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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124899463 | 12489946 | 3 | F | 20130617 | 20160802 | 20160622 | 20160805 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-39337BI | BOEHRINGER INGELHEIM | 70.34 | YR | M | Y | 110.09000 | KG | 20160805 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124899463 | 12489946 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 150 | MG | CAPSULE | BID | |||||
| 124899463 | 12489946 | 2 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 81 MG | 0 | 81 | MG | TABLET | QD | ||||||
| 124899463 | 12489946 | 3 | C | WARFARIN | WARFARIN | 1 | Unknown | 5 MG | 0 | 5 | MG | QD | |||||||
| 124899463 | 12489946 | 4 | C | LYRICA | PREGABALIN | 1 | Unknown | 5 MG | 0 | 5 | MG | QD | |||||||
| 124899463 | 12489946 | 5 | C | LYRICA | PREGABALIN | 1 | Oral | 300 MG | 0 | 100 | MG | CAPSULE | TID | ||||||
| 124899463 | 12489946 | 6 | C | LANTUS | INSULIN GLARGINE | 1 | Unknown | UNITS AS DIRECTED | 0 | ||||||||||
| 124899463 | 12489946 | 7 | C | MINOXIDIL. | MINOXIDIL | 1 | Oral | 10 MG | 0 | 2.5 | MG | TABLET | QID | ||||||
| 124899463 | 12489946 | 8 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Unknown | 0.4 MG | 0 | .4 | MG | QD | |||||||
| 124899463 | 12489946 | 9 | C | DIOVAN | VALSARTAN | 1 | Oral | 320 MG | 0 | 320 | MG | TABLET | QD | ||||||
| 124899463 | 12489946 | 10 | C | TEKTURNA | ALISKIREN HEMIFUMARATE | 1 | Oral | 300 MG | 0 | 300 | MG | TABLET | QD | ||||||
| 124899463 | 12489946 | 11 | C | COENZYME Q10 | UBIDECARENONE | 1 | Oral | 200 MG | 0 | 200 | MG | CAPSULE | QD | ||||||
| 124899463 | 12489946 | 12 | C | LIPITOR | ATORVASTATIN CALCIUM | 1 | Oral | 40 MG | 0 | 40 | MG | TABLET | QD | ||||||
| 124899463 | 12489946 | 13 | C | FUROSEMIDE. | FUROSEMIDE | 1 | Oral | 160 MG | 0 | 80 | MG | TABLET | BID | ||||||
| 124899463 | 12489946 | 14 | C | SOTALOL. | SOTALOL | 1 | Oral | 240 MG | 0 | 120 | MG | TABLET | BID | ||||||
| 124899463 | 12489946 | 15 | C | HUMALOG | INSULIN LISPRO | 1 | Subcutaneous | 100 UNIT/ML AS DIRECTED | 0 | ORAL SOLUTION | |||||||||
| 124899463 | 12489946 | 16 | C | ALEVE | NAPROXEN SODIUM | 1 | Oral | 0 | 220 | MG | TABLET | ||||||||
| 124899463 | 12489946 | 17 | C | POTASSIUM | POTASSIUM | 1 | Unknown | 10 MEQ | 0 | 10 | MEQ | QD | |||||||
| 124899463 | 12489946 | 18 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Oral | 20 MG | 0 | 10 | MG | TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124899463 | 12489946 | 1 | Atrial fibrillation |
| 124899463 | 12489946 | 2 | Anticoagulant therapy |
| 124899463 | 12489946 | 3 | Anticoagulant therapy |
| 124899463 | 12489946 | 4 | Anticoagulant therapy |
| 124899463 | 12489946 | 6 | Product used for unknown indication |
| 124899463 | 12489946 | 7 | Product used for unknown indication |
| 124899463 | 12489946 | 8 | Product used for unknown indication |
| 124899463 | 12489946 | 9 | Product used for unknown indication |
| 124899463 | 12489946 | 10 | Product used for unknown indication |
| 124899463 | 12489946 | 11 | Product used for unknown indication |
| 124899463 | 12489946 | 12 | Product used for unknown indication |
| 124899463 | 12489946 | 13 | Product used for unknown indication |
| 124899463 | 12489946 | 14 | Product used for unknown indication |
| 124899463 | 12489946 | 15 | Product used for unknown indication |
| 124899463 | 12489946 | 16 | Product used for unknown indication |
| 124899463 | 12489946 | 17 | Product used for unknown indication |
| 124899463 | 12489946 | 18 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124899463 | 12489946 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124899463 | 12489946 | Haemorrhagic anaemia | |
| 124899463 | 12489946 | 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 |
|---|---|---|---|---|---|---|
| 124899463 | 12489946 | 1 | 20120123 | 0 |