ID

12420

Beskrivning

A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India; ODM derived from: https://clinicaltrials.gov/show/NCT02117622

Länk

https://clinicaltrials.gov/show/NCT02117622

Nyckelord

  1. 2015-11-17 2015-11-17 -
Uppladdad den

17 november 2015

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Diabetes NCT02117622

Eligibility Diabetes NCT02117622

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02117622
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
informed consent obtained before any study-related activities (study related activities are any procedure related to recording of data according to the protocol). the historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (hba1c), fasting plasma glucose (fpg), severe hypoglycaemia before the start of tresiba therapy) can be used for baseline data
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with tresiba® based on the clinical judgment of their treating physician
Beskrivning

Patients with insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C3491971
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to tresiba®, the active substance or any of the excipients
Beskrivning

Allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
previous participation in this study
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Beskrivning

Mental incapacity

Datatyp

boolean

Alias
UMLS CUI [1]
C2229018
patients who are or have previously been on tresiba® therapy
Beskrivning

Tresiba® therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C3491971
patients who are participating in other studies or clinical trials
Beskrivning

Patients who are participating in other studies or clinical trials

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
Beskrivning

Patients who are pregnant

Datatyp

boolean

Alias
UMLS CUI [1]
C3242212

Similar models

Eligibility Diabetes NCT02117622

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02117622
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
informed consent obtained before any study-related activities (study related activities are any procedure related to recording of data according to the protocol). the historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (hba1c), fasting plasma glucose (fpg), severe hypoglycaemia before the start of tresiba therapy) can be used for baseline data
boolean
C0021430 (UMLS CUI [1])
Patients with insulin
Item
patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with tresiba® based on the clinical judgment of their treating physician
boolean
C3491971 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Allergy
Item
known or suspected allergy to tresiba®, the active substance or any of the excipients
boolean
C0020517 (UMLS CUI [1])
Study Subject Participation Status
Item
previous participation in this study
boolean
C2348568 (UMLS CUI [1])
Mental incapacity
Item
mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
boolean
C2229018 (UMLS CUI [1])
Tresiba® therapy
Item
patients who are or have previously been on tresiba® therapy
boolean
C3491971 (UMLS CUI [1])
Patients who are participating in other studies or clinical trials
Item
patients who are participating in other studies or clinical trials
boolean
C2348568 (UMLS CUI [1])
Patients who are pregnant
Item
patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
boolean
C3242212 (UMLS CUI [1])

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