ID

37753

Beschrijving

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Trefwoorden

Versies (1)
  1. 21-08-19 21-08-19 -
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GlaxoSmithKline

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21 augustus 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

Engels

Topotecan Post-Study Minimal Follow-up Report

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Beschrijving

Study Coordinating Center, Identification number

Datatype

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beschrijving

Patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschrijving

Person Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Month of Report
Beschrijving

Month of Report

Alias
UMLS CUI-1
C1704685
UMLS CUI-2
C0439231
Please mark the appropriate box to indicate month of report.
Beschrijving

Follow-Up Report, Month

Datatype

text

Alias
UMLS CUI [1,1]
C1704685
UMLS CUI [1,2]
C0439231
Specify
Beschrijving

Follow-Up Report, Month

Datatype

text

Alias
UMLS CUI [1,1]
C1704685
UMLS CUI [1,2]
C0439231
Outcome
Beschrijving

Outcome

Alias
UMLS CUI-1
C1547647
Has the patient died?
Beschrijving

Patient Outcome, Cessation of life

Datatype

boolean

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0011065
If 'No', Date of last contact
Beschrijving

Patient Outcome, Date last contact

Datatype

date

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0805839
Was the patient lost to follow-up?
Beschrijving

Patient Outcome, Lost to follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C1302313
Has disease progressed?
Beschrijving

Patient Outcome, Disease Progression

Datatype

text

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0242656
Date of first documented disease progression since the Topotecan study conclusion
Beschrijving

Patient Outcome, Disease Progression, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0242656
UMLS CUI [1,3]
C0011008
Please mark box to indicate any post study cancer therapy received
Beschrijving

Patient Outcome, Cancer treatment

Datatype

text

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0920425
Date treatment started
Beschrijving

Patient Outcome, Cancer treatment, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C1547647
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0808070
Form D
Beschrijving

Form D

Alias
UMLS CUI-1
C0011065
Cause of Death
Beschrijving

Cause of Death

Datatype

text

Alias
UMLS CUI [1]
C0007465
Specify
Beschrijving

Cause of Death

Datatype

text

Alias
UMLS CUI [1]
C0007465
Date of death
Beschrijving

Date of death

Datatype

date

Alias
UMLS CUI [1]
C1148348
Was an autopsy performed?
Beschrijving

Cessation of life, Autopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0004398
If 'Yes' please summarize findings (include diagnosis)
Beschrijving

Cessation of life, Autopsy, Finding

Datatype

text

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C0004398
UMLS CUI [1,3]
C0243095
Investigator's Signature
Beschrijving

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature (I certify that I have reviewed the follow-up data and that all information is complete and accurate.)
Beschrijving

Investigator Signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

Investigator Signature, Date in time

Datatype

date

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

Topotecan Post-Study Minimal Follow-up Report

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Month of Report
C1704685 (UMLS CUI-1)
C0439231 (UMLS CUI-2)
Item
Please mark the appropriate box to indicate month of report.
text
C1704685 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
Follow-Up Report, Month
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)
Follow-Up Report, Month
Item
Specify
text
C1704685 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
Item Group
Outcome
C1547647 (UMLS CUI-1)
Patient Outcome, Cessation of life
Item
Has the patient died?
boolean
C1547647 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Patient Outcome, Date last contact
Item
If 'No', Date of last contact
date
C1547647 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Patient Outcome, Lost to follow-up
Item
Was the patient lost to follow-up?
boolean
C1547647 (UMLS CUI [1,1])
C1302313 (UMLS CUI [1,2])
Item
Has disease progressed?
text
C1547647 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
Patient Outcome, Disease Progression
Code List
Has disease progressed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (if patient progressed on study) (3)
Patient Outcome, Disease Progression, Date in time
Item
Date of first documented disease progression since the Topotecan study conclusion
date
C1547647 (UMLS CUI [1,1])
C0242656 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Please mark box to indicate any post study cancer therapy received
text
C1547647 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Patient Outcome, Cancer treatment
Code List
Please mark box to indicate any post study cancer therapy received
CL Item
None (1)
CL Item
Chemotherapy (2)
CL Item
Surgery (3)
CL Item
Hormonal (4)
CL Item
Immunotherapy (5)
Patient Outcome, Cancer treatment, Start Date
Item
Date treatment started
date
C1547647 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
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 (1)
CL Item
Other, specify (2)
Cause of Death
Item
Specify
text
C0007465 (UMLS CUI [1])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Cessation of life, Autopsy
Item
Was an autopsy performed?
boolean
C0011065 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
Cessation of life, Autopsy, Finding
Item
If 'Yes' please summarize findings (include diagnosis)
text
C0011065 (UMLS CUI [1,1])
C0004398 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator's Signature (I certify that I have reviewed the follow-up data and that all information is complete and accurate.)
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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