ID

35661

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 or Persistent Carcinoma of the Cervix - 103369

English

Pre-Treatment Summary Sheet

1 forms  
Administrative data
Description

Administrative data

Last Name
Description

Last Name

Data type

text

First Name
Description

First Name

Data type

text

Hospital Number
Description

Hospital Number

Data type

integer

Institution
Description

Institution

Data type

text

Affiliate
Description

Affiliate

Data type

text

Treating Physician
Description

Treating Physician

Data type

text

Protocol Number
Description

Protocol Number

Data type

integer

Sequence Number
Description

Sequence Number

Data type

integer

Physical Examination
Description

Physical Examination

Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
Height
Description

Height

Data type

integer

Measurement units
  • cm
cm
Surface Area
Description

Surface Area

Data type

integer

Measurement units
  • m2
m2
Laboratory Findings
Description

Laboratory Findings

HCT
Description

HCT

Data type

integer

Measurement units
  • %
%
WBC
Description

WBC

Data type

integer

Platelets
Description

Platelets

Data type

integer

BUN
Description

BUN

Data type

integer

Measurement units
  • mg %
mg %
Creatinine
Description

Creatinine

Data type

integer

Measurement units
  • mg %
mg %
SGOT
Description

SGOT

Data type

integer

Measurement units
  • IU/ml
IU/ml
Bilirubin Total
Description

Bilirubin Total

Data type

integer

Measurement units
  • mg %
mg %
Bilirubin Direkt
Description

Bilirubin Direkt

Data type

integer

Measurement units
  • mg %
mg %
Alk-P'tase
Description

alkaline phosphatase

Data type

integer

Measurement units
  • IU/ml
IU/ml
Chest X-Ray
Description

Chest X-Ray

Data type

text

Findings
Description

Findings

Data type

text

EKG
Description

EKG

Data type

integer

Findings
Description

Findings

Data type

text

Cystoscopy
Description

Cystoscopy

Data type

integer

Findings
Description

Findings

Data type

text

Proctoscopy
Description

Proctoscopy

Data type

integer

Findings
Description

Findings

Data type

text

IVP
Description

IVP

Data type

integer

FIndings
Description

FIndings

Data type

text

Other
Description

Other

Data type

text

Findings
Description

Findings

Data type

text

Measurable Mass
Description

Measurable Mass

If no Measurable Mass, tick "Yes"
Description

Measurable Mass

Data type

boolean

Measurable Mass Location #1
Description

Locations of Mass # 1

Data type

text

Size of Mass #1
Description

Size of Mass #1

Data type

integer

Measurement units
  • cm
cm
Measurable Mass Location #2
Description

Location of Mass #2

Data type

text

Size of Mass #2
Description

Size of Mass #2

Data type

integer

Measurement units
  • cm
cm
Performance Grade
Description

Performance Grade

Record the Performance Grade
Description

Performance Grade

Data type

text

Record the Performance Grade - Karnofsky Scale
Description

Performance Grade - Karnofsky Scale

Data type

text

Performance Grade (description)
Description

Performance Grade (description)

Data type

text

Brief Clinical History
Description

Clinical History

Data type

text

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Similar models

Pre-Treatment Summary Sheet

1 forms
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
Hospital Number
Item
Hospital Number
integer
Institution
Item
Institution
text
Affiliate
Item
Affiliate
text
Treating Physician
Item
Treating Physician
text
Protocol Number
Item
Protocol Number
integer
Sequence Number
Item
Sequence Number
integer
Item Group
Physical Examination
Weight
Item
Weight
float
Height
Item
Height
integer
Surface Area
Item
Surface Area
integer
Item Group
Laboratory Findings
HCT
Item
HCT
integer
WBC
Item
WBC
integer
Platelets
Item
Platelets
integer
BUN
Item
BUN
integer
Creatinine
Item
Creatinine
integer
SGOT
Item
integer
Bilirubin Total
Item
Bilirubin Total
integer
Bilirubin Direkt
Item
Bilirubin Direkt
integer
alkaline phosphatase
Item
Alk-P'tase
integer
Item
Chest X-Ray
text
Chest X-Ray
Code List
Chest X-Ray
CL Item
Normal (1)
CL Item
Abnormal (if abnormal, list findings) (2)
CL Item
Not Applicable (3)
Findings
Item
Findings
text
Item
EKG
integer
EKG
Code List
EKG
CL Item
Normal (1)
CL Item
Abnormal (if abnormal, list findings) (2)
CL Item
Not Applicable (3)
Findings
Item
Findings
text
Item
Cystoscopy
integer
Cystoscopy
Code List
Cystoscopy
CL Item
Normal (1)
CL Item
Abnormal (if abnormal, list findings) (2)
CL Item
Not Applicable (3)
Findings
Item
Findings
text
Item
Proctoscopy
integer
Proctoscopy
Code List
Proctoscopy
CL Item
Normal (1)
CL Item
Abnormal (if abnormal, list findings) (2)
CL Item
Not Applicable (3)
Findings
Item
Findings
text
Item
IVP
integer
IVP
Code List
IVP
CL Item
Normal (1)
CL Item
Abnormal (if abnormal, list findings) (2)
CL Item
Not Applicable (3)
FIndings
Item
FIndings
text
Item
Other
text
Other
Code List
Other
CL Item
Normal (1)
CL Item
Abnormal (if abnormal, list findings) (2)
CL Item
Not Applicable (3)
Findings
Item
Findings
text
Item Group
Measurable Mass
Measurable Mass
Item
If no Measurable Mass, tick "Yes"
boolean
Locations of Mass # 1
Item
Measurable Mass Location #1
text
Size of Mass #1
Item
Size of Mass #1
integer
Location of Mass #2
Item
Measurable Mass Location #2
text
Size of Mass #2
Item
Size of Mass #2
integer
Item Group
Performance Grade
Item
Record the Performance Grade
text
Performance Grade
Code List
Record the Performance Grade
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Item
Record the Performance Grade - Karnofsky Scale
text
Performance Grade - Karnofsky Scale
Code List
Record the Performance Grade - Karnofsky Scale
CL Item
90-100 (1)
CL Item
70-80 (2)
CL Item
50-60 (3)
CL Item
30-40 (4)
CL Item
10-20 (5)
Item
Performance Grade (description)
text
Performance Grade (description)
Code List
Performance Grade (description)
CL Item
Fully active (1)
CL Item
Restricted in physically strenuous activities, but ambulatory (2)
CL Item
Ambulatory, capable of self-care; unable to work; up 50%of waking hours (3)
CL Item
Limited self-care: confined to bed or chair 50% of waking hours (4)
CL Item
Completely disabled; no self-care (5)
Clinical History
Item
Brief Clinical History
text
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