ID

35665

Beschrijving

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 

Trefwoorden

  1. 14-03-19 14-03-19 -
Houder van rechten

GSK group of companies

Geüploaded op

14 maart 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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

Common Toxicity Report

  1. StudyEvent: ODM
    1. Common Toxicity Report
Administrative data
Beschrijving

Administrative data

Last Name
Beschrijving

Last Name

Datatype

text

First Name
Beschrijving

First Name

Datatype

text

Section
Beschrijving

Section

Datatype

text

GOG #
Beschrijving

Inst.,Prot.,Seq.

Datatype

integer

Common Toxicity Report
Beschrijving

Common Toxicity Report

Course Number
Beschrijving

The toxicities listed below occurred following this course of therapy

Datatype

integer

Specific CTC Term or CTC Major Categories
Beschrijving

CTC Term

Datatype

text

CTC Grade
Beschrijving

CTC Grade

Datatype

integer

Due to Rx?
Beschrijving

potential connection to Rx

Datatype

text

CTEP AER Submitted?
Beschrijving

CTEP AER

Datatype

boolean

Specific CTC Term or Additional Information
Beschrijving

(e.g., lab values, clarifications)

Datatype

text

Date
Beschrijving

Date

Datatype

date

Was a transfusion administered at this course of therapy?
Beschrijving

administration at the course of therapy

Datatype

text

Did hospitalisation occur as a result of the toxicities above?
Beschrijving

hospitalisation

Datatype

boolean

Were cytokines administered this course?
Beschrijving

cytokines administered

Datatype

text

Comments
Beschrijving

Comments

Datatype

text

Similar models

Common Toxicity Report

  1. StudyEvent: ODM
    1. Common Toxicity Report
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Last Name
Item
Last Name
text
First Name
Item
First Name
text
Section
Item
Section
text
Gynecologic Oncology Group Number
Item
GOG #
integer
Item Group
Common Toxicity Report
Course Number
Item
Course Number
integer
Item
Specific CTC Term or CTC Major Categories
text
Code List
Specific CTC Term or CTC Major Categories
CL Item
WBC (1)
CL Item
ANC/AGC (2)
CL Item
Platelets (3)
CL Item
Hemoglobin (4)
CL Item
Hematologic-other than above (5)
CL Item
Allergy/Immunology (6)
CL Item
Auditory/Hearing (7)
CL Item
Cardiovascular (8)
CL Item
Coagulation (9)
CL Item
Constitutional symptoms (10)
CL Item
Dermatology (11)
CL Item
Endocrine (12)
CL Item
Gastrointestinal (13)
CL Item
Genitourinary/Renal (14)
CL Item
Hemorrhage (15)
CL Item
Hepatic (16)
CL Item
Infection/Febr.neutropenia (17)
CL Item
Lymphatics (18)
CL Item
Metabolic/Laboratory (19)
CL Item
Musculoskeletal (20)
CL Item
Neurology (21)
CL Item
Ocular/Visual (22)
CL Item
Pain (23)
CL Item
Pulmonary (24)
CL Item
Sexual Function (25)
CTC Grade
Item
CTC Grade
integer
Item
Due to Rx?
text
Code List
Due to Rx?
CL Item
Unlikely (1)
CL Item
Possible (2)
CL Item
Probable (3)
CL Item
Definite (4)
CTEP AER
Item
CTEP AER Submitted?
boolean
Specific CTC Term or Additional Information
Item
Specific CTC Term or Additional Information
text
Date
Item
Date
date
Item
Was a transfusion administered at this course of therapy?
text
Code List
Was a transfusion administered at this course of therapy?
CL Item
No (1)
CL Item
Yes, pRBC (2)
CL Item
Yes, platelets (3)
hospitalisation
Item
Did hospitalisation occur as a result of the toxicities above?
boolean
Item
Were cytokines administered this course?
text
Code List
Were cytokines administered this course?
CL Item
No (1)
CL Item
Yes, G-CSF/GM-CSF (2)
CL Item
Yes, thrombopoietin (3)
CL Item
Yes, erythropoietin (4)
Comments
Item
Comments
text

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