ID

13499

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: Dose Limiting Toxicity (DLT) Form

Keywords

Versions (3)
  1. 11/6/15 11/6/15 -
  2. 1/1/16 1/1/16 -
  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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Dose Limiting Toxicity (DLT) Form HOVON 132 AML/SAKK 30/13 EudraCT 2013-002843-26

English

Dose Limiting Toxicity (DLT) Form

1 forms  
Form Relation
Description

Form Relation

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

Form related to

Data type

integer

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

DLT Date

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C1512043
UMLS CUI [1,3]
C0011008
dd/mm/yyyy
Treatment
Description

Treatment

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

Has Induction cycle been given

Data type

boolean

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

Dose level

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1144149
mg
Date start of this induction cycle
Description

Induction start date

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C3179010
UMLS CUI [1,2]
C0808070
dd/mm/yyyy
Planned start date next treatment
Description

Next start date

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1115731
dd/mm/yyyy
Planned next treatment
Description

Planned next treatment

Data type

integer

Alias
UMLS CUI [1]
C3641097
Date off protocoll
Description

Date off protocoll

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Survival Status
Description

Survival Status

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

Date last contact

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0805839
dd/mm/yyyy
Survival Status
Description

Survival Status

Data type

integer

Alias
UMLS CUI [1]
C1148433
Cause of death
Description

Cause of death

Data type

integer

Alias
UMLS CUI [1]
C0007465
*Specify
Description

*Specify

Data type

text

Alias
UMLS CUI [1]
C1521902
Toxicity
Description

Toxicity

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

CTCAE grade ≥ 4 non hematological toxicity

Data type

integer

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

CTCAE grade ≥ 4 non hematological toxicity Date onset

Data type

date

Measurement units
  • 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
Description

CTCAE grade ≥ 4 non hematological toxicity Specification

Data type

text

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

Recovery

Was ANC recovered to > 0.5x109/L
Description

ANC Recovery

Data type

integer

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

Last date ANC

Data type

date

Measurement units
  • 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
Description

First date ANC

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1882078
dd/mm/yyyy
First date ANC >1.0 x 109/L
Description

First date ANC greater

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C1882078
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Platelets recovered to > 50x109/L
Description

Platelets recovered

Data type

integer

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

First date blood platelets

Data type

date

Measurement units
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C1882407
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
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Similar models

Dose Limiting Toxicity (DLT) Form

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