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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125412943 | 12541294 | 3 | F | 20160703 | 20160726 | 20160708 | 20160729 | EXP | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-43666DE | BOEHRINGER INGELHEIM | 68.00 | YR | M | Y | 90.00000 | KG | 20160729 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125412943 | 12541294 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 220 MG | N | 22512 | 110 | MG | CAPSULE, HARD | BID | |||||
| 125412943 | 12541294 | 2 | SS | PRAXBIND | IDARUCIZUMAB | 1 | Intravenous (not otherwise specified) | 5 G | N | 761025 | 5 | G | SUSPENSION FOR INJECTION | QD | |||||
| 125412943 | 12541294 | 3 | SS | PRAXBIND | IDARUCIZUMAB | 1 | Intravenous (not otherwise specified) | 5 G | N | 761025 | 5 | G | SUSPENSION FOR INJECTION | QD | |||||
| 125412943 | 12541294 | 4 | SS | PRAXBIND | IDARUCIZUMAB | 1 | Intravenous (not otherwise specified) | 5 G | N | 761025 | 5 | G | SUSPENSION FOR INJECTION | QD | |||||
| 125412943 | 12541294 | 5 | SS | PRAXBIND | IDARUCIZUMAB | 1 | N | 761025 | |||||||||||
| 125412943 | 12541294 | 6 | SS | PRAXBIND | IDARUCIZUMAB | 1 | N | 761025 | |||||||||||
| 125412943 | 12541294 | 7 | SS | PRAXBIND | IDARUCIZUMAB | 1 | N | 761025 | |||||||||||
| 125412943 | 12541294 | 8 | SS | PRAXBIND | IDARUCIZUMAB | 1 | N | 761025 | |||||||||||
| 125412943 | 12541294 | 9 | C | CANDESARTAN | CANDESARTAN | 1 | Oral | 16 MG | 0 | 16 | MG | TABLET | QD | ||||||
| 125412943 | 12541294 | 10 | C | HYDROCHLOROTHIAZID | HYDROCHLOROTHIAZIDE | 1 | Oral | 25 MG | 0 | 25 | MG | TABLET | QD | ||||||
| 125412943 | 12541294 | 11 | C | TORASEMID | TORSEMIDE | 1 | Oral | 20 MG | 0 | 20 | MG | TABLET | QD | ||||||
| 125412943 | 12541294 | 12 | C | TORASEMID | TORSEMIDE | 1 | Oral | 20 MG | 0 | 10 | MG | TABLET | BID | ||||||
| 125412943 | 12541294 | 13 | C | LANTUS | INSULIN GLARGINE | 1 | Subcutaneous | 18 U | 0 | 18 | IU | SUSPENSION FOR INJECTION | QD | ||||||
| 125412943 | 12541294 | 14 | C | H-INSULIN | 2 | Subcutaneous | 22 U | 0 | 22 | IU | SUSPENSION FOR INJECTION | QD | |||||||
| 125412943 | 12541294 | 15 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 80 MG | 0 | 40 | MG | BID | |||||||
| 125412943 | 12541294 | 16 | C | JONOSTERIL | CALCIUM ACETATEMAGNESIUM ACETATEPOTASSIUM ACETATESODIUM ACETATESODIUM CHLORIDE | 1 | Unknown | 1 ANZ | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125412943 | 12541294 | 1 | Atrial fibrillation |
| 125412943 | 12541294 | 2 | Shock haemorrhagic |
| 125412943 | 12541294 | 3 | Gastrointestinal haemorrhage |
| 125412943 | 12541294 | 4 | Mucosal haemorrhage |
| 125412943 | 12541294 | 5 | Haematemesis |
| 125412943 | 12541294 | 6 | Melaena |
| 125412943 | 12541294 | 7 | Blood urine present |
| 125412943 | 12541294 | 8 | Epistaxis |
| 125412943 | 12541294 | 9 | Hypertension |
| 125412943 | 12541294 | 10 | Hypertension |
| 125412943 | 12541294 | 11 | Hypertension |
| 125412943 | 12541294 | 12 | Oedema |
| 125412943 | 12541294 | 13 | Type 2 diabetes mellitus |
| 125412943 | 12541294 | 14 | Type 2 diabetes mellitus |
| 125412943 | 12541294 | 15 | Product used for unknown indication |
| 125412943 | 12541294 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125412943 | 12541294 | HO |
| 125412943 | 12541294 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125412943 | 12541294 | Blood creatinine abnormal | |
| 125412943 | 12541294 | Blood urine present | |
| 125412943 | 12541294 | Coagulation test abnormal | |
| 125412943 | 12541294 | Epistaxis | |
| 125412943 | 12541294 | Gastrointestinal haemorrhage | |
| 125412943 | 12541294 | Haematemesis | |
| 125412943 | 12541294 | Haemorrhage | |
| 125412943 | 12541294 | Melaena | |
| 125412943 | 12541294 | Mucosal haemorrhage | |
| 125412943 | 12541294 | Off label use | |
| 125412943 | 12541294 | Renal impairment | |
| 125412943 | 12541294 | Shock haemorrhagic |
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 |
|---|---|---|---|---|---|---|
| 125412943 | 12541294 | 1 | 20160703 | 0 | ||
| 125412943 | 12541294 | 2 | 20160703 | 20160703 | 0 | |
| 125412943 | 12541294 | 3 | 20160707 | 20160707 | 0 | |
| 125412943 | 12541294 | 4 | 20160708 | 20160708 | 0 |