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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125118802 | 12511880 | 2 | F | 2012 | 20160805 | 20160630 | 20160912 | PER | US-JNJFOC-20160603763 | JANSSEN | 54.34 | YR | A | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125118802 | 12511880 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | 15 ADN 7.5 MG | Y | N | UNKNOWN | 0 | TABLET | ||||||
| 125118802 | 12511880 | 2 | PS | XARELTO | RIVAROXABAN | 1 | Oral | 15 ADN 7.5 MG | Y | N | UNKNOWN | 22406 | TABLET | ||||||
| 125118802 | 12511880 | 3 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | Y | 0 | UNSPECIFIED | |||||||||
| 125118802 | 12511880 | 4 | SS | ASPIRIN. | ASPIRIN | 1 | Oral | Y | 0 | 81 | MG | UNSPECIFIED | |||||||
| 125118802 | 12511880 | 5 | SS | ASPIRIN. | ASPIRIN | 1 | Oral | Y | 0 | 81 | MG | UNSPECIFIED | |||||||
| 125118802 | 12511880 | 6 | SS | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | Y | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125118802 | 12511880 | 1 | Thrombosis prophylaxis |
| 125118802 | 12511880 | 2 | Pulmonary embolism |
| 125118802 | 12511880 | 3 | Product used for unknown indication |
| 125118802 | 12511880 | 4 | Cerebrovascular accident |
| 125118802 | 12511880 | 5 | Coronary artery disease |
| 125118802 | 12511880 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125118802 | 12511880 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125118802 | 12511880 | Gastrointestinal haemorrhage | |
| 125118802 | 12511880 | Haematochezia | |
| 125118802 | 12511880 | Inappropriate schedule of drug administration | |
| 125118802 | 12511880 | Incorrect dose administered | |
| 125118802 | 12511880 | Off label use | |
| 125118802 | 12511880 | Vaginal 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 |
|---|---|---|---|---|---|---|
| 125118802 | 12511880 | 1 | 20120724 | 20121112 | 0 | |
| 125118802 | 12511880 | 2 | 20120724 | 20121112 | 0 | |
| 125118802 | 12511880 | 4 | 201212 | 0 | ||
| 125118802 | 12511880 | 5 | 201212 | 0 | ||
| 125118802 | 12511880 | 6 | 201212 | 0 |