Informações:
Falhas:
ID
35671
Descrição
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
Palavras-chave
Versões (1)
- 15/03/2019 15/03/2019 -
Titular dos direitos
GSK group of companies
Transferido a
15 de março de 2019
DOI
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Licença
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
Similar models
GOG Toxicity Case Summary
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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)
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
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)
C0005902 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25157 (NCI Thesaurus Property)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
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])
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
Drug
Item
Drug
text
Dose
Item
Dose
text
Route
Item
Route
text
Drug
Item
Drug
text
Dose
Item
Dose
text
Route
Item
Route
text
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
CL Item
Yes (1)
CL Item
No (2)
CL Item
N/A (3)
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
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
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
CL Item
Baseline (1)
CL Item
Pre-course 2 (2)
CL Item
Pre-course 5 (3)
CL Item
Nine month follow-up (4)
CL Item
Baseline (1)
CL Item
Pre-course 2 (2)
CL Item
Pre-course 4 (3)
CL Item
Nine month follow-up (4)
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