Informações:
Falhas:
ID
25909
Descrição
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]; ODM derived from: https://clinicaltrials.gov/show/NCT01022424
Link
https://clinicaltrials.gov/show/NCT01022424
Palavras-chave
Versões (1)
- 26/09/2017 26/09/2017 -
Transferido a
26 de setembro de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Autosomal Dominant Polycystic Kidney Disease NCT01022424
Eligibility Autosomal Dominant Polycystic Kidney Disease NCT01022424
- StudyEvent: Eligibility
Similar models
Eligibility Autosomal Dominant Polycystic Kidney Disease NCT01022424
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Study Subject Participation Status | Protocol Compliance | Patient withdrawn from trial
Item
patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002)
boolean
C2348568 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0422727 (UMLS CUI [3])
C0525058 (UMLS CUI [2])
C0422727 (UMLS CUI [3])
Study Subject Participation Status | Adverse events resolved | Adverse events Stable
Item
patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up.
boolean
C2348568 (UMLS CUI [1])
C0877248 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0877248 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Estimated Glomerular Filtration Rate
Item
patients with egfr of less than 15 ml/min/1.73 m2
boolean
C3811844 (UMLS CUI [1])
Complications
Item
patients with any of the following complications:
boolean
C0009566 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Cardiovascular Diseases Serious | Heart failure | Liver diseases | Liver Cirrhosis
Item
serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)
boolean
C0007222 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
C0205404 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
Complications
Item
patients with any of the following complications or history thereof:
boolean
C0009566 (UMLS CUI [1])
Drug Allergy | Drug related anaphylaxis | Hypersensitivity Benzazepine derivatives | Hypersensitivity Suspected Benzazepine derivatives
Item
clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity
boolean
C0013182 (UMLS CUI [1])
C0850607 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0005034 (UMLS CUI [3,2])
C0243072 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0005034 (UMLS CUI [4,3])
C0243072 (UMLS CUI [4,4])
C0850607 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0005034 (UMLS CUI [3,2])
C0243072 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0005034 (UMLS CUI [4,3])
C0243072 (UMLS CUI [4,4])
Mental disorders Informed Consent Unable
Item
inability to personally give consent due to a mental illness
boolean
C0004936 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])