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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126035331 | 12603533 | 1 | I | 2015 | 20160718 | 20160728 | 20160728 | EXP | US-SA-2016SA133065 | AVENTIS | 68.00 | YR | E | F | Y | 65.31000 | KG | 20160728 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126035331 | 12603533 | 1 | PS | MULTAQ | DRONEDARONE | 1 | Oral | UNKNOWN | 22425 | 400 | MG | TABLET | QD | ||||||
| 126035331 | 12603533 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15AG917 | 0 | 20 | MG | FILM-COATED TABLET | QD | ||||||
| 126035331 | 12603533 | 3 | SS | METOPROLOL. | METOPROLOL | 1 | Oral | Y | UNKNOWN | 0 | |||||||||
| 126035331 | 12603533 | 4 | C | BABY ASPIRIN | ASPIRIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126035331 | 12603533 | 1 | Atrial fibrillation |
| 126035331 | 12603533 | 2 | Cardiovascular event prophylaxis |
| 126035331 | 12603533 | 3 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126035331 | 12603533 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126035331 | 12603533 | Anxiety | |
| 126035331 | 12603533 | Asthenia | |
| 126035331 | 12603533 | Condition aggravated | |
| 126035331 | 12603533 | Crying | |
| 126035331 | 12603533 | Depressed mood | |
| 126035331 | 12603533 | Dizziness | |
| 126035331 | 12603533 | Emotional disorder | |
| 126035331 | 12603533 | Fatigue | |
| 126035331 | 12603533 | Haemorrhage | |
| 126035331 | 12603533 | Heart rate increased | |
| 126035331 | 12603533 | Hypermetropia | |
| 126035331 | 12603533 | Limb mass | |
| 126035331 | 12603533 | Muscle spasms | |
| 126035331 | 12603533 | Osteoarthritis | |
| 126035331 | 12603533 | Suicidal ideation |
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 |
|---|---|---|---|---|---|---|
| 126035331 | 12603533 | 2 | 201509 | 0 | ||
| 126035331 | 12603533 | 3 | 2016 | 2016 | 0 |