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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126409831 | 12640983 | 1 | I | 20160123 | 20160801 | 20160810 | 20160810 | EXP | PHHY2016ES109266 | SANDOZ | 87.00 | YR | M | Y | 0.00000 | 20160810 | OT | ES | ES |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126409831 | 12640983 | 1 | SS | SINTROM | ACENOCOUMAROL | 1 | Oral | UNK | Y | 0 | TABLET | ||||||||
| 126409831 | 12640983 | 2 | PS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | UNK | 75757 | ||||||||||
| 126409831 | 12640983 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, QD | 0 | 5 | MG | QD | |||||||
| 126409831 | 12640983 | 4 | SS | LEFLUNOMIDE. | LEFLUNOMIDE | 1 | Oral | 20 MG, QD | Y | 0 | 20 | MG | QD | ||||||
| 126409831 | 12640983 | 5 | C | TEGRETOL | CARBAMAZEPINE | 1 | Unknown | U | 0 | ||||||||||
| 126409831 | 12640983 | 6 | C | LYRICA | PREGABALIN | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126409831 | 12640983 | 1 | Atrial fibrillation |
| 126409831 | 12640983 | 2 | Prophylaxis |
| 126409831 | 12640983 | 3 | Rheumatoid arthritis |
| 126409831 | 12640983 | 4 | Rheumatoid arthritis |
| 126409831 | 12640983 | 5 | Epilepsy |
| 126409831 | 12640983 | 6 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126409831 | 12640983 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126409831 | 12640983 | Anaemia | |
| 126409831 | 12640983 | Hypocoagulable state | |
| 126409831 | 12640983 | Lower gastrointestinal 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 |
|---|---|---|---|---|---|---|
| 126409831 | 12640983 | 1 | 20150210 | 20160123 | 0 | |
| 126409831 | 12640983 | 2 | 20120507 | 0 | ||
| 126409831 | 12640983 | 3 | 20141027 | 0 | ||
| 126409831 | 12640983 | 4 | 20071031 | 20160123 | 0 | |
| 126409831 | 12640983 | 6 | 20130322 | 0 |