This is a preview version of OpenVigil. Maybe, some calculations and buttons will not work as expected!
This version operates on German pharmacovigilance data - please use GERMAN terms for adverse events and germanized INN-drugnames (try without "-e" suffix)!
Currently, only the German MedDRA preferred term for an adverse event is available. Note that the user interface is not yet completely updated. Please ignore any remaining FDA-specific terminology.
Also note that the dataset is currently for proof-of-concept and thus not complete.
This web application permits you to access pharmacovigilance data and process a query on it, e.g. extracting individual safety reports (ISR) or counts or disproportionality analyses on selected cases.
Visit openvigil.sf.net for the Legalese, info on cave-ats, tutorials and
analysis examples as well as other tools for accessing, extracting, mining and analysing pharmacovigilance data
like OpenVigil 2 (includes drugname mapping and advanced filtering options) or OpenVigilFDA (uses up-to-date
cleaned data via the openFDA API.
Press to display more information about the database structure and content.
Refer to this overview of this installation to obtain detailed information for citation of data extracted by this installation.
This installation uses data from
1995-01-02 to 2015-09-29 (according to report dates in DEMO.FDA_DT).
Registered tables are:
DEMO with columns ISR CASENO I_F_COD FOLL_SEQ IMAGE EVENT_DT MFR_DT FDA_DT REPT_COD MFR_NUM MFR_SNDR AGE AGE_COD GNDR_COD E_SUB WT WT_COD REPT_DT OCCP_COD DEATH_DT TO_MFR CONFIG REPORTER_COUNTRY DSRC containing 200433 records.
DMAP with columns ISR DRUG_SEQ DRUG BRAND DRUGCLASS EXTRA DOSE ROUTE DSRC containing 699419 records.
DRUG with columns ISR DRUG_SEQ ROLE_COD DRUGNAME VAL_VBM ROUTE DOSE_VBM DECHAL RECHAL LOT_NUM EXP_DT NDA_NUM DSRC containing 699419 records.
DSRC with columns FNAME DT NERR_PARSER NERR_SQL TERR_PARSER TERR_SQL containing 6 records.
INDI with columns ISR DRUG_SEQ INDI_PT DSRC containing 0 records.
OUTC with columns ISR OUTC_CODE DSRC containing 13845 records.
RCGR with columns ISR PT SMQ LL HL SOC DSRC containing 558358 records.
REAC with columns ISR PT DSRC containing 558358 records.
RPSR with columns ISR RPSR_COD DSRC containing 0 records.
THER with columns ISR DRUG_SEQ START_DT END_DT DUR DUR_COD DSRC containing 0 records.
For advanced users: a description of the content of tables and columns in these tables can be found in chapters B. FILE DESCRIPTIONS, C. DATA ELEMENT DESCRIPTIONS, D. DATA ELEMENT CONTENTS AND MAXIMUM LENGTHS of the FDA Asc_nts.doc database description document (created by the FDA and can also be found in the archive of the original FDA AERS quaterly data file packages).
Note that DEMO.CASE is called DEMO.CASENO in OpenVigil 1.
OpenVigil 1 uses a DMAP table (which is automatically generated when using cleaned pharmacovigilance data (e.g., German or Canadian data).
When using U.S. american FDA AERS ASCII data, mapping (e.g., via RxNorm) is necessary. OpenVigil 2 and OpenVigilFDA provide automatic drugname mapping.
Import failures from the original pharmacovigilance data source into this database can be found in the data import table from aers2sql for this instance of OpenVigil. Pitfalls and shortcomings of pharmacovigilance data analyses are described in the OpenVigil Cave-At document.