ID

35665

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)
  1. 3/14/19 3/14/19 -
Copyright Holder

GSK group of companies

Uploaded on

March 14, 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

Common Toxicity Report

1 forms  
  1. StudyEvent: ODM
    1. Common Toxicity Report
Administrative data
Description

Administrative data

Last Name
Description

Last Name

Data type

text

First Name
Description

First Name

Data type

text

Section
Description

Section

Data type

text

GOG #
Description

Inst.,Prot.,Seq.

Data type

integer

Common Toxicity Report
Description

Common Toxicity Report

Course Number
Description

The toxicities listed below occurred following this course of therapy

Data type

integer

Specific CTC Term or CTC Major Categories
Description

CTC Term

Data type

text

CTC Grade
Description

CTC Grade

Data type

integer

Due to Rx?
Description

potential connection to Rx

Data type

text

CTEP AER Submitted?
Description

CTEP AER

Data type

boolean

Specific CTC Term or Additional Information
Description

(e.g., lab values, clarifications)

Data type

text

Date
Description

Date

Data type

date

Was a transfusion administered at this course of therapy?
Description

administration at the course of therapy

Data type

text

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

hospitalisation

Data type

boolean

Were cytokines administered this course?
Description

cytokines administered

Data type

text

Comments
Description

Comments

Data type

text

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Similar models

Common Toxicity Report

1 forms
  1. StudyEvent: ODM
    1. Common Toxicity Report
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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