ID

12219

Beschrijving

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

Trefwoorden

  1. 18-10-15 18-10-15 -
  2. 19-10-15 19-10-15 - Julian Varghese
Geüploaded op

19 oktober 2015

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Diabetes NCT02230618

Eligibility Diabetes NCT02230618

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

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
Beschrijving

informed consent

Datatype

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
Beschrijving

Diabetes Mellitus, Insulin-Dependent; ryzodeg

Datatype

boolean

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

Exclusion Criteria

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

allergy; ryzodeg

Datatype

boolean

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

participation status

Datatype

boolean

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

Clinical Research; Disruption

Datatype

boolean

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

therapy; ryzodeg

Datatype

boolean

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

clinical trials other

Datatype

boolean

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

pregnant; breast feeding

Datatype

boolean

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

Similar models

Eligibility Diabetes NCT02230618

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02230618
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 [1,1])
C3661220 (UMLS CUI [1,2])
participation status
Item
previous participation in this study
boolean
C2348568 (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
C2348568 (UMLS CUI [1])
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial