Information:
Fel:
ID
42096
Beskrivning
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
Nyckelord
Versioner (1)
- 2021-04-08 2021-04-08 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
8 april 2021
DOI
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Licens
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)
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
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
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
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])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (M)
CL Item
Female (F)
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other, specify (4)
Height (cm)
Item
Height (cm)
float
C0005890 (UMLS CUI [1])
Height (in)
Item
Height (in)
float
C0005890 (UMLS CUI [1])
CL Item
Oral (1)
CL Item
Axillary (2)
CL Item
Tympanic (3)
CL Item
Rectal (4)
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])
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])
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)
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])
C0011008 (UMLS CUI [1,2])
C0277554 (UMLS CUI [2])
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)
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])
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)
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])
C0011008 (UMLS CUI [1,2])
Item Group
Previous Radiotherapy for Small Cell Lung Cancer
C0007131 (UMLS CUI-1)
C0279134 (UMLS CUI-2)
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])
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])
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])
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])
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)
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])
C0808070 (UMLS CUI [1,2])
Radiation End Date
Item
Radiation End Date
date
C1522449 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])