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