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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97498122 | 9749812 | 2 | F | 20121209 | 20160819 | 20131212 | 20160822 | EXP | FR-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2013-BI-41727FF | BOEHRINGER INGELHEIM | 84.86 | YR | M | Y | 0.00000 | 20160822 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97498122 | 9749812 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | 22512 | 110 | MG | CAPSULE | BID | ||||||
| 97498122 | 9749812 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Other | 220 MG | 22512 | 110 | MG | CAPSULE | BID | ||||||
| 97498122 | 9749812 | 3 | C | KARDEGIC | ASPIRIN LYSINE | 1 | Unknown | DOSE PER APPLICATION: 75 | 0 | ||||||||||
| 97498122 | 9749812 | 4 | C | OMBREZ | 2 | Unknown | DOSE PER APPLICATION: 150 | 0 | |||||||||||
| 97498122 | 9749812 | 5 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 0 | |||||||||||
| 97498122 | 9749812 | 6 | C | MIFLASONE | BECLOMETHASONE DIPROPIONATE | 1 | Unknown | 0 | |||||||||||
| 97498122 | 9749812 | 7 | C | LASILIX | FUROSEMIDE | 1 | Unknown | 80 MG | 0 | 40 | MG | BID | |||||||
| 97498122 | 9749812 | 8 | C | RAMIPRIL. | RAMIPRIL | 1 | Unknown | 0 | 2.5 | MG | |||||||||
| 97498122 | 9749812 | 9 | C | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | DOSE PER APPLICATION: 5 | 0 | ||||||||||
| 97498122 | 9749812 | 10 | C | AMIODARONE | AMIODARONE | 1 | Unknown | DOSE PER APPLICATION: 200 | 0 | ||||||||||
| 97498122 | 9749812 | 11 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Unknown | DOSE PER APPLICATION: 25 | 0 | ||||||||||
| 97498122 | 9749812 | 12 | C | O2 | 2 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97498122 | 9749812 | 1 | Atrial fibrillation |
| 97498122 | 9749812 | 3 | Product used for unknown indication |
| 97498122 | 9749812 | 4 | Product used for unknown indication |
| 97498122 | 9749812 | 5 | Product used for unknown indication |
| 97498122 | 9749812 | 6 | Product used for unknown indication |
| 97498122 | 9749812 | 7 | Product used for unknown indication |
| 97498122 | 9749812 | 8 | Product used for unknown indication |
| 97498122 | 9749812 | 9 | Product used for unknown indication |
| 97498122 | 9749812 | 10 | Product used for unknown indication |
| 97498122 | 9749812 | 11 | Product used for unknown indication |
| 97498122 | 9749812 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97498122 | 9749812 | OT |
| 97498122 | 9749812 | HO |
| 97498122 | 9749812 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97498122 | 9749812 | Abdominal pain | |
| 97498122 | 9749812 | Anaemia | |
| 97498122 | 9749812 | Cardio-respiratory arrest | |
| 97498122 | 9749812 | Diarrhoea haemorrhagic | |
| 97498122 | 9749812 | Haematochezia | |
| 97498122 | 9749812 | Haemorrhage | |
| 97498122 | 9749812 | Infection | |
| 97498122 | 9749812 | Intestinal infarction | |
| 97498122 | 9749812 | Myocardial infarction | |
| 97498122 | 9749812 | 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 |
|---|---|---|---|---|---|---|
| 97498122 | 9749812 | 1 | 20120911 | 201212 | 0 | |
| 97498122 | 9749812 | 2 | 201212 | 0 |