ID

12311

Beschreibung

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: Rapid Reporting Form

Stichworte

Versionen (3)
  1. 06.11.15 06.11.15 -
  2. 01.01.16 01.01.16 -
  3. 11.02.16 11.02.16 -
Hochgeladen am

6. November 2015

DOI

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Lizenz

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

Englisch

Rapid Reporting Form

1 Formulare  
  1. StudyEvent: ODM
    1. Rapid Reporting Form
Form Relation
Beschreibung

Form Relation

DLT form related to induction cycle
Beschreibung

Form related to

Datentyp

integer

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

DLT Date

Datentyp

date

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

Treatment

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

Has Induction cycle been given

Datentyp

boolean

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

Dose level

Datentyp

float

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

Induction start date

Datentyp

date

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

Next start date

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C1115731
dd/mm/yyyy
Planned next treatment
Beschreibung

Planned next treatment

Datentyp

integer

Alias
UMLS CUI [1]
C3641097
Date off protocoll
Beschreibung

Date off protocoll

Datentyp

date

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

Survival Status

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

Date last contact

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1]
C0805839
dd/mm/yyyy
Survival Status
Beschreibung

Survival Status

Datentyp

integer

Alias
UMLS CUI [1]
C1148433
Cause of death
Beschreibung

Cause of death

Datentyp

integer

Alias
UMLS CUI [1]
C0007465
*Specify
Beschreibung

*Specify

Datentyp

text

Toxicity
Beschreibung

Toxicity

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

CTCAE grade ≥ 4 non hematological toxicity Date onset

Datentyp

integer

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

CTCAE grade ≥ 4 non hematological toxicity Date onset

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

CTCAE grade ≥ 4 non hematological toxicity Date onset Specification

Datentyp

text

Alias
UMLS CUI [1]
C0013221
Recovery
Beschreibung

Recovery

Was ANC recovered to > 0.5x109/L
Beschreibung

ANC Recovery

Datentyp

integer

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

Last date ANC

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

First date ANC

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

First date ANC greater

Datentyp

date

Maßeinheiten
  • 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
Beschreibung

Platelets recovered

Datentyp

integer

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

First date blood platelets

Datentyp

date

Maßeinheiten
  • dd/mm/yyyy
Alias
UMLS CUI [1,1]
C0005821
UMLS CUI [1,2]
C0439093
UMLS CUI [1,3]
C0011008
dd/mm/yyyy
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Ähnliche Modelle

Rapid Reporting Form

1 Formulare
  1. StudyEvent: ODM
    1. Rapid Reporting Form
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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