ID
29858
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
Link
https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs
Keywords
Versions (1)
- 4/24/18 4/24/18 - Halim Ugurlu
Copyright Holder
GSK
Uploaded on
April 24, 2018
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
GSK Study ID 104864-201 Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication
Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication
Description
Supportive Therapy Transfusion
Alias
- UMLS CUI-1
- C1879316
- UMLS CUI-2
- C0014822
- UMLS CUI-3
- C0436313
Description
If Yes to Supportive Therapy (Including Erythropoietin)
Alias
- UMLS CUI-1
- C1879316
- UMLS CUI-2
- C0014822
- UMLS CUI-3
- C0436313
Description
Type of transfusions
Data type
text
Alias
- UMLS CUI [1,1]
- C1879316
- UMLS CUI [1,2]
- C0332307
Description
Transfusions (Number of Units)
Data type
text
Alias
- UMLS CUI [1,1]
- C1879316
- UMLS CUI [1,2]
- C0237753
Description
Erythropoietin Dose
Data type
float
Measurement units
- units/kg
Alias
- UMLS CUI [1,1]
- C0014822
- UMLS CUI [1,2]
- C3174092
Description
Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1879316
Description
Supportive Anti-Infective Therapy
Alias
- UMLS CUI-1
- C1141958
- UMLS CUI-2
- C0436313
Description
If Yes to Supportive Anti-Infective Therapy
Alias
- UMLS CUI-1
- C1141958
- UMLS CUI-2
- C0436313
Description
If a treatment is recorded here, do not record on the Concomitant Medication section.
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
Total Daily Dose
Data type
text
Alias
- UMLS CUI [1]
- C2348070
Description
For Route, see general instructions for acceptable abbreviations.
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Where appropriate, medical conditions should be recorded in the Adverse Experiences section, utilizing the same terminology.
Data type
text
Alias
- UMLS CUI [1]
- C3843040
Description
Record PM for anti-infectives administered prophylactically, EM for anti-infectives used for symptomatic treatment, and TX for anti-infectives administered for a confirmed infection in the column provided.
Data type
text
Alias
- UMLS CUI [1]
- C1141958
Description
Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C3174092
Description
End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C3174092
Description
If Continuing to Medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Description
Concominant Medication
Alias
- UMLS CUI-1
- C2347852
Description
Record all concomitant medication taken during this course. Record PM for prophylactic treatment with Medical Condition for prophylactically administered medications. If a medication was marked 'Continuing' at the initial visit, it must be recorded below. Where appropriate, medical conditions should be recorded on the Adverse Experience Form, utilizing the same terminology
Data type
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Description
Total Daily Dose
Data type
text
Alias
- UMLS CUI [1]
- C2348070
Description
For Route, see General Instructions for acceptable abbreviations
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Description
Medical Condition
Data type
text
Alias
- UMLS CUI [1]
- C3843040
Description
Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
Description
End Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2347852
Description
If Continung to Medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Similar models
Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication
C0014822 (UMLS CUI-2)
C0436313 (UMLS CUI-3)
C0014822 (UMLS CUI [1,2])
C0436313 (UMLS CUI [1,3])
C0014822 (UMLS CUI-2)
C0436313 (UMLS CUI-3)
C0332307 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C1879316 (UMLS CUI [1,2])
C0436313 (UMLS CUI-2)
C1514463 (UMLS CUI [1,2])
C1521721 (UMLS CUI [1,3])
C0436313 (UMLS CUI-2)
C3174092 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])