Information:
Error:
ID
12420
Description
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
Keywords
Versions (1)
- 11/17/15 11/17/15 -
Uploaded on
November 17, 2015
DOI
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License
Creative Commons BY 4.0
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Eligibility Diabetes NCT02117622
Eligibility Diabetes NCT02117622
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT02117622
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])