ID
37919
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 (3)
- 2019-08-29 2019-08-29 -
- 2019-08-30 2019-08-30 -
- 2019-08-30 2019-08-30 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
30 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 15 ) - Vital Signs; Hematology; Administration of Study Medications
Beskrivning
Day 15 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
Hematology
Alias
- UMLS CUI-1
- C0474523
Beskrivning
Hematology
Alias
- UMLS CUI-1
- C0474523
Beskrivning
Hematology Test
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018941
Beskrivning
Hematology - No Result
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C1274040
Beskrivning
Hematology - Value
Datatyp
text
Alias
- UMLS CUI [1]
- C0474523
Beskrivning
Hematology - Value out of range and NOT clinically significant
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0438215
- UMLS CUI [1,3]
- C2826293
Beskrivning
Hematology - Value out of range and clinically significant
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C0438215
- UMLS CUI [1,3]
- C2826293
Beskrivning
Day 15 Administration of Study Medications
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0304229
Beskrivning
Were the study medications administered at Day 15?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
Beskrivning
If study medication was not administered at Day 15, mark reason(s) why
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C2826287
Beskrivning
If other reason for medication not administered, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2,1]
- C2826287
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C2348235
Beskrivning
Topotecan Administration
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0146224
Beskrivning
Was the topotecan dose reduced?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C1707814
Beskrivning
If topotecan dose was reduced, mark reason(s) dose was reduced
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C1707814
- UMLS CUI [1,3]
- C3146298
Beskrivning
If other reason topotecan dose was reduced, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C1707814
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C2348235
Beskrivning
Topotecan Dose Modification
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1707811
- UMLS CUI [1,2]
- C0146224
Beskrivning
If other topotecan dose reduction, specify
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C1707814
- UMLS CUI [1,2]
- C0146224
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Topotecan scheduled dose
Datatyp
float
Måttenheter
- mg/m2
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C3174092
- UMLS CUI [1,3]
- C0205539
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
- C3469597
- UMLS CUI-2
- C0045093
Beskrivning
Was the gemcitabine dose reduced?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0045093
- UMLS CUI [1,2]
- C1707814
Beskrivning
If gemcitabine dose was reduced, mark reason(s) dose was reduced
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0045093
- UMLS CUI [1,2]
- C1707814
- UMLS CUI [1,3]
- C3146298
Beskrivning
If other reason gemcitabine dose was reduced, specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0045093
- UMLS CUI [1,2]
- C1707814
- UMLS CUI [1,3]
- C3146298
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C2348235
Beskrivning
Gemcitabine Dose Modification
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1707811
- UMLS CUI [1,2]
- C0045093
Beskrivning
If other gemcitabine dose reduction, specify
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C1707814
- UMLS CUI [1,2]
- C0045093
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beskrivning
Gemcitabine scheduled dose
Datatyp
float
Måttenheter
- mg/m2
Alias
- UMLS CUI [1,1]
- C0045093
- UMLS CUI [1,2]
- C3174092
- UMLS CUI [1,3]
- C0205539
Beskrivning
Total mg to be given (Gemicitabine)
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439810
- UMLS CUI [1,3]
- C0045093
Beskrivning
Date Administered (Gemicitabine)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0045093
Beskrivning
Start Time (Gemicitabine)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0045093
Beskrivning
Stop Time (Gemicitabine)
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0045093
Beskrivning
Was complete dose given? (Gemicitabine)
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 15 ) - Vital Signs; Hematology; Administration of Study Medications
C0600091 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
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])
C0304229 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2])
C0304229 (UMLS CUI [1,2])
C2826287 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
C0146224 (UMLS CUI-2)
C1707814 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0146224 (UMLS CUI [1,2])
C0146224 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C3174092 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
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])
C0045093 (UMLS CUI-2)
C1707814 (UMLS CUI [1,2])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C1707814 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0045093 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C3174092 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
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])