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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114459944 | 11445994 | 4 | F | 20140829 | 20160810 | 20150902 | 20160817 | EXP | US-JNJFOC-20150900670 | JANSSEN | 75.32 | YR | E | F | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114459944 | 11445994 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | 15 | MG | TABLET | |||||
| 114459944 | 11445994 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 114459944 | 11445994 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15 + 20 MG | Y | U | UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 114459944 | 11445994 | 4 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | TABLET | |||||||
| 114459944 | 11445994 | 5 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 114459944 | 11445994 | 6 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | 15 | MG | TABLET | |||||
| 114459944 | 11445994 | 7 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15 + 20 MG | Y | U | UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 114459944 | 11445994 | 8 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | TABLET | |||||||
| 114459944 | 11445994 | 9 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | TABLET | |||||||
| 114459944 | 11445994 | 10 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | 15 | MG | TABLET | |||||
| 114459944 | 11445994 | 11 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | |||||
| 114459944 | 11445994 | 12 | PS | XARELTO | RIVAROXABAN | 1 | Oral | 15 + 20 MG | Y | U | UNKNOWN;UNKNOWN | 202439 | TABLET | ||||||
| 114459944 | 11445994 | 13 | SS | AGGRENOX | ASPIRINDIPYRIDAMOLE | 1 | Unknown | ONCE/DAY FOR MORE THAN 2 WEEKS | U | 0 | UNSPECIFIED | ||||||||
| 114459944 | 11445994 | 14 | C | AMIODARONE | AMIODARONE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 114459944 | 11445994 | 15 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | Unknown | 0 | 80 | MG | UNSPECIFIED | QD | |||||||
| 114459944 | 11445994 | 16 | C | LOVAZA | OMEGA-3-ACID ETHYL ESTERS | 1 | Unknown | 0 | 1 | G | UNSPECIFIED | BID | |||||||
| 114459944 | 11445994 | 17 | C | PAROXETINE. | PAROXETINE | 1 | Unknown | 0 | 40 | MG | UNSPECIFIED | QD | |||||||
| 114459944 | 11445994 | 18 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | 0 | 100 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114459944 | 11445994 | 1 | Atrial fibrillation |
| 114459944 | 11445994 | 2 | Atrial fibrillation |
| 114459944 | 11445994 | 3 | Atrial fibrillation |
| 114459944 | 11445994 | 4 | Atrial fibrillation |
| 114459944 | 11445994 | 5 | Cerebrovascular accident prophylaxis |
| 114459944 | 11445994 | 6 | Cerebrovascular accident prophylaxis |
| 114459944 | 11445994 | 7 | Cerebrovascular accident prophylaxis |
| 114459944 | 11445994 | 8 | Cerebrovascular accident prophylaxis |
| 114459944 | 11445994 | 9 | Thrombosis prophylaxis |
| 114459944 | 11445994 | 10 | Thrombosis prophylaxis |
| 114459944 | 11445994 | 11 | Thrombosis prophylaxis |
| 114459944 | 11445994 | 12 | Thrombosis prophylaxis |
| 114459944 | 11445994 | 13 | Vascular graft |
| 114459944 | 11445994 | 14 | Pulmonary embolism |
| 114459944 | 11445994 | 15 | Product used for unknown indication |
| 114459944 | 11445994 | 16 | Product used for unknown indication |
| 114459944 | 11445994 | 17 | Product used for unknown indication |
| 114459944 | 11445994 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114459944 | 11445994 | OT |
| 114459944 | 11445994 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114459944 | 11445994 | Cerebral haemorrhage | |
| 114459944 | 11445994 | Haemorrhagic stroke | |
| 114459944 | 11445994 | Pulmonary embolism | |
| 114459944 | 11445994 | Subdural haematoma |
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 |
|---|---|---|---|---|---|---|
| 114459944 | 11445994 | 1 | 20140425 | 20140525 | 0 | |
| 114459944 | 11445994 | 2 | 20141008 | 20141106 | 0 | |
| 114459944 | 11445994 | 3 | 20140831 | 20140930 | 0 | |
| 114459944 | 11445994 | 4 | 20140424 | 20140424 | 0 | |
| 114459944 | 11445994 | 5 | 20141008 | 20141106 | 0 | |
| 114459944 | 11445994 | 6 | 20140425 | 20140525 | 0 | |
| 114459944 | 11445994 | 7 | 20140831 | 20140930 | 0 | |
| 114459944 | 11445994 | 8 | 20140424 | 20140424 | 0 | |
| 114459944 | 11445994 | 9 | 20140424 | 20140424 | 0 | |
| 114459944 | 11445994 | 10 | 20140425 | 20140525 | 0 | |
| 114459944 | 11445994 | 11 | 20141008 | 20141106 | 0 | |
| 114459944 | 11445994 | 12 | 20140831 | 20140930 | 0 |