ID

35659

Description

Study ID: 103369 Clinical Study ID: 103369 Study Title: A Randomized Phase III Study of Cisplatin Versus Cisplatin plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: Topotecan Study Indication: Cancer 

Keywords

Versions (1)
  1. 3/14/19 3/14/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Cisplatin and Topotecan Recurrent on Persistent Carcinoma of the Cervix - 103369

English

Initial On Study Form

1 forms  
  1. StudyEvent: ODM
    1. Initial On Study Form
Administrative data
Description

Administrative data

Last Name
Description

Last Name

Data type

text

First Name
Description

First Name

Data type

text

GOG #
Description

Inst.,Prot.,Seq.

Data type

integer

Section
Description

Section

Data type

text

Tracking Informaion
Description

Tracking Informaion

Institution/Affiliate Name
Description

Institution/Affiliate Name

Data type

text

Treating Physician
Description

Treating Physician

Data type

text

Hospital Chart Number
Description

Hospital Chart Number

Data type

integer

Date of Birth
Description

m/d/y

Data type

date

Social Security Number
Description

Social Security Number

Data type

integer

Zip Code
Description

Zip Code

Data type

integer

Other GOG Patient No.
Description

if previously registered

Data type

integer

Method of Payment
Description

Payment Method

Data type

integer

If Other, please specify
Description

Specify Other

Data type

text

Demographic Information
Description

Demographic Information

Race
Description

Race

Data type

integer

If Other, please specify
Description

Specify Other

Data type

text

Height
Description

Height

Data type

integer

Measurement units
  • cm
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
Performance Status
Description

(Zubrod)

Data type

text

Previous Malignancy
Description

Previous Malignancy

Data type

boolean

Site of Previous Malignancy
Description

Site of Previous Malignancy

Data type

text

Date of Dx
Description

Date of Dx

Data type

date

Disease Information
Description

Disease Information

Primary Site
Description

Primary Site

Data type

integer

Date of Primary Diagnosis
Description

Primary Diagnosis Date

Data type

date

FIGO Stage
Description

FIGO Stage

Data type

text

Disease Status at Time of Registration
Description

Disease Status at Time of Registration

Data type

integer

Clinically/Radiologically Measurable?
Description

i.e. Evaluable for response

Data type

boolean

Method of Clinical/Radiological Measurement
Description

Clinical/Radiological Method Measurement

Data type

text

Brief clinical history
Description

clinical history

Data type

text

Cancer Therapy
Description

Cancer Therapy

Was any Prior Surgery performed?
Description

Prior Surgery

Data type

boolean

Date
Description

Date

Data type

date

Prior Hormonal
Description

Prior Hormonal

Data type

boolean

Specify
Description

Specify

Data type

text

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Prior Radiation
Description

Prior Radiation

Data type

boolean

Specify
Description

Specify

Data type

text

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Prior Immunological
Description

Prior Immunological

Data type

boolean

Specify
Description

Specify

Data type

text

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Prior Chemotherapy
Description

Prior Chemotherapy

Data type

boolean

Specify
Description

Specify

Data type

text

Start Date
Description

Start Date

Data type

boolean

End Date
Description

End Date

Data type

date

Number of Regimens
Description

Number of Regimens

Data type

integer

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Similar models

Initial On Study Form

1 forms
  1. StudyEvent: ODM
    1. Initial On Study Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Last Name
Item
Last Name
text
First Name
Item
First Name
text
Gynecologic Oncology Group Number
Item
GOG #
integer
Section
Item
Section
text
Item Group
Tracking Informaion
Institution/Affiliate Name
Item
Institution/Affiliate Name
text
Treating Physician
Item
Treating Physician
text
Hospital Chart Number
Item
Hospital Chart Number
integer
Birth Date
Item
Date of Birth
date
Social Security Number
Item
Social Security Number
integer
Zip Code
Item
Zip Code
integer
Other GOG Patient No.
Item
Other GOG Patient No.
integer
Item
Method of Payment
integer
Payment Method
Code List
Method of Payment
CL Item
1 0 Private (1)
CL Item
Medicare (2)
CL Item
Medicaid (3)
CL Item
Medicare/Private (4)
CL Item
Other government (5)
CL Item
Veteran's admin. (6)
CL Item
Self pay (7)
CL Item
No means (8)
CL Item
Other (9)
Specify Other
Item
If Other, please specify
text
Item Group
Demographic Information
Item
Race
integer
Race
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Hispanic (3)
CL Item
Asian (4)
CL Item
Native American (5)
CL Item
Native Hawaiian (6)
CL Item
Filipino (7)
CL Item
Eastern Indian (8)
CL Item
Other (9)
Specify Other
Item
If Other, please specify
text
Height
Item
Height
integer
Weight
Item
Weight
float
Performance status
Item
Performance Status
text
Previous Malignancy
Item
Previous Malignancy
boolean
Site of Previous Malignancy
Item
Site of Previous Malignancy
text
Date of Dx
Item
Date of Dx
date
Item Group
Disease Information
Item
Primary Site
integer
Primary Site
Code List
Primary Site
CL Item
Over (1)
CL Item
Peritoneum (2)
CL Item
Fallopian (3)
CL Item
Cervix (4)
CL Item
Vulva (5)
CL Item
Vagina (6)
CL Item
Endometrium (7)
CL Item
Uterine Sarcoma (8)
CL Item
GTD (9)
Primary Diagnosis Date
Item
Date of Primary Diagnosis
date
Item
FIGO Stage
text
FIGO Stage
Code List
FIGO Stage
CL Item
1A (1)
CL Item
1B (2)
CL Item
1C (3)
CL Item
2A (4)
CL Item
2B (5)
CL Item
2C (6)
CL Item
3A (7)
CL Item
3B (8)
CL Item
3C (9)
CL Item
4(A) (10)
CL Item
4B (11)
CL Item
N/A (12)
Item
Disease Status at Time of Registration
integer
Disease Status at Time of Registration
Code List
Disease Status at Time of Registration
CL Item
Primary (1)
CL Item
Persistent (post 1st line Rx) (2)
CL Item
Recurrent (3)
Clinical/Radiological Measurement
Item
Clinically/Radiologically Measurable?
boolean
Clinical/Radiological Method Measurement
Item
Method of Clinical/Radiological Measurement
text
clinical history
Item
Brief clinical history
text
Item Group
Cancer Therapy
Prior Surgery
Item
Was any Prior Surgery performed?
boolean
Date
Item
Date
date
Prior Hormonal
Item
Prior Hormonal
boolean
Specify
Item
Specify
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Prior Radiation
Item
Prior Radiation
boolean
Specify
Item
Specify
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Prior Immunological
Item
Prior Immunological
boolean
Specify
Item
Specify
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Prior Chemotherapy
Item
Prior Chemotherapy
boolean
Specify
Item
Specify
text
Start Date
Item
Start Date
boolean
End Date
Item
End Date
date
Number of Regimens
Item
Number of Regimens
integer
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