ID

42096

Description

lung 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. 4/8/21 4/8/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 8, 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

Module 1 - Screening (Demography; Vital Signs; History of Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Centre Number
Description

Centre Number

Data type

text

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

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Height (cm)
Description

Height (cm)

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Height (in)
Description

Height (in)

Data type

float

Measurement units
  • in
Alias
UMLS CUI [1]
C0005890
in
Temperature measurement site
Description

Temperature measurement site

Data type

integer

Alias
UMLS CUI [1]
C0489453
Temperature Unit
Description

Temperature Unit

Data type

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Temperature
Description

Temperature

Data type

float

Alias
UMLS CUI [1]
C0005903
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]
Sitting Diastolic 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

Pulse

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
History of Small Cell Lung Cancer
Description

History of Small Cell Lung Cancer

Alias
UMLS CUI-1
C0007131
UMLS CUI-2
C0262926
Date of the histological diagnosis of primary disease
Description

Date of the histological diagnosis of primary disease

Data type

date

Alias
UMLS CUI [1,1]
C0679557
UMLS CUI [1,2]
C0011008
UMLS CUI [2]
C0277554
Stage of current disease
Description

Mark one box only If Limited Disease --> The patient is not eligible for the study

Data type

integer

Alias
UMLS CUI [1]
C0699749
Previous Surgical Procedures for Small Cell Lung Cancer
Description

Previous Surgical Procedures for Small Cell Lung Cancer

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C0205156
UMLS CUI-3
C0007131
Has the patient had any procedures for small cell lung cancer?
Description

If "Yes" please record procedure below.

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205156
Previous Surgical Procedures for Small Cell Lung Cancer
Description

Previous Surgical Procedures for Small Cell Lung Cancer

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C0205156
UMLS CUI-3
C0007131
Surgical Procedure
Description

Surgical Procedure

Data type

text

Alias
UMLS CUI [1]
C0543467
Surgical Procedure Date
Description

Surgical Procedure Date

Data type

date

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0011008
Previous Radiotherapy for Small Cell Lung Cancer
Description

Previous Radiotherapy for Small Cell Lung Cancer

Alias
UMLS CUI-1
C0007131
UMLS CUI-2
C0279134
Has the patient had any radiotherapy as previous therapy for small cell lung cancer?
Description

If "Yes", please record details below, and answer the following question

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0279134
Has the patient had cranial irridation for treatment of CNS metastases?
Description

Has the patient had cranial irridation for treatment of CNS metastases?

Data type

boolean

Alias
UMLS CUI [1,1]
C0205918
UMLS CUI [1,2]
C3163632
UMLS CUI [2]
C0686377
Has the patient had prophylactic cranial irridation?
Description

Has the patient had prophylactic cranial irridation?

Data type

boolean

Alias
UMLS CUI [1]
C1514496
Has the patient had consolidation to primary site?
Description

Has the patient had consolidation to primary site?

Data type

boolean

Alias
UMLS CUI [1,1]
C3179017
UMLS CUI [1,2]
C0449695
Has the patient had radiotherapy to other sites for palliation?
Description

Has the patient had radiotherapy to other sites for palliation?

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0679251
Previous Radiotherapy for Small Cell Lung Cancer
Description

Previous Radiotherapy for Small Cell Lung Cancer

Alias
UMLS CUI-1
C0007131
UMLS CUI-2
C0279134
Field Site
Description

Field Site

Data type

text

Alias
UMLS CUI [1]
C1997599
Cumulative Dose (x100 R)
Description

Cumulative Dose (x100 R)

Data type

float

Alias
UMLS CUI [1]
C2986497
Radiation Start Date
Description

Radiation Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0808070
Radiation End Date
Description

Radiation End Date

Data type

date

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0806020
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Similar models

Module 1 - Screening (Demography; Vital Signs; History of Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer; Previous Radiotherapy for Small Cell Lung Cancer

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other, specify (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height (cm)
Item
Height (cm)
float
C0005890 (UMLS CUI [1])
Height (in)
Item
Height (in)
float
C0005890 (UMLS CUI [1])
Item
Temperature measurement site
integer
C0489453 (UMLS CUI [1])
Temperature site
Code List
Temperature measurement site
CL Item
Oral (1)
CL Item
Axillary (2)
CL Item
Tympanic (3)
CL Item
Rectal (4)
Item
Temperature Unit
integer
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Temperature Unit
Code List
Temperature Unit
CL Item
°C (1)
CL Item
°F (2)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Sitting Systolic Blood Pressure
Item
Sitting Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Sitting Diastolic Blood Pressure
Item
Sitting Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Item Group
History of Small Cell Lung Cancer
C0007131 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Date of the histological diagnosis of primary disease
Item
Date of the histological diagnosis of primary disease
date
C0679557 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0277554 (UMLS CUI [2])
Item
Stage of current disease
integer
C0699749 (UMLS CUI [1])
Stage of current disease
Code List
Stage of current disease
CL Item
Limited Disease (6)
CL Item
Extensive Disease (7)
Item Group
Previous Surgical Procedures for Small Cell Lung Cancer
C0543467 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
C0007131 (UMLS CUI-3)
Has the patient had any procedures for small cell lung cancer?
Item
Has the patient had any procedures for small cell lung cancer?
boolean
C0007131 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Item Group
Previous Surgical Procedures for Small Cell Lung Cancer
C0543467 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
C0007131 (UMLS CUI-3)
Surgical Procedure
Item
Surgical Procedure
text
C0543467 (UMLS CUI [1])
Surgical Procedure Date
Item
Surgical Procedure Date
date
C0543467 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Previous Radiotherapy for Small Cell Lung Cancer
C0007131 (UMLS CUI-1)
C0279134 (UMLS CUI-2)
Has the patient had any radiotherapy as previous therapy for small cell lung cancer?
Item
Has the patient had any radiotherapy as previous therapy for small cell lung cancer?
boolean
C0007131 (UMLS CUI [1,1])
C0279134 (UMLS CUI [1,2])
Has the patient had cranial irridation for treatment of CNS metastases?
Item
Has the patient had cranial irridation for treatment of CNS metastases?
boolean
C0205918 (UMLS CUI [1,1])
C3163632 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2])
Has the patient had prophylactic cranial irridation?
Item
Has the patient had prophylactic cranial irridation?
boolean
C1514496 (UMLS CUI [1])
Has the patient had consolidation to primary site?
Item
Has the patient had consolidation to primary site?
boolean
C3179017 (UMLS CUI [1,1])
C0449695 (UMLS CUI [1,2])
Has the patient had radiotherapy to other sites for palliation?
Item
Has the patient had radiotherapy to other sites for palliation?
boolean
C1522449 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0679251 (UMLS CUI [3])
Item Group
Previous Radiotherapy for Small Cell Lung Cancer
C0007131 (UMLS CUI-1)
C0279134 (UMLS CUI-2)
Field Site
Item
Field Site
text
C1997599 (UMLS CUI [1])
Cumulative Dose (x100 R)
Item
Cumulative Dose (x100 R)
float
C2986497 (UMLS CUI [1])
Radiation Start Date
Item
Radiation Start Date
date
C1522449 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Radiation End Date
Item
Radiation End Date
date
C1522449 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
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