Information:
Fel:
ID
20839
Beskrivning
Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00306384
Länk
https://clinicaltrials.gov/show/NCT00306384
Nyckelord
Versioner (1)
- 2017-03-21 2017-03-21 -
Uppladdad den
21 mars 2017
DOI
För en begäran logga in.
Licens
Creative Commons BY 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Eligibility Diabetes Mellitus NCT00306384
Eligibility Diabetes Mellitus NCT00306384
- StudyEvent: Eligibility
Similar models
Eligibility Diabetes Mellitus NCT00306384
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Gynaecological status
Item
females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Diabetes mellitus type 2 and study participation status
Item
type 2 diabetes mellitus and was enrolled in one of the following 7 controlled phase iii studies. the study will be open to all patients who completed one of these studies through the end-of-treatment visit:
boolean
C0011860 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C2348568 (UMLS CUI [2])
syr-322-plc-010 - nct00286455
Item
syr-322-plc-010 - nct00286455
boolean
syr-322-sulf-007 - nct00286468
Item
syr-322-sulf-007 - nct00286468
boolean
syr-322-met-008 - nct00286442
Item
syr-322-met-008 - nct00286442
boolean
syr-322-tzd-009 - nct00286494
Item
syr-322-tzd-009 - nct00286494
boolean
syr-322-ins-011 - nct00286429
Item
syr-322-ins-011 - nct00286429
boolean
01-05-tl-322opi-001 - nct00328627
Item
01-05-tl-322opi-001 - nct00328627
boolean
01-06-tl-322opi-002 - nct00395512
Item
01-06-tl-322opi-002 - nct00395512
boolean
alanine aminotransferase and serum creatinine measurement
Item
alanine aminotransferase less than or equal to 3 times the upper limit of normal and serum creatinine less than or equal to 2.0 mg per dl.
boolean
C0201836 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0201976 (UMLS CUI [2])
Home glucose monitor
Item
able and willing to monitor own blood glucose concentrations with a home glucose monitor.
boolean
C0917953 (UMLS CUI [1])
Comorbidity
Item
no major illness or debility that in the investigator's opinion prohibits the patient from completing the study.
boolean
C0009488 (UMLS CUI [1])
Adverse event
Item
the occurrence of any adverse event or condition during the controlled phase iii studies, which, in the opinion of the investigator, should exclude the patient from participating in the open-label extension.
boolean
C0877248 (UMLS CUI [1])
Pharmacotherapy
Item
is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
boolean
C0013216 (UMLS CUI [1])
Weight-loss drugs
Item
weight-loss drugs
boolean
C0376606 (UMLS CUI [1])
Investigational antidiabetics
Item
investigational antidiabetics, additional dipeptidyl peptidase-4 (dpp-4) and glucagon-like peptide-1 (glp 1) inhibitors
boolean
C0935929 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Incretin mimetics
Item
incretin mimetics,
boolean
C3839883 (UMLS CUI [1])
Glucocorticoids
Item
oral or systemically injected glucocorticoids.
boolean
C0017710 (UMLS CUI [1])