ID

35671

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. 2019-03-15 2019-03-15 -
Rättsinnehavare

GSK group of companies

Uppladdad den

15 mars 2019

DOI

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Licens

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

Tysk Engelsk

GOG Toxicity Case Summary

1 Formulär  
Administrative data
Beskrivning

Administrative data

Type
Beskrivning

Type

Datatyp

text

Reported
Beskrivning

Reported

Datatyp

text

Telephone
Beskrivning

Telephone

Datatyp

integer

Grade
Beskrivning

Grade

Datatyp

text

Protocol Number
Beskrivning

Protocol Number

Datatyp

integer

Regimen
Beskrivning

Regimen

Datatyp

text

Alias
UMLS CUI [1]
C0949219
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Hospital
Beskrivning

Hospital

Datatyp

text

Alias
UMLS CUI [1]
C0019994
Gynecologic Oncology Group Number
Beskrivning

Gynecologic Oncology Group Number

Datatyp

integer

Demographics
Beskrivning

Demographics

Date of report
Beskrivning

Date of report

Datatyp

date

Age
Beskrivning

Age

Datatyp

integer

Alias
UMLS CUI [1]
C0001779
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body Surface Area
Beskrivning

Body Surface Area

Datatyp

float

Alias
NCI Thesaurus ValueDomain
C25209
UMLS CUI-1
C0005902
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25157
Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Description
Beskrivning

Description

Type of treatment
Beskrivning

Type of treatment

Datatyp

integer

Administration Start Date
Beskrivning

Administration Start Date

Datatyp

date

Administration End Date
Beskrivning

Administration End Date

Datatyp

date

Drug
Beskrivning

Drug

Datatyp

text

Alias
UMLS CUI [1]
C2347852
Total Daily Dose
Beskrivning

Total Daily Dose

Datatyp

text

Alias
UMLS CUI [1]
C2348070
Route
Beskrivning

Route

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Protocol Treatment
Beskrivning

Protocol Treatment

Date of protocol initiation
Beskrivning

Date of protocol initiation

Datatyp

date

previous toxicity on this protocol
Beskrivning

previous toxicity on this protocol

Datatyp

text

Course # for this toxicity
Beskrivning

Course # for this toxicity

Datatyp

integer

Date course started
Beskrivning

Date course started

Datatyp

date

Drugs and Doses for this Course
Beskrivning

Drugs and Doses for this Course

Drug
Beskrivning

Drug

Datatyp

text

Dose
Beskrivning

Dose

Datatyp

text

Route
Beskrivning

Route

Datatyp

text

Cumulative Totals to Date
Beskrivning

Cumulative Totals to Date

Drug
Beskrivning

Drug

Datatyp

text

Dose
Beskrivning

Dose

Datatyp

text

Route
Beskrivning

Route

Datatyp

text

Serious Adverse Event
Beskrivning

Serious Adverse Event

Hospitalization
Beskrivning

Hospitalization

Datatyp

text

drug dose reduced
Beskrivning

drug dose reduced

Datatyp

text

SAE reaction
Beskrivning

SAE reaction

Datatyp

text

drug re-introduction
Beskrivning

drug re-introduction

Datatyp

text

SAE reaction reappear
Beskrivning

SAE reaction reappear

Datatyp

text

Pretreatment Counts for this Course
Beskrivning

Pretreatment Counts for this Course

Test
Beskrivning

Test

Datatyp

integer

Date
Beskrivning

Date

Datatyp

date

Nadir Counts
Beskrivning

Nadir Counts

Test
Beskrivning

Test

Datatyp

integer

Date taken
Beskrivning

Date taken

Datatyp

date

GOG #
Beskrivning

GOG #

Disease sites
Beskrivning

Disease sites

Datatyp

text

Concurrent non-malignant disease
Beskrivning

Concurrent non-malignant disease

Datatyp

text

Concurrent non-protocol medication
Beskrivning

Concurrent non-protocol medication

Datatyp

text

history of organ dysfunctions
Beskrivning

history of organ dysfunctions

Datatyp

text

Comment
Beskrivning

Comment

Datatyp

text

Quality of Life Cover Sheet (Investigator's details)
Beskrivning

Quality of Life Cover Sheet (Investigator's details)

Date
Beskrivning

Date

Datatyp

date

Name
Beskrivning

Patient name

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Gynecologic Oncology Group Number
Beskrivning

Gynecologic Oncology Group Number

Datatyp

integer

Time of Today's Assessment
Beskrivning

Time of Today's Assessment

Cisplatin or Cisplatin/Topotecan
Beskrivning

Cisplatin or Cisplatin/Topotecan

Datatyp

integer

MVAC
Beskrivning

MVAC

Datatyp

text

Protocol Regimen Schedule
Beskrivning

Protocol Regimen Schedule

Datatyp

integer

QoL assessment completion
Beskrivning

QoL assessment completion

Datatyp

boolean

Assistance to patient
Beskrivning

Assistance to patient

Datatyp

text

reason for uncompleted questionnaire
Beskrivning

reason for uncompleted questionnaire

Datatyp

integer

Other reason
Beskrivning

Other reason

Datatyp

text

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Similar models

GOG Toxicity Case Summary

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Type
Item
text
Reported
Item
text
Telephone
Item
integer
Grade
Item
text
Protocol Number
Item
integer
Regimen
Item
text
C0949219 (UMLS CUI [1])
Patient Initials
Item
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Hospital
Item
text
C0019994 (UMLS CUI [1])
Gynecologic Oncology Group Number
Item
integer
Item Group
Date of report
Item
date
Age
Item
integer
C0001779 (UMLS CUI [1])
Weight
Item
float
C0005910 (UMLS CUI [1])
Height
Item
integer
C0005890 (UMLS CUI [1])
Body Surface Area
Item
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Diagnosis
Item
text
C0011900 (UMLS CUI [1])
Item Group
Item
integer
undefined item
Code List
Type of treatment
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Administration Start Date
Item
date
Administration End Date
Item
date
Drug
Item
text
C2347852 (UMLS CUI [1])
Total Daily Dose
Item
text
C2348070 (UMLS CUI [1])
Route
Item
text
C0013153 (UMLS CUI [1])
Date of protocol initiation
Item
date
previous toxicity on this protocol
Item
text
Course # for this toxicity
Item
integer
Date course started
Item
date
Drug
Item
text
Dose
Item
text
Route
Item
text
Drug
Item
text
Dose
Item
text
Route
Item
text
Hospitalization
Code List
Hospitalization
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
drug dose reduced
Code List
drug dose reduced
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Item
text
SAE reaction
Code List
SAE reaction
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
drug re-introduction
Code List
drug re-introduction
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
SAE reaction reappear
Code List
SAE reaction reappear
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Item
integer
Test
Code List
Test
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Date
Item
date
Item Group
Item
integer
Test
Code List
Test
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Date taken
Item
date
Item Group
Disease sites
Item
text
Concurrent non-malignant disease
Item
text
Concurrent non-protocol medication
Item
text
history of organ dysfunctions
Item
text
Comment
Item
text
Date
Item
date
Patient name
Item
Name
text
C1299487 (UMLS CUI [1])
Gynecologic Oncology Group Number
Item
integer
Cisplatin or Cisplatin/Topotecan
Code List
Cisplatin or Cisplatin/Topotecan
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
Item
text
MVAC
Code List
MVAC
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
Protocol Regimen Schedule
Code List
Protocol Regimen Schedule
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
QoL assessment completion
Item
boolean
Assistance to patient
Item
text
reason for uncompleted questionnaire
Code List
reason for uncompleted questionnaire
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
CL Item
 (6)
Other reason
Item
text
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