ID
37973
Beschrijving
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
Trefwoorden
Versies (1)
- 03-09-19 03-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
3 september 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308
Survival Information; Form D; Termination Record
- StudyEvent: ODM
Beschrijving
Survival Information - Review of disease status
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Beschrijving
Date of Assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Mark only one.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschrijving
Date of Progression
Datatype
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Beschrijving
Lesion Evaluation or Clinical Assessment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Beschrijving
Survival Information - Outcome
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C1547647
Beschrijving
If "Yes", complete FORM D
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011065
Beschrijving
If patient did not die, Date of last contact
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
Was the patient lost to follow-up?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1302313
Beschrijving
Form D
Alias
- UMLS CUI-1
- C0011065
Beschrijving
Primary Cause of Death
Datatype
integer
Alias
- UMLS CUI [1]
- C0007465
Beschrijving
If Progressive Disease, specify details
Datatype
text
Alias
- UMLS CUI [1,1]
- C1335499
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Beschrijving
If Toxicity, specify details
Datatype
text
Alias
- UMLS CUI [1,1]
- C0040539
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Beschrijving
If other cause of Death, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Date of Death
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
Was an Autopsy performed?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Beschrijving
Include diagnosis
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Beschrijving
I certify that I have reviewed the follow-up data and that all information is complete and accurate
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Date of Investigator's Signature
Datatype
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschrijving
Termination Record
Alias
- UMLS CUI-1
- C0871548
Beschrijving
Termination Record - Review of Disease Status
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Beschrijving
Date of Assessment
Datatype
date
Alias
- UMLS CUI [1]
- C2985720
Beschrijving
Mark only one.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Beschrijving
Date of Progression
Datatype
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Beschrijving
Lesion Evaluation or Clinical Assessment
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Beschrijving
Termination Record - Best Overall Response
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2986560
Beschrijving
Termination Record - Study Conclusion
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C1707478
- UMLS CUI-3
- C0008972
Beschrijving
Mark the primary cause of study conclusion
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1707478
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [1,3]
- C0085978
Beschrijving
If other cause of study conclusion, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0008972
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Termination Record - Investigator Signature
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2346576
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Investigator's Signature - Date Signed
Datatype
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])