ID

13485

Description

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

Keywords

Versions (3)
  1. 11/9/15 11/9/15 -
  2. 12/28/15 12/28/15 -
  3. 2/11/16 2/11/16 -
Uploaded on

February 11, 2016

DOI

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License

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

English

Second Randomization Form

1 forms  
Default Itemgroup
Description

Default Itemgroup

Caller
Description

Caller

Data type

text

Alias
UMLS CUI [1]
C0557514
Last treatment
Description

Last treatment

Data type

integer

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

Date start last treatment

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
Eligibility (See Protocol Section 8)
Description

Eligibility (See Protocol Section 8)

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

Patient in CR(i)

Data type

integer

Alias
UMLS CUI [1]
C1704632
ANC
Description

Neutrophil count

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0948762
10^9/L
Platelets
Description

Platelets

Data type

float

Measurement units
  • 10^9/L
Alias
UMLS CUI [1]
C0005821
10^9/L
Serum Creatinine Clearance
Description

Creatinine Clearance

Data type

float

Measurement units
  • mL/min
Alias
UMLS CUI [1]
C0373595
mL/min
Total bilirubin
Description

Bilirubin

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
Bilirubin ULN
Description

Bilirubin, Total ULN

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
mg/dL
AST
Description

AST

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
AST (SGOT) ULN
Description

AST ULN

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519815
U/L
ALT
Description

ALT

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
ALT ULN
Description

ALT ULN

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519815
U/L
Severe cardiac dysfunction (see appendix G)
Description

Severe cardiac dysfunction

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0018801
Severe pulmonary dysfunction (see appendix F)
Description

Severe pulmonary dysfunction

Data type

boolean

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

Severe neurological or psychiatric disease

Data type

boolean

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

Active infections

Data type

boolean

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

Previous serious toxicities related to the use of lenalidomide

Data type

integer

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

CMV reactivation, which is not responsive to first line valganciclovir

Data type

boolean

Alias
UMLS CUI [1,1]
C0582172
UMLS CUI [1,2]
C1142560
UMLS CUI [1,3]
C0909381
Data from HOVON data center
Description

Data from HOVON data center

Date of Randomization
Description

Date of Randomization

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Treatment arm allocated
Description

Treatment arm allocated

Data type

integer

Alias
UMLS CUI [1]
C1522541
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Similar models

Second Randomization Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
C0948762 (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])
C0018801 (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
C0582172 (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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