ID

13068

Beschrijving

SMD_FLAG-IDA_98: FLAG-IDA in Induction Treatment of High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00487448

Link

https://clinicaltrials.gov/show/NCT00487448

Trefwoorden

  1. 14-01-16 14-01-16 -
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CC BY-NC 3.0

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14 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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Eligibility Myelodysplastic Syndrome NCT00487448

Eligibility Myelodysplastic Syndrome NCT00487448

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age < 75 years
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of myelodysplastic syndrome in order to fab criteria, excluding patients with chronic myeloid leukemia.
Beschrijving

myelodysplastic syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C3463824
ipi > 1 (high risk or intermedia risk-2) and/or ipe equal or > 3 (high risk o intermedia risk) or secondary acute myeloid leukemia.
Beschrijving

IPI

Datatype

boolean

Alias
UMLS CUI [1]
C1512894
resolved toxicity for previous treatments received to myelodysplastic syndrome .
Beschrijving

toxicity

Datatype

boolean

Alias
UMLS CUI [1]
C0600688
myelodysplastic syndrome de novo.
Beschrijving

myelodysplastic syndrome de novo.

Datatype

boolean

Alias
UMLS CUI [1]
C3463824
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
associated neoplasia.
Beschrijving

neoplasia

Datatype

boolean

Alias
UMLS CUI [1]
C1882062
chronic disease that can limit the patient follow up protocol (cardiovascular disease, active infection uncontrolled, etc.).
Beschrijving

chronic disease that can limit the patient follow up protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
age < 55 years with related donor hla compatible.
Beschrijving

age < 55 years with related donor hla compatible

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0019721
use an investigational drug in the 30 previous days.
Beschrijving

investigational drug

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
previous treatment with chemotherapy agents.
Beschrijving

chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
simultaneous treatment during the study with other drugs not allowed in the protocol.
Beschrijving

simultaneous treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0087111
bilirubin > 2 mg/dl and gpt >2 times the normal value.
Beschrijving

bilirubin and gpt

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C1557189
creatinine > 2 mg/dl.
Beschrijving

creatinine

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
hypersensibility to agents used in the protocol.
Beschrijving

hypersensibility

Datatype

boolean

Alias
UMLS CUI [1]
C0020517
secondary mds to chemo-radiotherapy .
Beschrijving

secondary mds to chemo-radiotherapy .

Datatype

boolean

Alias
UMLS CUI [1]
C3463824
hiv positive.
Beschrijving

hiv

Datatype

boolean

Alias
UMLS CUI [1]
C0019682
chronic myeloblastic leukemia
Beschrijving

CML

Datatype

boolean

Alias
UMLS CUI [1]
C0023474

Similar models

Eligibility Myelodysplastic Syndrome NCT00487448

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
age < 75 years
boolean
C0001779 (UMLS CUI [1])
myelodysplastic syndrome
Item
diagnosis of myelodysplastic syndrome in order to fab criteria, excluding patients with chronic myeloid leukemia.
boolean
C3463824 (UMLS CUI [1])
IPI
Item
ipi > 1 (high risk or intermedia risk-2) and/or ipe equal or > 3 (high risk o intermedia risk) or secondary acute myeloid leukemia.
boolean
C1512894 (UMLS CUI [1])
toxicity
Item
resolved toxicity for previous treatments received to myelodysplastic syndrome .
boolean
C0600688 (UMLS CUI [1])
myelodysplastic syndrome de novo.
Item
myelodysplastic syndrome de novo.
boolean
C3463824 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
neoplasia
Item
associated neoplasia.
boolean
C1882062 (UMLS CUI [1])
chronic disease that can limit the patient follow up protocol
Item
chronic disease that can limit the patient follow up protocol (cardiovascular disease, active infection uncontrolled, etc.).
boolean
C2348563 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
age < 55 years with related donor hla compatible
Item
age < 55 years with related donor hla compatible.
boolean
C0001779 (UMLS CUI [1])
C0019721 (UMLS CUI [2])
investigational drug
Item
use an investigational drug in the 30 previous days.
boolean
C0013230 (UMLS CUI [1])
chemotherapy
Item
previous treatment with chemotherapy agents.
boolean
C0392920 (UMLS CUI [1])
simultaneous treatment
Item
simultaneous treatment during the study with other drugs not allowed in the protocol.
boolean
C0087111 (UMLS CUI [1])
bilirubin and gpt
Item
bilirubin > 2 mg/dl and gpt >2 times the normal value.
boolean
C1278039 (UMLS CUI [1])
C1557189 (UMLS CUI [2])
creatinine
Item
creatinine > 2 mg/dl.
boolean
C0201976 (UMLS CUI [1])
hypersensibility
Item
hypersensibility to agents used in the protocol.
boolean
C0020517 (UMLS CUI [1])
secondary mds to chemo-radiotherapy .
Item
secondary mds to chemo-radiotherapy .
boolean
C3463824 (UMLS CUI [1])
hiv
Item
hiv positive.
boolean
C0019682 (UMLS CUI [1])
CML
Item
chronic myeloblastic leukemia
boolean
C0023474 (UMLS CUI [1])

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