ID

35662

Beschreibung

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 

Stichworte

  1. 14.03.19 14.03.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

14. März 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0

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Cisplatin and Topotecan Recurrent on Persistent Carcinoma of the Cervix - 103369

Drug Dose Form

  1. StudyEvent: ODM
    1. Drug Dose Form
Administrative data
Beschreibung

Administrative data

Last Name
Beschreibung

Last Name

Datentyp

text

First Name
Beschreibung

First Name

Datentyp

text

GOG#
Beschreibung

Inst.,Prot.,Seq.

Datentyp

integer

Section
Beschreibung

Section

Datentyp

integer

Investigational Product
Beschreibung

Investigational Product

Date of Course
Beschreibung

Date of Course

Datentyp

date

Course Number
Beschreibung

Course Number

Datentyp

integer

Course Timing
Beschreibung

Course Timing

Datentyp

text

Number of delayed days
Beschreibung

Number of delayed days

Datentyp

integer

Report reason for delay
Beschreibung

Comment

Datentyp

text

Drug Dose
Beschreibung

Drug Dose

Sequence Number
Beschreibung

Sequence Number

Datentyp

integer

Drugs and Dose Level
Beschreibung

Drugs and Dose Level

Datentyp

text

Change
Beschreibung

P/U

Datentyp

text

Total dose for this course
Beschreibung

Total dose for this course

Datentyp

text

Units
Beschreibung

Units

Datentyp

text

Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
kg
Surface Area
Beschreibung

Surface Area

Datentyp

integer

Maßeinheiten
  • m2
m2
Performance Status
Beschreibung

Performance Status

Datentyp

text

Tumor Measurements
Beschreibung

Tumor Measurements

Location
Beschreibung

Location

Datentyp

integer

Method of Tumor Measurement
Beschreibung

Method

Datentyp

text

Date of assessment
Beschreibung

Date of assessment

Datentyp

date

Tumor measurements
Beschreibung

Tumor measurements

Datentyp

text

Maßeinheiten
  • cm
cm
Best Tumor Response
Beschreibung

Best Tumor Response

Best Tumor Response
Beschreibung

Best Tumor Response

Datentyp

text

Date of Progression
Beschreibung

Date of Progression

Datentyp

date

Date of Best Response
Beschreibung

Date of Best Response

Datentyp

date

Pre-treatment Hematologies and Chemistries
Beschreibung

Pre-treatment Hematologies and Chemistries

Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Other (Specify)
Beschreibung

Other

Datentyp

text

Comments
Beschreibung

Comments

Datentyp

text

HGB
Beschreibung

Hemoglobin

Datentyp

float

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

Haematocrit (HCT)

Datentyp

float

Alias
UMLS CUI [1]
C0018935
WBC
Beschreibung

WBC

Datentyp

text

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

LaboratoryProcedureGranulocyteResultPercentageValue

Datentyp

float

Maßeinheiten
  • %
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
Beschreibung

Platelets

Datentyp

text

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

BUN

Datentyp

float

Maßeinheiten
  • mg/dL
mg/dL
Creatinine
Beschreibung

Chemistry, Clinical, Creatinine measurement

Datentyp

float

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

Creatinine Clearance

Datentyp

float

Maßeinheiten
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
AST (SGOT)
Beschreibung

AST

Datentyp

float

Maßeinheiten
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
Bilirubin
Beschreibung

Bilirubin

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1]
C0005437
mg/dL
CA125
Beschreibung

LaboratoryProcedureCA-125AntigenTumorMarkerResultValue

Datentyp

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

Ähnliche Modelle

Drug Dose Form

  1. StudyEvent: ODM
    1. Drug Dose Form
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
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
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
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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