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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112685313 | 11268531 | 3 | F | 201412 | 20160815 | 20150714 | 20160912 | PER | US-JNJFOC-20150704824 | JANSSEN | 72.74 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112685313 | 11268531 | 1 | PS | XARELTO | RIVAROXABAN | 1 | Oral | N | UNKNOWN | 22406 | 15 | MG | TABLET | ||||||
| 112685313 | 11268531 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112685313 | 11268531 | 1 | Anticoagulant therapy |
| 112685313 | 11268531 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112685313 | 11268531 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112685313 | 11268531 | Internal haemorrhage | |
| 112685313 | 11268531 | 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 |
|---|---|---|---|---|---|---|
| 112685313 | 11268531 | 1 | 20131219 | 20141016 | 0 | |
| 112685313 | 11268531 | 2 | 201501 | 0 |