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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125160292 | 12516029 | 2 | F | 20140701 | 20160829 | 20160630 | 20160912 | PER | US-JNJFOC-20160508170 | JANSSEN | 84.71 | YR | E | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125160292 | 12516029 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 125160292 | 12516029 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 125160292 | 12516029 | 3 | PS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 202439 | 20 | MG | TABLET | |||||
| 125160292 | 12516029 | 4 | SS | ASPIRIN. | ASPIRIN | 1 | Unknown | U | 0 | 81 | MG | TABLET | QD | ||||||
| 125160292 | 12516029 | 5 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | U | 0 | 20 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125160292 | 12516029 | 1 | Atrial fibrillation |
| 125160292 | 12516029 | 2 | Cerebrovascular accident prophylaxis |
| 125160292 | 12516029 | 3 | Thrombosis prophylaxis |
| 125160292 | 12516029 | 4 | Product used for unknown indication |
| 125160292 | 12516029 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125160292 | 12516029 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125160292 | 12516029 | Internal haemorrhage | |
| 125160292 | 12516029 | Rectal 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 |
|---|---|---|---|---|---|---|
| 125160292 | 12516029 | 1 | 20140402 | 201407 | 0 | |
| 125160292 | 12516029 | 2 | 20140402 | 201407 | 0 | |
| 125160292 | 12516029 | 3 | 20140402 | 201407 | 0 |