ID
37973
Description
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
Mots-clés
Versions (1)
- 03/09/2019 03/09/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
3 septembre 2019
DOI
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Licence
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
Description
Survival Information - Review of disease status
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Description
Date of Assessment
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Mark only one.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Description
Date of Progression
Type de données
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Description
Lesion Evaluation or Clinical Assessment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Description
Survival Information - Outcome
Alias
- UMLS CUI-1
- C0038953
- UMLS CUI-2
- C1547647
Description
If "Yes", complete FORM D
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011065
Description
If patient did not die, Date of last contact
Type de données
date
Alias
- UMLS CUI [1]
- C0805839
Description
Was the patient lost to follow-up?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1302313
Description
Form D
Alias
- UMLS CUI-1
- C0011065
Description
Primary Cause of Death
Type de données
integer
Alias
- UMLS CUI [1]
- C0007465
Description
If Progressive Disease, specify details
Type de données
text
Alias
- UMLS CUI [1,1]
- C1335499
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Description
If Toxicity, specify details
Type de données
text
Alias
- UMLS CUI [1,1]
- C0040539
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C1522508
Description
If other cause of Death, specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0007465
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Date of Death
Type de données
date
Alias
- UMLS CUI [1]
- C1148348
Description
Was an Autopsy performed?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0884358
Description
Include diagnosis
Type de données
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0243095
Description
I certify that I have reviewed the follow-up data and that all information is complete and accurate
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date of Investigator's Signature
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Termination Record
Alias
- UMLS CUI-1
- C0871548
Description
Termination Record - Review of Disease Status
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0449438
Description
Date of Assessment
Type de données
date
Alias
- UMLS CUI [1]
- C2985720
Description
Mark only one.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
Description
Date of Progression
Type de données
date
Alias
- UMLS CUI [1,1]
- C0242656
- UMLS CUI [1,2]
- C0011008
Description
Lesion Evaluation or Clinical Assessment
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [2]
- C4534461
Description
Termination Record - Best Overall Response
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2986560
Description
Termination Record - Study Conclusion
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C1707478
- UMLS CUI-3
- C0008972
Description
Mark the primary cause of study conclusion
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1707478
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [1,3]
- C0085978
Description
If other cause of study conclusion, specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0008972
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Description
Termination Record - Investigator Signature
Alias
- UMLS CUI-1
- C0871548
- UMLS CUI-2
- C2346576
Description
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.
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's Signature - Date Signed
Type de données
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])