ID

29858

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

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https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Nyckelord

Versioner (1)
  1. 2018-04-24 2018-04-24 - Halim Ugurlu
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GSK

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24 april 2018

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GSK Study ID 104864-201 Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication

Engelsk

Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication

1 Formulär  
Identification Numbers
Beskrivning

Identification Numbers

Alias
UMLS CUI-1
C1300638
Patient Number
Beskrivning

Patient Number

Datatyp

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Patient Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Supportive Therapy Transfusion
Beskrivning

Supportive Therapy Transfusion

Alias
UMLS CUI-1
C1879316
UMLS CUI-2
C0014822
UMLS CUI-3
C0436313
Has the patient received any transfusions since the end of Screening?
Beskrivning

Supportive Therapy Transfusion (Including Erythropoietin)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C0014822
UMLS CUI [1,3]
C0436313
If Yes to Supportive Therapy (Including Erythropoietin)
Beskrivning

If Yes to Supportive Therapy (Including Erythropoietin)

Alias
UMLS CUI-1
C1879316
UMLS CUI-2
C0014822
UMLS CUI-3
C0436313
Specify the type of transfusions
Beskrivning

Type of transfusions

Datatyp

text

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C0332307
Transfusions (Number of Units)
Beskrivning

Transfusions (Number of Units)

Datatyp

text

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C0237753
Erythropoietin Dose
Beskrivning

Erythropoietin Dose

Datatyp

float

Måttenheter
  • units/kg
Alias
UMLS CUI [1,1]
C0014822
UMLS CUI [1,2]
C3174092
units/kg
Date of transfusion
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1879316
Supportive Anti-Infective Therapy
Beskrivning

Supportive Anti-Infective Therapy

Alias
UMLS CUI-1
C1141958
UMLS CUI-2
C0436313
Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) since the end of Screening?
Beskrivning

Supportive Anti-Infective Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1141958
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C1521721
If Yes to Supportive Anti-Infective Therapy
Beskrivning

If Yes to Supportive Anti-Infective Therapy

Alias
UMLS CUI-1
C1141958
UMLS CUI-2
C0436313
Drug name (Trade Name Preferred)
Beskrivning

If a treatment is recorded here, do not record on the Concomitant Medication section.

Datatyp

text

Alias
UMLS CUI [1]
C2360065
Total Daily Dose (e.g. 500mg)
Beskrivning

Total Daily Dose

Datatyp

text

Alias
UMLS CUI [1]
C2348070
Route
Beskrivning

For Route, see general instructions for acceptable abbreviations.

Datatyp

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Beskrivning

Where appropriate, medical conditions should be recorded in the Adverse Experiences section, utilizing the same terminology.

Datatyp

text

Alias
UMLS CUI [1]
C3843040
Other
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1]
C1141958
Start Date (be as precise as possible)
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C3174092
End Date
Beskrivning

End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C3174092
If Continuing to Medication
Beskrivning

If Continuing to Medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Concominant Medication
Beskrivning

Concominant Medication

Alias
UMLS CUI-1
C2347852
Drug name (Trade name Preferred)
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C2347852
Total Daily Dose (e.g. 500mg)
Beskrivning

Total Daily Dose

Datatyp

text

Alias
UMLS CUI [1]
C2348070
Route
Beskrivning

For Route, see General Instructions for acceptable abbreviations

Datatyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C2347852
Medical Condition
Beskrivning

Medical Condition

Datatyp

text

Alias
UMLS CUI [1]
C3843040
Start Date (be as precise as possible)
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2347852
End Date
Beskrivning

End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C2347852
If Continung to Medication
Beskrivning

If Continung to Medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Tillbaka till toppen

Similar models

Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Identification Numbers
C1300638 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
Supportive Therapy Transfusion
C1879316 (UMLS CUI-1)
C0014822 (UMLS CUI-2)
C0436313 (UMLS CUI-3)
Supportive Therapy Transfusion (Including Erythropoietin)
Item
Has the patient received any transfusions since the end of Screening?
boolean
C1879316 (UMLS CUI [1,1])
C0014822 (UMLS CUI [1,2])
C0436313 (UMLS CUI [1,3])
Item Group
If Yes to Supportive Therapy (Including Erythropoietin)
C1879316 (UMLS CUI-1)
C0014822 (UMLS CUI-2)
C0436313 (UMLS CUI-3)
Type of transfusions
Item
Specify the type of transfusions
text
C1879316 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Transfusions (Number of Units)
Item
Transfusions (Number of Units)
text
C1879316 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Erythropoietin Dose
Item
Erythropoietin Dose
float
C0014822 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
Date
Item
Date of transfusion
date
C0011008 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
Item Group
Supportive Anti-Infective Therapy
C1141958 (UMLS CUI-1)
C0436313 (UMLS CUI-2)
Supportive Anti-Infective Therapy
Item
Has the patient received any anti-infectives (e.g., antibiotics, antifungals, antivirals) since the end of Screening?
boolean
C1141958 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1521721 (UMLS CUI [1,3])
Item Group
If Yes to Supportive Anti-Infective Therapy
C1141958 (UMLS CUI-1)
C0436313 (UMLS CUI-2)
Drug name
Item
Drug name (Trade Name Preferred)
text
C2360065 (UMLS CUI [1])
Total Daily Dose
Item
Total Daily Dose (e.g. 500mg)
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Medical Condition
Item
Medical Condition
text
C3843040 (UMLS CUI [1])
Item
Other
text
C1141958 (UMLS CUI [1])
Other
Code List
Other
CL Item
anti-infectives administered prophylactically (PM)
CL Item
anti-infectives used for symptomatic treatment (EM)
CL Item
anti-infectives administered for a confirmed infection in the column provided (TX)
Start Date
Item
Start Date (be as precise as possible)
date
C0808070 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
If Continuing to Medication
Item
If Continuing to Medication
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Concominant Medication
C2347852 (UMLS CUI-1)
Drug name
Item
Drug name (Trade name Preferred)
text
C2360065 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose (e.g. 500mg)
text
C2348070 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Medical Condition
Item
Medical Condition
text
C3843040 (UMLS CUI [1])
Start Date
Item
Start Date (be as precise as possible)
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
If Continung to Medication
Item
If Continung to Medication
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Tillbaka till toppen 

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