ID

13807

Descripción

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

Palabras clave

Versiones (1)
  1. 7/3/16 7/3/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

7 de marzo de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01334086

Inglés

Eligibility Acute Myeloid Leukemia NCT01334086

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
acute myeloid leukemia (aml), any subtype including acute promyelocytic leukemia (apl). patients with either de novo or secondary aml are eligible.
Descripción

AML

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023467
no prior aml induction chemotherapy.
Descripción

prior aml induction chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0392920
due to receive standard 3+7 induction chemotherapy using daunorubicin on days 1-3, plus cytarabine continuous infusion daily on days 1-7.
Descripción

ID.3

Tipo de datos

boolean

age 18 and over.
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
serum bilirubin < or = 1.5 times the upper limit of normal (uln).
Descripción

bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1278039
serum aspartate aminotransferase and alanine aminotransferase < or = 2.5 times the uln.
Descripción

AST and ALT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0201899
serum creatinine < 200 umol/l
Descripción

creatinine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled nausea or vomiting within 48 hours prior to start of induction therapy. grade 0-1 nausea is permitted at the start of induction.
Descripción

nausea or vomiting

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027497
UMLS CUI [2]
C0042963
known hypersensitivity to granisetron or aprepitant.
Descripción

hypersensitivity to granisetron or aprepitant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0061863
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1176306
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.
Descripción

CYP3A4 inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3830624
not able to swallow or absorb oral medications.
Descripción

not able to swallow or absorb oral medications

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0175795
documented active central nervous system (cns) leukemia or recent cns hemorrhage.
Descripción

cns leukemia or recent cns hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1332884
UMLS CUI [2]
C1560581
1. other investigational agents during induction therapy
Descripción

investigational therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C0205420
2. radiotherapy during, or one month prior to, induction therapy
Descripción

radiotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0040223
3. systemic corticosteroids
Descripción

systemic corticosteroids

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2825233
4. other chemotherapy agents on days 1-8
Descripción

other chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C0205394
pregnant or breast feeding.
Descripción

pregnancy or lactation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
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Similar models

Eligibility Acute Myeloid Leukemia NCT01334086

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
creatinine
Item
serum creatinine < 200 umol/l
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
investigational therapy
Item
1. other investigational agents during induction therapy
boolean
C0949266 (UMLS CUI [1,1])
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])
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])
pregnancy or lactation
Item
pregnant or breast feeding.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
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