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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124215452 | 12421545 | 2 | F | 20151003 | 20160627 | 20160531 | 20160705 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-33449BP | BOEHRINGER INGELHEIM | 83.05 | YR | M | Y | 70.04000 | KG | 20160705 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124215452 | 12421545 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 150 | MG | CAPSULE | BID | |||||
| 124215452 | 12421545 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 150 MG | Y | 22512 | 75 | MG | CAPSULE | BID | |||||
| 124215452 | 12421545 | 3 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 150 | MG | CAPSULE | BID | |||||
| 124215452 | 12421545 | 4 | C | DIGOXIN. | DIGOXIN | 1 | Oral | 0 | QD | ||||||||||
| 124215452 | 12421545 | 5 | C | COREG | CARVEDILOL | 1 | Oral | 0 | QD | ||||||||||
| 124215452 | 12421545 | 6 | C | ENTECAVIR. | ENTECAVIR | 1 | Oral | 0 | QD | ||||||||||
| 124215452 | 12421545 | 7 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0.4 MG | 0 | .4 | MG | QD | |||||||
| 124215452 | 12421545 | 8 | C | LASIX | FUROSEMIDE | 1 | Oral | 20 MG | 0 | 40 | MG | QOD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124215452 | 12421545 | 1 | Atrial fibrillation |
| 124215452 | 12421545 | 4 | Cardiac failure congestive |
| 124215452 | 12421545 | 5 | Hypertension |
| 124215452 | 12421545 | 6 | Chronic hepatitis B |
| 124215452 | 12421545 | 7 | Benign prostatic hyperplasia |
| 124215452 | 12421545 | 8 | Cardiac failure congestive |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124215452 | 12421545 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124215452 | 12421545 | Rectal 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 |
|---|---|---|---|---|---|---|
| 124215452 | 12421545 | 1 | 201505 | 0 | ||
| 124215452 | 12421545 | 2 | 201510 | 0 | ||
| 124215452 | 12421545 | 3 | 2015 | 0 | ||
| 124215452 | 12421545 | 4 | 2015 | 0 | ||
| 124215452 | 12421545 | 8 | 2015 | 0 |