ID
42285
Descripción
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
Palabras clave
Versiones (2)
- 4/5/21 4/5/21 -
- 4/5/21 4/5/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
4 de mayo de 2021
DOI
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Licencia
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)
Descripción
Form D
Alias
- UMLS CUI-1
- C0011065
Descripción
Call SB and report death.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0007465
Descripción
Specify other cause of death
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Descripción
Date of Death
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
If "Yes" please summarise findings (include diagnosis)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0004398
Descripción
Include diagnosis
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
- UMLS CUI [1,3]
- C0011900
Descripción
Physician's Signature
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519316
- UMLS CUI [1,2]
- C0031831
Descripción
Signature Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0807937
Descripción
Patient Symptom Assessment
Alias
- UMLS CUI-1
- C3494437
Descripción
If Course 1, please indicate the visit
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0750729
Descripción
If Course 1, please indicate the visit
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0545082
Descripción
Date of Assessment
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985720
Descripción
Patient Symptom Assessment
Alias
- UMLS CUI-1
- C3494437
Descripción
Symptom
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1457887
Descripción
Symptom Intensity
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0518690
Descripción
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
Descripción
Please mark the appropriate box to indicate month of report
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439231
- UMLS CUI [1,2]
- C0684224
Descripción
Specify Other month
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1518544
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C2348235
Descripción
Topotecan Post-Study Minimal Follow-Up Report: Outcome
Alias
- UMLS CUI-1
- C1704685
- UMLS CUI-2
- C0146224
- UMLS CUI-3
- C1547647
Descripción
Has the patient died?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0011065
Descripción
i.e. visit, telephone
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0805839
Descripción
Was the patient lost to follow-up?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1302313
Descripción
Has disease progressed?
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1335499
Descripción
Date of first documented disease progression since the Topotecan study conclusion
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0242656
- UMLS CUI [2,1]
- C1707478
- UMLS CUI [2,2]
- C0146224
Descripción
Please mark box to indicate any post study cancer therapy received
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1882428
- UMLS CUI [1,2]
- C0920425
Descripción
Chemotherapy - date treatment started
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1531783
- UMLS CUI [1,2]
- C0392920
Descripción
Radiotherapy - date treatment started
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1531783
- UMLS CUI [1,2]
- C0392920
Descripción
Surgery - date treatment started
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3173309
- UMLS CUI [1,2]
- C0543467
Descripción
Hormonal - date treatment started
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1531783
- UMLS CUI [1,2]
- C0279025
Descripción
Immunotherapy - date treatment started
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1531783
- UMLS CUI [1,2]
- C0021083
Descripción
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
Descripción
Cause of Death
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0007465
Descripción
Specify other Cause of Death
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Descripción
Date of Death
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
If "Yes", summarise findings
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0004398
Descripción
Include diagnosis.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Descripción
Topotecan Post-Study Minimal Follow-Up Report: Investigator's Signature
Alias
- UMLS CUI-1
- C1704685
- UMLS CUI-2
- C0146224
- UMLS CUI-3
- C2346576
Descripción
I certify that I have reviewed the follow-up data and that all information is complete and accurate.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator's Signature Date
Tipo de datos
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])