ID
37939
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)
- 2019-09-01 2019-09-01 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
1 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
Course 3 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log
Beskrivning
Review of Disease Status
Alias
- UMLS CUI-1
- C0699749 (disease stage)
- UMLS CUI-2
- C0699752 (Review of)
- SNOMED
- 55210009
Beskrivning
Date of Assessment
Datatyp
date
Alias
- UMLS CUI [1]
- C2985720 (Assessment Date)
Beskrivning
Assessment not done
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0220825 (Evaluation)
- LOINC
- LP36377-7
- UMLS CUI [1,2]
- C1272696 (Not Done)
- SNOMED
- 385660001
Beskrivning
Mark only one
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0220825 (Evaluation)
- LOINC
- LP36377-7
- UMLS CUI [1,2]
- C2826287 (Not-Done Reason)
Beskrivning
Date of Progression
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0242656 (Disease Progression)
- SNOMED
- 246453008
- LOINC
- LP121764-7
- UMLS CUI [1,2]
- C0011008 (Date in time)
- SNOMED
- 410671006
Beskrivning
Mark one
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0221198 (Lesion)
- SNOMED
- 52988006
- UMLS CUI [1,2]
- C1516048 (Assessed)
- UMLS CUI [2]
- C4534461 (Clinical assessment)
- LOINC
- LA27942-4
Beskrivning
Therapeutic Interventions
Alias
- UMLS CUI-1
- C0808232 (Therapeutic Intervention)
Beskrivning
If “Yes", complete Therapeutic Interventions log.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0808232 (Therapeutic Intervention)
- UMLS CUI [2,1]
- C0013221 (Drug toxicity)
- SNOMED
- 7895008
- UMLS CUI [2,2]
- C0304229 (Experimental drug)
Beskrivning
End of Course Eligibility
Alias
- UMLS CUI-1
- C0013893 (Eligibility Determination)
- UMLS CUI-2
- C0750729 (Course)
- SNOMED
- 288524001
- UMLS CUI-3
- C0444930 (End)
- SNOMED
- 261782000
Beskrivning
Hemoglobin >= 9.0 g/dL [90 g/L] Neutrophils >= 1000 cells/mm3 [>= 1.0 x 10*9 /L] Platelets >= 100,000/mm3 [>= 100.0 x 10*9 /L] No clinically significant non-hematologic drug related toxicity If "Yes“, proceed to next course. If "No”, complete Unscheduled Laboratory Tests.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0013893 (Eligibility Determination)
Beskrivning
Unscheduled Laboratory Tests - Hematology
Alias
- UMLS CUI-1
- C0022885 (Laboratory Procedures)
- SNOMED
- 269814003
- UMLS CUI-2
- C3854240 (Unscheduled)
- SNOMED
- 2341000175109
- LOINC
- LA22869-4
- UMLS CUI-3
- C0474523 (Hematology finding)
- SNOMED
- 250207003
Beskrivning
Hematology Sample Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0474523 (Hematology finding)
- SNOMED
- 250207003
- UMLS CUI [1,2]
- C1302413 (Specimen collection date)
- SNOMED
- 399445004
Beskrivning
Hematology Laboratory Name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0474523 (Hematology finding)
- SNOMED
- 250207003
- UMLS CUI [1,2]
- C3258037 (Performing laboratory name)
- LOINC
- LP135668-4
Beskrivning
Unscheduled Laboratory Tests - Hematology
Alias
- UMLS CUI-1
- C0022885 (Laboratory Procedures)
- SNOMED
- 269814003
- UMLS CUI-2
- C3854240 (Unscheduled)
- SNOMED
- 2341000175109
- LOINC
- LA22869-4
- UMLS CUI-3
- C0474523 (Hematology finding)
- SNOMED
- 250207003
Beskrivning
Hematology Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018941 (Hematologic Tests)
- SNOMED
- 252275004
Beskrivning
Hematology - No Result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018941 (Hematologic Tests)
- SNOMED
- 252275004
- UMLS CUI [1,2]
- C1274040 (Result)
- SNOMED
- 394617004
Beskrivning
Hematology - Value
Datatyp
text
Alias
- UMLS CUI [1]
- C0474523 (Hematology finding)
- SNOMED
- 250207003
Beskrivning
Hematology - Value out of range and NOT clinically significant
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0474523 (Hematology finding)
- SNOMED
- 250207003
- UMLS CUI [1,2]
- C0438215 (Laboratory test result abnormal)
- SNOMED
- 165346000
- UMLS CUI [1,3]
- C2826293 (Clinical Significance)
Beskrivning
Hematology - Value out of range and clinically significant
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0474523 (Hematology finding)
- SNOMED
- 250207003
- UMLS CUI [1,2]
- C0438215 (Laboratory test result abnormal)
- SNOMED
- 165346000
- UMLS CUI [1,3]
- C2826293 (Clinical Significance)
Beskrivning
Therapeutic Interventions
Alias
- UMLS CUI-1
- C0808232 (Therapeutic Intervention)
Beskrivning
Line Number
Datatyp
integer
Alias
- UMLS CUI [1]
- C0449788 (Count of entities)
- SNOMED
- 410681005
Beskrivning
Procedure
Datatyp
text
Alias
- UMLS CUI [1]
- C2700391 (Procedure (set of actions))
Beskrivning
Procedure details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2700391 (Procedure (set of actions))
- UMLS CUI [1,2]
- C1522508 (Details)
- LOINC
- MTHU027859
Beskrivning
Procedure Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C2700391 (Procedure (set of actions))
- UMLS CUI [1,2]
- C0040223 (Time)
- SNOMED
- 410670007
- LOINC
- LP73517-2
Beskrivning
Procedure Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2700391 (Procedure (set of actions))
- UMLS CUI [1,2]
- C0011008 (Date in time)
- SNOMED
- 410671006
Similar models
Course 3 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log
C0600091 (UMLS CUI [1,2])
C0699752 (UMLS CUI-2)
C1272696 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
C4534461 (UMLS CUI [2])
C0013221 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0750729 (UMLS CUI-2)
C0444930 (UMLS CUI-3)
C3854240 (UMLS CUI-2)
C0474523 (UMLS CUI-3)
C1302413 (UMLS CUI [1,2])
C3258037 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C0474523 (UMLS CUI-3)
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0438215 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C1522508 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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