Informações:
Falhas:
ID
14531
Descrição
Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00148070
Link
https://clinicaltrials.gov/show/NCT00148070
Palavras-chave
Versões (1)
- 19/04/2016 19/04/2016 -
Transferido a
19 de abril de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00148070
Eligibility Metastatic Breast Cancer NCT00148070
- StudyEvent: Eligibility
Similar models
Eligibility Metastatic Breast Cancer NCT00148070
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Metastatic breast cancer
Item
patients with biopsy proven, measurable metastatic breast cancer. patients with bone-only, and/or effusion-only disease are excluded.
boolean
C0278488 (UMLS CUI [1])
C0153690 (UMLS CUI [2])
C0747641 (UMLS CUI [3])
C0153690 (UMLS CUI [2])
C0747641 (UMLS CUI [3])
Karnofsky performance status
Item
karnofsky performance status equal to 70 or greater.
boolean
C0206065 (UMLS CUI [1])
ANC, hemoglobin and platelets
Item
anc > 1500, hgb > 10, plt > 100.
boolean
C0948762 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver and renal function
Item
patients with some degree of hepatic dysfunction and renal dysfunction are encouraged, in order to evaluate the ability of the ermbt in tailoring dose in these patient populations.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232804 (UMLS CUI [2])
Age
Item
age less than 18 years.
boolean
C0001779 (UMLS CUI [1])
Allergy to erythromycin
Item
allergy to erythromycin.
boolean
C0020517 (UMLS CUI [1,1])
C0014806 (UMLS CUI [1,2])
C0014806 (UMLS CUI [1,2])
Docetaxel and paclitaxel
Item
previous treatment with docetaxel. prior paclitaxel is allowed.
boolean
C0246415 (UMLS CUI [1])
C0144576 (UMLS CUI [2])
C0144576 (UMLS CUI [2])
Peripheral neuropathy grade
Item
grade > 2 peripheral neuropathy.
boolean
C3869673 (UMLS CUI [1])
Confounding factors
Item
no confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy).
boolean
C0009673 (UMLS CUI [1])
Gynaecological status
Item
patients who are pregnant or nursing will not be eligible for this protocol. women of childbearing age who are not practicing reliable birth control must have a documented negative serum hcg.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
Cyp3a inhibitors
Item
patients who require concurrent treatment with drugs which are known to induce or inhibit cyp3a activity will be ineligible for the trial. this list includes the drugs midazolam, anti-mycotic agents (ketoconazole and related compounds), macrolide antibiotics (erythromycin and related compounds), nifedipine, anti-seizure drugs, and rifampin (induction).
boolean
C3850056 (UMLS CUI [1])