ID

42250

Beschrijving

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

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Versies (1)
  1. 18-04-21 18-04-21 -
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GlaxoSmithKline

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18 april 2021

DOI

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Licentie

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)

Engels

Screening - Prior an Concomitant Medication; Telephone Randomisation

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beschrijving

Patient Number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beschrijving

Patient Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Prior and Concomitant Medication
Beschrijving

Prior and Concomitant Medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Has the patient taken any medication in the past 30 years?
Beschrijving

If "Yes" please record details below. Where appropriate, medical conditions should be recorded in the Significant Medical/ Surgical History and Physical examination section, utilising the same terminology. Record PM for prophylactic treatment with the Medical Condition for prophylactically administered medications.

Datatype

boolean

Alias
UMLS CUI [1]
C2826257
Prior and Concomitant Medication
Beschrijving

Prior and Concomitant Medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Drug Name
Beschrijving

Trade Name preferred

Datatype

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Beschrijving

Total Daily Dose

Datatype

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Administration Route
Beschrijving

Administration Route

Datatype

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Beschrijving

Medical Condition

Datatype

text

Alias
UMLS CUI [1]
C0012634
Medication Start Date
Beschrijving

Medication Start Date

Datatype

date

Alias
UMLS CUI [1]
C2826734
Medication End Date
Beschrijving

Medication End Date

Datatype

date

Alias
UMLS CUI [1]
C2826744
Medication Continuing
Beschrijving

Medication Continuing

Datatype

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Telephone Randomisation
Beschrijving

Telephone Randomisation

Alias
UMLS CUI-1
C0039457
UMLS CUI-2
C0034656
Has the patient been registered and randomised using the centralised telephone system?
Beschrijving

If "Yes" please record the patient's randomisation number

Datatype

boolean

Alias
UMLS CUI [1]
C1514821
UMLS CUI [2]
C0034656
UMLS CUI [3]
C0039457
Randomisation Number
Beschrijving

Randomisation Number

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Patient's randomised treatment arm
Beschrijving

Patient's randomised treatment arm

Datatype

text

Alias
UMLS CUI [1]
C1522541
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Similar models

Screening - Prior an Concomitant Medication; Telephone Randomisation

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Item Group
Prior and Concomitant Medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Has the patient taken any medication in the past 30 years?
Item
Has the patient taken any medication in the past 30 years?
boolean
C2826257 (UMLS CUI [1])
Item Group
Prior and Concomitant Medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Administration Route
Item
Administration Route
text
C0013153 (UMLS CUI [1])
Medical Condition
Item
Medical Condition
text
C0012634 (UMLS CUI [1])
Medication Start Date
Item
Medication Start Date
date
C2826734 (UMLS CUI [1])
Medication End Date
Item
Medication End Date
date
C2826744 (UMLS CUI [1])
Item
Medication Continuing
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Medication Continuing
Code List
Medication Continuing
CL Item
Medication Continuing (1)
Item Group
Telephone Randomisation
C0039457 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
Has the patient been registered and randomised using the centralised telephone system?
Item
Has the patient been registered and randomised using the centralised telephone system?
boolean
C1514821 (UMLS CUI [1])
C0034656 (UMLS CUI [2])
C0039457 (UMLS CUI [3])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Patient's randomised treatment arm
text
C1522541 (UMLS CUI [1])
Patient's randomised treatment arm
Code List
Patient's randomised treatment arm
CL Item
Regimen 1 - Topotecan for 5 Days and Cisplatin on Day 5 (TC)
CL Item
Regimen 2 - Topotecan for 5 Days and Etoposide for 5 Days (TE)
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