ID

29858

Descripción

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

Palabras clave

Versiones (1)
  1. 24/4/18 24/4/18 - Halim Ugurlu
Titular de derechos de autor

GSK

Subido en

24 de abril de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

Inglés

Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication

1 formularios  
Identification Numbers
Descripción

Identification Numbers

Alias
UMLS CUI-1
C1300638
Patient Number
Descripción

Patient Number

Tipo de datos

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Descripción

Patient Initials

Tipo de datos

text

Alias
UMLS CUI [1]
C2986440
Supportive Therapy Transfusion
Descripción

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?
Descripción

Supportive Therapy Transfusion (Including Erythropoietin)

Tipo de datos

boolean

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

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
Descripción

Type of transfusions

Tipo de datos

text

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

Transfusions (Number of Units)

Tipo de datos

text

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

Erythropoietin Dose

Tipo de datos

float

Unidades de medida
  • units/kg
Alias
UMLS CUI [1,1]
C0014822
UMLS CUI [1,2]
C3174092
units/kg
Date of transfusion
Descripción

Date

Tipo de datos

date

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

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?
Descripción

Supportive Anti-Infective Therapy

Tipo de datos

boolean

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

If Yes to Supportive Anti-Infective Therapy

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

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

Tipo de datos

text

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

Total Daily Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2348070
Route
Descripción

For Route, see general instructions for acceptable abbreviations.

Tipo de datos

text

Alias
UMLS CUI [1]
C0013153
Medical Condition
Descripción

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

Tipo de datos

text

Alias
UMLS CUI [1]
C3843040
Other
Descripción

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.

Tipo de datos

text

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

Start Date

Tipo de datos

date

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

End Date

Tipo de datos

date

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

If Continuing to Medication

Tipo de datos

boolean

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

Concominant Medication

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

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

Tipo de datos

text

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

Total Daily Dose

Tipo de datos

text

Alias
UMLS CUI [1]
C2348070
Route
Descripción

For Route, see General Instructions for acceptable abbreviations

Tipo de datos

text

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

Medical Condition

Tipo de datos

text

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

Start Date

Tipo de datos

date

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

End Date

Tipo de datos

date

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

If Continung to Medication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Volver a la parte superior de la página

Similar models

Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial