ID

35662

Descripción

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 

Palabras clave

Versiones (1)
  1. 14/3/19 14/3/19 -
Titular de derechos de autor

GSK group of companies

Subido en

14 de marzo de 2019

DOI

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Licencia

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

Inglés

Drug Dose Form

1 formularios  
  1. StudyEvent: ODM
    1. Drug Dose Form
Administrative data
Descripción

Administrative data

Last Name
Descripción

Last Name

Tipo de datos

text

First Name
Descripción

First Name

Tipo de datos

text

GOG#
Descripción

Inst.,Prot.,Seq.

Tipo de datos

integer

Section
Descripción

Section

Tipo de datos

integer

Investigational Product
Descripción

Investigational Product

Date of Course
Descripción

Date of Course

Tipo de datos

date

Course Number
Descripción

Course Number

Tipo de datos

integer

Course Timing
Descripción

Course Timing

Tipo de datos

text

Number of delayed days
Descripción

Number of delayed days

Tipo de datos

integer

Report reason for delay
Descripción

Comment

Tipo de datos

text

Drug Dose
Descripción

Drug Dose

Sequence Number
Descripción

Sequence Number

Tipo de datos

integer

Drugs and Dose Level
Descripción

Drugs and Dose Level

Tipo de datos

text

Change
Descripción

P/U

Tipo de datos

text

Total dose for this course
Descripción

Total dose for this course

Tipo de datos

text

Units
Descripción

Units

Tipo de datos

text

Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
kg
Surface Area
Descripción

Surface Area

Tipo de datos

integer

Unidades de medida
  • m2
m2
Performance Status
Descripción

Performance Status

Tipo de datos

text

Tumor Measurements
Descripción

Tumor Measurements

Location
Descripción

Location

Tipo de datos

integer

Method of Tumor Measurement
Descripción

Method

Tipo de datos

text

Date of assessment
Descripción

Date of assessment

Tipo de datos

date

Tumor measurements
Descripción

Tumor measurements

Tipo de datos

text

Unidades de medida
  • cm
cm
Best Tumor Response
Descripción

Best Tumor Response

Best Tumor Response
Descripción

Best Tumor Response

Tipo de datos

text

Date of Progression
Descripción

Date of Progression

Tipo de datos

date

Date of Best Response
Descripción

Date of Best Response

Tipo de datos

date

Pre-treatment Hematologies and Chemistries
Descripción

Pre-treatment Hematologies and Chemistries

Assessment Date
Descripción

Assessment Date

Tipo de datos

date

Other (Specify)
Descripción

Other

Tipo de datos

text

Comments
Descripción

Comments

Tipo de datos

text

HGB
Descripción

Hemoglobin

Tipo de datos

float

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

Haematocrit (HCT)

Tipo de datos

float

Alias
UMLS CUI [1]
C0018935
WBC
Descripción

WBC

Tipo de datos

text

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

LaboratoryProcedureGranulocyteResultPercentageValue

Tipo de datos

float

Unidades de medida
  • %
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
Descripción

Platelets

Tipo de datos

text

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

BUN

Tipo de datos

float

Unidades de medida
  • mg/dL
mg/dL
Creatinine
Descripción

Chemistry, Clinical, Creatinine measurement

Tipo de datos

float

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

Creatinine Clearance

Tipo de datos

float

Unidades de medida
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
AST (SGOT)
Descripción

AST

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
Bilirubin
Descripción

Bilirubin

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
CA125
Descripción

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Tipo de datos

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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Drug Dose Form

1 formularios
  1. StudyEvent: ODM
    1. Drug Dose Form
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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