ID

12310

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2015-11-06 2015-11-06 -
  2. 2016-01-01 2016-01-01 -
  3. 2016-02-11 2016-02-11 -
Uppladdad den

6 november 2015

DOI

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Licens

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

Engelsk

Dose Limiting Toxicity (DLT) Form

1 Formulär  
Form Relation
Beskrivning

Form Relation

DLT form related to induction cycle
Beskrivning

Form related to

Datatyp

integer

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

DLT Date

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C1512043
UMLS CUI [1,3]
C0011008
dd/mm/yyyy
Treatment
Beskrivning

Treatment

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

Has Induction cycle been given

Datatyp

boolean

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

Dose level

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1144149
mg
Date start of this induction cycle
Beskrivning

Induction start date

Datatyp

date

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

Next start date

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1115731
dd/mm/yyyy
Planned next treatment
Beskrivning

Planned next treatment

Datatyp

integer

Alias
UMLS CUI [1]
C3641097
Date off protocoll
Beskrivning

Date off protocoll

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0011008
dd/mm/yyyy
Survival Status
Beskrivning

Survival Status

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

Date last contact

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0805839
dd/mm/yyyy
Survival Status
Beskrivning

Survival Status

Datatyp

integer

Alias
UMLS CUI [1]
C1148433
Cause of death
Beskrivning

Cause of death

Datatyp

integer

Alias
UMLS CUI [1]
C0007465
*Specify
Beskrivning

*Specify

Datatyp

text

Toxicity
Beskrivning

Toxicity

Alias
UMLS CUI-1
C0013221
CTCAE grade ≥ 4 non hematological toxicity Date onset
Beskrivning

CTCAE grade ≥ 4 non hematological toxicity Date onset

Datatyp

integer

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0013221
CTCAE grade ≥ 4 non hematological toxicity Date onset
Beskrivning

CTCAE grade ≥ 4 non hematological toxicity Date onset

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C0574845
dd/mm/yyyy
CTCAE grade ≥ 4 non hematological toxicity Date onset Specification
Beskrivning

CTCAE grade ≥ 4 non hematological toxicity Date onset Specification

Datatyp

text

Alias
UMLS CUI [1]
C0013221
Recovery
Beskrivning

Recovery

Was ANC recovered to > 0.5x109/L
Beskrivning

ANC Recovery

Datatyp

integer

Alias
UMLS CUI [1]
C0948762
Last date ANC was measured
Beskrivning

Last date ANC

Datatyp

date

Måttenheter
  • 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
Beskrivning

First date ANC

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C0439093
UMLS CUI [1,3]
C0011008
dd/mm/yyyy
First date ANC >1.0 x 109/L
Beskrivning

First date ANC greater

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0948762
UMLS CUI [1,2]
C0439093
UMLS CUI [1,3]
C0011008
dd/mm/yyyy
Platelets recovered to > 50x109/L
Beskrivning

Platelets recovered

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C0439093
First date platelets >50 x 109/L
Beskrivning

First date blood platelets

Datatyp

date

Måttenheter
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C0439093
UMLS CUI [1,3]
C0011008
dd/mm/yyyy
Tillbaka till toppen

Similar models

Dose Limiting Toxicity (DLT) Form

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
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)
CL Item
induction cycle II (2)
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
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)
CL Item
cycle III  (3)
CL Item
autoHSCT  (4)
CL Item
alloHSCT  (5)
CL Item
treatment off protocol (6)
Date off protocoll
Item
Date off protocoll
date
C2348563 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
C1148433 (UMLS CUI-1)
Date last contact
Item
Date last known to be alive or death
date
C0805839 (UMLS CUI [1])
Item
integer
C1148433 (UMLS CUI [1])
Survival Status
Code List
Survival Status
CL Item
alive (0)
CL Item
dead (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
text
Item Group
C0013221 (UMLS CUI-1)
Item
CTCAE grade ≥ 4 non hematological toxicity Date onset
integer
C0013221 (UMLS CUI [1])
CTCAE grade ≥ 4 non hematological toxicity Date onset
Code List
CTCAE grade ≥ 4 non hematological toxicity Date onset
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])
C0574845 (UMLS CUI [1,2])
CTCAE grade ≥ 4 non hematological toxicity Date onset Specification
Item
text
C0013221 (UMLS CUI [1])
Item Group
Item
Was ANC recovered to > 0.5x109/L
integer
C0948762 (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
C0948762 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
First date ANC greater
Item
First date ANC >1.0 x 109/L
date
C0948762 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Platelets recovered to > 50x109/L
integer
C0005821 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
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
C0005821 (UMLS CUI [1,1])
C0439093 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Tillbaka till toppen 

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