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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119205315 | 11920531 | 5 | F | 20130429 | 20160725 | 20160115 | 20160912 | PER | US-JNJFOC-20160108030 | JANSSEN | 55.00 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119205315 | 11920531 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 4 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 5 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 6 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 7 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 8 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 9 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 10 | PS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN;UNKNOWN | 202439 | 20 | MG | TABLET | QD | ||||
| 119205315 | 11920531 | 11 | SS | ASPIRIN. | ASPIRIN | 1 | Oral | Y | 0 | 81 | MG | TABLET | QD | ||||||
| 119205315 | 11920531 | 12 | SS | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Oral | U | 0 | 81 | MG | TABLET | QD | ||||||
| 119205315 | 11920531 | 13 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 119205315 | 11920531 | 14 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 119205315 | 11920531 | 15 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 119205315 | 11920531 | 16 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 119205315 | 11920531 | 17 | C | CILOSTAZOL. | CILOSTAZOL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 119205315 | 11920531 | 18 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119205315 | 11920531 | 1 | Atrial fibrillation |
| 119205315 | 11920531 | 2 | Atrial fibrillation |
| 119205315 | 11920531 | 3 | Heart rate irregular |
| 119205315 | 11920531 | 4 | Heart rate irregular |
| 119205315 | 11920531 | 5 | Coronary arterial stent insertion |
| 119205315 | 11920531 | 6 | Coronary arterial stent insertion |
| 119205315 | 11920531 | 7 | Thrombosis prophylaxis |
| 119205315 | 11920531 | 8 | Thrombosis prophylaxis |
| 119205315 | 11920531 | 9 | Cerebrovascular accident prophylaxis |
| 119205315 | 11920531 | 10 | Cerebrovascular accident prophylaxis |
| 119205315 | 11920531 | 11 | Product used for unknown indication |
| 119205315 | 11920531 | 12 | Product used for unknown indication |
| 119205315 | 11920531 | 13 | Product used for unknown indication |
| 119205315 | 11920531 | 14 | Product used for unknown indication |
| 119205315 | 11920531 | 15 | Product used for unknown indication |
| 119205315 | 11920531 | 16 | Product used for unknown indication |
| 119205315 | 11920531 | 17 | Product used for unknown indication |
| 119205315 | 11920531 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119205315 | 11920531 | OT |
| 119205315 | 11920531 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119205315 | 11920531 | Epistaxis | |
| 119205315 | 11920531 | Oesophageal varices haemorrhage | |
| 119205315 | 11920531 | Rectal haemorrhage | |
| 119205315 | 11920531 | 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 |
|---|---|---|---|---|---|---|
| 119205315 | 11920531 | 1 | 2013 | 20140622 | 0 | |
| 119205315 | 11920531 | 2 | 20121121 | 20130112 | 0 | |
| 119205315 | 11920531 | 3 | 20121121 | 20130112 | 0 | |
| 119205315 | 11920531 | 4 | 2013 | 20140622 | 0 | |
| 119205315 | 11920531 | 5 | 20121121 | 20130112 | 0 | |
| 119205315 | 11920531 | 6 | 2013 | 20140622 | 0 | |
| 119205315 | 11920531 | 7 | 20121121 | 20130112 | 0 | |
| 119205315 | 11920531 | 8 | 2013 | 20140622 | 0 | |
| 119205315 | 11920531 | 9 | 20121121 | 20130112 | 0 | |
| 119205315 | 11920531 | 10 | 2013 | 20140622 | 0 | |
| 119205315 | 11920531 | 13 | 2013 | 20140823 | 0 | |
| 119205315 | 11920531 | 14 | 2013 | 0 | ||
| 119205315 | 11920531 | 17 | 2013 | 0 | ||
| 119205315 | 11920531 | 18 | 2012 | 0 |