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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125455082 | 12545508 | 2 | F | 20160628 | 20160711 | 20160713 | EXP | FR-JNJFOC-20160705600 | JANSSEN | LAMBERT A, CORDEANU M, GAERTNER S, NOURI S, ALT M, STEPHAN D. RIVAROXABAN-INDUCED LIVER INJURY: RESULTS FROM A VENOS THROMBOEMBOLISM REGISTRY.. INTERNATIONAL JOURNAL OF CARDIOLOGY 2015;191:265-266. | 54.00 | YR | A | M | Y | 0.00000 | 20160713 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125455082 | 12545508 | 1 | PS | TRAMADOL HYDROCHLORIDE. | TRAMADOL HYDROCHLORIDE | 1 | Unknown | U | U | 20281 | UNSPECIFIED | ||||||||
| 125455082 | 12545508 | 2 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 125455082 | 12545508 | 3 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | U | U | 19872 | UNSPECIFIED | ||||||||
| 125455082 | 12545508 | 4 | SS | AMOXICILLIN CLAVULANIC ACID | AMOXICILLINCLAVULANIC ACID | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 125455082 | 12545508 | 5 | SS | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 125455082 | 12545508 | 6 | SS | RIVAROXABAN | RIVAROXABAN | 1 | Unknown | Y | 0 | 15 | MG | UNSPECIFIED | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125455082 | 12545508 | 1 | Product used for unknown indication |
| 125455082 | 12545508 | 3 | Product used for unknown indication |
| 125455082 | 12545508 | 4 | Product used for unknown indication |
| 125455082 | 12545508 | 5 | Product used for unknown indication |
| 125455082 | 12545508 | 6 | Pulmonary embolism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125455082 | 12545508 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125455082 | 12545508 | Hepatotoxicity |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |