Informações:
Falhas:
ID
29223
Descrição
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00655200
Link
https://clinicaltrials.gov/show/NCT00655200
Palavras-chave
Versões (1)
- 09/03/18 09/03/18 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
9 marzo 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Diabetes NCT00655200
Eligibility Diabetes NCT00655200
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes NCT00655200
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
patients diagnosed with type 1 or type 2 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0011860 (UMLS CUI [2])
Insulin naive
Item
newly diagnosed insulin naive patients
boolean
C0021641 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,2])
Insulin, Human | Basal insulin
Item
patients currently on human insulin or on basal insulin
boolean
C0795635 (UMLS CUI [1])
C0650607 (UMLS CUI [2])
C0650607 (UMLS CUI [2])
Levemir | Insulin detemir
Item
patients prescribed with levemir™ flexpen™ (insulin detemir) therapy
boolean
C1314782 (UMLS CUI [1])
C0537270 (UMLS CUI [2])
C0537270 (UMLS CUI [2])
Adherence Prescription information
Item
usage should be in accordance with the current prescribing information (see attached prescribing information)
boolean
C1510802 (UMLS CUI [1,1])
C1546473 (UMLS CUI [1,2])
C1546473 (UMLS CUI [1,2])
Hypersensitivity Insulin detemir | Hypersensitivity Levemir | Hypersensitivity Insulin detemir Excipient | Hypersensitivity Levemir Excipient
Item
previous history of hypersensitivity to insulin detemir (levemir™) and its excipients (see attached prescribing information)
boolean
C0020517 (UMLS CUI [1,1])
C0537270 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1314782 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0537270 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C1314782 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0537270 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1314782 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0537270 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C1314782 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Medical contraindication Prescription information | Warning Prescription information
Item
contraindications and warnings specified in the current prescribing information (see attached prescribing information)
boolean
C1301624 (UMLS CUI [1,1])
C1546473 (UMLS CUI [1,2])
C0871599 (UMLS CUI [2,1])
C1546473 (UMLS CUI [2,2])
C1546473 (UMLS CUI [1,2])
C0871599 (UMLS CUI [2,1])
C1546473 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
pregnant women, those planning to become pregnant, or women who are breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Other Coding
Item
patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
boolean
C3846158 (UMLS CUI [1])
Children | Age
Item
children below 6 years old
boolean
C0008059 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])