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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122422853 | 12242285 | 3 | F | 201311 | 20160622 | 20160406 | 20160704 | EXP | US-JNJFOC-20160401903 | JANSSEN | 78.36 | YR | E | F | Y | 0.00000 | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122422853 | 12242285 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15, 20 MG | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 122422853 | 12242285 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15, 20 MG | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 122422853 | 12242285 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15, 20 MG | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 122422853 | 12242285 | 4 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | |||||||
| 122422853 | 12242285 | 5 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15, 20 MG | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 122422853 | 12242285 | 6 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15, 20 MG | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 122422853 | 12242285 | 7 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | |||||||
| 122422853 | 12242285 | 8 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15, 20 MG | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 122422853 | 12242285 | 9 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15, 20 MG | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 122422853 | 12242285 | 10 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15, 20 MG | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 122422853 | 12242285 | 11 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15, 20 MG | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 0 | TABLET | ||||||
| 122422853 | 12242285 | 12 | PS | XARELTO | RIVAROXABAN | 1 | Oral | Y | U | UNKNOWN;UNKNOWN;UNKNOWN | 202439 | TABLET | |||||||
| 122422853 | 12242285 | 13 | SS | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | Y | 0 | 75 | MG | UNSPECIFIED | |||||||
| 122422853 | 12242285 | 14 | SS | ASPIRIN. | ASPIRIN | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 122422853 | 12242285 | 15 | SS | ASPIRIN. | ASPIRIN | 1 | Unknown | Y | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122422853 | 12242285 | 1 | Atrial fibrillation |
| 122422853 | 12242285 | 2 | Atrial fibrillation |
| 122422853 | 12242285 | 3 | Atrial fibrillation |
| 122422853 | 12242285 | 4 | Atrial fibrillation |
| 122422853 | 12242285 | 5 | Thrombosis prophylaxis |
| 122422853 | 12242285 | 6 | Thrombosis prophylaxis |
| 122422853 | 12242285 | 7 | Thrombosis prophylaxis |
| 122422853 | 12242285 | 8 | Thrombosis prophylaxis |
| 122422853 | 12242285 | 9 | Cerebrovascular accident prophylaxis |
| 122422853 | 12242285 | 10 | Cerebrovascular accident prophylaxis |
| 122422853 | 12242285 | 11 | Cerebrovascular accident prophylaxis |
| 122422853 | 12242285 | 12 | Cerebrovascular accident prophylaxis |
| 122422853 | 12242285 | 13 | Product used for unknown indication |
| 122422853 | 12242285 | 14 | Product used for unknown indication |
| 122422853 | 12242285 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122422853 | 12242285 | OT |
| 122422853 | 12242285 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122422853 | 12242285 | Anaemia | |
| 122422853 | 12242285 | Gastrointestinal haemorrhage | |
| 122422853 | 12242285 | Melaena |
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 |
|---|---|---|---|---|---|---|
| 122422853 | 12242285 | 1 | 20130109 | 201308 | 0 | |
| 122422853 | 12242285 | 2 | 20141021 | 20150112 | 0 | |
| 122422853 | 12242285 | 3 | 20131114 | 201408 | 0 | |
| 122422853 | 12242285 | 4 | 20140826 | 0 | ||
| 122422853 | 12242285 | 5 | 20131114 | 201408 | 0 | |
| 122422853 | 12242285 | 6 | 20130109 | 201308 | 0 | |
| 122422853 | 12242285 | 7 | 20140826 | 0 | ||
| 122422853 | 12242285 | 8 | 20141021 | 20150112 | 0 | |
| 122422853 | 12242285 | 9 | 20131114 | 201408 | 0 | |
| 122422853 | 12242285 | 10 | 20141021 | 20150112 | 0 | |
| 122422853 | 12242285 | 11 | 20130109 | 201308 | 0 | |
| 122422853 | 12242285 | 12 | 20140826 | 0 | ||
| 122422853 | 12242285 | 13 | 201408 | 0 | ||
| 122422853 | 12242285 | 15 | 201408 | 0 |