ID

39363

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 (2)
  1. 3/14/19 3/14/19 -
  2. 12/31/19 12/31/19 -
Copyright Holder

GSK group of companies

Uploaded on

December 31, 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

English

Pathology Report

1 forms  
  1. StudyEvent: ODM
    1. Pathology Report
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Last Name
Description

Last Name

Data type

text

Alias
UMLS CUI [1]
C1301584
First Name
Description

First Name

Data type

text

Alias
UMLS CUI [1]
C1443235
Section
Description

Section

Data type

text

Alias
UMLS CUI [1]
C1547540
GOG #
Description

Inst.,Prot.,Seq.

Data type

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C1512288
Primary
Description

Primary

Alias
UMLS CUI-1
C0006826
UMLS CUI-2
C0450429
UMLS CUI-3
C0205225
UMLS CUI-4
C1515974
Primary Site
Description

Primary Site

Data type

integer

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C1515974
Other, specify
Description

Specify Other

Data type

text

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C1515974
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C1521902
Histology Type
Description

Histology Type

Alias
UMLS CUI-1
C1317416
Carcinomas, All Sites
Description

Carcinomas

Data type

integer

Alias
UMLS CUI [1,1]
C0449574
UMLS CUI [1,2]
C0007097
Sarcomas, All Sites
Description

Sarcomas

Data type

integer

Alias
UMLS CUI [1,1]
C1261473
UMLS CUI [1,2]
C1317416
LMP Tumors of the Ovary
Description

LMP Tumors of the Ovary

Data type

integer

Alias
UMLS CUI [1,1]
C0919267
UMLS CUI [1,2]
C0154129
UMLS CUI [1,3]
C1317416
Sex Cord Stromal Tumors
Description

Sex Cord Stromal Tumors

Data type

integer

Alias
UMLS CUI [1,1]
C0206724
UMLS CUI [1,2]
C1317416
Germ Cell Tumors
Description

Germ Cell Tumors

Data type

integer

Alias
UMLS CUI [1,1]
C0205851
UMLS CUI [1,2]
C1317416
Other
Description

Other Histology Types

Data type

integer

Alias
UMLS CUI [1]
C1299220
Specify Other
Description

Specify Other

Data type

text

Alias
UMLS CUI [1,1]
C1299220
UMLS CUI [1,2]
C1521902
Histologic Grade
Description

Histologic Grade

Alias
UMLS CUI-1
C0919553
Histologic Grade of Primary Tumor
Description

Primary Tumor Histologic Grade

Data type

text

Alias
UMLS CUI [1,1]
C0919553
UMLS CUI [1,2]
C0677930
Specimens
Description

Specimens

Alias
UMLS CUI-1
C2347026
Specimens obtained from:
Description

Specimens

Data type

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0455713
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Site of specimen(s) submitted:
Description

Site of specimen(s)

Data type

text

Alias
UMLS CUI [1]
C2981497
Secondary
Description

Secondary

Alias
UMLS CUI-1
C3266877
Specimen(s) obtained from:
Description

Specimen(s)

Data type

integer

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0455713
Date specimen obtained
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Site of Specimen Obtained
Description

Site of Specimen Obtained

Data type

text

Alias
UMLS CUI [1]
C2981497
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Similar models

Pathology Report

1 forms
  1. StudyEvent: ODM
    1. Pathology Report
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Last Name
Item
Last Name
text
C1301584 (UMLS CUI [1])
First Name
Item
First Name
text
C1443235 (UMLS CUI [1])
Section
Item
Section
text
C1547540 (UMLS CUI [1])
Gynecologic Oncology Group Number
Item
GOG #
integer
C2348585 (UMLS CUI [1,1])
C1512288 (UMLS CUI [1,2])
Item Group
Primary
C0006826 (UMLS CUI-1)
C0450429 (UMLS CUI-2)
C0205225 (UMLS CUI-3)
C1515974 (UMLS CUI-4)
Item
Primary Site
integer
C0006826 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
Primary Site
Code List
Primary Site
CL Item
Ovary (1)
CL Item
Peritoneum (2)
CL Item
Fallopian Tube (3)
CL Item
Cervix (4)
CL Item
Vagina (5)
CL Item
Vulva (6)
CL Item
Endometrium (7)
CL Item
Corpus (8)
CL Item
GTD (9)
CL Item
Other (10)
Specify Other
Item
Other, specify
text
C0006826 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C1521902 (UMLS CUI [1,6])
Item Group
Histology Type
C1317416 (UMLS CUI-1)
Item
Carcinomas, All Sites
integer
C0449574 (UMLS CUI [1,1])
C0007097 (UMLS CUI [1,2])
Carciomas
Code List
Carcinomas, All Sites
CL Item
Adenocarcinoma, type unspecified (1)
CL Item
Adenocarcinoma with squamous differentiation (2)
CL Item
Adenosquamos carcinoma (3)
CL Item
Clear cell carcinoma (4)
CL Item
Endometrioid adenocarcinoma (5)
CL Item
Mixed epithelial tumor (6)
CL Item
Mucinous epithelial tumor (7)
CL Item
Serous adenocarcinoma (8)
CL Item
Small cell carcinoma (9)
CL Item
Squamous cell carcinoma, invasive (10)
CL Item
Transitional cell carcinoma (11)
CL Item
Undifferentiated carcinoma (12)
CL Item
Villoglandular carcinoma (13)
Item
Sarcomas, All Sites
integer
C1261473 (UMLS CUI [1,1])
C1317416 (UMLS CUI [1,2])
Sarcomas
Code List
Sarcomas, All Sites
CL Item
Carcinosarcoma, homologous (1)
CL Item
Carcinosarcoma, heterologous (2)
CL Item
Endometrial stromal sarcoma, high grade (3)
CL Item
Leiomyosarcoma (4)
Item
LMP Tumors of the Ovary
integer
C0919267 (UMLS CUI [1,1])
C0154129 (UMLS CUI [1,2])
C1317416 (UMLS CUI [1,3])
LMP Tumors of the Ovary
Code List
LMP Tumors of the Ovary
CL Item
Mucinous tumor of low malignant potential (1)
CL Item
Serous tumor of low malignant potential (2)
CL Item
Mixed serous/mucinous LMP (3)
Item
Sex Cord Stromal Tumors
integer
C0206724 (UMLS CUI [1,1])
C1317416 (UMLS CUI [1,2])
Sex Cord Stromal Tumors
Code List
Sex Cord Stromal Tumors
CL Item
Granulosa cell tumor (1)
CL Item
Sex cord stomal tumor, unclassified (2)
Item
Germ Cell Tumors
integer
C0205851 (UMLS CUI [1,1])
C1317416 (UMLS CUI [1,2])
Germ Cell Tumors
Code List
Germ Cell Tumors
CL Item
Dysgerminoma (1)
CL Item
Endodermal sinus tumor (2)
CL Item
Germ cell tumor, mixed (3)
CL Item
Teratoma, immature (4)
CL Item
Teratoma, mature cystic (5)
Item
Other
integer
C1299220 (UMLS CUI [1])
Other Hystology Types
Code List
Other
CL Item
Normal tissue (1)
CL Item
Benign NOS (2)
CL Item
Fibroma (3)
CL Item
Serous cystadenoma (4)
CL Item
Mucinous cystadenoma (5)
Specify Other
Item
Specify Other
text
C1299220 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Histologic Grade
C0919553 (UMLS CUI-1)
Item
Histologic Grade of Primary Tumor
text
C0919553 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
Primary Tumor Histologic Grade
Code List
Histologic Grade of Primary Tumor
CL Item
well differentiated (1)
CL Item
Moderately differenciated (2)
CL Item
Poorly differentiated (3)
CL Item
N/A (4)
Item Group
Specimens
C2347026 (UMLS CUI-1)
Item
Specimens obtained from:
integer
C0200345 (UMLS CUI [1,1])
C0455713 (UMLS CUI [1,2])
Specimens obtained from:
Code List
Specimens obtained from:
CL Item
Biopsy (1)
CL Item
Primary Surgery (2)
CL Item
Cytology (3)
CL Item
Staging Surgery (advanced) (4)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Site of specimen(s)
Item
Site of specimen(s) submitted:
text
C2981497 (UMLS CUI [1])
Item Group
Secondary
C3266877 (UMLS CUI-1)
Item
Specimen(s) obtained from:
integer
C0200345 (UMLS CUI [1,1])
C0455713 (UMLS CUI [1,2])
Specimen(s)
Code List
Specimen(s) obtained from:
CL Item
Cytology (1)
CL Item
Second Look (2)
CL Item
Persistence (3)
CL Item
Recurrence (4)
Date
Item
Date specimen obtained
date
C0011008 (UMLS CUI [1])
Site of Specimen Obtained
Item
Site of Specimen Obtained
text
C2981497 (UMLS CUI [1])
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