ID

39016

Description

Along-term Study of OPC-262 in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01634282

Link

https://clinicaltrials.gov/show/NCT01634282

Keywords

Versions (1)
  1. 11/20/19 11/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes, Type 2 NCT01634282

English

Eligibility Diabetes, Type 2 NCT01634282

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who completed study 262-09-001 (namely, patients who visited the hospital at visit week 24）
Description

Clinical Trial Specified Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
patients who are capable of giving informed consent prior to participating in this clinical study
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)
Description

Contraceptive methods | Partner Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who withdrew from study 262-09-001
Description

Patients Withdrawn Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
patients who experienced serious adverse events that the relationship with the study drug was not denied in study 262-09-001
Description

Serious Adverse Event | Relationship Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0013230
patients who experienced serious adverse events that the relationship with the study drug are denied in study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study
Description

Serious Adverse Event | Relationship Investigational New Drugs Rejected | Symptoms Present

Data type

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1548437
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0150312
patients who met the exclusion criteria of study 262-09-001 during the study period of study 262-09-001
Description

Exclusion Criteria Fulfill Clinical Trial Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0205369
female patients who wish to become pregnant during the study period of study 262-09-002 or within 4 weeks after the study
Description

Pregnancy intended

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1283828
patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Diabetes, Type 2 NCT01634282

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Specified Completed
Item
patients who completed study 262-09-001 (namely, patients who visited the hospital at visit week 24）
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Informed Consent
Item
patients who are capable of giving informed consent prior to participating in this clinical study
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods | Partner Contraceptive methods
Item
patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period)
boolean
C0700589 (UMLS CUI [1])
C0682323 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Patients Withdrawn Clinical Trial Specified
Item
patients who withdrew from study 262-09-001
boolean
C0030705 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Serious Adverse Event | Relationship Investigational New Drugs
Item
patients who experienced serious adverse events that the relationship with the study drug was not denied in study 262-09-001
boolean
C1519255 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Serious Adverse Event | Relationship Investigational New Drugs Rejected | Symptoms Present
Item
patients who experienced serious adverse events that the relationship with the study drug are denied in study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study
boolean
C1519255 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1548437 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
Exclusion Criteria Fulfill Clinical Trial Specified
Item
patients who met the exclusion criteria of study 262-09-001 during the study period of study 262-09-001
boolean
C0680251 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Pregnancy intended
Item
female patients who wish to become pregnant during the study period of study 262-09-002 or within 4 weeks after the study
boolean
C0032961 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Study Subject Participation Status Inappropriate
Item
patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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