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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125159992 | 12515999 | 2 | F | 20150124 | 20160728 | 20160630 | 20160912 | PER | US-JNJFOC-20160521779 | JANSSEN | 78.12 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125159992 | 12515999 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | TABLET | |||||||
| 125159992 | 12515999 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 125159992 | 12515999 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | 15 | MG | TABLET | |||||
| 125159992 | 12515999 | 4 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | 15 | MG | TABLET | |||||
| 125159992 | 12515999 | 5 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | 15 | MG | TABLET | |||||
| 125159992 | 12515999 | 6 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | TABLET | |||||||
| 125159992 | 12515999 | 7 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 125159992 | 12515999 | 8 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | 15 | MG | TABLET | |||||
| 125159992 | 12515999 | 9 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | TABLET | |||||||
| 125159992 | 12515999 | 10 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | 15 | MG | TABLET | |||||
| 125159992 | 12515999 | 11 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 125159992 | 12515999 | 12 | PS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN | 202439 | 15 | MG | TABLET | |||||
| 125159992 | 12515999 | 13 | SS | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | Y | 0 | 75 | MG | UNSPECIFIED | |||||||
| 125159992 | 12515999 | 14 | SS | ECOTRIN | ASPIRIN | 1 | Unknown | Y | 0 | 81 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125159992 | 12515999 | 1 | Thrombosis prophylaxis |
| 125159992 | 12515999 | 2 | Thrombosis prophylaxis |
| 125159992 | 12515999 | 3 | Thrombosis prophylaxis |
| 125159992 | 12515999 | 4 | Thrombosis prophylaxis |
| 125159992 | 12515999 | 5 | Cerebrovascular accident prophylaxis |
| 125159992 | 12515999 | 6 | Cerebrovascular accident prophylaxis |
| 125159992 | 12515999 | 7 | Cerebrovascular accident prophylaxis |
| 125159992 | 12515999 | 8 | Cerebrovascular accident prophylaxis |
| 125159992 | 12515999 | 9 | Atrial fibrillation |
| 125159992 | 12515999 | 10 | Atrial fibrillation |
| 125159992 | 12515999 | 11 | Atrial fibrillation |
| 125159992 | 12515999 | 12 | Atrial fibrillation |
| 125159992 | 12515999 | 13 | Product used for unknown indication |
| 125159992 | 12515999 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125159992 | 12515999 | OT |
| 125159992 | 12515999 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125159992 | 12515999 | Gastrointestinal haemorrhage | |
| 125159992 | 12515999 | Lower 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 |
|---|---|---|---|---|---|---|
| 125159992 | 12515999 | 1 | 20150204 | 0 | ||
| 125159992 | 12515999 | 2 | 20130706 | 20131011 | 0 | |
| 125159992 | 12515999 | 3 | 20131017 | 20131116 | 0 | |
| 125159992 | 12515999 | 4 | 20131024 | 20150124 | 0 | |
| 125159992 | 12515999 | 5 | 20131024 | 20150124 | 0 | |
| 125159992 | 12515999 | 6 | 20150204 | 0 | ||
| 125159992 | 12515999 | 7 | 20130706 | 20131011 | 0 | |
| 125159992 | 12515999 | 8 | 20131017 | 20131116 | 0 | |
| 125159992 | 12515999 | 9 | 20150204 | 0 | ||
| 125159992 | 12515999 | 10 | 20131017 | 20131116 | 0 | |
| 125159992 | 12515999 | 11 | 20130706 | 20131011 | 0 | |
| 125159992 | 12515999 | 12 | 20131024 | 20150124 | 0 |