ID
37973
Beschreibung
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
Stichworte
Versionen (1)
- 03.09.19 03.09.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
3. September 2019
DOI
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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
Beschreibung
Survival Information - Review of disease status
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Beschreibung
Date of Assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Mark only one.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschreibung
Date of Progression
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Beschreibung
Lesion Evaluation or Clinical Assessment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Beschreibung
Survival Information - Outcome
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C1547647
Beschreibung
If "Yes", complete FORM D
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschreibung
If patient did not die, Date of last contact
Datentyp
date
Alias
- UMLS CUI [1]
- C0805839
Beschreibung
Was the patient lost to follow-up?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1302313
Beschreibung
Form D
Alias
- UMLS CUI-1
- C0011065
Beschreibung
Primary Cause of Death
Datentyp
integer
Alias
- UMLS CUI [1]
- C0007465
Beschreibung
If Progressive Disease, specify details
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1335499
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Beschreibung
If Toxicity, specify details
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0040539
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Beschreibung
If other cause of Death, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Date of Death
Datentyp
date
Alias
- UMLS CUI [1]
- C1148348
Beschreibung
Was an Autopsy performed?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beschreibung
Include diagnosis
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Beschreibung
I certify that I have reviewed the follow-up data and that all information is complete and accurate
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Date of Investigator's Signature
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Termination Record
Alias
- UMLS CUI-1
- C0871548
Beschreibung
Termination Record - Review of Disease Status
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Beschreibung
Date of Assessment
Datentyp
date
Alias
- UMLS CUI [1]
- C2985720
Beschreibung
Mark only one.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschreibung
Date of Progression
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Beschreibung
Lesion Evaluation or Clinical Assessment
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Beschreibung
Termination Record - Best Overall Response
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2986560
Beschreibung
Termination Record - Study Conclusion
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C1707478
- UMLS CUI-3
- C0008972
Beschreibung
Mark the primary cause of study conclusion
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1707478
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [1,3]
- C0085978
Beschreibung
If other cause of study conclusion, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008972
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschreibung
Termination Record - Investigator Signature
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2346576
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator's Signature - Date Signed
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
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])