ID

12824

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: Second Randomization Form

Palabras clave

Versiones (3)
  1. 9/11/15 9/11/15 -
  2. 28/12/15 28/12/15 -
  3. 11/2/16 11/2/16 -
Subido en

28 de diciembre de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0
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Second Randomization Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

Inglés

Second Randomization Form

1 formularios  
Default Itemgroup
Descripción

Default Itemgroup

Caller
Descripción

Caller

Tipo de datos

text

Alias
UMLS CUI [1]
C0557514
Last treatment
Descripción

Last treatment

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1276413
UMLS CUI [1,2]
C2348792
Date start last treatment
Descripción

Date start last treatment

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
Eligibility (See Protocol Section 8)
Descripción

Eligibility (See Protocol Section 8)

Alias
UMLS CUI-1
C1516637
Patient in CR(i)
Descripción

Patient in CR(i)

Tipo de datos

integer

Alias
UMLS CUI [1]
C1704632
ANC
Descripción

Neutrophil count

Tipo de datos

float

Unidades de medida
  • 10^9/L
Alias
UMLS CUI [1]
C0027950
10^9/L
Platelets
Descripción

Platelets

Tipo de datos

float

Unidades de medida
  • 10^9/L
Alias
UMLS CUI [1]
C0005821
10^9/L
Serum Creatinine Clearance
Descripción

Creatinine Clearance

Tipo de datos

float

Unidades de medida
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
Total bilirubin
Descripción

Bilirubin

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Bilirubin ULN
Descripción

Bilirubin, Total ULN

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
mg/dL
AST
Descripción

AST

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
AST (SGOT) ULN
Descripción

AST ULN

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519815
U/L
ALT
Descripción

ALT

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
ALT ULN
Descripción

ALT ULN

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519815
U/L
Severe cardiac dysfunction (see appendix G)
Descripción

Severe cardiac dysfunction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C3277906
Severe pulmonary dysfunction (see appendix F)
Descripción

Severe pulmonary dysfunction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1709770
UMLS CUI [1,3]
C0205082
Severe neurological or psychiatric disease
Descripción

Severe neurological or psychiatric disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0027765
Serious active infections
Descripción

Active infections

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C3714514
Previous serious toxicities related to the use of lenalidomide
Descripción

Previous serious toxicities related to the use of lenalidomide

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1144149
CMV reactivation, which is not responsive to first line valganciclovir
Descripción

CMV reactivation, which is not responsive to first line valganciclovir

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0010825
UMLS CUI [1,2]
C1142560
UMLS CUI [1,3]
C0909381
Data from HOVON data center
Descripción

Data from HOVON data center

Date of Randomization
Descripción

Date of Randomization

Tipo de datos

date

Unidades de medida
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Treatment arm allocated
Descripción

Treatment arm allocated

Tipo de datos

integer

Alias
UMLS CUI [1]
C1522541
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Similar models

Second Randomization Form

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Caller
Item
Caller
text
C0557514 (UMLS CUI [1])
Item
Last treatment
integer
C1276413 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Last treatment
Code List
Last treatment
CL Item
post induction cycle III (3)
C3179010 (UMLS CUI-1)
CL Item
autoHSCT (4)
C0472699 (UMLS CUI-1)
Date start last treatment
Item
Date start last treatment
date
C0087111 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item Group
Eligibility (See Protocol Section 8)
C1516637 (UMLS CUI-1)
Item
Patient in CR(i)
integer
C1704632 (UMLS CUI [1])
Patient in CR(i)
Code List
Patient in CR(i)
CL Item
no CR(i) (0)
C3844738 (UMLS CUI-1)
CL Item
CR  (1)
C0677874 (UMLS CUI-1)
CL Item
CRi (2)
C3538993 (UMLS CUI-1)
Neutrophil count
Item
ANC
float
C0027950 (UMLS CUI [1])
Platelets
Item
Platelets
float
C0005821 (UMLS CUI [1])
Creatinine Clearance
Item
Serum Creatinine Clearance
float
C0373595 (UMLS CUI [1])
Bilirubin
Item
Total bilirubin
float
C0201913 (UMLS CUI [1])
Bilirubin, Total ULN
Item
Bilirubin ULN
float
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
AST
Item
AST
float
C0201899 (UMLS CUI [1])
AST ULN
Item
AST (SGOT) ULN
float
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
ALT ULN
Item
ALT ULN
float
C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Severe cardiac dysfunction
Item
Severe cardiac dysfunction (see appendix G)
boolean
C0009488 (UMLS CUI [1,1])
C3277906 (UMLS CUI [1,2])
Severe pulmonary dysfunction
Item
Severe pulmonary dysfunction (see appendix F)
boolean
C0009488 (UMLS CUI [1,1])
C1709770 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Severe neurological or psychiatric disease
Item
Severe neurological or psychiatric disease
boolean
C0009488 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
Active infections
Item
Serious active infections
boolean
C0009488 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
Item
Previous serious toxicities related to the use of lenalidomide
integer
C0020517 (UMLS CUI [1,1])
C1144149 (UMLS CUI [1,2])
Previous serious toxicities related to the use of lenalidomide
Code List
Previous serious toxicities related to the use of lenalidomide
CL Item
no  (0)
C1298908 (UMLS CUI-1)
CL Item
yes  (1)
C1705108 (UMLS CUI-1)
CL Item
NA (2)
CMV reactivation, which is not responsive to first line valganciclovir
Item
CMV reactivation, which is not responsive to first line valganciclovir
boolean
C0010825 (UMLS CUI [1,1])
C1142560 (UMLS CUI [1,2])
C0909381 (UMLS CUI [1,3])
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Treatment arm allocated
integer
C1522541 (UMLS CUI [1])
Treatment arm allocated
Code List
Treatment arm allocated
CL Item
Arm A: Observation only (1)
C0009932 (UMLS CUI-1)
CL Item
Arm B: Maintenance with Lenalidomide (2)
C0304231 (UMLS CUI-1)
C1144149 (UMLS CUI-2)
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