ID

37649

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

Study End

1 forms  
  1. StudyEvent: ODM
    1. Study End
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Study End
Description

Study End

Alias
UMLS CUI-1
C0008972
UMLS CUI-2
C0444930
Did the patient prematurely terminate the study or was she prematurely withdrawn?
Description

Clinical Trials, Withdraw

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
If "yes", please document the date
Description

Clinical Trials, Withdraw, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0011008
If "yes", please provide the primary reason for withdrawal
Description

Clinical Trials, Withdraw, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0566251
Please specify
Description

Clinical Trials, Withdraw, Reason and justification

Data type

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0566251
Confirmation of the investigator
Description

Confirmation of the investigator

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C0750484
Signature of the responsible investigator I hereby declare that the data documented in his case report form are an exact and correct repetition of the patient's findings, that the trial was conducted according to protocol, and that the patient's consent for the study participation has been obtained.
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name in printed letters or practice stamp
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study End

1 forms
  1. StudyEvent: ODM
    1. Study End
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
Study End
C0008972 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
Clinical Trials, Withdraw
Item
Did the patient prematurely terminate the study or was she prematurely withdrawn?
boolean
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
Clinical Trials, Withdraw, Date in time
Item
If "yes", please document the date
date
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
If "yes", please provide the primary reason for withdrawal
text
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Clinical Trials, Withdraw, Reason and justification
Code List
If "yes", please provide the primary reason for withdrawal
CL Item
Adverse event (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol violation (incl. non-compliance) (3)
CL Item
Patient is lost to follow-up (4)
CL Item
Other, please specify (5)
Clinical Trials, Withdraw, Reason and justification
Item
Please specify
text
C0008976 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Item Group
Confirmation of the investigator
C2346576 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Investigator Signature
Item
Signature of the responsible investigator I hereby declare that the data documented in his case report form are an exact and correct repetition of the patient's findings, that the trial was conducted according to protocol, and that the patient's consent for the study participation has been obtained.
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Name in printed letters or practice stamp
text
C2826892 (UMLS CUI [1])
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