ID
37973
Beskrivning
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer
Nyckelord
Versioner (1)
- 2019-09-03 2019-09-03 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
3 september 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308
Survival Information; Form D; Termination Record
- StudyEvent: ODM
Beskrivning
Survival Information - Review of disease status
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Beskrivning
Date of Assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Mark only one.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beskrivning
Date of Progression
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Beskrivning
Lesion Evaluation or Clinical Assessment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Beskrivning
Survival Information - Outcome
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C1547647
Beskrivning
If "Yes", complete FORM D
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beskrivning
If patient did not die, Date of last contact
Datatyp
date
Alias
- UMLS CUI [1]
- C0805839
Beskrivning
Was the patient lost to follow-up?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1302313
Beskrivning
Form D
Alias
- UMLS CUI-1
- C0011065
Beskrivning
Primary Cause of Death
Datatyp
integer
Alias
- UMLS CUI [1]
- C0007465
Beskrivning
If Progressive Disease, specify details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1335499
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Beskrivning
If Toxicity, specify details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0040539
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Beskrivning
If other cause of Death, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Date of Death
Datatyp
date
Alias
- UMLS CUI [1]
- C1148348
Beskrivning
Was an Autopsy performed?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beskrivning
Include diagnosis
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Beskrivning
I certify that I have reviewed the follow-up data and that all information is complete and accurate
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Date of Investigator's Signature
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Termination Record
Alias
- UMLS CUI-1
- C0871548
Beskrivning
Termination Record - Review of Disease Status
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Beskrivning
Date of Assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720
Beskrivning
Mark only one.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beskrivning
Date of Progression
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Beskrivning
Lesion Evaluation or Clinical Assessment
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Beskrivning
Termination Record - Best Overall Response
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2986560
Beskrivning
Termination Record - Study Conclusion
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C1707478
- UMLS CUI-3
- C0008972
Beskrivning
Mark the primary cause of study conclusion
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1707478
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [1,3]
- C0085978
Beskrivning
If other cause of study conclusion, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0008972
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Termination Record - Investigator Signature
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2346576
Beskrivning
I certify that I have reviewed the data on the case report form, including laboratory data, and the Adverse Event and Serious Adverse Event sections, and that all information is complete and accurate.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator's Signature - Date Signed
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Survival Information; Form D; Termination Record
- StudyEvent: ODM
C0439231 (UMLS CUI-2)
C0684224 (UMLS CUI-3)
C0684224 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0012634 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
C4534461 (UMLS CUI [2])
C1547647 (UMLS CUI-2)
C2348235 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0884358 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C0449438 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
C4534461 (UMLS CUI [2])
C2986560 (UMLS CUI-2)
C1707478 (UMLS CUI-2)
C0008972 (UMLS CUI-3)
C0008972 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2346576 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])