ID
37965
Beschrijving
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
Trefwoorden
Versies (2)
- 02-09-19 02-09-19 -
- 02-09-19 02-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
2 september 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308
Course -- (Day 1) - Eligibility; Vital Signs; Administration of Study Medications
Beschrijving
Eligibility
Alias
- UMLS CUI-1
- C0013893
Beschrijving
Was this course delayed?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0205421
Beschrijving
If course was delayed, reason for delay
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0205421
- UMLS CUI [1,3]
- C0392360
Beschrijving
If other reason for course delay, specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0750729
- UMLS CUI [1,2]
- C0205421
- UMLS CUI [1,3]
- C0392360
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C2348235
Beschrijving
Is the patient eligible to continue in the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1302261
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Sitting after 5 mins.
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Sitting after 5 mins.
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Sitting after 5 mins.
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Temperature
Datatype
float
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Temperature Unit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschrijving
Light clothes and shoes off. Round to the nearest kg ob Ib.
Datatype
integer
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Weight Unit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C0439148
Beschrijving
Body Surface Area
Datatype
float
Maateenheden
- m2
Alias
- UMLS CUI [1]
- C0005902
Beschrijving
Administration of Study Medications
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0304229
Beschrijving
Were the study medications administered at Day 1?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
Beschrijving
If study medication was not administered at Day 1, mark reason(s) why
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3469597
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C2826287
Beschrijving
If other reason for medication not administered, specify
Datatype
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
Beschrijving
Topotecan Administration
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0146224
Beschrijving
Was the topotecan dose reduced?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C1707814
Beschrijving
If topotecan dose was reduced, mark reason(s) dose was reduced
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C1707814
- UMLS CUI [1,3]
- C3146298
Beschrijving
If other reason topotecan dose was reduced, specify
Datatype
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
Beschrijving
Topotecan Dose Modification
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1707811
- UMLS CUI [1,2]
- C0146224
Beschrijving
If other topotecan dose reduction, specify
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C1707814
- UMLS CUI [1,2]
- C0146224
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Topotecan scheduled dose
Datatype
float
Maateenheden
- mg/m2
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C3174092
- UMLS CUI [1,3]
- C0205539
Beschrijving
Total mg to be given (Topotecan)
Datatype
float
Maateenheden
- mg
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439810
- UMLS CUI [2]
- C0146224
Beschrijving
Date Administered (Topotecan)
Datatype
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C0146224
Beschrijving
Start Time (Topotecan)
Datatype
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2]
- C0146224
Beschrijving
Stop Time (Topotecan)
Datatype
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2]
- C0146224
Beschrijving
Was complete dose given? (Topotecan)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [2]
- C0146224
Beschrijving
If complete dose Topotecan was not given, provide actual mg given:
Datatype
float
Maateenheden
- mg
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [2]
- C0146224
Beschrijving
Gemcitabine Administration
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0045093
Beschrijving
Was the gemcitabine dose reduced?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0045093
- UMLS CUI [1,2]
- C1707814
Beschrijving
If gemcitabine dose was reduced, mark reason(s) dose was reduced
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0045093
- UMLS CUI [1,2]
- C1707814
- UMLS CUI [1,3]
- C3146298
Beschrijving
If other reason gemcitabine dose was reduced, specify
Datatype
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
Beschrijving
Gemcitabine Dose Modification
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1707811
- UMLS CUI [1,2]
- C0045093
Beschrijving
If other gemcitabine dose reduction, specify
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C1707814
- UMLS CUI [1,2]
- C0045093
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Gemcitabine scheduled dose
Datatype
float
Maateenheden
- mg/m2
Alias
- UMLS CUI [1,1]
- C0045093
- UMLS CUI [1,2]
- C3174092
- UMLS CUI [1,3]
- C0205539
Beschrijving
Total mg to be given (Gemicitabine)
Datatype
float
Maateenheden
- mg
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439810
- UMLS CUI [1,3]
- C0045093
Beschrijving
Date Administered (Gemicitabine)
Datatype
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0045093
Beschrijving
Start Time (Gemicitabine)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0045093
Beschrijving
Stop Time (Gemicitabine)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0045093
Beschrijving
Was complete dose given? (Gemicitabine)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0045093
Beschrijving
If complete dose Gemcitabine was not given, provide actual mg given:
Datatype
float
Maateenheden
- mg
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0045093
Similar models
Course -- (Day 1) - Eligibility; Vital Signs; Administration of Study Medications
C0600091 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,2])
C0205421 (UMLS CUI [1,2])
C0205421 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205421 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
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])