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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110359616 | 11035961 | 6 | F | 20130730 | 20160629 | 20150415 | 20160706 | EXP | US-JNJFOC-20150118901 | JANSSEN | 70.20 | YR | E | F | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110359616 | 11035961 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | U | UNKNOWN;UNKNOWN | 0 | TABLET | |||||||
| 110359616 | 11035961 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | U | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 110359616 | 11035961 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | U | UNKNOWN;UNKNOWN | 0 | 20 | MG | TABLET | QD | ||||
| 110359616 | 11035961 | 4 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | U | UNKNOWN;UNKNOWN | 0 | TABLET | |||||||
| 110359616 | 11035961 | 5 | SS | XARELTO | RIVAROXABAN | 1 | Oral | U | U | UNKNOWN;UNKNOWN | 0 | TABLET | |||||||
| 110359616 | 11035961 | 6 | PS | XARELTO | RIVAROXABAN | 1 | Oral | U | U | UNKNOWN;UNKNOWN | 202439 | 20 | MG | TABLET | QD | ||||
| 110359616 | 11035961 | 7 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 110359616 | 11035961 | 8 | C | PLENDIL | FELODIPINE | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110359616 | 11035961 | 1 | Anticoagulant therapy |
| 110359616 | 11035961 | 2 | Anticoagulant therapy |
| 110359616 | 11035961 | 3 | Cerebrovascular accident prophylaxis |
| 110359616 | 11035961 | 4 | Cerebrovascular accident prophylaxis |
| 110359616 | 11035961 | 5 | Atrial fibrillation |
| 110359616 | 11035961 | 6 | Atrial fibrillation |
| 110359616 | 11035961 | 7 | Anticoagulant therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110359616 | 11035961 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110359616 | 11035961 | Epistaxis | |
| 110359616 | 11035961 | Gastrointestinal haemorrhage | |
| 110359616 | 11035961 | Haemorrhagic stroke | |
| 110359616 | 11035961 | Internal haemorrhage | |
| 110359616 | 11035961 | Ischaemic stroke | |
| 110359616 | 11035961 | Myocardial infarction | |
| 110359616 | 11035961 | Renal 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 |
|---|---|---|---|---|---|---|
| 110359616 | 11035961 | 1 | 20120411 | 20130730 | 0 | |
| 110359616 | 11035961 | 2 | 20120215 | 20120730 | 0 | |
| 110359616 | 11035961 | 3 | 20120215 | 20120730 | 0 | |
| 110359616 | 11035961 | 4 | 20120411 | 20130730 | 0 | |
| 110359616 | 11035961 | 5 | 20120411 | 20130730 | 0 | |
| 110359616 | 11035961 | 6 | 20120215 | 20120730 | 0 |