ID
42285
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
Trefwoorden
Versies (2)
- 04-05-21 04-05-21 -
- 04-05-21 04-05-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 mei 2021
DOI
Voor een aanvraag inloggen.
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)
Form D; Patient Symptom Assessment; Topotecan Post-Study Minimal Follow-Up Report (Month of Report; Outcome, Form D)
Beschrijving
Form D
Alias
- UMLS CUI-1
- C0011065
Beschrijving
Call SB and report death.
Datatype
text
Alias
- UMLS CUI [1]
- C0007465
Beschrijving
Specify other cause of death
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Date of Death
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
If "Yes" please summarise findings (include diagnosis)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschrijving
Include diagnosis
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0011900
Beschrijving
Physician's Signature
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0031831
Beschrijving
Signature Date
Datatype
date
Alias
- UMLS CUI [1]
- C0807937
Beschrijving
Patient Symptom Assessment
Alias
- UMLS CUI-1
- C3494437
Beschrijving
If Course 1, please indicate the visit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0750729
Beschrijving
If Course 1, please indicate the visit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0545082
Beschrijving
Date of Assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Patient Symptom Assessment
Alias
- UMLS CUI-1
- C3494437
Beschrijving
Symptom
Datatype
integer
Alias
- UMLS CUI [1]
- C1457887
Beschrijving
Symptom Intensity
Datatype
integer
Alias
- UMLS CUI [1]
- C0518690
Beschrijving
Topotecan Post-Study Minimal Follow-Up Report: Month of Report
Alias
- UMLS CUI-1
- C1704685
- UMLS CUI-2
- C0146224
- UMLS CUI-3
- C0439231
- UMLS CUI-4
- C0684224
Beschrijving
Please mark the appropriate box to indicate month of report
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439231
- UMLS CUI [1,2]
- C0684224
Beschrijving
Specify Other month
Datatype
text
Alias
- UMLS CUI [1,1]
- C1518544
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Topotecan Post-Study Minimal Follow-Up Report: Outcome
Alias
- UMLS CUI-1
- C1704685
- UMLS CUI-2
- C0146224
- UMLS CUI-3
- C1547647
Beschrijving
Has the patient died?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschrijving
i.e. visit, telephone
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
Was the patient lost to follow-up?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1302313
Beschrijving
Has disease progressed?
Datatype
integer
Alias
- UMLS CUI [1]
- C1335499
Beschrijving
Date of first documented disease progression since the Topotecan study conclusion
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [2,1]
- C1707478
- UMLS CUI [2,2]
- C0146224
Beschrijving
Please mark box to indicate any post study cancer therapy received
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1882428
- UMLS CUI [1,2]
- C0920425
Beschrijving
Chemotherapy - date treatment started
Datatype
date
Alias
- UMLS CUI [1,1]
- C1531783
- UMLS CUI [1,2]
- C0392920
Beschrijving
Radiotherapy - date treatment started
Datatype
date
Alias
- UMLS CUI [1,1]
- C1531783
- UMLS CUI [1,2]
- C0392920
Beschrijving
Surgery - date treatment started
Datatype
date
Alias
- UMLS CUI [1,1]
- C3173309
- UMLS CUI [1,2]
- C0543467
Beschrijving
Hormonal - date treatment started
Datatype
date
Alias
- UMLS CUI [1,1]
- C1531783
- UMLS CUI [1,2]
- C0279025
Beschrijving
Immunotherapy - date treatment started
Datatype
date
Alias
- UMLS CUI [1,1]
- C1531783
- UMLS CUI [1,2]
- C0021083
Beschrijving
Topotecan Post-Study Minimal Follow-Up Report: Form D - (To be completed if the patient died)
Alias
- UMLS CUI-1
- C1704685
- UMLS CUI-2
- C0146224
- UMLS CUI-3
- C0011065
Beschrijving
Cause of Death
Datatype
text
Alias
- UMLS CUI [1]
- C0007465
Beschrijving
Specify other Cause of Death
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Beschrijving
Date of Death
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
If "Yes", summarise findings
Datatype
boolean
Alias
- UMLS CUI [1]
- C0004398
Beschrijving
Include diagnosis.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Beschrijving
Topotecan Post-Study Minimal Follow-Up Report: Investigator's Signature
Alias
- UMLS CUI-1
- C1704685
- UMLS CUI-2
- C0146224
- UMLS CUI-3
- C2346576
Beschrijving
I certify that I have reviewed the follow-up data and that all information is complete and accurate.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator's Signature Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Form D; Patient Symptom Assessment; Topotecan Post-Study Minimal Follow-Up Report (Month of Report; Outcome, Form D)
C0019994 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0243095 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0031831 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
C0146224 (UMLS CUI-2)
C0439231 (UMLS CUI-3)
C0684224 (UMLS CUI-4)
C0684224 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0146224 (UMLS CUI-2)
C1547647 (UMLS CUI-3)
C0242656 (UMLS CUI [1,2])
C1707478 (UMLS CUI [2,1])
C0146224 (UMLS CUI [2,2])
C0920425 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,2])
C0279025 (UMLS CUI [1,2])
C0021083 (UMLS CUI [1,2])
C0146224 (UMLS CUI-2)
C0011065 (UMLS CUI-3)
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0243095 (UMLS CUI [1,2])
C0146224 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])