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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125617441 | 12561744 | 1 | I | 20160713 | 20160715 | 20160715 | EXP | LV-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-45903LV | BOEHRINGER INGELHEIM | 83.00 | YR | M | Y | 74.00000 | KG | 20160715 | MD | LV | LV |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125617441 | 12561744 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 220 MG | 22512 | 110 | MG | CAPSULE, HARD | BID | ||||||
| 125617441 | 12561744 | 2 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | |||||||||||
| 125617441 | 12561744 | 3 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | 0 | |||||||||||
| 125617441 | 12561744 | 4 | C | PERINDOPRIL | PERINDOPRIL | 1 | Unknown | 0 | |||||||||||
| 125617441 | 12561744 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 0 | |||||||||||
| 125617441 | 12561744 | 6 | C | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125617441 | 12561744 | 1 | Atrial fibrillation |
| 125617441 | 12561744 | 2 | Product used for unknown indication |
| 125617441 | 12561744 | 3 | Product used for unknown indication |
| 125617441 | 12561744 | 4 | Product used for unknown indication |
| 125617441 | 12561744 | 5 | Product used for unknown indication |
| 125617441 | 12561744 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125617441 | 12561744 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125617441 | 12561744 | Gastrointestinal haemorrhage | |
| 125617441 | 12561744 | Melaena |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |