ID

42285

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 (2)
  1. 2021-05-04 2021-05-04 -
  2. 2021-05-04 2021-05-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 maj 2021

DOI

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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)

Engelsk

Form D; Patient Symptom Assessment; Topotecan Post-Study Minimal Follow-Up Report (Month of Report; Outcome, Form D)

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Centre Number
Beskrivning

Centre Number

Datatyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Form D
Beskrivning

Form D

Alias
UMLS CUI-1
C0011065
Cause of Death
Beskrivning

Call SB and report death.

Datatyp

text

Alias
UMLS CUI [1]
C0007465
Specify other cause of death
Beskrivning

Specify other cause of death

Datatyp

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Date of Death
Beskrivning

Date of Death

Datatyp

date

Alias
UMLS CUI [1]
C1148348
Was a post-mortem done?
Beskrivning

If "Yes" please summarise findings (include diagnosis)

Datatyp

boolean

Alias
UMLS CUI [1]
C0004398
Please summarise autopsy findings
Beskrivning

Include diagnosis

Datatyp

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0011900
Physician's Signature
Beskrivning

Physician's Signature

Datatyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C0031831
Signature Date
Beskrivning

Signature Date

Datatyp

date

Alias
UMLS CUI [1]
C0807937
Patient Symptom Assessment
Beskrivning

Patient Symptom Assessment

Alias
UMLS CUI-1
C3494437
Course Number
Beskrivning

If Course 1, please indicate the visit

Datatyp

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0750729
If Course 1, please indicate the visit
Beskrivning

If Course 1, please indicate the visit

Datatyp

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0545082
Date of Assessment
Beskrivning

Date of Assessment

Datatyp

date

Alias
UMLS CUI [1]
C2985720
Patient Symptom Assessment
Beskrivning

Patient Symptom Assessment

Alias
UMLS CUI-1
C3494437
Symptom
Beskrivning

Symptom

Datatyp

integer

Alias
UMLS CUI [1]
C1457887
Symptom Intensity
Beskrivning

Symptom Intensity

Datatyp

integer

Alias
UMLS CUI [1]
C0518690
Topotecan Post-Study Minimal Follow-Up Report: Month of Report
Beskrivning

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
Please mark the appropriate box to indicate month of report
Beskrivning

Please mark the appropriate box to indicate month of report

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439231
UMLS CUI [1,2]
C0684224
Specify Other month
Beskrivning

Specify Other month

Datatyp

text

Alias
UMLS CUI [1,1]
C1518544
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Topotecan Post-Study Minimal Follow-Up Report: Outcome
Beskrivning

Topotecan Post-Study Minimal Follow-Up Report: Outcome

Alias
UMLS CUI-1
C1704685
UMLS CUI-2
C0146224
UMLS CUI-3
C1547647
Has the patient died?
Beskrivning

Has the patient died?

Datatyp

boolean

Alias
UMLS CUI [1]
C0011065
If patient died, enter date of last patient contact
Beskrivning

i.e. visit, telephone

Datatyp

date

Alias
UMLS CUI [1]
C0805839
Was the patient lost to follow-up?
Beskrivning

Was the patient lost to follow-up?

Datatyp

boolean

Alias
UMLS CUI [1]
C1302313
Has disease progressed?
Beskrivning

Has disease progressed?

Datatyp

integer

Alias
UMLS CUI [1]
C1335499
Date of first documented disease progression since the Topotecan study conclusion
Beskrivning

Date of first documented disease progression since the Topotecan study conclusion

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0242656
UMLS CUI [2,1]
C1707478
UMLS CUI [2,2]
C0146224
Please mark box to indicate any post study cancer therapy received
Beskrivning

Please mark box to indicate any post study cancer therapy received

Datatyp

integer

Alias
UMLS CUI [1,1]
C1882428
UMLS CUI [1,2]
C0920425
Chemotherapy - date treatment started
Beskrivning

Chemotherapy - date treatment started

Datatyp

date

Alias
UMLS CUI [1,1]
C1531783
UMLS CUI [1,2]
C0392920
Radiotherapy - date treatment started
Beskrivning

Radiotherapy - date treatment started

Datatyp

date

Alias
UMLS CUI [1,1]
C1531783
UMLS CUI [1,2]
C0392920
Surgery - date treatment started
Beskrivning

Surgery - date treatment started

Datatyp

date

Alias
UMLS CUI [1,1]
C3173309
UMLS CUI [1,2]
C0543467
Hormonal - date treatment started
Beskrivning

Hormonal - date treatment started

Datatyp

date

Alias
UMLS CUI [1,1]
C1531783
UMLS CUI [1,2]
C0279025
Immunotherapy - date treatment started
Beskrivning

Immunotherapy - date treatment started

Datatyp

date

Alias
UMLS CUI [1,1]
C1531783
UMLS CUI [1,2]
C0021083
Topotecan Post-Study Minimal Follow-Up Report: Form D - (To be completed if the patient died)
Beskrivning

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
Cause of Death
Beskrivning

Cause of Death

Datatyp

text

Alias
UMLS CUI [1]
C0007465
Specify other Cause of Death
Beskrivning

Specify other Cause of Death

Datatyp

text

Alias
UMLS CUI [1,1]
C0007465
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Date of Death
Beskrivning

Date of Death

Datatyp

date

Alias
UMLS CUI [1]
C1148348
Was a post mortem done?
Beskrivning

If "Yes", summarise findings

Datatyp

boolean

Alias
UMLS CUI [1]
C0004398
Summarise autopsy findings
Beskrivning

Include diagnosis.

Datatyp

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0243095
Topotecan Post-Study Minimal Follow-Up Report: Investigator's Signature
Beskrivning

Topotecan Post-Study Minimal Follow-Up Report: Investigator's Signature

Alias
UMLS CUI-1
C1704685
UMLS CUI-2
C0146224
UMLS CUI-3
C2346576
Investigator's Signature
Beskrivning

I certify that I have reviewed the follow-up data and that all information is complete and accurate.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's Signature Date
Beskrivning

Investigator's Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Form D; Patient Symptom Assessment; Topotecan Post-Study Minimal Follow-Up Report (Month of Report; Outcome, Form D)

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Form D
C0011065 (UMLS CUI-1)
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Cause of Death
Code List
Cause of Death
CL Item
Progressive Disease (P)
CL Item
Toxicity: Haematologic (Complete Adverse Experience form) (H)
CL Item
Toxicity: Non-Haematologic (Complete Adverse Experience form) (N)
CL Item
Other, specify (Complete Adverse Experience form) (O)
Specify other cause of death
Item
Specify other cause of death
text
C0007465 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Was a post-mortem done?
Item
Was a post-mortem done?
boolean
C0004398 (UMLS CUI [1])
Please summarise autopsy findings
Item
Please summarise autopsy findings
text
C0004398 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Physician's Signature
Item
Physician's Signature
text
C1519316 (UMLS CUI [1,1])
C0031831 (UMLS CUI [1,2])
Signature Date
Item
Signature Date
date
C0807937 (UMLS CUI [1])
Item Group
Patient Symptom Assessment
C3494437 (UMLS CUI-1)
Course Number
Item
Course Number
integer
C0237753 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
If Course 1, please indicate the visit
integer
C0750729 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
If Course 1, please indicate the visit
Code List
If Course 1, please indicate the visit
CL Item
Screening (1)
CL Item
Prenext Course (2)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Patient Symptom Assessment
C3494437 (UMLS CUI-1)
Item
Symptom
integer
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Shortness of Breath (1)
CL Item
Cough (2)
CL Item
Chest pain (3)
CL Item
Coughing up blood (4)
CL Item
Loss of appetite (5)
CL Item
Interference with sleep (6)
CL Item
Hoarseness (7)
CL Item
Fatigue (8)
CL Item
Interference with daily activities (9)
Item
Symptom Intensity
integer
C0518690 (UMLS CUI [1])
Symptom Intensity
Code List
Symptom Intensity
CL Item
Not at all (1)
CL Item
A Little (2)
CL Item
Quite A Bit (3)
CL Item
Very Much (4)
Item Group
Topotecan Post-Study Minimal Follow-Up Report: Month of Report
C1704685 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
C0439231 (UMLS CUI-3)
C0684224 (UMLS CUI-4)
Item
Please mark the appropriate box to indicate month of report
integer
C0439231 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
Please mark the appropriate box to indicate month of report
Code List
Please mark the appropriate box to indicate month of report
CL Item
3 (1)
CL Item
6 (2)
CL Item
9 (3)
CL Item
12 (4)
CL Item
15 (5)
CL Item
18 (6)
CL Item
21 (7)
CL Item
24 (8)
CL Item
Other, specify (9)
Specify Other month
Item
Specify Other month
text
C1518544 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item Group
Topotecan Post-Study Minimal Follow-Up Report: Outcome
C1704685 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
C1547647 (UMLS CUI-3)
Has the patient died?
Item
Has the patient died?
boolean
C0011065 (UMLS CUI [1])
If patient died, enter date of last patient contact
Item
If patient died, enter date of last patient contact
date
C0805839 (UMLS CUI [1])
Was the patient lost to follow-up?
Item
Was the patient lost to follow-up?
boolean
C1302313 (UMLS CUI [1])
Item
Has disease progressed?
integer
C1335499 (UMLS CUI [1])
Has disease progressed?
Code List
Has disease progressed?
CL Item
No (1)
CL Item
Yes (2)
CL Item
N/A (If patient progressed on study) (3)
Date of first documented disease progression since the Topotecan study conclusion
Item
Date of first documented disease progression since the Topotecan study conclusion
date
C0011008 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C1707478 (UMLS CUI [2,1])
C0146224 (UMLS CUI [2,2])
Item
Please mark box to indicate any post study cancer therapy received
integer
C1882428 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Please mark box to indicate any post study cancer therapy received
Code List
Please mark box to indicate any post study cancer therapy received
CL Item
None (1)
CL Item
Chemotherapy (2)
CL Item
Radiotherapy (3)
CL Item
Surgery (4)
CL Item
Hormonal (5)
CL Item
Immunotherapy (6)
Chemotherapy - date treatment started
Item
Chemotherapy - date treatment started
date
C1531783 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Radiotherapy - date treatment started
Item
Radiotherapy - date treatment started
date
C1531783 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Surgery - date treatment started
Item
Surgery - date treatment started
date
C3173309 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Hormonal - date treatment started
Item
Hormonal - date treatment started
date
C1531783 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
Immunotherapy - date treatment started
Item
Immunotherapy - date treatment started
date
C1531783 (UMLS CUI [1,1])
C0021083 (UMLS CUI [1,2])
Item Group
Topotecan Post-Study Minimal Follow-Up Report: Form D - (To be completed if the patient died)
C1704685 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
C0011065 (UMLS CUI-3)
Item
Cause of Death
text
C0007465 (UMLS CUI [1])
Cause of Death
Code List
Cause of Death
CL Item
Progressive Disease (P)
CL Item
Other, specify (O)
Specify other Cause of Death
Item
Specify other Cause of Death
text
C0007465 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Date of Death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Was a post mortem done?
Item
Was a post mortem done?
boolean
C0004398 (UMLS CUI [1])
Summarise autopsy findings
Item
Summarise autopsy findings
text
C0004398 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item Group
Topotecan Post-Study Minimal Follow-Up Report: Investigator's Signature
C1704685 (UMLS CUI-1)
C0146224 (UMLS CUI-2)
C2346576 (UMLS CUI-3)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Investigator's Signature Date
Item
Investigator's Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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