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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126194053 | 12619405 | 3 | F | 20160628 | 20160804 | 20160803 | 20160816 | EXP | PL-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-49489PN | BOEHRINGER INGELHEIM | 65.36 | YR | F | Y | 87.00000 | KG | 20160816 | MD | COUNTRY NOT SPECIFIED | PL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126194053 | 12619405 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | UNK | 22512 | 150 | MG | CAPSULE | BID | ||||
| 126194053 | 12619405 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Y | UNK | 22512 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126194053 | 12619405 | 1 | Atrial fibrillation |
| 126194053 | 12619405 | 2 | Cerebrovascular accident |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126194053 | 12619405 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126194053 | 12619405 | Asthenia | |
| 126194053 | 12619405 | Bone pain | |
| 126194053 | 12619405 | Cough | |
| 126194053 | 12619405 | Dyspnoea | |
| 126194053 | 12619405 | Myalgia |
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 |
|---|---|---|---|---|---|---|
| 126194053 | 12619405 | 1 | 20160623 | 20160720 | 0 |