Informações:
Falhas:
ID
13237
Descrição
A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01994837
Link
https://clinicaltrials.gov/show/NCT01994837
Palavras-chave
Versões (1)
- 25/01/2016 25/01/2016 -
Titular dos direitos
CC BY-NC 3.0
Transferido a
25 de janeiro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Eligibility Acute Myelogenous Leukemia NCT01994837
Eligibility Acute Myelogenous Leukemia NCT01994837
- StudyEvent: Eligibility
Similar models
Eligibility Acute Myelogenous Leukemia NCT01994837
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
AML
Item
1. histological or cytological confirmation of relapsed or refractory aml (by world health organization (who) classification) or untreated aml in patients who are unfit for intensive therapy.
boolean
C0023467 (UMLS CUI [1])
ECOG
Item
2. subject has an eastern cooperative oncology group (ecog) performance score of 0 to 2.
boolean
C1520224 (UMLS CUI [1])
renal function
Item
3. subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 ml/min; determined via urine collection for 24-hour creatinine clearance or by the cockcroft gault formula using ideal body mass (ibm) instead of mass.
boolean
C0373595 (UMLS CUI [1])
liver function
Item
4. subject must have adequate liver function.
boolean
C0232741 (UMLS CUI [1])
anti-cancer therapy
Item
1. subject has received acute anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) prior to first dose of abt-199.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C1875319 (UMLS CUI [4])
C1522449 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C1875319 (UMLS CUI [4])
monoclonal antibody
Item
2. subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.
boolean
C0003250 (UMLS CUI [1])
CYP3A inducer
Item
3. subject has received potent cyp3a inducers (such as rifampin, carbamazepine, phenytoin and st. john's wort and warfarin or requires the use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of this effect) within 7 days prior to the first dose of study drug.
boolean
C0059563 (UMLS CUI [1])
cyp3a inhibitors
Item
4. subject has received cyp3a inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 5 days prior to the first dose of study drug.
boolean
C0059563 (UMLS CUI [1])
leukocytes
Item
5. subject has a white blood cell count > 25 x 10^9/l.
boolean
C0023508 (UMLS CUI [1])
APL
Item
6. subject has acute promyelocytic leukemia (french-american-british class m3 aml).
boolean
C0023487 (UMLS CUI [1])
cns leukemia
Item
7. subjects with known active cns disease.
boolean
C1332884 (UMLS CUI [1])