ID
29865
Description
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
Lien
https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Mots-clés
Versions (1)
- 24/04/2018 24/04/2018 - Halim Ugurlu
Détendeur de droits
GSK
Téléchargé le
24 avril 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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GSK Study ID 104864-201-Medication (next Course)
Medication
- StudyEvent: ODM
Description
Topotecan and Ara-C Study Medication Record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0146224
- UMLS CUI-4
- C0733521
Description
Record the patient's weight below, on Day 1 of infusion
Type de données
text
Alias
- UMLS CUI [1]
- C0005910
Description
Record the patient's body surface area below, on Day 1 of infusion
Type de données
float
Unités de mesure
- m^2
Alias
- UMLS CUI [1]
- C0005902
Description
Ideal Weight
Type de données
text
Alias
- UMLS CUI [1]
- C0421272
Description
Please mark the box below if the ideal weight was used to calculate body surface area.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0421272
Description
Topotecan Administration
Alias
- UMLS CUI-1
- C3469597
- UMLS CUI-2
- C0146224
Description
Day
Type de données
text
Alias
- UMLS CUI [1]
- C0439228
Description
Totally Daily Dose for this Infusion
Type de données
float
Unités de mesure
- mg
Alias
- UMLS CUI [1]
- C2348070
Description
Infusion start date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Description
Infusion Start time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Description
Infusion Stop date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Description
Infusion Stop time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0040223
Description
Ara-C Administration
Alias
- UMLS CUI-1
- C0733521
- UMLS CUI-2
- C3469597
Description
Day
Type de données
text
Alias
- UMLS CUI [1]
- C0439228
Description
Totally Daily Dose for this Infusion
Type de données
float
Unités de mesure
- mg
Alias
- UMLS CUI [1]
- C2348070
Description
Infusion start date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Description
Infusion Start time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Description
Infusion Stop date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Description
Infusion Stop time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0040223
Description
Idarubicin and Ara-C Study Medication Record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0020789
- UMLS CUI-4
- C0020789
Description
Record the patient's weight below, on Day 1 of infusion
Type de données
text
Alias
- UMLS CUI [1]
- C0005910
Description
Record the patient's body surface area below, on Day 1 of infusion
Type de données
float
Unités de mesure
- m^2
Alias
- UMLS CUI [1]
- C0005902
Description
Ideal Weight
Type de données
text
Alias
- UMLS CUI [1]
- C0421272
Description
Please mark the box below if the ideal weight was used to calculate body surface area.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0421272
Description
Idarubicin Administration
Alias
- UMLS CUI-1
- C0013153
- UMLS CUI-2
- C0020789
Description
Day
Type de données
text
Alias
- UMLS CUI [1]
- C0439228
Description
Totally Daily Dose for this Infusion
Type de données
float
Unités de mesure
- mg
Alias
- UMLS CUI [1]
- C2348070
Description
Infusion start date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Description
Infusion Start time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Description
Infusion Stop date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Description
Infusion Stop time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0040223
Description
Ara-C Administration
Alias
- UMLS CUI-1
- C0733521
- UMLS CUI-2
- C3469597
Description
Day
Type de données
text
Alias
- UMLS CUI [1]
- C0439228
Description
Totally Daily Dose for this Infusion
Type de données
float
Unités de mesure
- mg
Alias
- UMLS CUI [1]
- C2348070
Description
Infusion start date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0439659
Description
Infusion Start time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0040223
Description
Infusion Stop date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0574032
Description
Infusion Stop time
Type de données
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0574032
- UMLS CUI [1,3]
- C0040223
Description
Dose Reduction
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C0547047
Description
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
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0547047
Description
If Yes to Dose Reduction
Type de données
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0547047
Description
Retreatment Interval
Alias
- UMLS CUI-1
- C0376495
- UMLS CUI-2
- C1272706
Description
Retreatment Interval
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C1272706
Description
If No to
Type de données
text
Alias
- UMLS CUI [1,1]
- C0376495
- UMLS CUI [1,2]
- C1272706
- UMLS CUI [1,3]
- C1518422
Description
Approved by
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C1708968
Description
Date of Approve
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
G-CSF Study Medication Record
Alias
- UMLS CUI-1
- C2734539
- UMLS CUI-2
- C0008972
- UMLS CUI-3
- C0079459
Description
Day 14 to 28
Type de données
text
Alias
- UMLS CUI [1]
- C0439228
Description
Dose
Type de données
text
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0079459
Description
Route
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0079459
Description
Date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Time
Type de données
time
Alias
- UMLS CUI [1]
- C0040223
Description
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
Description
Day
Type de données
text
Alias
- UMLS CUI [1]
- C0439228
Description
Date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Prior to infusion
Type de données
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1301732
Description
Actual Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0237400
Description
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
Pulse After 5 Minutes Sitting
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1,1]
- C0232117
- UMLS CUI [1,2]
- C0277814
Description
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
Description
Day
Type de données
text
Alias
- UMLS CUI [1]
- C0439228
Description
Date
Type de données
date
Alias
- UMLS CUI [1]
- C0011008
Description
Prior to infusion
Type de données
text
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C1301732
Description
Actual Time
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0237400
Description
Sitting Blood Pressure (Systolic) After 5 Minutes Sitting
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
Sitting Blood Pressure (Diastolic) After 5 Minutes Sitting
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
Pulse After 5 Minutes Sitting
Type de données
integer
Unités de mesure
- 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])