ID

35665

Descripción

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 

Palabras clave

Versiones (1)
  1. 14/3/19 14/3/19 -
Titular de derechos de autor

GSK group of companies

Subido en

14 de marzo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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Cisplatin and Topotecan Recurrent or Persistent Carcinoma of the Cervix - 103369

Inglés

Common Toxicity Report

1 formularios  
  1. StudyEvent: ODM
    1. Common Toxicity Report
Administrative data
Descripción

Administrative data

Last Name
Descripción

Last Name

Tipo de datos

text

First Name
Descripción

First Name

Tipo de datos

text

Section
Descripción

Section

Tipo de datos

text

GOG #
Descripción

Inst.,Prot.,Seq.

Tipo de datos

integer

Common Toxicity Report
Descripción

Common Toxicity Report

Course Number
Descripción

The toxicities listed below occurred following this course of therapy

Tipo de datos

integer

Specific CTC Term or CTC Major Categories
Descripción

CTC Term

Tipo de datos

text

CTC Grade
Descripción

CTC Grade

Tipo de datos

integer

Due to Rx?
Descripción

potential connection to Rx

Tipo de datos

text

CTEP AER Submitted?
Descripción

CTEP AER

Tipo de datos

boolean

Specific CTC Term or Additional Information
Descripción

(e.g., lab values, clarifications)

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

Was a transfusion administered at this course of therapy?
Descripción

administration at the course of therapy

Tipo de datos

text

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

hospitalisation

Tipo de datos

boolean

Were cytokines administered this course?
Descripción

cytokines administered

Tipo de datos

text

Comments
Descripción

Comments

Tipo de datos

text

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Similar models

Common Toxicity Report

1 formularios
  1. StudyEvent: ODM
    1. Common Toxicity Report
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
CTC Term
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
potential connection to Rx
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
administration at the course of therapy
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
cytokines administered
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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