ID

12210

Descrição

Post Marketing Surveillance (PMS) Study of Ryzodeg™ (Insulin Degludec /Insulin Aspart) in Patients With Diabetes Mellitus in Routine Clinical Practice in India; ODM derived from: https://clinicaltrials.gov/show/NCT02230618

Link

https://clinicaltrials.gov/show/NCT02230618

Palavras-chave

  1. 18/10/2015 18/10/2015 -
  2. 19/10/2015 19/10/2015 - Julian Varghese
Transferido a

18 de outubro de 2015

DOI

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Licença

Creative Commons BY-NC 3.0 Legacy

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Eligibility Diabetes NCT02230618

Eligibility Diabetes NCT02230618

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02230618
Inclusion Criteria
Descrição

Inclusion Criteria

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

informed consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with ryzodeg™ based on the clinical judgment of their treating physician
Descrição

Diabetes Mellitus, Insulin-Dependent; ryzodeg

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C3661220
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or suspected allergy to ryzodeg™ any of the active substances or any of the excipients
Descrição

allergy; ryzodeg

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C3661220
previous participation in this study
Descrição

participation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679823
mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Descrição

Clinical Research; Disruption

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0008972
UMLS CUI [2]
C0332453
patients who are or have previously been on ryzodeg™ therapy
Descrição

therapy; ryzodeg

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C3661220
patients who are participating in other studies or clinical trials
Descrição

clinical trials other

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205394
patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
Descrição

pregnant; breast feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C0006147

Similar models

Eligibility Diabetes NCT02230618

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02230618
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
informed consent obtained before any study-related activities. (study-related activities are any procedures that are related to recording of data according to the protocol). the historical data including the data before informed consent obtained (e.g., hba1c (glycated haemoglobin ), fpg (fasting plasma glucose), pppg (postprandial plasma glucose), severe hypoglycaemia before the start of ryzodeg therapy) can be used for baseline data
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Insulin-Dependent; ryzodeg
Item
patients with insulin requiring diabetes mellitus and who are scheduled to start treatment with ryzodeg™ based on the clinical judgment of their treating physician
boolean
C0011854 (UMLS CUI [1])
C3661220 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
allergy; ryzodeg
Item
known or suspected allergy to ryzodeg™ any of the active substances or any of the excipients
boolean
C0020517 (UMLS CUI [1])
C3661220 (UMLS CUI [2])
participation
Item
previous participation in this study
boolean
C0679823 (UMLS CUI [1])
Clinical Research; Disruption
Item
mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
boolean
C0008972 (UMLS CUI [1])
C0332453 (UMLS CUI [2])
therapy; ryzodeg
Item
patients who are or have previously been on ryzodeg™ therapy
boolean
C0087111 (UMLS CUI [1])
C3661220 (UMLS CUI [2])
clinical trials other
Item
patients who are participating in other studies or clinical trials
boolean
C0008976 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
pregnant; breast feeding
Item
patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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