ID
37892
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 (2)
- 2019-08-26 2019-08-26 -
- 2019-08-28 2019-08-28 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
28 augusti 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 1 (Day 1 ) - Vital Signs; Administration of Study Medications
Beskrivning
Day 1 Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Sitting after 5 mins.
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Sitting after 5 mins.
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Sitting after 5 mins.
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beskrivning
Temperature
Datatyp
float
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Temperature Unit
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beskrivning
Light clothes and shoes off. Round to the nearest kg or Ib.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Wieght Unit
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beskrivning
Body Surface Area
Datatyp
float
Måttenheter
- m2
Alias
- UMLS CUI [1]
- C0005902
Beskrivning
Topotecan Administration
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0146224
Beskrivning
Total mg to be given (Topotecan)
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439810
- UMLS CUI [2]
- C0146224
Beskrivning
Date Administered (Topotecan)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C0146224
Beskrivning
Start Time (Topotecan)
Datatyp
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2]
- C0146224
Beskrivning
Stop Time (Topotecan)
Datatyp
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2]
- C0146224
Beskrivning
Was complete dose given? (Topotecan)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [2]
- C0146224
Beskrivning
If complete dose Topotecan was not given, provide actual mg given:
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [2]
- C0146224
Beskrivning
Gemcitabine Administration
Alias
- UMLS CUI-1
- C0045093
- UMLS CUI-2
- C3469597
Beskrivning
Total mg to be given (Gemcitabine)
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439810
- UMLS CUI [1,3]
- C0045093
Beskrivning
Date Administered (Gemcitabine)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0045093
Beskrivning
Start Time (Gemcitabine)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0045093
Beskrivning
Stop Time (Gemcitabine)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0045093
Beskrivning
Was complete dose given? (Gemcitabine)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0045093
Beskrivning
If complete dose Gemcitabine was not given, provide actual mg given:
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0045093
Similar models
Course 1 (Day 1 ) - Vital Signs; Administration of Study Medications
C0600091 (UMLS CUI [1,2])
C0146224 (UMLS CUI-2)
C0439810 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
C0011008 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
C0146224 (UMLS CUI [2])
C0146224 (UMLS CUI [2])
C0205197 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
C0205197 (UMLS CUI [1,2])
C0146224 (UMLS CUI [2])
C3469597 (UMLS CUI-2)
C0439810 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
C0045093 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])