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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125542883 | 12554288 | 3 | F | 20160719 | 20160713 | 20160727 | EXP | FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-45387FF | BOEHRINGER INGELHEIM | 0.00 | M | Y | 120.00000 | KG | 20160727 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125542883 | 12554288 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 220 MG | 22512 | 110 | MG | CAPSULE | BID | ||||||
| 125542883 | 12554288 | 2 | C | APROVEL | IRBESARTAN | 1 | Unknown | 300 MG | 0 | 300 | MG | TABLET | QD | ||||||
| 125542883 | 12554288 | 3 | C | ZANIDIP | LERCANIDIPINE HYDROCHLORIDE | 1 | Unknown | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 125542883 | 12554288 | 4 | C | AMAREL | GLIMEPIRIDE | 1 | Unknown | 1 MG | 0 | 1 | MG | TABLET | QD | ||||||
| 125542883 | 12554288 | 5 | C | MONICOR LP | ISOSORBIDE MONONITRATE | 1 | Unknown | 40 MG | 0 | 40 | MG | QD | |||||||
| 125542883 | 12554288 | 6 | C | ALDALIX | FUROSEMIDE SODIUMSPIRONOLACTONE | 1 | Unknown | 0 | |||||||||||
| 125542883 | 12554288 | 7 | C | TAHOR | ATORVASTATIN CALCIUM | 1 | Unknown | 0 | 10 | MG | |||||||||
| 125542883 | 12554288 | 8 | C | LASILIX | FUROSEMIDE | 1 | Unknown | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125542883 | 12554288 | 1 | Atrial fibrillation |
| 125542883 | 12554288 | 2 | Product used for unknown indication |
| 125542883 | 12554288 | 3 | Product used for unknown indication |
| 125542883 | 12554288 | 4 | Product used for unknown indication |
| 125542883 | 12554288 | 5 | Product used for unknown indication |
| 125542883 | 12554288 | 6 | Product used for unknown indication |
| 125542883 | 12554288 | 7 | Product used for unknown indication |
| 125542883 | 12554288 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125542883 | 12554288 | DE |
| 125542883 | 12554288 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125542883 | 12554288 | Dehydration | |
| 125542883 | 12554288 | Dyspnoea | |
| 125542883 | 12554288 | Haemorrhage subcutaneous | |
| 125542883 | 12554288 | Hypersensitivity vasculitis | |
| 125542883 | 12554288 | Hyperthermia | |
| 125542883 | 12554288 | Nosocomial infection | |
| 125542883 | 12554288 | Oedema peripheral | |
| 125542883 | 12554288 | Purpura | |
| 125542883 | 12554288 | Renal failure |
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 |
|---|---|---|---|---|---|---|
| 125542883 | 12554288 | 1 | 20120904 | 0 |