Open Vigil FDA v1.0.3

OpenVigilFDA is a web-based user interface to the FDA Adverse Event Reporting System (AERS) database for extraction and analysis of drug/adverse event safety reports using the openFDA online-API. This data is helpful for generating hypotheses for new adverse drug reactions, drug-drug-interactions and safety comparisons. openFDA aims at providing a clean and curated access to the underlying AERS and can count reports stratified to an extraction condition. Results are used by OpenVigilFDA for statistics and reported to the user via HTML or several other outputs.
For more information and for citation please refer to Böhm R, von Hehn L, Herdegen T, Klein HJ, Bruhn O, Petri H, Höcker J. OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications. PLoS One. 2016 Jun 21;11(6):e0157753. PMID: 27326858 http://dx.plos.org/10.1371/journal.pone.0157753

Overview of software version and database update time
More Info on Pharmacovigilance Show/Hide
More about OpenVigilFDA: Show/Hide
Cave-at/Limitations/Disclaimers: Show/Hide


Step 1: Which data do you have, e.g., drugname, adverse event, age, indication)?
Which data do you want to extract or analyze (e.g., by counting or by a disproportionality analysis (DPA))?
Chose a way of extraction, counting or analysis for one or more subpopulations/conditions or use the clinical or scientific special analysis scenarios:
Step 1b: Optional: Refine drugname-mapping and restrict the report background to a subpopulation, e.g., males 40-60 years, treated for HYPERTENSION). Show/Hide

Step 2: Enter a report identifier (safetyreportid) to get the record(s) associated with this case!

E.g., entering 10004179 will show a report in which 9 events occured while taking 8 drugs. The last part of the webpage contains the original JSON-format result from openFDA for further inspection.

Safety report identifier:
Step 2: Enter a freely-constructed search query for the openFDA API!

Possible search parameters are search=datafield:datavalue,_exist_:datafield; count=datafield; skip/limit=number of reports
Use boolean logic (AND, OR) to concatenate.

Query:

You can store your query in the textarea below. It will be saved in your browser's cookies for later usage.

Step 2: Enter the new adverse event and the medication list of the patient!

As result, you will get a list (horiz. table) of the frequency of reports for this adverse event and each drug in the input list. This allows you to compare them and select those most likely being associated with the newly occuring adverse event (e.g., selection by highest PRR value or highest percentage DE/D).

Adverse event (MedDRA preferred term):
Current medication list (openFDA substance_name):
Drug #0
Drug #1
Drug #2
Drug #3
Drug #4
Drug #5
Drug #6
Drug #7
Drug #8
Drug #9


Step 2: Enter two drugnames for comparison and interaction-check!

As result, you will get a list (horiz. table) of the frequency of reports for a certain adverse event and for either one of the drugs and their combination. This allows you to compare similar drugs (e.g., same drugclass) for marked differences in their adverse-event-profile or to detect possible synergistic or antagonistic effects, i.e., drug-drug-interactions, on these adverse events.

Drug 1
Drug 2
Step 2: Fill in at least one of the fields below to filter out the cases you are interested in.

Drugname
Adverse event
Step 2: Define up to 4 x 4 conditions.

Select subgroups of reported adverse events/drugs/patients to compare against each other
Remember that you can use background correction!
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Group 1.1
Minimum/maximum reporting dates (YYYY-MM-DD, e.g. 2011-12-24) -
Minimum/maximum age (in years, e.g., 2.4) -
Patient sex
Minimum duration of treatment (in years)
Drugname
Drugclass (Mechanism of Action)
Drugclass (Chemical/Ingredient)
Drugclass (EPC)
Adverse event
Indication
Verbatim openFDA query string

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Group 2.1
Minimum/maximum reporting dates (YYYY-MM-DD, e.g. 2011-12-24) -
Minimum/maximum age (in years, e.g., 2.4) -
Patient sex
Minimum duration of treatment (in years)
Drugname
Drugclass (Mechanism of Action)
Drugclass (Chemical/Ingredient)
Drugclass (EPC)
Adverse event
Indication
Verbatim openFDA query string

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Step 2: Use the fields below to filter out the cases you are interested in. Using no filter criteria results in all reports (whole dataset) being selected.

Drugname
Adverse event
Drugclass (Mechanism of Action)
Indication
Count the number of results using a factor (optional)
Step 2: Select the filtering conditions! Which records shall be extracted? E.g., focus on a specific drugname (patient.drug.openfda.substance_name is equal HALOPERIDOL) or adverse reaction (patient.reaction.reactionmeddrapt.exact is equal DIZZINESS).

concat.(database fieldoperatorvalue)


Count the number of results using (factor):



Export results as human readable HTML or JSON output or XML output or CSV output (counting result lists).