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mm[Hg]
Pulse
Description

After 5 Minutes Sitting

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
12-Lead Electrocardiogram
Description

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Mark the box if not required
Description

Mark the box if not required

Data type

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1514873
Date ECG performed
Description

Date ECG performed

Data type

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
ECG result
Description

ECG result

Data type

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

Pre-Next Course: Serious Adverse Experiences; Vital Signs; 12-Lead ECG

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Serious Adverse Experiences
C1519255 (UMLS CUI-1)
Has the patient had any serious adverse experiences during this course?
Item
Has the patient had any serious adverse experiences during this course?
boolean
C1519255 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature
integer
C0005903 (UMLS CUI [1])
Temperature
Code List
Temperature
CL Item
°C  (1)
CL Item
°F (2)
Item
Temperature site
integer
C0489453 (UMLS CUI [1])
Temperature site
Code List
Temperature site
CL Item
Oral  (1)
CL Item
Axillary  (2)
CL Item
Tympanic  (3)
CL Item
Rectal (4)
Sitting Systolic Blood Pressure
Item
Sitting Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic Sitting Blood Pressure
Item
Diastolic Sitting Blood Pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
Item
Mark the box if not required
integer
C0430456 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Mark the box if not required
Code List
Mark the box if not required
CL Item
Not required (1)
Date ECG performed
Item
Date ECG performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
ECG result
integer
C0438154 (UMLS CUI [1])
ECG result
Code List
ECG result
CL Item
No significant worsening since screening (2)
CL Item
Worsening since screening (Record in the Advrse Experience section) (3)
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