ID
37892
Description
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
Mots-clés
Versions (2)
- 26/08/2019 26/08/2019 -
- 28/08/2019 28/08/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
28 août 2019
DOI
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Licence
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
Description
Day 1 Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Sitting after 5 mins.
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Sitting after 5 mins.
Type de données
integer
Unités de mesure
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Sitting after 5 mins.
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1]
- C0232117
Description
Temperature
Type de données
float
Alias
- UMLS CUI [1]
- C0005903
Description
Temperature Unit
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Description
Light clothes and shoes off. Round to the nearest kg or Ib.
Type de données
integer
Alias
- UMLS CUI [1]
- C0005910
Description
Wieght Unit
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Description
Body Surface Area
Type de données
float
Unités de mesure
- m2
Alias
- UMLS CUI [1]
- C0005902
Description
Topotecan Administration
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0146224
Description
Total mg to be given (Topotecan)
Type de données
float
Unités de mesure
- mg
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439810
- UMLS CUI [2]
- C0146224
Description
Date Administered (Topotecan)
Type de données
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2]
- C0146224
Description
Start Time (Topotecan)
Type de données
time
Alias
- UMLS CUI [1]
- C1301880
- UMLS CUI [2]
- C0146224
Description
Stop Time (Topotecan)
Type de données
time
Alias
- UMLS CUI [1]
- C1522314
- UMLS CUI [2]
- C0146224
Description
Was complete dose given? (Topotecan)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [2]
- C0146224
Description
If complete dose Topotecan was not given, provide actual mg given:
Type de données
float
Unités de mesure
- mg
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [2]
- C0146224
Description
Gemcitabine Administration
Alias
- UMLS CUI-1
- C0045093
- UMLS CUI-2
- C3469597
Description
Total mg to be given (Gemcitabine)
Type de données
float
Unités de mesure
- mg
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0439810
- UMLS CUI [1,3]
- C0045093
Description
Date Administered (Gemcitabine)
Type de données
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0045093
Description
Start Time (Gemcitabine)
Type de données
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0045093
Description
Stop Time (Gemcitabine)
Type de données
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0045093
Description
Was complete dose given? (Gemcitabine)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205197
- UMLS CUI [1,3]
- C0045093
Description
If complete dose Gemcitabine was not given, provide actual mg given:
Type de données
float
Unités de mesure
- 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])