ID
29858
Beschrijving
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
Trefwoorden
Versies (1)
- 24-04-18 24-04-18 - Halim Ugurlu
Houder van rechten
GSK
Geüploaded op
24 april 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication
Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication
Beschrijving
Supportive Therapy Transfusion
Alias
- UMLS CUI-1
- C1879316
- UMLS CUI-2
- C0014822
- UMLS CUI-3
- C0436313
Beschrijving
If Yes to Supportive Therapy (Including Erythropoietin)
Alias
- UMLS CUI-1
- C1879316
- UMLS CUI-2
- C0014822
- UMLS CUI-3
- C0436313
Beschrijving
Type of transfusions
Datatype
text
Alias
- UMLS CUI [1,1]
- C1879316
- UMLS CUI [1,2]
- C0332307
Beschrijving
Transfusions (Number of Units)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1879316
- UMLS CUI [1,2]
- C0237753
Beschrijving
Erythropoietin Dose
Datatype
float
Maateenheden
- units/kg
Alias
- UMLS CUI [1,1]
- C0014822
- UMLS CUI [1,2]
- C3174092
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1879316
Beschrijving
Supportive Anti-Infective Therapy
Alias
- UMLS CUI-1
- C1141958
- UMLS CUI-2
- C0436313
Beschrijving
If Yes to Supportive Anti-Infective Therapy
Alias
- UMLS CUI-1
- C1141958
- UMLS CUI-2
- C0436313
Beschrijving
If a treatment is recorded here, do not record on the Concomitant Medication section.
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Total Daily Dose
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
For Route, see general instructions for acceptable abbreviations.
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Where appropriate, medical conditions should be recorded in the Adverse Experiences section, utilizing the same terminology.
Datatype
text
Alias
- UMLS CUI [1]
- C3843040
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C1141958
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C3174092
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C3174092
Beschrijving
If Continuing to Medication
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0549178
Beschrijving
Concominant Medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C2347852
Beschrijving
Total Daily Dose
Datatype
text
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
For Route, see General Instructions for acceptable abbreviations
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Beschrijving
Medical Condition
Datatype
text
Alias
- UMLS CUI [1]
- C3843040
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2347852
Beschrijving
If Continung to Medication
Datatype
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])