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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127366061 | 12736606 | 1 | I | 20160512 | 20160905 | 20160912 | 20160912 | EXP | IT-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-58251IT | BOEHRINGER INGELHEIM | 83.55 | YR | M | Y | 75.00000 | KG | 20160912 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127366061 | 12736606 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 110 MG | Y | 22512 | 110 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127366061 | 12736606 | 1 | Atrial fibrillation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127366061 | 12736606 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127366061 | 12736606 | Asthenia | |
| 127366061 | 12736606 | Dyspnoea | |
| 127366061 | 12736606 | Haemoglobin decreased | |
| 127366061 | 12736606 | Oedema |
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 |
|---|---|---|---|---|---|---|
| 127366061 | 12736606 | 1 | 20140814 | 20160512 | 0 |