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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125125402 | 12512540 | 2 | F | 20141016 | 20160811 | 20160630 | 20160912 | PER | US-JNJFOC-20160515927 | JANSSEN | 44.25 | YR | A | M | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125125402 | 12512540 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 125125402 | 12512540 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 125125402 | 12512540 | 3 | PS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 202439 | 20 | MG | TABLET | |||||
| 125125402 | 12512540 | 4 | SS | COUMADIN | WARFARIN SODIUM | 1 | Oral | Y | 0 | 5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125125402 | 12512540 | 1 | Atrial fibrillation |
| 125125402 | 12512540 | 2 | Cerebrovascular accident prophylaxis |
| 125125402 | 12512540 | 3 | Thrombosis prophylaxis |
| 125125402 | 12512540 | 4 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125125402 | 12512540 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125125402 | 12512540 | Anastomotic ulcer haemorrhage | |
| 125125402 | 12512540 | International normalised ratio increased | |
| 125125402 | 12512540 | Upper gastrointestinal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 125125402 | 12512540 | 1 | 20141001 | 20141018 | 0 | |
| 125125402 | 12512540 | 2 | 20141001 | 20141018 | 0 | |
| 125125402 | 12512540 | 3 | 20141001 | 20141018 | 0 | |
| 125125402 | 12512540 | 4 | 20141006 | 20141018 | 0 |