ID

35662

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

Drug Dose Form

1 forms  
  1. StudyEvent: ODM
    1. Drug Dose 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

integer

Investigational Product
Description

Investigational Product

Date of Course
Description

Date of Course

Data type

date

Course Number
Description

Course Number

Data type

integer

Course Timing
Description

Course Timing

Data type

text

Number of delayed days
Description

Number of delayed days

Data type

integer

Report reason for delay
Description

Comment

Data type

text

Drug Dose
Description

Drug Dose

Sequence Number
Description

Sequence Number

Data type

integer

Drugs and Dose Level
Description

Drugs and Dose Level

Data type

text

Change
Description

P/U

Data type

text

Total dose for this course
Description

Total dose for this course

Data type

text

Units
Description

Units

Data type

text

Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
Surface Area
Description

Surface Area

Data type

integer

Measurement units
  • m2
m2
Performance Status
Description

Performance Status

Data type

text

Tumor Measurements
Description

Tumor Measurements

Location
Description

Location

Data type

integer

Method of Tumor Measurement
Description

Method

Data type

text

Date of assessment
Description

Date of assessment

Data type

date

Tumor measurements
Description

Tumor measurements

Data type

text

Measurement units
  • cm
cm
Best Tumor Response
Description

Best Tumor Response

Best Tumor Response
Description

Best Tumor Response

Data type

text

Date of Progression
Description

Date of Progression

Data type

date

Date of Best Response
Description

Date of Best Response

Data type

date

Pre-treatment Hematologies and Chemistries
Description

Pre-treatment Hematologies and Chemistries

Assessment Date
Description

Assessment Date

Data type

date

Other (Specify)
Description

Other

Data type

text

Comments
Description

Comments

Data type

text

HGB
Description

Hemoglobin

Data type

float

Alias
UMLS CUI [1]
C0019046
Haematocrit (HCT)
Description

Haematocrit (HCT)

Data type

float

Alias
UMLS CUI [1]
C0018935
WBC
Description

WBC

Data type

text

Alias
UMLS CUI [1]
C0023508
Granulocytes (%)
Description

LaboratoryProcedureGranulocyteResultPercentageValue

Data type

float

Measurement units
  • %
Alias
NCI Thesaurus ObjectClass
C25294
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C20200
UMLS 2011AA Property
C1274040
NCI Thesaurus Property-2
C12530
UMLS 2011AA Property-2
C0018183
NCI Thesaurus ValueDomain
C25613
UMLS 2011AA ValueDomain
C0439165
NCI Thesaurus ValueDomain-2
C25712
UMLS 2011AA ValueDomain-2
C1522609
%
Platelets
Description

Platelets

Data type

text

Alias
UMLS CUI [1]
C0005821
[BUN] BUN
Description

BUN

Data type

float

Measurement units
  • mg/dL
mg/dL
Creatinine
Description

Chemistry, Clinical, Creatinine measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201975
Creatinine Clearance
Description

Creatinine Clearance

Data type

float

Measurement units
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
AST (SGOT)
Description

AST

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
Bilirubin
Description

Bilirubin

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
CA125
Description

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Data type

float

Alias
UMLS 2011AA ObjectClass
C0022885
NCI Thesaurus Property
C325
UMLS 2011AA Property
C0006610
UMLS 2011AA Property-2
C1274040
NCI Thesaurus ObjectClass
C25294
NCI Thesaurus Property-2
C20200
NCI Thesaurus Property-3
C17220
UMLS 2011AA Property-3
C0041365
NCI Thesaurus ValueDomain
C25712
UMLS 2011AA ValueDomain
C1522609
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Similar models

Drug Dose Form

1 forms
  1. StudyEvent: ODM
    1. Drug Dose 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
Item
GOG#
integer
Section
Item
Section
integer
Item Group
Investigational Product
Date of Course
Item
Date of Course
date
Course Number
Item
Course Number
integer
Item
Course Timing
text
Course Timing
Code List
Course Timing
CL Item
On time (1)
CL Item
Delayed (2)
CL Item
Taken off study treatment (3)
Number of delayed days
Item
Number of delayed days
integer
Comment
Item
Report reason for delay
text
Item Group
Drug Dose
Sequence Number
Item
Sequence Number
integer
Drugs and Dose Level
Item
Drugs and Dose Level
text
Change
Item
Change
text
Total dose for this course
Item
Total dose for this course
text
Units
Item
Units
text
Weight
Item
Weight
float
Surface Area
Item
Surface Area
integer
Performance Status
Item
Performance Status
text
Item Group
Tumor Measurements
Item
Location
integer
Location
Code List
Location
CL Item
Location #1 (1)
CL Item
Location #2 (2)
CL Item
Location #3 (3)
Method
Item
Method of Tumor Measurement
text
Date of assessment
Item
Date of assessment
date
Tumor measurements
Item
Tumor measurements
text
Item Group
Best Tumor Response
Item
Best Tumor Response
text
Best Tumor Response
Code List
Best Tumor Response
CL Item
Complete Response (NED) (1)
CL Item
Partial (>50% decrease each lesion followed) (2)
CL Item
Stable (3)
CL Item
Increasing Disease (>50% increase in any tumor) (4)
CL Item
Not evaluated this course (5)
Date of Progression
Item
Date of Progression
date
Date of Best Response
Item
Date of Best Response
date
Item Group
Pre-treatment Hematologies and Chemistries
Assessment Date
Item
Assessment Date
date
Other
Item
Other (Specify)
text
Comments
Item
Comments
text
Hemoglobin
Item
HGB
float
C0019046 (UMLS CUI [1])
Haematocrit (HCT)
Item
Haematocrit (HCT)
float
C0018935 (UMLS CUI [1])
WBC
Item
WBC
text
C0023508 (UMLS CUI [1])
LaboratoryProcedureGranulocyteResultPercentageValue
Item
Granulocytes (%)
float
C25294 (NCI Thesaurus ObjectClass)
C0022885 (UMLS 2011AA ObjectClass)
C20200 (NCI Thesaurus Property)
C1274040 (UMLS 2011AA Property)
C12530 (NCI Thesaurus Property-2)
C0018183 (UMLS 2011AA Property-2)
C25613 (NCI Thesaurus ValueDomain)
C0439165 (UMLS 2011AA ValueDomain)
C25712 (NCI Thesaurus ValueDomain-2)
C1522609 (UMLS 2011AA ValueDomain-2)
Platelets
Item
Platelets
text
C0005821 (UMLS CUI [1])
BUN
Item
[BUN] BUN
float
Chemistry, Clinical, Creatinine measurement
Item
Creatinine
float
C0008000 (UMLS CUI [1,1])
C0201975 (UMLS CUI [1,2])
Creatinine Clearance
Item
Creatinine Clearance
float
C0373595 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
Bilirubin
Item
Bilirubin
float
C0005437 (UMLS CUI [1])
LaboratoryProcedureCA-125AntigenTumorMarkerResultValue
Item
CA125
float
C0022885 (UMLS 2011AA ObjectClass)
C325 (NCI Thesaurus Property)
C0006610 (UMLS 2011AA Property)
C1274040 (UMLS 2011AA Property-2)
C25294 (NCI Thesaurus ObjectClass)
C20200 (NCI Thesaurus Property-2)
C17220 (NCI Thesaurus Property-3)
C0041365 (UMLS 2011AA Property-3)
C25712 (NCI Thesaurus ValueDomain)
C1522609 (UMLS 2011AA ValueDomain)
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