ID

37142

Descripción

Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Palabras clave

Versiones (1)
  1. 4/7/19 4/7/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de julio de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

Inglés

Post-Study Minimal Follow-Up Report

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Center Number
Descripción

Institution name, Identifier

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Descripción

Patient number

Tipo de datos

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Descripción

Person Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Month of Report
Descripción

Month of Report

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

Follow-Up Report, Month

Tipo de datos

text

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

Follow-Up Report, Month

Tipo de datos

text

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

Outcome

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

Cessation of life

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011065
If No, Date of last contact
Descripción

Date last contact

Tipo de datos

date

Alias
UMLS CUI [1]
C0805839
Has disease progressed?
Descripción

Disease Progression

Tipo de datos

text

Alias
UMLS CUI [1]
C0242656
Date of first documented disease progression since the topotecan study conclusion
Descripción

Disease Progression, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0808070
Please mark box to indicate any post study cancer therapy received
Descripción

cancer treatment, post, Clinical Trials

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0032756
UMLS CUI [1,3]
C0008976
date treatment started
Descripción

cancer treatment, post, Clinical Trials, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0032756
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0808070
Form D
Descripción

Form D

Alias
UMLS CUI-1
C0011065
Cause of Death
Descripción

Cause of death

Tipo de datos

text

Alias
UMLS CUI [1]
C0007465
Cause of Death - Specify
Descripción

Cause of death

Tipo de datos

text

Alias
UMLS CUI [1]
C0007465
Date of Death
Descripción

Date of death

Tipo de datos

date

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

Autopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004398
If ‘Yes’ please summarize findings (include diagnosis)
Descripción

Autopsy, Finding, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0004398
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0011900
Investigator's Signature
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 [1,1]
C0011065
UMLS CUI [1,2]
C2346576
Date
Descripción

Cessation of life, Investigator Signature, Date in time

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C2346576
UMLS CUI [1,3]
C0011008
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Similar models

Post-Study Minimal Follow-Up Report

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Institution name, Identifier
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (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 b (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)
Cessation of life
Item
Has the patient died?
boolean
C0011065 (UMLS CUI [1])
Date last contact
Item
If No, Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Has disease progressed?
text
C0242656 (UMLS CUI [1])
Disease Progression
Code List
Has disease progressed?
CL Item
No (1)
CL Item
Yes (2)
CL Item
N/A (3)
Disease Progression, Start Date
Item
Date of first documented disease progression since the topotecan study conclusion
date
C0242656 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Please mark box to indicate any post study cancer therapy received
text
C0920425 (UMLS CUI [1,1])
C0032756 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
cancer treatment, post, Clinical Trials
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)
cancer treatment, post, Clinical Trials, Start Date
Item
date treatment started
date
C0920425 (UMLS CUI [1,1])
C0032756 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
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
Cause of Death - Specify
text
C0007465 (UMLS CUI [1])
Date of death
Item
Date of Death
date
C1148348 (UMLS CUI [1])
Autopsy
Item
Was an autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Autopsy, Finding, Diagnosis
Item
If ‘Yes’ please summarize findings (include diagnosis)
text
C0004398 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Cessation of life, Investigator Signature
Item
Investigator's Signature
text
C0011065 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Cessation of life, Investigator Signature, Date in time
Item
Date
date
C0011065 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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