http://purl.obolibrary.org/obo/oae.owl
http://purl.org/mp
http://www.w3.org/2006/time#2016
http://www.w3.org/ns/oa#
OpenPVSignal ontology describes a model able to present pharmacovigilance signal information, originally contained in free-text reports.
OpenPVSignal
draft-v0.9-20200521
18
discontinued
hospitalization
no change
1-10
11-20
18 or older
21-30
31-40
41-50
51-60
61-70
71 or older
%
AU
AU/mL
BAU
BAU/mL
BU
CCID_50
Ci
D'ag'U
DF
FFU
IU
IU/L
IU/mL
L
Lf
LfU/mL
PFU
PNU
PNU/mL
TCID_50
U
USP'U
X
bar
bead
capsule
cellular sheet
cloth
cm^2
dL
disc
douche
drop
g
globule
granule
gum
hp_C
hp_M
hp_Q
hp_X
kp_C
lozenge
mCi
mCi/mL
mEq
mL
mU
mcg
mg
mg/actuat
mg/hr
mg/mL
mg/mg
mmol
mol
ng
nmol
organisms
pastille
patch
pellet
pill
pouch
puff
ring
salve
stick
strip
suppository
swab
tablet
tampon
tape
tbsp
tsp
uCi
uL
ug
ug/mL
umol
unt
unt/mL
vial
wafer
μg
Certain
Conditional
Doubtful
Not assessable
Possible
Probable
Unrelated
female
male
Further investigation needed
causal association
causal association most probable
causal association probable
no clear conclusion
rejected
clinical trial report
health care professional
health care professional, other than physician
informal carer
other
patient
pharmaceutical company
pharmacist
physician
study
Dechallenge
Rechallenge
Eudravigilance
FAERS
LAREB
WHO Vigibase
death after drug withdrawl
negative - condition still applied
positive - condition not applied
unknown
collyrium
inhaled
injected
injected (intramuscular)
injected (intraveneous)
intrathecal
nasal
oral
other
rectal
smoked
subcutaneous
sublingual
topical (skin)
death
hospitalization for treatment
irrelevant death
no recovery
permanent injury
recovering
recovery after dose reduction
recovery after drug withdrawal
recovery after hospitalization
recovery with no further information
recovery with sequelae
recovery without drug withdrawal
unknown
death
hospitalization for treatment
irrelevant death
negative rechallenge - condition not appeared
permanent injury
positive rechallenge - condition appeared again
recovering
recovery after drug withdrawl
recovery after hospitalization
recovery with no further information
recovery with sequelae
recovery without drug withdrawl
unknown
Adverse drug reaction
Drug-drug interaction
Off-label use
true
S7
#Adverse_Drug-Drug_interaction
A negative response to a drug combination that may lead to unexpected side effects.
#Adverse_Drug-Drug_interaction
Adverse Drug-Drug interaction
#Adverse_Effect
Note for Guidance on Clinical Safety Data Management:
Definitions and Standards for Expedited Reporting - http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002749.pdf -
#Adverse_Effect
Noxious and unintended response to a medicinal product.
#Adverse_Effect
Adverse Effect
#Adverse_Effect_Mechanism
Spratto, G.R.; Woods, A.L. (2010). Delmar Nurse's Drug Handbook. Cengage Learning. ISBN 978-1-4390-5616-5.
#Adverse_Effect_Mechanism
Adverse Effect Mechanism
#Adverse_Effect_Mechanism
A free-text description of the mechanism of action related with an adverse effect.
#Adverse_Effect_Mechanism
Adverse Effect Mechanism
#Author
The person or organization that wrote or was responsible for writing the respective PV signal report.
#Author
Author
#Bibliographic_reference
Reference to published material that is cited in the PV signal report (e.g. scientific paper, book, report etc.)
#Bibliographic_reference
Bibliographic reference
#Case_Report_Information
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3010033/
#Case_Report_Information
Description of the findings from case report publications which are mentioned in the PV signal report.
#Case_Report_Information
Case Report Information
#Clinical_trial_information
Description of the findings from clinical trials which are mentioned in the PV signal report.
#Clinical_trial_information
Clinical Trial Information
#Cohort_Profile
Characteristics of a Cohort study group
#Cohort_Profile
Cohort Profile
#Conclusion
The free-text description of the main outcome of the PV signal report.
#Conclusion
Conclusion
#Condition
https://meshb.nlm.nih.gov/record/ui?ui=D004194
#Condition
Disease
#Condition
A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.
#Condition
Condition
#Confidence_interval_0.95
Based on the https://www.investopedia.com/terms/c/confidenceinterval.asp
#Confidence_interval_0.95
The marginal values of the range in which the respective statistical measure (e.g. PRR or ROR) belongs with a propability of 95%.
#Confidence_interval_0.95
Confidence Interval 0.95
#Discussion
The signal section that discusses the findings.
#Discussion
Discussion
#Disproportionality_Analysis_Measure
https://www.jmp.com/content/dam/jmp/documents/en/white-papers/disproportionality-105686.pdf
#Disproportionality_Analysis_Measure
Statistical feature depicting the comparison between the rate at which a particular event of interest (e.g. adverse effect) co-occurs with a given drug, and the rate of this event occuring without the drug.
#Disproportionality_Analysis_Measure
Disproportionality Analysis Measure
#Dosage
http://www.medlinguistics.com/didyouknow.asp
#Dosage
https://www.verywell.com/drug-dose-definition-and-examples-1123989
#Dosage
The regulated administration of individual doses, the quantity of drug to be administered at one time, or the total quantity administered during a specified period, i.e. the dosage not only tells the quantity of medicine to be taken, but it also tells the frequency or the number of times a medicine has to be taken by the patient.
#Dosage
Dosage
#Drug
The Need for Definitions in Pharmacovigilance Marie Lindquist - https://www.ncbi.nlm.nih.gov/pubmed/17867720
#Drug
Product intended to be administered to humans for treating or preventing disease, with the view to making a medical diagnosis or to restore, correct or modify physiological functions
#Drug
Drug
#Drug-Drug_interaction
The effect of a drug combination. Can be either positive or detrimental.
#Drug-Drug_interaction
Drug-Drug interaction
#DrugClass
https://en.wikipedia.org/wiki/Drug_class
#DrugClass
A set of medications that have similar chemical structures, the same mechanism of action (i.e., bind to the same biological target), a related mode of action, and/or are used to treat the same disease.
#DrugClass
Drug Class
#Drug_Class_Effect_Information
Free text information regarding the administration of drugs with similar structure and mechanism of action (i.e. they belong to the same class) as described in the PV signal report.
#Drug_Class_Effect_Information
Free text information regarding the effect of the drugs belonging to a specific drug class.
#Drug_Class_Effect_Information
Drug Class Effect Information
#Drug_Exposure_Time
The time related information regarding the administration of a drug to a patient (e.g. when it started and when it ended).
#Drug_Exposure_Time
Drug Exposure Time
#Drug_Intake_Form
https://en.wikipedia.org/wiki/Dosage_form
#Drug_Intake_Form
Administration Route
#Drug_Intake_Form
Dosage Form
#Drug_Intake_Form
The form of the drug taken by the patient (e.g. injection, pill etc.).
#Drug_Intake_Form
Drug Intake Form
#Drug_Usage
The details of an overall drug administration process (e.g. exposure, intake form, dosage).
#Drug_Usage
Drug Usage
#Free_text_reporting_element
Free-text snippets that could be used in human readable reports (e.g. in printing PDFs)
#Free_text_reporting_element
Free text reporting element
#Incidence
Refers to the occurrence of new cases of disease or injury in a population over a specified period of time
#Incidence
Incidence
#Indication
https://www.medicinenet.com/script/main/art.asp?articlekey=32545
#Indication
A medical condition which makes a particular treatment or procedure advisable
#Indication
Indication
#Individual_Case_Safety_Report
Individual Case Report
#Individual_Case_Safety_Report
Spontaneous Report
#Individual_Case_Safety_Report
A report triggered by a suspicion of a healthcare professional or a patient that observed signs and symptoms could have been caused by a medicine.
#Individual_Case_Safety_Report
Individual Case Safety Report
#Introduction
The initial part of a PV signal report, typically providing contextual information about the signal.
#Introduction
Introduction
#Lareb_Report
An Individual Case Safety Report submitted in the Dutch spontaneous report system maintained by Lareb.
#Lareb_Report
Lareb Report
#Literature_information
Description of the findings in scientific literature as contained in the PV signal report.
#Literature_information
Literature Information
#Mechanism
A free-text description of a drug's mechanism of action, as described in the PV signal report.
#Mechanism
Mechanism
#Medication_Errors
20000224
#Medication_Errors
Medication errors are defined as any preventable events that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient or consumer. Such events may be related to professional practice, health care products, procedures and systems, including prescribing, order communication, product labeling, packaging and nomenclature, compounding, dispensing, distribution, administration, education, monitoring and use. A medication error can ultimately result in an adverse drug reaction (medication error with an ADR) or may have no clinical consequences (medication error without an ADR). A medication error can also be intercepted prior to the patient's exposure to the error. A potential medication error is a scenario which does not involve an actual patient, and represents circumstances or information capable of leading to the occurrence of a medication error. Medication errors cause a large number of ADRs annually: create a major public-health burden representing 18.7-56% of all adverse drug events among hospital patients; may cause unintended harm; are considered preventable. Medication errors result from a variety of human (e.g., healthcare professional; care giver; patient) and product-related reasons, for example: miscommunication of drug orders due to poor handwriting; confusion between drugs with similar names; poor packaging design; confusion of dosing units; unclear instructions. Medication errors can have an impact on: patients; healthcare professionals; pharmaceutical manufacturers; regulatory agencies; health insurance providers; national patient safety organisations
#Medication_Errors
http://purl.bioontology.org/ontology/MEDDRA/20000224
#Medication_Errors
Medication errors
#Number_of_prescriptions_on_population
The count of the specific drug prescriptions on a population basis.
#Number_of_prescriptions_on_population
Number of prescriptions on population
#Past_Diagnosis
Previous diagnosis of conditions
#Past_Diagnosis
Past Diagnosis
#Patient
The Need for Definitions in Pharmacovigilance Marie Lindquist - https://www.ncbi.nlm.nih.gov/pubmed/17867720
#Patient
Person awaiting or under medical care or treatment by a health professional
#Patient
Patient
#Pharmacovigilance_Signal_Report
Free text reports published by PV monitoring organizations regarding a PV signal. Examples include reports published by FDA, WHO-UMC and Lareb.
#Pharmacovigilance_Signal_Report
Pharmacovigilance Signal Report
#Potential_Confounder
Confounders are factors other than the exposure/intervention that may affect the outcome of interest and that can be related to exposure/intervention.
#Potential_Confounder
Potential Confounder
#Prevalence
The proportion of persons in a population who have a particular disease or attribute
#Prevalence
Prevalence
#Relative_Reporting_Ratio
http://openvigil.sourceforge.net/doc/DPA.pdf
#Relative_Reporting_Ratio
Depicts the observed frequency of the adverse event to expected frequency in the total population sample.
#Relative_Reporting_Ratio
Relative Reporting Ratio (RRR)
#Reporting_Odds_Ratio
The Need for Definitions in Pharmacovigilance Marie Lindquist - https://www.ncbi.nlm.nih.gov/pubmed/17867720
#Reporting_Odds_Ratio
The Odds of exposure (to a Medicinal product ) in cases (e.g. individuals with an Adverse reaction) divided by the Odds of exposure in controls (e.g. individuals without the Adverse reaction).
#Reporting_Odds_Ratio
Reporting Odds Ratio (ROR)
#Reports_group
A set of Individual Case Safety Reports corresponding to specific criteria (e.g. country of origin).
#Reports_group
Reports group
#Response_to_Pharmacovigilance_Signal_Report
Arguments to the claims of a PV signal report, as contained in the PV signal report itself in free-text format. Typically, such a response would be issued by a pharmaceutical company producing the investigated drug.
#Response_to_Pharmacovigilance_Signal_Report
Response to Pharmacovigilance Signal Report
#Signal
Council for International Organisations of Medical Sciences Working
group VIII, Practical Aspects of Signal Detection in Pharmacovigilance
(CIOMS, Geneva 2010)
#Signal
Information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.
#Signal
Signal
#Statistical_Entity
Concepts that depict the result of the calculation of specific statistical processes (e.g. disproportionality analysis)
#Statistical_Entity
Statistical Entity
#Structured_Product_Labels_information
Free-text description of information elaborated the leaflet which is typically part of the drug's packaging (a.k.a Structured Product Label, or Summary of Product Characteristics - SmPC), as contained in the PV signal report.
#Structured_Product_Labels_information
Structured Product Labels information
#Summary
The free text summary of a pharmacovigilance signal report
#Summary
Summary
#Vaccine
A vaccine is a processed material with the function that when administered, it prevents or ameliorates a disorder in a target organism by inducing or modifying adaptive immune responses specific to the antigens in the vaccine.
#Vaccine
Vaccine
#VigiBase_Report
An Individual Case Safety Report stored in the VigiBase database maintained by WHO-UMC.
#VigiBase_Report
VigiBase report
#Warning_Information
Information related with adverse effects or contraindications that are already identified in various data sources (e.g. product labels).
#Warning_Information
Warning Information
#belongs_to_reports_group
Relates a spontaneous report with a report group.
#belongs_to_reports_group
belongs to reports group
#concerns_action_upon_adverse_effect
Depicts the actions upon the diagnosis of the adverse effect, as reported in the respective spontaneous report.
#concerns_action_upon_adverse_effect
concerns action upon adverse effect
#concerns_indication_for_use
Identifies the condition which can be considered the reason for the respective drug administration.
#concerns_indication_for_use
concerns indication for use
#hasClass
Relates a drug with the drug class that it belongs to.
#hasClass
belongs to class
#has_ATC_code
Identifies the ATC code of the respective drug.
#has_ATC_code
has ATC code
#has_ICD_code
Identifies the ICD code of the respective condition.
#has_ICD_code
has ICD code
#has_ID
Refers to the ID used for the specific spontaneous report, to be referenced in the overall signal report.
#has_ID
has ID
#has_MeSH_tree_number
Identifies the MeSH tree code of the respective entity.
#has_MeSH_tree_number
has MeSH tree number
#has_MedDRA_code
Identifies the MedDRA code of the respective adverse effect.
#has_MedDRA_code
has MedDRA code
#has_MedDRA_prefered_term
Identifies the MedDRA preferred term regarding the respective adverse effect.
#has_MedDRA_prefered_term
has MedDRA prefered term
#has_RxNorm_code
Identifies the RxNorm code of the respective drug.
#has_RxNorm_code
has RxNorm code
#has_SNOMED-CT_code
Indentifies the SNOMED-CT code of the respective entity
#has_SNOMED-CT_code
has SNOMED-CT code
#has_affiliation
Depicts the respective author's professional affiliation(s).
#has_affiliation
has affiliation
#has_age
Refers to the patient's age. It should be noted that the target value can be either an integer or an enumeration depiction the respective age decade.
#has_age
has age
#has_average_age
Depicts the average age of the patients referred by a specific spontaneous reports group.
#has_average_age
has average age
#has_content
Links to the free text of the respective element. Formatting information could be included (e.g. in HTML format).
#has_content
has content
#has_count
Depicts the total number of patients belonging to a specific report group.
#has_count
has count
#has_count_of_men
Depicts the total number of men belonging to a specific report group.
#has_count_of_men
has count of men
#has_count_of_women
Depicts the total number of women belonging to a specific report group.
#has_count_of_women
has count of women
#has_creation_date
Declares the date(s) that the respective pharmacovigilance signal report has been created.
#has_creation_date
has creation date
#has_dosage_unit
Refers to the unit of a drug dosage.
#has_dosage_unit
has dosage unit
#has_drugbank_code
Identifies the drugbank code of the respective drug.
#has_drugbank_code
has drugbank code
#has_evaluation
Evaluation of the imputability on the basis of the data contained in PV reports/reports groups
#has_evaluation
has evaluation
#has_expected_count
Depicts the expected number of cases for a specific drug-adverse event pair.
#has_expected_count
has expected count
#has_expected_count_of_men
Depicts the expected number of cases for a specific drug-adverse event pair regarding women.
#has_expected_count_of_men
has expected count of men
#has_expected_count_of_women
Depicts the expected number of cases for a specific drug-adverse event pair regarding men.
#has_expected_count_of_women
has expected count of women
#has_first_name
Declares the person's first name.
#has_first_name
has first name
#has_free_text_reporting_element
Relates a free-text reporting element with the pharmacovigilance report that it belongs to.
#has_free_text_reporting_element
has free text reporting element
#has_gender
Depicts the patient's gender.
#has_gender
has gender
#has_last_name
Declares the person's last name.
#has_last_name
has last name
#has_lower_limit
Depicts the confidence interval's lower limit.
#has_lower_limit
has lower limit
#has_max_age
Depicts the maximum age of the patients referred by a specific spontaneous reports group.
#has_max_age
has max age
#has_mechanism
Depicts the relation between a drug or a drug class and a mechanism of action.
#has_mechanism
has mechanism
#has_median_age
Depicts the median age of the patients referred by a specific spontaneous reports group.
#has_median_age
has median age
#has_min_age
Depicts the minimum age of the patients referred by a specific spontaneous reports group.
#has_min_age
has min age
#has_overall_conclusion
It depicts the final conclusion of the report in an enumeratable form.
#has_overall_conclusion
has overall conclusion
#has_potential_confounding_factor
Relates a Signal or report/reports group to a potential confounding factor.
#has_potential_confounding_factor
has potential confounding factor
#has_registration_date
Declares the date(s) that the respective drug has been registered.
#has_registration_date
has registration date
#has_reporter_type
Depicts the category of the person that submitted the respective spontaneous report.
#has_reporter_type
has reporter type
#has_subject
Depicts the subject of the respective free-text section.
#has_subject
has subject
#has_trade_name
Depicts the respective drug's trade name.
#has_trade_name
has trade name
#has_upper_limit
Depicts the confidence interval's upper limit.
#has_upper_limit
has upper limit
#has_value
Depicts the value of the respective statistical data item.
#has_value
has value
#initially_identified_on
Depicts the date that the respective signal has been originally identified on.
#initially_identified_on
initially identified on
#is_part_of
Depicts that a free-text snippet could be part of a larger free-text section.
#is_part_of
is part of
#is_related_with_drug_exposure
Relates the information regarding a specific drug usage with the respective time exposure.
#is_related_with_drug_exposure
is related with drug exposure
#is_related_with_drug_intake
Relates the usage of a drug with a specific intake form.
#is_related_with_drug_intake
is related with drug intake form
#is_subgroup_of
Enables the identification of a spontaneous report group as part of another spontaneous report group.
#is_subgroup_of
is subgroup of
#is_supported_by_cohort_profile
Relates a pharmacovigilance signal with a cohort profile.
#is_supported_by_cohort_profile
is supported by cohort profile
#is_supported_by_individual_case_report
Relates a pharmacovigilance signal with the corresponding individual case reports.
#is_supported_by_individual_case_report
is supported by individual case report
#is_supported_by_statistical_entity
Relates a pharmacovigilance signal with the supporting statistical data.
#is_supported_by_statistical_entity
is supported by statistical entity
#modified_on
Declares the date(s) that the respective pharmacovigilance signal report has been modified.
#modified_on
modified on
#refers_to_adverse_effect
Depicts a reference to the respective adverse effect.
#refers_to_adverse_effect
refers to adverse effect
#refers_to_author
Identifies the author that the respective manuscript refers to.
#refers_to_author
refers to author
#refers_to_challenge_type
Refers to the type of challenge outcome as reported in Report Groups.
#refers_to_challenge_type
refers to challenge type
#refers_to_class
Depicts a reference with the respective drug class.
#refers_to_class
refers to class
#refers_to_cohort_profile
Depicts a reference for Incidence or Prevalence to a cohort profile.
#refers_to_cohort_profile
refers to cohort profile
#refers_to_concomitant_drug
Explicitly states that the respective drug is reported as a concomittant drug in the specific spontaneous report.
#refers_to_concomitant_drug
refers to concomitant drug
#refers_to_confidence_interval
Depicts a relation with a specific confidence interval.
#refers_to_confidence_interval
refers to confidence interval
#refers_to_country
Assosiates a report group to a country.
#refers_to_country
refers to country
#refers_to_database
Identifies the database that the respective data are related with.
#refers_to_database
refers to database
#refers_to_dechallenge_outcome
Depicts the outcome of the dechallenge process applied to the respective adverse effect, as reported in the spontaneous report.
#refers_to_dechallenge_outcome
refers to dechallenge outcome
#refers_to_dechallenge_process
Depicts if the respective dosage is used as part of a dechallenge process.
#refers_to_dechallenge_process
refers to dechallenge process
#refers_to_dosage
Relates a drug usage with a specifc dosage.
#refers_to_dosage
refers to dosage
#refers_to_dose_value
Depicts the dose value of the respective dosage scheme, including the units (e.g. mg).
#refers_to_dose_value
refers to dose value
#refers_to_drug
Depicts a relation with the respective drug.
#refers_to_drug
refers to drug
#refers_to_drug_drug_interaction
Depicts a reference to group of interacting drugs.
#refers_to_drug_drug_interaction
refers to drug-drug interraction
#refers_to_form_of_intake
Depicts the intake form of a respective drug.
#refers_to_form_of_intake
refers to form of intake
#refers_to_geographical_region
Assosiates a report group to a geographical region.
#refers_to_geographical_region
refers to geographical region
#refers_to_information_component
Associates a lower point of am information component credibility interval to the information component it derives from.
#refers_to_information_component
refers to information component
#refers_to_interacting_drug
Explicitly states that the respective drug is reported as an interacting drug in the specific spontaneous report.
#refers_to_interacting_drug
refers to interacting drug
#refers_to_interval_between_administrations
Identifies the time passed between two consecutive drug administrations.
#refers_to_interval_between_administrations
refers to interval between administrations
#refers_to_known_adverse_effect
Depicts a reference to the respective known adverse effect.
#refers_to_known_adverse_effect
refers to known adverse effect
#refers_to_medication_error
Depicts a reference to the respective medication error.
#refers_to_medication_error
refers to medication error
#refers_to_number_of_reports
Identifies the count of the spontaneous reports based on which the respective statistical data item has been calculated.
#refers_to_number_of_reports
refers to number of reports
#refers_to_outcome_after_action
Depicts the outcome of the action against the respective adverse effect, as reported in the spontaneous report.
#refers_to_outcome_after_action
refers to outcome after action
#refers_to_partial_dechallenge_outcome
Depicts the outcome of the partial dechallenge process applied to the respective adverse effect, as reported in the spontaneous report.
#refers_to_partial_dechallenge_outcome
refers to partial dechallenge outcome
#refers_to_partial_dechallenge_process
Depicts if the respective dosage is used as part of a partial dechallenge process.
#refers_to_partial_dechallenge_process
refers to partial dechallenge process
#refers_to_partial_rechallenge_outcome
Depicts the outcome of the partial rechallenge process applied to the respective adverse effect, as reported in the spontaneous report.
#refers_to_partial_rechallenge_outcome
refers to partial rechallenge outcome
#refers_to_partial_rechallenge_process
Depicts if the respective dosage is used as part of a partial rechallenge process.
#refers_to_partial_rechallenge_process
refers to partial rechallenge process
#refers_to_past_diagnosis
Assosiates an Individual Case Safety Report with a past diagnosis.
#refers_to_past_diagnosis
refers to past diagnosis
#refers_to_patient
Identifies the patient that the respective spontaneous report refers to.
#refers_to_patient
refers to patient
#refers_to_pharmacovigilance_signal_report
Relates a pharmacovigilance signal response to the pharmacovigilance signal report.
#refers_to_pharmacovigilance_signal_report
refers to pharmacovigilance signal report
#refers_to_primary_suspect_drug
Explicitly states that the respective drug is reported as the primary suspect drug in the specific spontaneous report.
#refers_to_primary_suspect_drug
refers to primary suspect drug
#refers_to_rechallenge_outcome
Depicts the outcome of the rechallenge process applied to the respective adverse effect, as reported in the spontaneous report.
#refers_to_rechallenge_outcome
refers to rechallenge outcome
#refers_to_rechallenge_process
Depicts if the respective dosage is used as part of a rechallenge process.
#refers_to_rechallenge_process
refers to rechallenge process
#refers_to_reported_drug_usage
Relates a spontaneous report with the respective drug usages.
#refers_to_reported_drug_usage
refers to reported drug usage
#refers_to_secondary_suspect_drug
Explicitly states that the respective drug is reported as a secondary suspect drug in the specific spontaneous report.
#refers_to_secondary_suspect_drug
refers to secondary suspect drug
#refers_to_signal
Relates a pharmacovigilance signal report with the respective signal.
#refers_to_signal
refers to signal
#refers_to_signal_category
Refers to the the type of signal in question.
#refers_to_signal_category
refers to signal category
#refers_to_unconfirmed_adverse_effect
Depicts a reference to the respective unconfirmed adverse effect.
#refers_to_unconfirmed_adverse_effect
refers to unconfirmed adverse effect
#time_to_onset
Identifies the time passed before the adverse effect symptoms start, according to the respective spontaneous report.
#time_to_onset
time to onset
#Information_Component_(IC)
IC stands for “information component”, which is an indicator value for disproportionate reporting when using the method for disproportionality analysis developed by UMC.
#Information_Component_(IC)
https://www.who-umc.org/vigibase/vigilyze/analytics-in-vigilyze/
#Information_Component_(IC)
Information Component (IC)
#Information_Component_(IC0005)
The lower endpoint of a 99.9% credibility interval for the Information Component, IC0005 is used to support analysis of subgroup-specific associations between substances and effects analogously to how IC025 is used for general analysis of substance-effect associations: a positive value for IC0005 suggests, but does not prove, a causal relation between the substance and the reaction in the subgroup under consideration.
#Information_Component_(IC0005)
https://www.who-umc.org/vigibase/vigilyze/analytics-in-vigilyze/
#Information_Component_(IC0005)
Information Component 0005 (IC0005)
#Information_Component_005_(IC005)
The lower endpoint of a 99% credibility interval for the Information Component, IC005 is used to support analysis of subgroup-specific associations between substances and effects analogously to how IC025 is used for general analysis of substance-effect associations: a positive value for IC005 suggests, but does not prove, a causal relation between the substance and the reaction in the subgroup under consideration.
#Information_Component_005_(IC005)
https://www.who-umc.org/vigibase/vigilyze/analytics-in-vigilyze/
#Information_Component_005_(IC005)
Information Component 005 (IC005)
#Information_Component__025_(IC025)
IC025 is the lower end of a 95% credibility interval for the Information Component. A positive IC025 value is the traditional threshold used in statistical signal detection at UMC. IC025 is also used as one component of the disproportionality parameter in the vigiRank method.
#Information_Component__025_(IC025)
https://www.who-umc.org/vigibase/vigilyze/analytics-in-vigilyze/
#Information_Component__025_(IC025)
Information Component 025 (IC025)
#Proportional_Reporting_Ratio_(POR)
https://en.wikipedia.org/wiki/Proportional_reporting_ratio
#Proportional_Reporting_Ratio_(POR)
Depicts the extent to which a particular adverse effect is reported for individuals taking a specific drug, compared to the frequency at which the same adverse event is reported for patients taking some other drug (or who are taking any drug in a specified class of drugs).
#Proportional_Reporting_Ratio_(POR)
Proportional Reporting Ratio (PRR)
xsd:string
xsd:string
xsd:string
xsd:int
xsd:string
xsd:string
xsd:string
xsd:string
#Adverse_Effect
#Adverse_Effect
#Drug
#Drug