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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126650492 | 12665049 | 2 | F | 20160913 | 20160818 | 20160920 | EXP | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-53057DE | BOEHRINGER INGELHEIM | 64.00 | YR | M | Y | 0.00000 | 20160920 | PH | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126650492 | 12665049 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 220 MG | Y | 22512 | 110 | MG | BID | ||||||
| 126650492 | 12665049 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Y | 22512 | |||||||||||
| 126650492 | 12665049 | 3 | C | BISOHEXAL | BISOPROLOL FUMARATE | 1 | Oral | 5 MG | 0 | 5 | MG | TABLET | QD | ||||||
| 126650492 | 12665049 | 4 | C | L- THYROXIN | 2 | Oral | 1 ANZ | 0 | TABLET | QD | |||||||||
| 126650492 | 12665049 | 5 | C | CORDAREX | AMIODARONE | 1 | Oral | 200 MG | 0 | 200 | MG | TABLET | QD | ||||||
| 126650492 | 12665049 | 6 | C | DORZOLAMID | 2 | Intraocular | 3 ANZ | 0 | EYE DROPS | TID | |||||||||
| 126650492 | 12665049 | 7 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 2 ANZ | 0 | INHALATION POWDER, HARD CAPSULE | BID | ||||||||
| 126650492 | 12665049 | 8 | C | HUMINSULIN BASAL (NPH) KWIKPEN | 2 | Subcutaneous | STRENGTH: 100I.E./ML 3 ML | 0 | SUSPENSION FOR INJECTION | ||||||||||
| 126650492 | 12665049 | 9 | C | BIFITERAL | LACTULOSE | 1 | Oral | DOSE PER APPLICATION: 667 G/L SYRUP DAILY DOSE: 1343G/DL | 0 | SYRUP | BID | ||||||||
| 126650492 | 12665049 | 10 | C | NEOMYCIN | NEOMYCIN | 1 | Unknown | FORMULATION: PULVER EH | 0 | ||||||||||
| 126650492 | 12665049 | 11 | C | PANTOPRAZOL HEXAL | 2 | Intravenous (not otherwise specified) | 80 MG | 0 | 40 | MG | BID | ||||||||
| 126650492 | 12665049 | 12 | C | PANTOPRAZOL HEXAL | 2 | Oral | 80 MG | 0 | 40 | MG | TABLET | BID | |||||||
| 126650492 | 12665049 | 13 | C | JONOSTERIL FREEFLEX | 2 | Intravenous (not otherwise specified) | 500 ML | 0 | 500 | ML | QD | ||||||||
| 126650492 | 12665049 | 14 | C | KABIVEN PERIPHER | 2 | Intravenous (not otherwise specified) | DOSE PER APPLICATION AND DAILY DOSE: 1.92 L | 0 | ORAL EMULSION | QD | |||||||||
| 126650492 | 12665049 | 15 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | 10 ML | 0 | 10 | ML | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126650492 | 12665049 | 1 | Atrial fibrillation |
| 126650492 | 12665049 | 2 | Atrial fibrillation |
| 126650492 | 12665049 | 3 | Product used for unknown indication |
| 126650492 | 12665049 | 4 | Product used for unknown indication |
| 126650492 | 12665049 | 5 | Product used for unknown indication |
| 126650492 | 12665049 | 6 | Product used for unknown indication |
| 126650492 | 12665049 | 7 | Product used for unknown indication |
| 126650492 | 12665049 | 8 | Product used for unknown indication |
| 126650492 | 12665049 | 9 | Product used for unknown indication |
| 126650492 | 12665049 | 10 | Product used for unknown indication |
| 126650492 | 12665049 | 11 | Product used for unknown indication |
| 126650492 | 12665049 | 13 | Product used for unknown indication |
| 126650492 | 12665049 | 14 | Product used for unknown indication |
| 126650492 | 12665049 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126650492 | 12665049 | HO |
| 126650492 | 12665049 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126650492 | 12665049 | Cardiac cirrhosis | |
| 126650492 | 12665049 | Cardiac failure | |
| 126650492 | 12665049 | Gastric ulcer | |
| 126650492 | 12665049 | Melaena | |
| 126650492 | 12665049 | Portal hypertensive gastropathy | |
| 126650492 | 12665049 | Varices oesophageal |
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 |
|---|---|---|---|---|---|---|
| 126650492 | 12665049 | 9 | 20160727 | 0 | ||
| 126650492 | 12665049 | 10 | 20160727 | 0 | ||
| 126650492 | 12665049 | 11 | 20160726 | 0 | ||
| 126650492 | 12665049 | 12 | 20160731 | 0 | ||
| 126650492 | 12665049 | 13 | 20160726 | 0 | ||
| 126650492 | 12665049 | 14 | 20160727 | 0 | ||
| 126650492 | 12665049 | 15 | 20160727 | 0 |