ID

14566

Description

Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01835288

Link

https://clinicaltrials.gov/show/NCT01835288

Keywords

  1. 4/21/16 4/21/16 -
Uploaded on

April 21, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01835288

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01835288

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
aml, any french- american- british (fab) subtype except m3, with confirmed mutation in the npm1 gene
Description

aml

Data type

boolean

Alias
UMLS CUI [1]
C0023467
relapsed and/or refractory aml from any duration of complete remission (cr); any number of prior therapies allowed
Description

relapsed and/or refractory aml

Data type

boolean

Alias
UMLS CUI [1]
C2367456
eastern cooperative oncology group (ecog) performance status 0-2, life expectancy > 3 months
Description

eastern cooperative oncology group (ecog) performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
serum creatinine =< 2.0 mg/dl
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin =< 2.0 mg/dl
Description

bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C1278039
alanine aminotransferase (alt)/aspartate aminotransferase (ast) =< 3 x upper limit of normal (uln)
Description

alanine aminotransferase

Data type

boolean

Alias
UMLS CUI [1]
C0201836
ability to understand and the willingness to sign a written informed consent document
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method
Description

pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI [1]
C3242212
patients who are currently receiving another investigational drug
Description

investigational drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients who are currently receiving other anti-cancer agents
Description

anti-cancer agents

Data type

boolean

Alias
UMLS CUI [1]
C0003392
uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C3714514
known hypersensitivity to arsenic trioxide
Description

hypersensitivity to arsenic trioxide

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0052416

Similar models

Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01835288

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
aml
Item
aml, any french- american- british (fab) subtype except m3, with confirmed mutation in the npm1 gene
boolean
C0023467 (UMLS CUI [1])
relapsed and/or refractory aml
Item
relapsed and/or refractory aml from any duration of complete remission (cr); any number of prior therapies allowed
boolean
C2367456 (UMLS CUI [1])
eastern cooperative oncology group (ecog) performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2, life expectancy > 3 months
boolean
C1520224 (UMLS CUI [1])
serum creatinine
Item
serum creatinine =< 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
bilirubin =< 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
alanine aminotransferase
Item
alanine aminotransferase (alt)/aspartate aminotransferase (ast) =< 3 x upper limit of normal (uln)
boolean
C0201836 (UMLS CUI [1])
informed consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnant or breast-feeding
Item
pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method
boolean
C3242212 (UMLS CUI [1])
investigational drug
Item
patients who are currently receiving another investigational drug
boolean
C0013230 (UMLS CUI [1])
anti-cancer agents
Item
patients who are currently receiving other anti-cancer agents
boolean
C0003392 (UMLS CUI [1])
infection
Item
uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
boolean
C3714514 (UMLS CUI [1])
hypersensitivity to arsenic trioxide
Item
known hypersensitivity to arsenic trioxide
boolean
C0020517 (UMLS CUI [1,1])
C0052416 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial