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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125545701 | 12554570 | 1 | I | 20160207 | 20160712 | 20160713 | 20160713 | EXP | ES-AGEMED-405346240 | ES-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-45609ES | BOEHRINGER INGELHEIM | 72.00 | YR | F | Y | 0.00000 | 20160713 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125545701 | 12554570 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | U | 22512 | 220 | MG | CAPSULE | QD | |||||
| 125545701 | 12554570 | 2 | C | CROMATONBIC B12 | 2 | Unknown | 0 | ||||||||||||
| 125545701 | 12554570 | 3 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Unknown | 0 | |||||||||||
| 125545701 | 12554570 | 4 | C | EFFICIB | METFORMIN HYDROCHLORIDESITAGLIPTIN PHOSPHATE | 1 | Unknown | 50/100 | 0 | ||||||||||
| 125545701 | 12554570 | 5 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | 0 | |||||||||||
| 125545701 | 12554570 | 6 | C | DILTIAZEM. | DILTIAZEM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125545701 | 12554570 | 1 | Transient ischaemic attack |
| 125545701 | 12554570 | 2 | Product used for unknown indication |
| 125545701 | 12554570 | 3 | Product used for unknown indication |
| 125545701 | 12554570 | 4 | Product used for unknown indication |
| 125545701 | 12554570 | 5 | Product used for unknown indication |
| 125545701 | 12554570 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125545701 | 12554570 | HO |
| 125545701 | 12554570 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125545701 | 12554570 | Cerebral 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 |
|---|---|---|---|---|---|---|
| 125545701 | 12554570 | 1 | 20141201 | 0 |