Information:
Fel:
ID
13234
Beskrivning
Alisertib for Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01779843
Länk
https://clinicaltrials.gov/show/NCT01779843
Nyckelord
Versioner (1)
- 2016-01-25 2016-01-25 -
Rättsinnehavare
CC BY-NC 3.0
Uppladdad den
25 januari 2016
DOI
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Licens
Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT01779843
Eligibility Acute Myelogenous Leukemia NCT01779843
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myelogenous Leukemia NCT01779843
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
AML
Item
pathologically confirmed, newly diagnosed acute myelogenous leukemia
boolean
C0023467 (UMLS CUI [1])
contraception
Item
agree to use an acceptable method for contraception during the entire study treatment period through 4 months after the last dose of mln8237
boolean
C0700589 (UMLS CUI [1])
oral medication
Item
able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after mln8237 administration
boolean
C0175795 (UMLS CUI [1])
chemotherapy, radiotherapy
Item
have received systemic antineoplastic therapy, including radiotherapy within 14 days of study treatment, with the exception of hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1522449 (UMLS CUI [2])
pregnant or breastfeeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
cytogenic prognosis
Item
presence of "favorable" or "better risk" cytogenic prognosis
boolean
C0033325 (UMLS CUI [1])
transplantation
Item
prior allogeneic bone marrow or organ transplantation
boolean
C0040732 (UMLS CUI [1])
acute bilineal/biphenotypic leukemia
Item
diagnosis of acute bilineal/biphenotypic leukemia
boolean
C0023464 (UMLS CUI [1])
malignancy
Item
history of a different malignancy except if disease-free for at least 5 years and at low risk or recurrence; or cervical cancer in situ, basal cell or squamous cell carcinoma of the skin within the past 5 years
boolean
C0006826 (UMLS CUI [1])
uncontrolled intercurrent illness
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1])
HIV
Item
hiv positive on combination antiretroviral therapy
boolean
C0019682 (UMLS CUI [1])
Hepatitis
Item
diagnosis of active hepatitis b or c
boolean
C0019158 (UMLS CUI [1])
NYHA
Item
current or history of congestive heart failure nyha class 3 or 4, or documented diastolic or systolic dysfunction
boolean
C1275491 (UMLS CUI [1])
cardiac arrhythmia
Item
current or history of ventricular or life threatening arrhythmias or diagnosis of long qt syndrome
boolean
C0003811 (UMLS CUI [1])
sleep apnea syndrome or other condition that could result in excessive daytime sleepiness
Item
known history of uncontrolled sleep apnea syndrome or other condition that could result in excessive daytime sleepiness
boolean
C0037315 (UMLS CUI [1])
proton pump inhibitor, H2 antagonists, pancreatic enzymes
Item
requirement for constant administration of proton pump inhibitor, h2 antagonist or pancreatic enzymes
boolean
C0358591 (UMLS CUI [1])
C0019593 (UMLS CUI [2])
C0920330 (UMLS CUI [3])
C0019593 (UMLS CUI [2])
C0920330 (UMLS CUI [3])
infection
Item
systemic infection requiring iv antibiotic therapy within 14 days of first dose of study drug
boolean
C0009450 (UMLS CUI [1])
enzyme inducers
Item
treatment with clinically significant enzyme inducers
boolean
C3819045 (UMLS CUI [1])