Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100234911 | 10023491 | 1 | I | 201304 | 20131129 | 20131231 | 20131231 | EXP | 2013SA125501 | SANOFI | 72.00 | YR | M | N | 73.00000 | KG | 20131230 | N | OT | DE |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100234911 | 10023491 | 1 | PS | MULTAQ (DRONEDARONE) / ORAL / TABLET / 400 MILLIGRAM(S) | 1 | ORAL | D | 22425 | 400 | MG | |||||||||
| 100234911 | 10023491 | 2 | SS | METOPROLOL (METOPROLOL TARTRATE) | 1 | D | 0 | ||||||||||||
| 100234911 | 10023491 | 4 | C | VITAMNIN K | 2 | 0 | |||||||||||||
| 100234911 | 10023491 | 5 | C | RAMIPRIL | 1 | 0 | |||||||||||||
| 100234911 | 10023491 | 6 | C | METOPROLOL | 1 | 0 | |||||||||||||
| 100234911 | 10023491 | 8 | C | PHENPROCOUMON | 1 | 0 | |||||||||||||
| 100234911 | 10023491 | 10 | C | TRAVATAN | 1 | 0 | |||||||||||||
| 100234911 | 10023491 | 12 | C | L-THYROXIN | 1 | 0 | |||||||||||||
| 100234911 | 10023491 | 14 | C | OMEPRAZOLE | 1 | 0 | |||||||||||||
| 100234911 | 10023491 | 16 | C | JUNIK | 2 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 100234911 | 10023491 | 1 | Atrial fibrillation |
| 100234911 | 10023491 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 100234911 | 10023491 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 100234911 | 10023491 | Bradyarrhythmia | |
| 100234911 | 10023491 | Syncope |
Reporting Sources (this data is often not reported and may therefore be missing here)
| Event ID | CASEID | RPSR COD |
|---|---|---|
| 100234911 | 10023491 | SDY |
| 100234911 | 10023491 | FGN |
| 100234911 | 10023491 | HP |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 100234911 | 10023491 | 1 | 201304 | 0 |