ID

42250

Beskrivning

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)
  1. 2021-04-18 2021-04-18 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

18 april 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Safety and efficacy of topotecan in patients with extensive-disease small-cell lung cancer (104864/410)

Engelsk

Screening - Prior an Concomitant Medication; Telephone Randomisation

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

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

Prior and Concomitant Medication

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

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.

Datatyp

boolean

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

Prior and Concomitant Medication

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

Trade Name preferred

Datatyp

text

Alias
UMLS CUI [1]
C0013227
Total Daily Dose
Beskrivning

Total Daily Dose

Datatyp

text

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

Administration Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Beskrivning

Medical Condition

Datatyp

text

Alias
UMLS CUI [1]
C0012634
Medication Start Date
Beskrivning

Medication Start Date

Datatyp

date

Alias
UMLS CUI [1]
C2826734
Medication End Date
Beskrivning

Medication End Date

Datatyp

date

Alias
UMLS CUI [1]
C2826744
Medication Continuing
Beskrivning

Medication Continuing

Datatyp

integer

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

Telephone Randomisation

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

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

Datatyp

boolean

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

Randomisation Number

Datatyp

text

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

Patient's randomised treatment arm

Datatyp

text

Alias
UMLS CUI [1]
C1522541
Tillbaka till toppen

Similar models

Screening - Prior an Concomitant Medication; Telephone Randomisation

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial