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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116131364 | 11613136 | 4 | F | 20130710 | 20160712 | 20151008 | 20160912 | PER | US-JNJFOC-20150903660 | JANSSEN | 67.22 | YR | E | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116131364 | 11613136 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 10 AND 20 MG | U | U | 0 | TABLET | |||||||
| 116131364 | 11613136 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 10 AND 20 MG | U | U | 0 | TABLET | |||||||
| 116131364 | 11613136 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 10 AND 20 MG | U | U | 0 | TABLET | |||||||
| 116131364 | 11613136 | 4 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 10 AND 20 MG | U | U | 0 | TABLET | |||||||
| 116131364 | 11613136 | 5 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 10 AND 20 MG | U | U | 0 | TABLET | |||||||
| 116131364 | 11613136 | 6 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 10 AND 20 MG | U | U | 0 | TABLET | |||||||
| 116131364 | 11613136 | 7 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 10 AND 20 MG | U | U | 0 | TABLET | |||||||
| 116131364 | 11613136 | 8 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 10 AND 20 MG | U | U | 0 | TABLET | |||||||
| 116131364 | 11613136 | 9 | PS | XARELTO | RIVAROXABAN | 1 | Oral | 10 AND 20 MG | U | U | 202439 | TABLET | |||||||
| 116131364 | 11613136 | 10 | SS | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 116131364 | 11613136 | 11 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 116131364 | 11613136 | 12 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 0 | UNSPECIFIED | ||||||||||
| 116131364 | 11613136 | 13 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116131364 | 11613136 | 1 | Atrial fibrillation |
| 116131364 | 11613136 | 2 | Atrial fibrillation |
| 116131364 | 11613136 | 3 | Atrial fibrillation |
| 116131364 | 11613136 | 4 | Embolism |
| 116131364 | 11613136 | 5 | Embolism |
| 116131364 | 11613136 | 6 | Embolism |
| 116131364 | 11613136 | 7 | Cerebrovascular accident prophylaxis |
| 116131364 | 11613136 | 8 | Cerebrovascular accident prophylaxis |
| 116131364 | 11613136 | 9 | Cerebrovascular accident prophylaxis |
| 116131364 | 11613136 | 10 | Product used for unknown indication |
| 116131364 | 11613136 | 11 | Product used for unknown indication |
| 116131364 | 11613136 | 12 | Product used for unknown indication |
| 116131364 | 11613136 | 13 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116131364 | 11613136 | OT |
| 116131364 | 11613136 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116131364 | 11613136 | Internal haemorrhage | |
| 116131364 | 11613136 | Rectal 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 |
|---|---|---|---|---|---|---|
| 116131364 | 11613136 | 1 | 20150304 | 0 | ||
| 116131364 | 11613136 | 2 | 20120416 | 2012 | 0 | |
| 116131364 | 11613136 | 3 | 20130101 | 20130701 | 0 | |
| 116131364 | 11613136 | 4 | 20150304 | 0 | ||
| 116131364 | 11613136 | 5 | 20120416 | 2012 | 0 | |
| 116131364 | 11613136 | 6 | 20130101 | 20130701 | 0 | |
| 116131364 | 11613136 | 7 | 20130101 | 20130701 | 0 | |
| 116131364 | 11613136 | 8 | 20150304 | 0 | ||
| 116131364 | 11613136 | 9 | 20120416 | 2012 | 0 |