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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119194635 | 11919463 | 5 | F | 20140101 | 20160829 | 20160115 | 20160912 | PER | US-JNJFOC-20160101560 | JANSSEN | 64.00 | YR | A | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119194635 | 11919463 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | U | UNKNOWN | 0 | TABLET | |||||||
| 119194635 | 11919463 | 2 | PS | XARELTO | RIVAROXABAN | 1 | Oral | 10-20 MG | U | U | UNKNOWN | 202439 | 15 | MG | TABLET | QD | |||
| 119194635 | 11919463 | 3 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119194635 | 11919463 | 1 | Cardiac failure congestive |
| 119194635 | 11919463 | 2 | Cardiac failure congestive |
| 119194635 | 11919463 | 3 | Cardiac failure congestive |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119194635 | 11919463 | HO |
| 119194635 | 11919463 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119194635 | 11919463 | Haemorrhagic stroke | |
| 119194635 | 11919463 | Internal haemorrhage | |
| 119194635 | 11919463 | Off label use | |
| 119194635 | 11919463 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 119194635 | 11919463 | 1 | 20140101 | 20140131 | 0 | |
| 119194635 | 11919463 | 2 | 201403 | 201404 | 0 | |
| 119194635 | 11919463 | 3 | 201312 | 201403 | 0 |