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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125621611 | 12562161 | 1 | I | 20160706 | 20160711 | 20160715 | 20160715 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-45495BP | BOEHRINGER INGELHEIM | 89.94 | YR | F | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125621611 | 12562161 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 150 | MG | CAPSULE | BID | |||||
| 125621611 | 12562161 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 150 MG | Y | 22512 | 75 | MG | CAPSULE | BID | |||||
| 125621611 | 12562161 | 3 | C | VITAMIN C | ASCORBIC ACID | 1 | Oral | 500 MG | 0 | 500 | MG | TABLET | QD | ||||||
| 125621611 | 12562161 | 4 | C | CALCIUM CARBONATE. | CALCIUM CARBONATE | 1 | Oral | 600 MG | 0 | 600 | MG | TABLET | QD | ||||||
| 125621611 | 12562161 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Oral | 2000 U | 0 | 2000 | IU | CAPSULE | QD | ||||||
| 125621611 | 12562161 | 6 | C | Baby Aspirin | ASPIRIN | 1 | Oral | 81 MG | 0 | 81 | MG | TABLET | QD | ||||||
| 125621611 | 12562161 | 7 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Oral | 30 MG | 0 | 30 | MG | CAPSULE | QD | ||||||
| 125621611 | 12562161 | 8 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 50 MCG | 0 | 50 | UG | TABLET | QD | ||||||
| 125621611 | 12562161 | 9 | C | LORAZEPAM. | LORAZEPAM | 1 | Oral | 1 MG | 0 | .5 | MG | TABLET | BID | ||||||
| 125621611 | 12562161 | 10 | C | LOSARTAN. | LOSARTAN | 1 | Oral | 100 MG | 0 | 100 | MG | TABLET | QD | ||||||
| 125621611 | 12562161 | 11 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 125621611 | 12562161 | 12 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Oral | 150 MG | 0 | 50 | MG | TABLET | TID | ||||||
| 125621611 | 12562161 | 13 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 25 MG | 0 | 12.5 | MG | TABLET | BID | ||||||
| 125621611 | 12562161 | 14 | C | RESTASIS | CYCLOSPORINE | 1 | Other | DOSE PER APPLICATION: 0.05 %, DAILY DOSE: 0.10% | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125621611 | 12562161 | 1 | Atrial fibrillation |
| 125621611 | 12562161 | 3 | Vitamin supplementation |
| 125621611 | 12562161 | 4 | Mineral supplementation |
| 125621611 | 12562161 | 5 | Vitamin supplementation |
| 125621611 | 12562161 | 6 | Product used for unknown indication |
| 125621611 | 12562161 | 7 | Spondylitis |
| 125621611 | 12562161 | 8 | Hypothyroidism |
| 125621611 | 12562161 | 9 | Anxiety |
| 125621611 | 12562161 | 10 | Hypertension |
| 125621611 | 12562161 | 11 | Blood cholesterol increased |
| 125621611 | 12562161 | 12 | Hypertension |
| 125621611 | 12562161 | 13 | Arrhythmia |
| 125621611 | 12562161 | 14 | Macular degeneration |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125621611 | 12562161 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125621611 | 12562161 | Atrial fibrillation |
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 |
|---|---|---|---|---|---|---|
| 125621611 | 12562161 | 1 | 20160409 | 20160707 | 0 | |
| 125621611 | 12562161 | 2 | 20160707 | 0 | ||
| 125621611 | 12562161 | 8 | 201604 | 0 | ||
| 125621611 | 12562161 | 13 | 20160707 | 0 |