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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119373687 | 11937368 | 7 | F | 20131225 | 20160712 | 20160121 | 20160718 | EXP | JP-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-03654NB | BOEHRINGER INGELHEIM | 83.49 | YR | M | Y | 57.40000 | KG | 20160718 | MD | COUNTRY NOT SPECIFIED | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119373687 | 11937368 | 1 | PS | PRAZAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | Y | 22512 | 220 | MG | CAPSULE | QD | |||||
| 119373687 | 11937368 | 2 | SS | PRAZAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | Y | 22512 | 220 | MG | CAPSULE | QD | |||||
| 119373687 | 11937368 | 3 | SS | PRAZAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Y | 22512 | |||||||||||
| 119373687 | 11937368 | 4 | SS | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Oral | 75 MG | Y | 0 | 75 | MG | QD | ||||||
| 119373687 | 11937368 | 5 | C | WARFARIN | WARFARIN | 1 | Oral | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119373687 | 11937368 | 1 | Atrial fibrillation |
| 119373687 | 11937368 | 2 | Cerebrovascular accident prophylaxis |
| 119373687 | 11937368 | 3 | Thrombosis prophylaxis |
| 119373687 | 11937368 | 4 | Stomatitis |
| 119373687 | 11937368 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119373687 | 11937368 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119373687 | 11937368 | Cerebellar infarction | |
| 119373687 | 11937368 | Drug effect incomplete | |
| 119373687 | 11937368 | Stomatitis | |
| 119373687 | 11937368 | 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 |
|---|---|---|---|---|---|---|
| 119373687 | 11937368 | 1 | 20131113 | 20131125 | 0 | |
| 119373687 | 11937368 | 2 | 20140115 | 20150121 | 0 | |
| 119373687 | 11937368 | 4 | 20150518 | 0 | ||
| 119373687 | 11937368 | 5 | 2013 | 0 |