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