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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123968332 | 12396833 | 2 | F | 201402 | 20160714 | 20160524 | 20160727 | EXP | GB-AUROBINDO-AUR-APL-2016-04214 | AUROBINDO | 67.54 | YR | M | Y | 67.00000 | KG | 20160727 | CN | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123968332 | 12396833 | 1 | PS | Flecainide Acetate Tablets 50mg | FLECAINIDE ACETATE | 1 | Oral | TWO TABLETS , DAILY | N | U | 202821 | TABLET | |||||||
| 123968332 | 12396833 | 2 | C | FLECAINIDE | FLECAINIDE | 1 | Oral | 50 MG, UNK | U | 0 | 50 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123968332 | 12396833 | 1 | Atrial fibrillation |
| 123968332 | 12396833 | 2 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123968332 | 12396833 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123968332 | 12396833 | Abdominal pain | |
| 123968332 | 12396833 | Chills | |
| 123968332 | 12396833 | Feeling hot | |
| 123968332 | 12396833 | Head discomfort | |
| 123968332 | 12396833 | Hot flush | |
| 123968332 | 12396833 | Myalgia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 123968332 | 12396833 | 1 | 201402 | 0 | ||
| 123968332 | 12396833 | 2 | 2015 | 0 |