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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126921301 | 12692130 | 1 | I | 20160725 | 20160819 | 20160827 | 20160827 | PER | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-54558BP | BOEHRINGER INGELHEIM | 63.11 | YR | F | Y | 0.00000 | 20160827 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126921301 | 12692130 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 150 | MG | CAPSULE | BID | |||||
| 126921301 | 12692130 | 2 | C | TOPAMAX | TOPIRAMATE | 1 | Oral | 50 MG | 0 | 50 | MG | TABLET | QD | ||||||
| 126921301 | 12692130 | 3 | C | TOPAMAX | TOPIRAMATE | 1 | Oral | 100 MG | 0 | 100 | MG | TABLET | QD | ||||||
| 126921301 | 12692130 | 4 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Oral | 1000 MG | 0 | 500 | MG | TABLET | BID | ||||||
| 126921301 | 12692130 | 5 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Oral | 10 MG | 0 | 10 | MG | TABLET | QD | ||||||
| 126921301 | 12692130 | 6 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 126921301 | 12692130 | 7 | C | DILTIAZEM. | DILTIAZEM | 1 | Oral | 120 MG | 0 | 120 | MG | CAPSULE | QD | ||||||
| 126921301 | 12692130 | 8 | C | MULTIVITAMIN | VITAMINS | 1 | Oral | 1 ANZ | 0 | TABLET | QD | ||||||||
| 126921301 | 12692130 | 9 | C | FISH OIL | FISH OIL | 1 | Oral | 2000 MG | 0 | 2000 | MG | CAPSULE | QD | ||||||
| 126921301 | 12692130 | 10 | C | NIACIN. | NIACIN | 1 | Oral | 500 MG | 0 | 500 | MG | TABLET | QD | ||||||
| 126921301 | 12692130 | 11 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 81 MG | 0 | 81 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126921301 | 12692130 | 1 | Atrial fibrillation |
| 126921301 | 12692130 | 2 | Migraine |
| 126921301 | 12692130 | 4 | Migraine |
| 126921301 | 12692130 | 5 | Asthma |
| 126921301 | 12692130 | 6 | Hypersensitivity |
| 126921301 | 12692130 | 7 | Atrial fibrillation |
| 126921301 | 12692130 | 8 | Product used for unknown indication |
| 126921301 | 12692130 | 9 | Blood cholesterol increased |
| 126921301 | 12692130 | 10 | Blood cholesterol increased |
| 126921301 | 12692130 | 11 | Atrial fibrillation |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126921301 | 12692130 | Dyspepsia | |
| 126921301 | 12692130 | Insomnia |
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 |
|---|---|---|---|---|---|---|
| 126921301 | 12692130 | 1 | 20160526 | 20160805 | 0 | |
| 126921301 | 12692130 | 7 | 20160525 | 0 |