ID

19643

Description

Effect of Aprepitant on Cyclophosphamide Pharmacokinetics in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00719173

Link

https://clinicaltrials.gov/show/NCT00719173

Keywords

Versions (1)
  1. 1/18/17 1/18/17 -
Uploaded on

January 18, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00719173

English

Eligibility Breast Cancer NCT00719173

1 forms  
Criteria
Description

Criteria

diagnosis of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
planning to receive cyclophosphamide 600 mg/m²-1,000 mg/m² iv infusion
Description

Cyclophosphamide Intravenous infusion Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0010583
UMLS CUI [1,2]
C0021440
UMLS CUI [1,3]
C1301732
no cyclophosphamide dose change between courses 1 and 2
Description

Cyclophosphamide Dose unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0010583
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
life expectancy ≥ 2 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
anc ≥ 1,500/μl
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count ≥ 100 x 10^9/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin ≥ 9.0 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
serum creatinine ≤ 1.5 mg/dl
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
ast/alt ≤ 2 times upper limit of normal
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
not pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
no contraindication to aprepitant
Description

Medical contraindication aprepitant

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1176306
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

disease characteristic

Data type

boolean

Alias
UMLS CUI [1]
C0599878
no concurrent medications that are cyp3a4 substrates, inhibitors, and/or inducers, with the exception of the dexamethasone contained as part of the standard antiemetic regimen
Description

Cytochrome P-450 CYP3A4 Substrate | Cytochrome P450 3A4 Inhibitor | Cytochrome P450 3A4 Inducer | Dexamethasone | Antiemetics Standard therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3714798
UMLS CUI [1,2]
C3891814
UMLS CUI [2]
C3830624
UMLS CUI [3]
C3830625
UMLS CUI [4]
C0011777
UMLS CUI [5,1]
C0003297
UMLS CUI [5,2]
C2936643
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Similar models

Eligibility Breast Cancer NCT00719173

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast Carcinoma
Item
diagnosis of breast cancer
boolean
C0678222 (UMLS CUI [1])
Cyclophosphamide Intravenous infusion Planned
Item
planning to receive cyclophosphamide 600 mg/m²-1,000 mg/m² iv infusion
boolean
C0010583 (UMLS CUI [1,1])
C0021440 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Cyclophosphamide Dose unchanged
Item
no cyclophosphamide dose change between courses 1 and 2
boolean
C0010583 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 2 months
boolean
C0023671 (UMLS CUI [1])
Absolute neutrophil count
Item
anc ≥ 1,500/μl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count ≥ 100 x 10^9/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin ≥ 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast/alt ≤ 2 times upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication aprepitant
Item
no contraindication to aprepitant
boolean
C1301624 (UMLS CUI [1,1])
C1176306 (UMLS CUI [1,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
disease characteristic
Item
see disease characteristics
boolean
C0599878 (UMLS CUI [1])
Cytochrome P-450 CYP3A4 Substrate | Cytochrome P450 3A4 Inhibitor | Cytochrome P450 3A4 Inducer | Dexamethasone | Antiemetics Standard therapy
Item
no concurrent medications that are cyp3a4 substrates, inhibitors, and/or inducers, with the exception of the dexamethasone contained as part of the standard antiemetic regimen
boolean
C3714798 (UMLS CUI [1,1])
C3891814 (UMLS CUI [1,2])
C3830624 (UMLS CUI [2])
C3830625 (UMLS CUI [3])
C0011777 (UMLS CUI [4])
C0003297 (UMLS CUI [5,1])
C2936643 (UMLS CUI [5,2])
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