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
Versions (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
- StudyEvent: ODM
Description
Demographics
Description
Date of report
Data type
date
Description
Age
Data type
integer
Alias
- UMLS CUI [1]
- C0001779
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body Surface Area
Data type
float
Alias
- NCI Thesaurus ValueDomain
- C25209
- UMLS CUI-1
- C0005902
- NCI Thesaurus ObjectClass
- C16960
- NCI Thesaurus Property
- C25157
Description
Diagnosis
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
Description
Description
Type of treatment
Data type
integer
Description
Administration Start Date
Data type
date
Description
Administration End Date
Data type
date
Description
Drug
Data type
text
Alias
- UMLS CUI [1]
- C2347852
Description
Total Daily Dose
Data type
text
Alias
- UMLS CUI [1]
- C2348070
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Protocol Treatment
Description
Date of protocol initiation
Data type
date
Description
previous toxicity on this protocol
Data type
text
Description
SAE course
Data type
integer
Description
Date course started
Data type
date
Description
Drugs and Doses for this Course
Description
Cumulative Totals to Date
Description
Serious Adverse Event
Description
Hospitalization
Data type
text
Description
drug dose reduced
Data type
text
Description
SAE reaction
Data type
text
Description
drug re-introduction
Data type
text
Description
SAE reaction reappear
Data type
text
Description
Pretreatment Counts for this Course
Description
Nadir Counts
Description
GOG #
Description
Disease sites
Data type
text
Description
Concurrent non-malignant disease
Data type
text
Description
Concurrent non-protocol medication
Data type
text
Description
history of organ dysfunctions
Data type
text
Description
Sequence of events leading up to and/or ralted to ADR
Data type
text
Description
Quality of Life Cover Sheet (Investigator's details)
Description
Time of Today's Assessment
Description
Cisplatin or Cisplatin/Topotecan
Data type
integer
Description
MVAC
Data type
text
Description
Protocol Regimen Schedule
Data type
integer
Description
QoL assessment completion
Data type
boolean
Description
Assistance to patient
Data type
text
Description
reason for uncompleted questionnaire
Data type
integer
Description
Other reason
Data type
text
Similar models
GOG Toxicity Case Summary
- StudyEvent: ODM
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)