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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122291462 | 12229146 | 2 | F | 20150115 | 20160805 | 20160401 | 20160912 | PER | US-JNJFOC-20160301186 | JANSSEN | 70.40 | YR | E | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122291462 | 12229146 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | 0 | TABLET | |||||||||
| 122291462 | 12229146 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | 0 | 20 | MG | TABLET | |||||||
| 122291462 | 12229146 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | 0 | TABLET | |||||||||
| 122291462 | 12229146 | 4 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | 0 | 20 | MG | TABLET | |||||||
| 122291462 | 12229146 | 5 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | 0 | TABLET | |||||||||
| 122291462 | 12229146 | 6 | PS | XARELTO | RIVAROXABAN | 1 | Oral | U | 202439 | 20 | MG | TABLET | |||||||
| 122291462 | 12229146 | 7 | SS | COUMADIN | WARFARIN SODIUM | 1 | Oral | 0 | 5 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122291462 | 12229146 | 1 | Atrial fibrillation |
| 122291462 | 12229146 | 2 | Atrial fibrillation |
| 122291462 | 12229146 | 3 | Thrombosis prophylaxis |
| 122291462 | 12229146 | 4 | Thrombosis prophylaxis |
| 122291462 | 12229146 | 5 | Cerebrovascular accident prophylaxis |
| 122291462 | 12229146 | 6 | Cerebrovascular accident prophylaxis |
| 122291462 | 12229146 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122291462 | 12229146 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122291462 | 12229146 | Conjunctival haemorrhage | |
| 122291462 | 12229146 | Internal haemorrhage | |
| 122291462 | 12229146 | International normalised ratio increased |
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 |
|---|---|---|---|---|---|---|
| 122291462 | 12229146 | 2 | 20150506 | 20160128 | 0 | |
| 122291462 | 12229146 | 4 | 20150506 | 20160128 | 0 | |
| 122291462 | 12229146 | 6 | 20150506 | 20160128 | 0 |