ID
29865
Beskrivning
Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Länk
https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Nyckelord
Versioner (1)
- 24/04/2018 24/04/2018 - Halim Ugurlu
Rättsinnehavare
GSK
Uppladdad den
24 avril 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK Study ID 104864-201-Medication (next Course)
Medication
- StudyEvent: ODM
Beskrivning
Topotecan and Ara-C Study Medication Record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0146224
- UMLS CUI-4
- C0733521
Beskrivning
Record the patient's weight below, on Day 1 of infusion
Datatyp
text
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Record the patient's body surface area below, on Day 1 of infusion
Datatyp
float
Måttenheter
- m^2
Alias
- UMLS CUI [1]
- C0005902
Beskrivning
Ideal Weight
Datatyp
text
Alias
- UMLS CUI [1]
- C0421272
Beskrivning
Please mark the box below if the ideal weight was used to calculate body surface area.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0421272
Beskrivning
Topotecan Administration
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0146224
Beskrivning
Day
Datatyp
text
Alias
- UMLS CUI [1]
- C0439228
Beskrivning
Totally Daily Dose for this Infusion
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Infusion start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Beskrivning
Infusion Start time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Beskrivning
Infusion Stop date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Beskrivning
Infusion Stop time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0040223
Beskrivning
Ara-C Administration
Alias
- UMLS CUI-1
- C0733521
- UMLS CUI-2
- C3469597
Beskrivning
Day
Datatyp
text
Alias
- UMLS CUI [1]
- C0439228
Beskrivning
Totally Daily Dose for this Infusion
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Infusion start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Beskrivning
Infusion Start time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Beskrivning
Infusion Stop date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Beskrivning
Infusion Stop time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0040223
Beskrivning
Idarubicin and Ara-C Study Medication Record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0020789
- UMLS CUI-4
- C0020789
Beskrivning
Record the patient's weight below, on Day 1 of infusion
Datatyp
text
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Record the patient's body surface area below, on Day 1 of infusion
Datatyp
float
Måttenheter
- m^2
Alias
- UMLS CUI [1]
- C0005902
Beskrivning
Ideal Weight
Datatyp
text
Alias
- UMLS CUI [1]
- C0421272
Beskrivning
Please mark the box below if the ideal weight was used to calculate body surface area.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0421272
Beskrivning
Idarubicin Administration
Alias
- UMLS CUI-1
- C0013153
- UMLS CUI-2
- C0020789
Beskrivning
Day
Datatyp
text
Alias
- UMLS CUI [1]
- C0439228
Beskrivning
Totally Daily Dose for this Infusion
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Infusion start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Beskrivning
Infusion Start time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Beskrivning
Infusion Stop date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Beskrivning
Infusion Stop time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0040223
Beskrivning
Ara-C Administration
Alias
- UMLS CUI-1
- C0733521
- UMLS CUI-2
- C3469597
Beskrivning
Day
Datatyp
text
Alias
- UMLS CUI [1]
- C0439228
Beskrivning
Totally Daily Dose for this Infusion
Datatyp
float
Måttenheter
- mg
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Infusion start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Beskrivning
Infusion Start time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Beskrivning
Infusion Stop date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Beskrivning
Infusion Stop time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0040223
Beskrivning
Dose Reduction
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C0547047
Beskrivning
For any patient who does not have CR at course 1 and who has grade 3 or 4 non-hematologic toxicity (excluding toxicities of nausea, vomiting or alopecia) may receive a 25% dose reduction at course 2 only. Refer to protocol Section 6.2.3
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0547047
Beskrivning
If Yes to Dose Reduction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0547047
Beskrivning
Retreatment Interval
Alias
- UMLS CUI-1
- C0376495
- UMLS CUI-2
- C1272706
Beskrivning
Retreatment Interval
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C1272706
Beskrivning
If No to
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C1272706
- UMLS CUI [1,3]
- C1518422
Beskrivning
Approved by
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Beskrivning
Date of Approve
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
G-CSF Study Medication Record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0079459
Beskrivning
Day 14 to 28
Datatyp
text
Alias
- UMLS CUI [1]
- C0439228
Beskrivning
Dose
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0079459
Beskrivning
Route
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0079459
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Time
Datatyp
time
Alias
- UMLS CUI [1]
- C0040223
Beskrivning
Vital Signs-TAG Regiment only
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0146224
- UMLS CUI-3
- C0733521
- UMLS CUI-4
- C0079459
- UMLS CUI-5
- C0013227
Beskrivning
Day
Datatyp
text
Alias
- UMLS CUI [1]
- C0439228
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Prior to infusion
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1301732
Beskrivning
Actual Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0237400
Beskrivning
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beskrivning
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beskrivning
Pulse After 5 Minutes Sitting
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0232117
- UMLS CUI [1,2]
- C0277814
Beskrivning
Vital Signs-IDAG Regiment only-Vital signs are to be performed on Days 1, 2, and 3 prior to idarubicin infusion and post ara-C infusion. On Days 4 and 5, vital signs are to be performed prior and post ara-C infusion
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0020789
- UMLS CUI-3
- C0733521
- UMLS CUI-4
- C0079459
- UMLS CUI-5
- C0013227
Beskrivning
Day
Datatyp
text
Alias
- UMLS CUI [1]
- C0439228
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Prior to infusion
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1301732
Beskrivning
Actual Time
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0237400
Beskrivning
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Beskrivning
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Beskrivning
Pulse After 5 Minutes Sitting
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1,1]
- C0232117
- UMLS CUI [1,2]
- C0277814
Similar models
Medication
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0008972 (UMLS CUI-2)
C0146224 (UMLS CUI-3)
C0733521 (UMLS CUI-4)
C0146224 (UMLS CUI-2)
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0008972 (UMLS CUI-2)
C0020789 (UMLS CUI-3)
C0020789 (UMLS CUI-4)
C0020789 (UMLS CUI-2)
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0574032 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0547047 (UMLS CUI [1,2])
C0547047 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,2])
C1272706 (UMLS CUI [1,2])
C1518422 (UMLS CUI [1,3])
C1708968 (UMLS CUI [1,2])
C0008972 (UMLS CUI-2)
C0079459 (UMLS CUI-3)
C0079459 (UMLS CUI [1,2])
C0146224 (UMLS CUI-2)
C0733521 (UMLS CUI-3)
C0079459 (UMLS CUI-4)
C0013227 (UMLS CUI-5)
C1301732 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0020789 (UMLS CUI-2)
C0733521 (UMLS CUI-3)
C0079459 (UMLS CUI-4)
C0013227 (UMLS CUI-5)
C1301732 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
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