ID

13499

Descripción

Randomized study with a run-in dose-selection phase to assess the added value of Lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS) (IPSS-R risk score> 4.5) Form Description: Dose Limiting Toxicity (DLT) Form

Palabras clave

Versiones (3)
  1. 6/11/15 6/11/15 -
  2. 1/1/16 1/1/16 -
  3. 11/2/16 11/2/16 -
Subido en

11 de febrero de 2016

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.

Dose Limiting Toxicity (DLT) Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

Inglés

Dose Limiting Toxicity (DLT) Form

1 formularios  
Form Relation
Descripción

Form Relation

Alias
UMLS CUI-1
C1276413
UMLS CUI-2
C2348792
DLT form related to induction cycle
Descripción

Form related to

Tipo de datos

integer

Alias
UMLS CUI [1]
C1302181
Date DLT evaluation was done
Descripción

DLT Date

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C1512043
UMLS CUI [1,3]
C0011008
dd/mm/yyyy
Treatment
Descripción

Treatment

Alias
UMLS CUI-1
C0087111
Has Induction cycle been given (either partially or completely)
Descripción

Has Induction cycle been given

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3179010
Dose level Lenalidomide (fill out 20 mg, 15 mg, 10 mg)
Descripción

Dose level

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1144149
mg
Date start of this induction cycle
Descripción

Induction start date

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C3179010
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
Planned start date next treatment
Descripción

Next start date

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1115731
dd/mm/yyyy
Planned next treatment
Descripción

Planned next treatment

Tipo de datos

integer

Alias
UMLS CUI [1]
C3641097
Date off protocoll
Descripción

Date off protocoll

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Survival Status
Descripción

Survival Status

Alias
UMLS CUI-1
C1148433
Date last known to be alive or death
Descripción

Date last contact

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0805839
dd/mm/yyyy
Survival Status
Descripción

Survival Status

Tipo de datos

integer

Alias
UMLS CUI [1]
C1148433
Cause of death
Descripción

Cause of death

Tipo de datos

integer

Alias
UMLS CUI [1]
C0007465
*Specify
Descripción

*Specify

Tipo de datos

text

Alias
UMLS CUI [1]
C1521902
Toxicity
Descripción

Toxicity

Alias
UMLS CUI-1
C0013221
CTCAE grade ≥ 4 non hematological toxicity
Descripción

CTCAE grade ≥ 4 non hematological toxicity

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C1516728
CTCAE grade ≥ 4 non hematological toxicity Date onset
Descripción

CTCAE grade ≥ 4 non hematological toxicity Date onset

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C1516728
UMLS CUI [1,3]
C0011008
dd/mm/yyyy
CTCAE grade ≥ 4 non hematological toxicity Specification
Descripción

CTCAE grade ≥ 4 non hematological toxicity Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C1516728
UMLS CUI [1,3]
C1521902
Recovery
Descripción

Recovery

Was ANC recovered to > 0.5x109/L
Descripción

ANC Recovery

Tipo de datos

integer

Alias
UMLS CUI [1]
C1882078
Last date ANC was measured
Descripción

Last date ANC

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
First date ANC >0.5 x 109/L
Descripción

First date ANC

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1882078
dd/mm/yyyy
First date ANC >1.0 x 109/L
Descripción

First date ANC greater

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C1882078
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Platelets recovered to > 50x109/L
Descripción

Platelets recovered

Tipo de datos

integer

Alias
UMLS CUI [1]
C1882407
First date platelets >50 x 109/L
Descripción

First date blood platelets

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Volver a la parte superior de la página

Similar models

Dose Limiting Toxicity (DLT) Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Form Relation
C1276413 (UMLS CUI-1)
C2348792 (UMLS CUI-2)
Item
DLT form related to induction cycle
integer
C1302181 (UMLS CUI [1])
Form related to
Code List
DLT form related to induction cycle
CL Item
induction cycle I  (1)
C3179010 (UMLS CUI-1)
CL Item
induction cycle II (2)
C3179010 (UMLS CUI-1)
DLT Date
Item
Date DLT evaluation was done
date
C0013221 (UMLS CUI [1,1])
C1512043 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Treatment
C0087111 (UMLS CUI-1)
Has Induction cycle been given
Item
Has Induction cycle been given (either partially or completely)
boolean
C3179010 (UMLS CUI [1])
Dose level
Item
Dose level Lenalidomide (fill out 20 mg, 15 mg, 10 mg)
float
C0178602 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
Induction start date
Item
Date start of this induction cycle
date
C3179010 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Next start date
Item
Planned start date next treatment
date
C1115731 (UMLS CUI [1])
Item
Planned next treatment
integer
C3641097 (UMLS CUI [1])
Planned next treatment
Code List
Planned next treatment
CL Item
cycle II (2)
C1302181 (UMLS CUI-1)
CL Item
cycle III  (3)
C1302181 (UMLS CUI-1)
CL Item
autoHSCT  (4)
C0194037 (UMLS CUI-1)
CL Item
alloHSCT  (5)
C1705576 (UMLS CUI-1)
CL Item
treatment off protocol (6)
C0087111 (UMLS CUI-1)
C1518546 (UMLS CUI-2)
Date off protocoll
Item
Date off protocoll
date
C2348563 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Survival Status
C1148433 (UMLS CUI-1)
Date last contact
Item
Date last known to be alive or death
date
C0805839 (UMLS CUI [1])
Item
Survival Status
integer
C1148433 (UMLS CUI [1])
Survival Status
Code List
Survival Status
CL Item
alive (0)
C2584946 (UMLS CUI-1)
CL Item
dead (1)
C0011065 (UMLS CUI-1)
Item
Cause of death
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
Cause of death
CL Item
leukemia  (1)
C0023418 (UMLS CUI-1)
CL Item
pneumonia  (2)
C0032285 (UMLS CUI-1)
CL Item
other infection  (3)
C0009450 (UMLS CUI-1)
CL Item
hemorrhage (4)
C0019080 (UMLS CUI-1)
CL Item
veno-occlusive disease*  (5)
C0948441 (UMLS CUI-1)
CL Item
other* (8)
*Specify
Item
*Specify
text
C1521902 (UMLS CUI [1])
Item Group
Toxicity
C0013221 (UMLS CUI-1)
Item
CTCAE grade ≥ 4 non hematological toxicity
integer
C0013221 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
CTCAE grade ≥ 4 non hematological toxicity Date onset
Code List
CTCAE grade ≥ 4 non hematological toxicity
CL Item
no (0)
CL Item
yes, fill out items 15 and 16 (1)
CTCAE grade ≥ 4 non hematological toxicity Date onset
Item
CTCAE grade ≥ 4 non hematological toxicity Date onset
date
C0013221 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
CTCAE grade ≥ 4 non hematological toxicity Specification
Item
CTCAE grade ≥ 4 non hematological toxicity Specification
text
C0013221 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Recovery
Item
Was ANC recovered to > 0.5x109/L
integer
C1882078 (UMLS CUI [1])
ANC Recovery
Code List
Was ANC recovered to > 0.5x109/L
CL Item
no, give last date ANC was measured box 18 (0)
CL Item
yes, fill out date of recovery box 19 and/or 20 (1)
CL Item
never below (2)
Last date ANC
Item
Last date ANC was measured
date
C0948762 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
First date ANC
Item
First date ANC >0.5 x 109/L
date
C1882078 (UMLS CUI [1])
First date ANC greater
Item
First date ANC >1.0 x 109/L
date
C1882078 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Platelets recovered to > 50x109/L
integer
C1882407 (UMLS CUI [1])
Platelets recovered
Code List
Platelets recovered to > 50x109/L
CL Item
no  (0)
CL Item
yes, fill out date of recovery  (1)
CL Item
never below (2)
First date blood platelets
Item
First date platelets >50 x 109/L
date
C1882407 (UMLS CUI [1,1])
C0011008 (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