ID

35671

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

  1. 3/15/19 3/15/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 15, 2019

DOI

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License

Creative Commons BY-NC 3.0

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

GOG Toxicity Case Summary

Administrative data
Description

Administrative data

Type
Description

Type

Data type

text

Reported by
Description

Reported

Data type

text

Telephone
Description

Telephone

Data type

integer

Grade
Description

Grade

Data type

text

Protocol Number
Description

Protocol Number

Data type

integer

Treatment Regimen
Description

Regimen

Data type

text

Alias
UMLS CUI [1]
C0949219
Patient Initials
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
Name of the hospital
Description

Hospital

Data type

text

Alias
UMLS CUI [1]
C0019994
GOG #
Description

Inst.,Prot.,Seq.

Data type

integer

Demographics
Description

Demographics

Date report submitted
Description

Date of report

Data type

date

Age
Description

Age

Data type

integer

Alias
UMLS CUI [1]
C0001779
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body Surface Area (m^2)
Description

Body Surface Area

Data type

float

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

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Description
Description

Description

Type of previous treatment
Description

Type of treatment

Data type

integer

Start date of administration
Description

Administration Start Date

Data type

date

End date of administration
Description

Administration End Date

Data type

date

Drug
Description

Drug

Data type

text

Alias
UMLS CUI [1]
C2347852
Total Daily Dose
Description

Total Daily Dose

Data type

text

Alias
UMLS CUI [1]
C2348070
Route
Description

Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Protocol Treatment
Description

Protocol Treatment

Date this protocol was initiated
Description

Date of protocol initiation

Data type

date

previous toxicity on this protocol
Description

previous toxicity on this protocol

Data type

text

Course # for this toxicity
Description

SAE course

Data type

integer

Date this course started
Description

Date course started

Data type

date

Drugs and Doses for this Course
Description

Drugs and Doses for this Course

Drug
Description

Please record all drugs and doses for this course only

Data type

text

Dose
Description

Dose

Data type

text

Route
Description

Route

Data type

text

Cumulative Totals to Date
Description

Cumulative Totals to Date

Drug
Description

Please record all drugs and doses to date

Data type

text

Dose
Description

Dose

Data type

text

Route
Description

Route

Data type

text

Serious Adverse Event
Description

Serious Adverse Event

Was patient hospitalized for reaction?
Description

Hospitalization

Data type

text

Was treatment with suspected drug reduced in dosage?
Description

drug dose reduced

Data type

text

Did reaction abate?
Description

SAE reaction

Data type

text

Was drug reintroduced or dose increased?
Description

drug re-introduction

Data type

text

Did reaction reappear?
Description

SAE reaction reappear

Data type

text

Pretreatment Counts for this Course
Description

Pretreatment Counts for this Course

Test
Description

Test

Data type

integer

Date taken
Description

Date

Data type

date

Nadir Counts
Description

Nadir Counts

Test
Description

Test

Data type

integer

Date taken
Description

Date taken

Data type

date

GOG #
Description

GOG #

Sites of metastatic disease?
Description

Disease sites

Data type

text

Concurrent non-malignant disease?
Description

Concurrent non-malignant disease

Data type

text

Concurrent non-protocol medication?
Description

Concurrent non-protocol medication

Data type

text

History of any major organ dysfunctions?
Description

history of organ dysfunctions

Data type

text

Comment
Description

Sequence of events leading up to and/or ralted to ADR

Data type

text

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

Quality of Life Cover Sheet (Investigator's details)

Date of Form
Description

Date

Data type

date

Patient name
Description

Patient name

Data type

text

Alias
UMLS CUI [1]
C1299487
GOG #
Description

Inst.,Prot.,Seq.

Data type

integer

Time of Today's Assessment
Description

Time of Today's Assessment

Cisplatin or Cisplatin/Topotecan
Description

Cisplatin or Cisplatin/Topotecan

Data type

integer

MVAC
Description

MVAC

Data type

text

If the Protocol Regimen is scheduled to be given Today
Description

Protocol Regimen Schedule

Data type

integer

Was any assistance given to the patient in completing the QoL assessment?
Description

QoL assessment completion

Data type

boolean

If assistance was provided, please describe below how the patient was helped:
Description

Assistance to patient

Data type

text

If the questionnaire was not completed, please indicate why:
Description

reason for uncompleted questionnaire

Data type

integer

If other reason, please specify below
Description

Other reason

Data type

text

Similar models

GOG Toxicity Case Summary

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Type
Item
Type
text
Reported
Item
Reported by
text
Telephone
Item
Telephone
integer
Grade
Item
Grade
text
Protocol Number
Item
Protocol Number
integer
Regimen
Item
Treatment Regimen
text
C0949219 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Hospital
Item
Name of the hospital
text
C0019994 (UMLS CUI [1])
Gynecologic Oncology Group Number
Item
GOG #
integer
Item Group
Demographics
Date of report
Item
Date report submitted
date
Age
Item
Age
integer
C0001779 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Surface Area
Item
Body Surface Area (m^2)
float
C25209 (NCI Thesaurus ValueDomain)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item Group
Description
Item
Type of previous treatment
integer
Code List
Type of previous treatment
CL Item
Surgery (1)
CL Item
Radiotherapy (2)
CL Item
Chemotherapy (3)
Administration Start Date
Item
Start date of administration
date
Administration End Date
Item
End date of administration
date
Drug
Item
Drug
text
C2347852 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Item Group
Protocol Treatment
Date of protocol initiation
Item
Date this protocol was initiated
date
previous toxicity on this protocol
Item
previous toxicity on this protocol
text
Course # for this toxicity
Item
Course # for this toxicity
integer
Date course started
Item
Date this course started
date
Item Group
Drugs and Doses for this Course
Drug
Item
Drug
text
Dose
Item
Dose
text
Route
Item
Route
text
Item Group
Cumulative Totals to Date
Drug
Item
Drug
text
Dose
Item
Dose
text
Route
Item
Route
text
Item Group
Serious Adverse Event
Item
Was patient hospitalized for reaction?
text
Code List
Was patient hospitalized for reaction?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
Was treatment with suspected drug reduced in dosage?
text
Code List
Was treatment with suspected drug reduced in dosage?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
Did reaction abate?
text
Code List
Did reaction abate?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
Was drug reintroduced or dose increased?
text
Code List
Was drug reintroduced or dose increased?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item
Did reaction reappear?
text
Code List
Did reaction reappear?
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
Item Group
Pretreatment Counts for this Course
Item
Test
integer
Code List
Test
CL Item
Platelets (1)
CL Item
WBC (2)
CL Item
Granulocytes (3)
CL Item
HGB (4)
CL Item
HCT (5)
Date
Item
Date taken
date
Item Group
Nadir Counts
Item
Test
integer
Code List
Test
CL Item
Platelets (1)
CL Item
WBC (2)
CL Item
Granulocytes (3)
CL Item
HGB (4)
CL Item
HCT (5)
Date taken
Item
Date taken
date
Item Group
GOG #
Disease sites
Item
Sites of metastatic disease?
text
Concurrent non-malignant disease
Item
Concurrent non-malignant disease?
text
Concurrent non-protocol medication
Item
Concurrent non-protocol medication?
text
history of organ dysfunctions
Item
History of any major organ dysfunctions?
text
Comment
Item
Comment
text
Item Group
Quality of Life Cover Sheet (Investigator's details)
Date
Item
Date of Form
date
Patient name
Item
text
C1299487 (UMLS CUI [1])
Gynecologic Oncology Group Number
Item
GOG #
integer
Item Group
Time of Today's Assessment
Item
Cisplatin or Cisplatin/Topotecan
integer
Code List
Cisplatin or Cisplatin/Topotecan
CL Item
Baseline (1)
CL Item
Pre-course 2 (2)
CL Item
Pre-course 5 (3)
CL Item
Nine month follow-up (4)
Item
MVAC
text
Code List
MVAC
CL Item
Baseline (1)
CL Item
Pre-course 2 (2)
CL Item
Pre-course 4 (3)
CL Item
Nine month follow-up (4)
Item
If the Protocol Regimen is scheduled to be given Today
integer
Code List
If the Protocol Regimen is scheduled to be given Today
CL Item
Chemotherapy will be given today without delay (1)
CL Item
Chemotherapy will be given today but was delayed (2)
CL Item
Chemotherapy will not be given because patient is off study treatment (3)
QoL assessment completion
Item
Was any assistance given to the patient in completing the QoL assessment?
boolean
Assistance to patient
Item
If assistance was provided, please describe below how the patient was helped:
text
Item
If the questionnaire was not completed, please indicate why:
integer
Code List
If the questionnaire was not completed, please indicate why:
CL Item
The patient refused due to illness (1)
CL Item
The patient refused for reasons other than illness (2)
CL Item
The questionnaire was not given due to institutional error (3)
CL Item
The patient is now off treatment and cannot be contacted even by phone (4)
CL Item
The patient has died (5)
CL Item
Other (6)
Other reason
Item
If other reason, please specify below
text

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