Information:
Error:
ID
32067
Description
Safety and Tolerability of Varenicline in Schizophrenia (SATOVA); ODM derived from: https://clinicaltrials.gov/show/NCT00702793
Link
https://clinicaltrials.gov/show/NCT00702793
Keywords
Versions (1)
- 10/16/18 10/16/18 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
October 16, 2018
DOI
To request one please log in.
License
Creative Commons BY 4.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Schizophrenia NCT00702793
Eligibility Schizophrenia NCT00702793
- StudyEvent: Eligibility
Similar models
Eligibility Schizophrenia NCT00702793
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Inpatient | Schizophrenia | Schizoaffective Disorder
Item
inpatients with a diagnosis of schizophrenia or schizoaffective disorder
boolean
C0021562 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C0036341 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
Age
Item
individuals between the ages of 19 and 65 years of age
boolean
C0001779 (UMLS CUI [1])
Tobacco use Number of cigarettes per day | Smoking abstinence Duration
Item
individuals that had smoked 10 cigarette/day or more during the previous year, and had no period of smoking abstinence longer than 3 months in the past year
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0814442 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C3694146 (UMLS CUI [1,2])
C0814442 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Discharge from hospital Timepoint Expected
Item
individuals that are not expected to be discharged from hospital within 4 months.
boolean
C0586003 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C2348792 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Allergic Reaction Investigational New Drugs
Item
clinically significant allergic reactions to the study medication
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
Laboratory test result abnormal
Item
clinically significant abnormalities in the screening laboratory values
boolean
C0438215 (UMLS CUI [1])
At risk for deliberate self harm
Item
subjects at significant risk of self-harm
boolean
C1276053 (UMLS CUI [1])
Varenicline
Item
previous treatment with varenicline
boolean
C1569608 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
women who are pregnant, breast-feeding, or of child-bearing potential not using adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Gender Contraceptive methods Absent
Item
men not using adequate contraception
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Pharmaceutical Preparations Interfere with Evaluation Investigational New Drugs
Item
use of medications that might interfere with the study medication evaluation
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0521102 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Nicotine replacement
Item
nicotine replacement
boolean
C1278444 (UMLS CUI [1])
Nortriptyline
Item
nortriptyline
boolean
C0028420 (UMLS CUI [1])
Clonidine
Item
clonidine
boolean
C0009014 (UMLS CUI [1])