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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125140122 | 12514012 | 2 | F | 20140606 | 20160803 | 20160630 | 20160912 | PER | US-JNJFOC-20160527939 | JANSSEN | 50.74 | YR | A | F | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125140122 | 12514012 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 125140122 | 12514012 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 125140122 | 12514012 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 125140122 | 12514012 | 4 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 125140122 | 12514012 | 5 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 125140122 | 12514012 | 6 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 125140122 | 12514012 | 7 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 125140122 | 12514012 | 8 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 125140122 | 12514012 | 9 | PS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 202439 | 20 | MG | TABLET | QD | ||||
| 125140122 | 12514012 | 10 | SS | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Oral | Y | 0 | 75 | MG | TABLET | QD | ||||||
| 125140122 | 12514012 | 11 | SS | ASPIRIN. | ASPIRIN | 1 | Oral | Y | 0 | 81 | MG | TABLET | QD | ||||||
| 125140122 | 12514012 | 12 | SS | ASPIRIN. | ASPIRIN | 1 | Oral | Y | 0 | TABLET | |||||||||
| 125140122 | 12514012 | 13 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | Y | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125140122 | 12514012 | 1 | Atrial fibrillation |
| 125140122 | 12514012 | 2 | Atrial fibrillation |
| 125140122 | 12514012 | 3 | Atrial fibrillation |
| 125140122 | 12514012 | 4 | Cerebrovascular accident prophylaxis |
| 125140122 | 12514012 | 5 | Cerebrovascular accident prophylaxis |
| 125140122 | 12514012 | 6 | Cerebrovascular accident prophylaxis |
| 125140122 | 12514012 | 7 | Anticoagulant therapy |
| 125140122 | 12514012 | 8 | Anticoagulant therapy |
| 125140122 | 12514012 | 9 | Anticoagulant therapy |
| 125140122 | 12514012 | 10 | Arrhythmia |
| 125140122 | 12514012 | 11 | Product used for unknown indication |
| 125140122 | 12514012 | 12 | Product used for unknown indication |
| 125140122 | 12514012 | 13 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125140122 | 12514012 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125140122 | 12514012 | Epistaxis | |
| 125140122 | 12514012 | Faeces discoloured | |
| 125140122 | 12514012 | Vaginal 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 |
|---|---|---|---|---|---|---|
| 125140122 | 12514012 | 1 | 20140916 | 0 | ||
| 125140122 | 12514012 | 2 | 20141009 | 0 | ||
| 125140122 | 12514012 | 3 | 20140611 | 201406 | 0 | |
| 125140122 | 12514012 | 4 | 20141009 | 0 | ||
| 125140122 | 12514012 | 5 | 20140916 | 0 | ||
| 125140122 | 12514012 | 6 | 20140611 | 201406 | 0 | |
| 125140122 | 12514012 | 7 | 20140611 | 201406 | 0 | |
| 125140122 | 12514012 | 8 | 20140916 | 0 | ||
| 125140122 | 12514012 | 9 | 20141009 | 0 | ||
| 125140122 | 12514012 | 10 | 20140613 | 0 | ||
| 125140122 | 12514012 | 11 | 20140613 | 0 |