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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116376494 | 11637649 | 4 | F | 201505 | 20160726 | 20151016 | 20160808 | EXP | US-JNJFOC-20151011499 | JANSSEN | 63.25 | YR | A | F | Y | 0.00000 | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116376494 | 11637649 | 1 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 15 | MG | TABLET | QD | ||||
| 116376494 | 11637649 | 2 | SS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 0 | 15 | MG | TABLET | QD | ||||
| 116376494 | 11637649 | 3 | PS | XARELTO | RIVAROXABAN | 1 | Oral | Y | N | UNKNOWN | 202439 | 15 | MG | TABLET | QD | ||||
| 116376494 | 11637649 | 4 | SS | ASPIRIN. | ASPIRIN | 1 | Oral | Y | 0 | 81 | MG | TABLET | QD | ||||||
| 116376494 | 11637649 | 5 | SS | INDOMETHACIN. | INDOMETHACIN | 1 | Oral | Y | 0 | 25 | MG | CAPSULE | QD | ||||||
| 116376494 | 11637649 | 6 | C | AMIODARONE | AMIODARONE | 1 | Oral | 0 | 200 | MG | TABLET | QD | |||||||
| 116376494 | 11637649 | 7 | C | LISINOPRIL. | LISINOPRIL | 1 | Oral | 0 | 20 | MG | TABLET | BID | |||||||
| 116376494 | 11637649 | 8 | C | ATORVASTATIN | ATORVASTATIN | 1 | Oral | 0 | 10 | MG | TABLET | QD | |||||||
| 116376494 | 11637649 | 9 | C | GLIPIZIDE. | GLIPIZIDE | 1 | Oral | 0 | 10 | MG | TABLET | BID | |||||||
| 116376494 | 11637649 | 10 | C | JANUVIA | SITAGLIPTIN PHOSPHATE | 1 | Oral | 0 | 100 | MG | TABLET | QD | |||||||
| 116376494 | 11637649 | 11 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | 0 | 1000 | MG | TABLET | BID | |||||||
| 116376494 | 11637649 | 12 | C | CARVEDILOL. | CARVEDILOL | 1 | Oral | 0 | 6.25 | MG | TABLET | BID | |||||||
| 116376494 | 11637649 | 13 | C | LASIX | FUROSEMIDE | 1 | Oral | 0 | 40 | MG | TABLET | QD | |||||||
| 116376494 | 11637649 | 14 | C | ALDACTONE | SPIRONOLACTONE | 1 | Oral | 0 | .5 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116376494 | 11637649 | 1 | Thrombosis prophylaxis |
| 116376494 | 11637649 | 2 | Cerebrovascular accident prophylaxis |
| 116376494 | 11637649 | 3 | Atrial fibrillation |
| 116376494 | 11637649 | 4 | Cardiac disorder |
| 116376494 | 11637649 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116376494 | 11637649 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116376494 | 11637649 | Acute kidney injury | |
| 116376494 | 11637649 | Anaemia | |
| 116376494 | 11637649 | Coagulopathy | |
| 116376494 | 11637649 | Gastrointestinal haemorrhage | |
| 116376494 | 11637649 | Haematoma | |
| 116376494 | 11637649 | Haemorrhage | |
| 116376494 | 11637649 | Spontaneous 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 |
|---|---|---|---|---|---|---|
| 116376494 | 11637649 | 1 | 20150513 | 20150517 | 0 | |
| 116376494 | 11637649 | 2 | 20150513 | 20150517 | 0 | |
| 116376494 | 11637649 | 3 | 20150513 | 20150517 | 0 | |
| 116376494 | 11637649 | 10 | 201506 | 0 | ||
| 116376494 | 11637649 | 11 | 20150701 | 0 |