ID

12420

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02117622

Trefwoorden

  1. 17-11-15 17-11-15 -
Geüploaded op

17 november 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 NCT02117622

Eligibility Diabetes NCT02117622

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

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
Beschrijving

Informed Consent

Datatype

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
Beschrijving

Patients with insulin

Datatype

boolean

Alias
UMLS CUI [1]
C3491971
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Allergy

Datatype

boolean

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

Study Subject Participation Status

Datatype

boolean

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

Mental incapacity

Datatype

boolean

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

Tresiba® therapy

Datatype

boolean

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

Patients who are participating in other studies or clinical trials

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

Patients who are pregnant

Datatype

boolean

Alias
UMLS CUI [1]
C3242212

Similar models

Eligibility Diabetes NCT02117622

  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02117622
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 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])

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