ID
37973
Descripción
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
Palabras clave
Versiones (1)
- 3/9/19 3/9/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
3 de septiembre de 2019
DOI
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Licencia
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
Descripción
Survival Information - Review of disease status
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Descripción
Date of Assessment
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985720
Descripción
Mark only one.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Descripción
Date of Progression
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Descripción
Lesion Evaluation or Clinical Assessment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Descripción
Survival Information - Outcome
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C1547647
Descripción
If "Yes", complete FORM D
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0011065
Descripción
If patient did not die, Date of last contact
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0805839
Descripción
Was the patient lost to follow-up?
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1302313
Descripción
Form D
Alias
- UMLS CUI-1
- C0011065
Descripción
Primary Cause of Death
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0007465
Descripción
If Progressive Disease, specify details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1335499
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Descripción
If Toxicity, specify details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0040539
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Descripción
If other cause of Death, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Descripción
Date of Death
Tipo de datos
date
Alias
- UMLS CUI [1]
- C1148348
Descripción
Was an Autopsy performed?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Descripción
Include diagnosis
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Descripción
I certify that I have reviewed the follow-up data and that all information is complete and accurate
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Date of Investigator's Signature
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Termination Record
Alias
- UMLS CUI-1
- C0871548
Descripción
Termination Record - Review of Disease Status
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Descripción
Date of Assessment
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985720
Descripción
Mark only one.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Descripción
Date of Progression
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Descripción
Lesion Evaluation or Clinical Assessment
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Descripción
Termination Record - Best Overall Response
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2986560
Descripción
Termination Record - Study Conclusion
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C1707478
- UMLS CUI-3
- C0008972
Descripción
Mark the primary cause of study conclusion
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1707478
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [1,3]
- C0085978
Descripción
If other cause of study conclusion, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0008972
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Descripción
Termination Record - Investigator Signature
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2346576
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator's Signature - Date Signed
Tipo de datos
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])