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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126255731 | 12625573 | 1 | I | 20150608 | 20160726 | 20160805 | 20160805 | EXP | PHHY2016ES106728 | SANDOZ | 87.15 | YR | F | Y | 65.80000 | KG | 20160805 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126255731 | 12625573 | 1 | SS | SINTROM | ACENOCOUMAROL | 1 | Oral | 10.5 MG, UNK | Y | 0 | 10.5 | MG | TABLET | ||||||
| 126255731 | 12625573 | 2 | SS | SINTROM | ACENOCOUMAROL | 1 | Oral | 7 MG, UNK | Y | 0 | 7 | MG | TABLET | ||||||
| 126255731 | 12625573 | 3 | SS | SINTROM | ACENOCOUMAROL | 1 | Oral | 8 MG, UNK | Y | 0 | 8 | MG | TABLET | ||||||
| 126255731 | 12625573 | 4 | SS | SINTROM | ACENOCOUMAROL | 1 | Oral | 7 MG, UNK | Y | 0 | 7 | MG | TABLET | ||||||
| 126255731 | 12625573 | 5 | SS | SINTROM | ACENOCOUMAROL | 1 | Oral | 0 UNK, UNK | Y | 0 | TABLET | ||||||||
| 126255731 | 12625573 | 6 | SS | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 126255731 | 12625573 | 7 | PS | AMIODARONE | AMIODARONE | 1 | Oral | 200 MG, QD | U | 75315 | 200 | MG | QD | ||||||
| 126255731 | 12625573 | 8 | SS | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 20 MG, QD | U | 0 | 20 | MG | QD | ||||||
| 126255731 | 12625573 | 9 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Oral | 50 MG, QD | U | 0 | 50 | MG | QD | ||||||
| 126255731 | 12625573 | 10 | C | ISOSORBIDE MONONITRATE. | ISOSORBIDE MONONITRATE | 1 | Unknown | 40 MG, BID | U | 0 | 40 | MG | BID | ||||||
| 126255731 | 12625573 | 11 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Unknown | 40 MG, QD | U | 0 | 40 | MG | QD | ||||||
| 126255731 | 12625573 | 12 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 1 MG, QD (AT NIGHT) | U | 0 | 1 | MG | QD | ||||||
| 126255731 | 12625573 | 13 | C | IPRATROPIUM BROMIDE. | IPRATROPIUM BROMIDE | 1 | Unknown | 2 DF, TID (TWO INHALATIONS THREE TIMES DAILY) | U | 0 | 2 | DF | TID | ||||||
| 126255731 | 12625573 | 14 | C | ULTRA LEVURA//SACCHAROMYCES BOULARDII | 2 | Unknown | 50 MG, QD (2 CAPSULE ONCE A DAILY) | U | 0 | 50 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126255731 | 12625573 | 1 | Atrial fibrillation |
| 126255731 | 12625573 | 6 | Product used for unknown indication |
| 126255731 | 12625573 | 7 | Product used for unknown indication |
| 126255731 | 12625573 | 8 | Product used for unknown indication |
| 126255731 | 12625573 | 9 | Product used for unknown indication |
| 126255731 | 12625573 | 10 | Product used for unknown indication |
| 126255731 | 12625573 | 11 | Product used for unknown indication |
| 126255731 | 12625573 | 12 | Product used for unknown indication |
| 126255731 | 12625573 | 13 | Product used for unknown indication |
| 126255731 | 12625573 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126255731 | 12625573 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126255731 | 12625573 | Upper 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 |
|---|---|---|---|---|---|---|
| 126255731 | 12625573 | 1 | 20150514 | 0 | ||
| 126255731 | 12625573 | 2 | 20150518 | 0 | ||
| 126255731 | 12625573 | 3 | 20150521 | 0 | ||
| 126255731 | 12625573 | 4 | 20150525 | 0 | ||
| 126255731 | 12625573 | 5 | 20150608 | 20150608 | 0 |