ID

35662

Beskrivning

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 

Nyckelord

Versioner (1)
  1. 2019-03-14 2019-03-14 -
Rättsinnehavare

GSK group of companies

Uppladdad den

14 mars 2019

DOI

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Licens

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

Engelsk

Drug Dose Form

1 Formulär  
  1. StudyEvent: ODM
    1. Drug Dose Form
Administrative data
Beskrivning

Administrative data

Last Name
Beskrivning

Last Name

Datatyp

text

First Name
Beskrivning

First Name

Datatyp

text

GOG#
Beskrivning

Inst.,Prot.,Seq.

Datatyp

integer

Section
Beskrivning

Section

Datatyp

integer

Investigational Product
Beskrivning

Investigational Product

Date of Course
Beskrivning

Date of Course

Datatyp

date

Course Number
Beskrivning

Course Number

Datatyp

integer

Course Timing
Beskrivning

Course Timing

Datatyp

text

Number of delayed days
Beskrivning

Number of delayed days

Datatyp

integer

Report reason for delay
Beskrivning

Comment

Datatyp

text

Drug Dose
Beskrivning

Drug Dose

Sequence Number
Beskrivning

Sequence Number

Datatyp

integer

Drugs and Dose Level
Beskrivning

Drugs and Dose Level

Datatyp

text

Change
Beskrivning

P/U

Datatyp

text

Total dose for this course
Beskrivning

Total dose for this course

Datatyp

text

Units
Beskrivning

Units

Datatyp

text

Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
kg
Surface Area
Beskrivning

Surface Area

Datatyp

integer

Måttenheter
  • m2
m2
Performance Status
Beskrivning

Performance Status

Datatyp

text

Tumor Measurements
Beskrivning

Tumor Measurements

Location
Beskrivning

Location

Datatyp

integer

Method of Tumor Measurement
Beskrivning

Method

Datatyp

text

Date of assessment
Beskrivning

Date of assessment

Datatyp

date

Tumor measurements
Beskrivning

Tumor measurements

Datatyp

text

Måttenheter
  • cm
cm
Best Tumor Response
Beskrivning

Best Tumor Response

Best Tumor Response
Beskrivning

Best Tumor Response

Datatyp

text

Date of Progression
Beskrivning

Date of Progression

Datatyp

date

Date of Best Response
Beskrivning

Date of Best Response

Datatyp

date

Pre-treatment Hematologies and Chemistries
Beskrivning

Pre-treatment Hematologies and Chemistries

Assessment Date
Beskrivning

Assessment Date

Datatyp

date

Other (Specify)
Beskrivning

Other

Datatyp

text

Comments
Beskrivning

Comments

Datatyp

text

HGB
Beskrivning

Hemoglobin

Datatyp

float

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

Haematocrit (HCT)

Datatyp

float

Alias
UMLS CUI [1]
C0018935
WBC
Beskrivning

WBC

Datatyp

text

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

LaboratoryProcedureGranulocyteResultPercentageValue

Datatyp

float

Måttenheter
  • %
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
Beskrivning

Platelets

Datatyp

text

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

BUN

Datatyp

float

Måttenheter
  • mg/dL
mg/dL
Creatinine
Beskrivning

Chemistry, Clinical, Creatinine measurement

Datatyp

float

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

Creatinine Clearance

Datatyp

float

Måttenheter
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
AST (SGOT)
Beskrivning

AST

Datatyp

float

Måttenheter
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
Bilirubin
Beskrivning

Bilirubin

Datatyp

float

Måttenheter
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
CA125
Beskrivning

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Datatyp

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 Formulär
  1. StudyEvent: ODM
    1. Drug Dose Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
Tillbaka till toppen 

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