Informatie:
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ID
13807
Beschrijving
Aprepitant as Antiemetic Prophylaxis in Patients With Acute Myeloid Leukemia Undergoing Induction Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01334086
Link
https://clinicaltrials.gov/show/NCT01334086
Trefwoorden
Versies (1)
- 07-03-16 07-03-16 -
Houder van rechten
CC BY-NC 3.0
Geüploaded op
7 maart 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01334086
Eligibility Acute Myeloid Leukemia NCT01334086
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myeloid Leukemia NCT01334086
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
AML
Item
acute myeloid leukemia (aml), any subtype including acute promyelocytic leukemia (apl). patients with either de novo or secondary aml are eligible.
boolean
C0023467 (UMLS CUI [1])
prior aml induction chemotherapy
Item
no prior aml induction chemotherapy.
boolean
C1514463 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
ID.3
Item
due to receive standard 3+7 induction chemotherapy using daunorubicin on days 1-3, plus cytarabine continuous infusion daily on days 1-7.
boolean
age
Item
age 18 and over.
boolean
C0001779 (UMLS CUI [1])
bilirubin
Item
serum bilirubin < or = 1.5 times the upper limit of normal (uln).
boolean
C1278039 (UMLS CUI [1])
AST and ALT
Item
serum aspartate aminotransferase and alanine aminotransferase < or = 2.5 times the uln.
boolean
C0201836 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
creatinine
Item
serum creatinine < 200 umol/l
boolean
C0201976 (UMLS CUI [1])
nausea or vomiting
Item
uncontrolled nausea or vomiting within 48 hours prior to start of induction therapy. grade 0-1 nausea is permitted at the start of induction.
boolean
C0027497 (UMLS CUI [1])
C0042963 (UMLS CUI [2])
C0042963 (UMLS CUI [2])
hypersensitivity to granisetron or aprepitant
Item
known hypersensitivity to granisetron or aprepitant.
boolean
C0020517 (UMLS CUI [1,1])
C0061863 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1176306 (UMLS CUI [2,2])
C0061863 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1176306 (UMLS CUI [2,2])
CYP3A4 inhibitors
Item
patients currently receiving treatment with strong cyp3a4 inhibitors or substrates and treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
boolean
C3830624 (UMLS CUI [1])
not able to swallow or absorb oral medications
Item
not able to swallow or absorb oral medications.
boolean
C0175795 (UMLS CUI [1])
cns leukemia or recent cns hemorrhage
Item
documented active central nervous system (cns) leukemia or recent cns hemorrhage.
boolean
C1332884 (UMLS CUI [1])
C1560581 (UMLS CUI [2])
C1560581 (UMLS CUI [2])
investigational therapy
Item
1. other investigational agents during induction therapy
boolean
C0949266 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,2])
radiotherapy
Item
2. radiotherapy during, or one month prior to, induction therapy
boolean
C1522449 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
systemic corticosteroids
Item
3. systemic corticosteroids
boolean
C2825233 (UMLS CUI [1])
other chemotherapy
Item
4. other chemotherapy agents on days 1-8
boolean
C0003392 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
pregnancy or lactation
Item
pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])