ID

37142

Description

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

Keywords

Versions (1)
  1. 7/4/19 7/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 4, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

English

Post-Study Minimal Follow-Up Report

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Center Number
Description

Institution name, Identifier

Data type

integer

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

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Month of Report
Description

Month of Report

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

Follow-Up Report, Month

Data type

text

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

Follow-Up Report, Month

Data type

text

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

Outcome

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

Cessation of life

Data type

boolean

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

Date last contact

Data type

date

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

Disease Progression

Data type

text

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

Disease Progression, Start Date

Data type

date

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

cancer treatment, post, Clinical Trials

Data type

text

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

cancer treatment, post, Clinical Trials, Start Date

Data type

date

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

Form D

Alias
UMLS CUI-1
C0011065
Cause of Death
Description

Cause of death

Data type

text

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

Cause of death

Data type

text

Alias
UMLS CUI [1]
C0007465
Date of Death
Description

Date of death

Data type

date

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

Autopsy

Data type

boolean

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

Autopsy, Finding, Diagnosis

Data type

text

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

Cessation of life, Investigator Signature, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0011065
UMLS CUI [1,2]
C2346576
UMLS CUI [1,3]
C0011008
Back to the top of the page

Similar models

Post-Study Minimal Follow-Up Report

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial