ID
37209
Beschrijving
Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer
Trefwoorden
Versies (1)
- 08-07-19 08-07-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 juli 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502
Prenext Course Visit
- StudyEvent: ODM
Beschrijving
Serious Adverse Event
Alias
- UMLS CUI-1
- C0146224
- UMLS CUI-2
- C0392920
- UMLS CUI-3
- C1519255
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Body temperature measurement, Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beschrijving
Body Temperature, Unit of Measure
Datatype
text
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1519795
Beschrijving
Body Temperature
Datatype
float
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Systolic Pressure, Sitting position
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beschrijving
Diastolic blood pressure, Sitting position
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beschrijving
Heart rate while sitting
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C2029904
Beschrijving
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beschrijving
12 lead ECG, Requirement
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1514873
Beschrijving
12 lead ECG, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Beschrijving
12 lead ECG, Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Beschrijving
Topotecan Study Medication Compliance - Daily X5 Days Regimen
Alias
- UMLS CUI-1
- C0146224
- UMLS CUI-2
- C0392920
Beschrijving
Topotecan, Chemotherapy Regimen, Dispensed Amount
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C0805077
Beschrijving
Topotecan, Chemotherapy Regimen, Capsule, Taken
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C0006935
- UMLS CUI [1,4]
- C1883727
Beschrijving
Topotecan, Chemotherapy Regimen, Returned Amount
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C2699071
Beschrijving
Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 1-5
Alias
- UMLS CUI-1
- C0146224
- UMLS CUI-2
- C0392920
Beschrijving
Topotecan, Chemotherapy Regimen, Dispensed Amount
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C0805077
Beschrijving
Topotecan, Chemotherapy Regimen, Capsule, Taken
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C0006935
- UMLS CUI [1,4]
- C1883727
Beschrijving
Topotecan, Chemotherapy Regimen, Returned Amount
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C2699071
Beschrijving
Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 8-12
Alias
- UMLS CUI-1
- C0146224
- UMLS CUI-2
- C0392920
Beschrijving
Topotecan, Chemotherapy Regimen, Dispensed Amount
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C0805077
Beschrijving
Topotecan, Chemotherapy Regimen, Capsule, Taken
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C0006935
- UMLS CUI [1,4]
- C1883727
Beschrijving
Topotecan, Chemotherapy Regimen, Returned Amount
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C2699071
Beschrijving
Topotecan Study Medication Compliance - 5 Days On, 2 Days Off for 3 Weeks Regimen - Days 15-19
Alias
- UMLS CUI-1
- C0146224
- UMLS CUI-2
- C0392920
Beschrijving
Topotecan, Chemotherapy Regimen, Dispensed Amount
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C0805077
Beschrijving
Topotecan, Chemotherapy Regimen, Capsule, Taken
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C0006935
- UMLS CUI [1,4]
- C1883727
Beschrijving
Topotecan, Chemotherapy Regimen, Returned Amount
Datatype
text
Alias
- UMLS CUI [1,1]
- C0146224
- UMLS CUI [1,2]
- C0392920
- UMLS CUI [1,3]
- C2699071
Similar models
Prenext Course Visit
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0392920 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0392920 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0392920 (UMLS CUI-2)
C0392920 (UMLS CUI [1,2])
C0805077 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
C0392920 (UMLS CUI [1,2])
C2699071 (UMLS CUI [1,3])
C0392920 (UMLS CUI-2)
C0392920 (UMLS CUI [1,2])
C0805077 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
C0392920 (UMLS CUI [1,2])
C2699071 (UMLS CUI [1,3])
C0392920 (UMLS CUI-2)
C0392920 (UMLS CUI [1,2])
C0805077 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
C0392920 (UMLS CUI [1,2])
C2699071 (UMLS CUI [1,3])
C0392920 (UMLS CUI-2)
C0392920 (UMLS CUI [1,2])
C0805077 (UMLS CUI [1,3])
C0392920 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
C1883727 (UMLS CUI [1,4])
C0392920 (UMLS CUI [1,2])
C2699071 (UMLS CUI [1,3])