ID
37907
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)
- 29.08.19 29.08.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
29. August 2019
DOI
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Lizenz
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 1 Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Sitting (after 5 mins.)
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Sitting after (5 mins.)
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Sitting (after 5 mins.)
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschreibung
Temperature
Datentyp
float
Alias
- UMLS CUI [1]
- C0005903
Beschreibung
Temperature Unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschreibung
Tumor Marker (CA-125)
Alias
- UMLS CUI-1
- C0041365
- UMLS CUI-2
- C0201549
Beschreibung
Tumor Marker Sample Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0201549
- UMLS CUI [1,3]
- C1302413
Beschreibung
Laboratory Name
Datentyp
text
Alias
- UMLS CUI [1]
- C3258037
Beschreibung
Tumor Marker Value
Datentyp
integer
Maßeinheiten
- U/mL
Alias
- UMLS CUI [1,1]
- C0041365
- UMLS CUI [1,2]
- C0201549
Beschreibung
Laboratory Tests - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschreibung
Laboratory Tests - Haematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Beschreibung
Haematology Test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beschreibung
Haematology - No Result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Beschreibung
Haematology - Value
Datentyp
text
Alias
- UMLS CUI [1]
- C0474523
Beschreibung
Haematology - Value out of range and NOT clinically significant
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0438215
- UMLS CUI [1,3]
- C2826293
Beschreibung
Haematology - Value out of range and clinically significant
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0438215
- UMLS CUI [1,3]
- C2826293
Beschreibung
Laboratory Tests - Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beschreibung
Laboratory Tests - Chemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0008000
Beschreibung
Chemistry - Test
Datentyp
integer
Alias
- UMLS CUI [1]
- C0525044
Beschreibung
Chemistry - No Result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
Beschreibung
Chemistry - Value
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
Beschreibung
Chemistry - Value out of range and NOT clinically significant
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0438215
- UMLS CUI [1,4]
- C2826293
Beschreibung
Chemistry - Value out of range and NOT clinically significant
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0438215
- UMLS CUI [1,4]
- C2826293
Beschreibung
Lesion Assessment
Alias
- UMLS CUI-1
- C0221198
- UMLS CUI-2
- C1516048
Beschreibung
Lesion Assessment Record
Alias
- UMLS CUI-1
- C0221198
- UMLS CUI-2
- C1516048
Beschreibung
Lesion No.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C0221198
Beschreibung
Lesion Site Code
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0449695
- UMLS CUI [1,2]
- C0805701
Beschreibung
Lesion Site Description
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0449695
- UMLS CUI [1,2]
- C0678257
Beschreibung
Lesion Measurement - Method Code
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C2911685
- UMLS CUI [1,4]
- C0805701
Beschreibung
Lesion Measurement - Date Performed
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1299991
- UMLS CUI [1,2]
- C0221198
- UMLS CUI [1,3]
- C0011008
Beschreibung
Measurable/ Non measurable Lesion Code
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1513040
- UMLS CUI [2]
- C1334988
Beschreibung
Lesion Size - 1. Diameter (cm)
Datentyp
float
Maßeinheiten
- cm
Alias
- UMLS CUI [1,1]
- C0449453
- UMLS CUI [1,2]
- C1301886
Beschreibung
Lesion Size - 2. Diameter (cm)
Datentyp
float
Maßeinheiten
- cm
Alias
- UMLS CUI [1,1]
- C0449453
- UMLS CUI [1,2]
- C1301886
Beschreibung
Lesion Non-Evaluable
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1883425
Beschreibung
Lesion Non-Evaluable - Lesion Measurement Method Code
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1883425
- UMLS CUI [1,3]
- C1299991
- UMLS CUI [1,4]
- C0805701
Beschreibung
Lesion Non-Evaluable - Date Performed
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1883425
- UMLS CUI [1,3]
- C0011008
Beschreibung
Lesion Non-Evaluable Status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0221198
- UMLS CUI [1,2]
- C1883425
- UMLS CUI [1,3]
- C0449438
Ähnliche Modelle
Course 1 Prior to next Course (Day 25 - 28) - Vital Signs; Tumor Marker (CA-125); Laboratory Tests; Lesion Assessment Record
C0019994 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0422727 (UMLS CUI [2])
C0201549 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
C0201549 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C0474523 (UMLS CUI-2)
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])
C0008000 (UMLS CUI-2)
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI-2)
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C1274040 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
C1516048 (UMLS CUI [1,2])
C1516048 (UMLS CUI-2)
C0221198 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1513040 (UMLS CUI [1,2])
C1334988 (UMLS CUI [2])
C1301886 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,2])
C1883425 (UMLS CUI [1,2])
C1883425 (UMLS CUI [1,2])
C1299991 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C1883425 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1883425 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])