ID

37647

Description

Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Keywords

Versions (1)
  1. 8/13/19 8/13/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 13, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

English

Prior to Seventh Cycle

1 forms  
  1. StudyEvent: ODM
    1. Prior to Seventh Cycle
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Serious adverse event
Description

Serious adverse event

Alias
UMLS CUI-1
C1519255
Has a serious adverse event occurred during the course of the previous cycle?
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Quality-of-life questionnaire
Description

Quality-of-life questionnaire

Alias
UMLS CUI-1
C0034394
UMLS CUI-2
C0034380
Has the patient completed the questionnaire?
Description

Questionnaires, Quality of life

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
If No, Reason
Description

Questionnaires, Quality of life, Compliance behavior, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C1321605
UMLS CUI [1,4]
C0566251
Did the patient need help for the completion of the questionnaire
Description

Questionnaires, Quality of life, Supportive assistance

Data type

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C1521721
Name of the supporting person
Description

Questionnaires, Quality of life, Supportive assistance, Name

Data type

text

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0034380
UMLS CUI [1,3]
C1521721
UMLS CUI [1,4]
C0027365
Status of the study
Description

Status of the study

Alias
UMLS CUI-1
C0008976
UMLS CUI-2
C0449438
Will the next treatment cycle be performed in the patient?
Description

Continuation status, Clinical Trials

Data type

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
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Similar models

Prior to Seventh Cycle

1 forms
  1. StudyEvent: ODM
    1. Prior to Seventh Cycle
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Serious adverse event
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Has a serious adverse event occurred during the course of the previous cycle?
boolean
C1519255 (UMLS CUI [1])
Item Group
Quality-of-life questionnaire
C0034394 (UMLS CUI-1)
C0034380 (UMLS CUI-2)
Questionnaires, Quality of life
Item
Has the patient completed the questionnaire?
boolean
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
Questionnaires, Quality of life, Compliance behavior, Reason and justification
Item
If No, Reason
text
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Questionnaires, Quality of life, Supportive assistance
Item
Did the patient need help for the completion of the questionnaire
boolean
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C1521721 (UMLS CUI [1,3])
Questionnaires, Quality of life, Supportive assistance, Name
Item
Name of the supporting person
text
C0034394 (UMLS CUI [1,1])
C0034380 (UMLS CUI [1,2])
C1521721 (UMLS CUI [1,3])
C0027365 (UMLS CUI [1,4])
Item Group
Status of the study
C0008976 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
Continuation status, Clinical Trials
Item
Will the next treatment cycle be performed in the patient?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
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