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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125900243 | 12590024 | 3 | F | 20160626 | 20160927 | 20160725 | 20160928 | EXP | DE-BFARM-16226394 | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-45053DE | BOEHRINGER INGELHEIM | 70.00 | YR | F | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125900243 | 12590024 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | Y | 22512 | ||||||||||
| 125900243 | 12590024 | 2 | SS | PREDNISOLON | PREDNISOLONE | 1 | Oral | Y | 0 | 5 | MG | ||||||||
| 125900243 | 12590024 | 3 | SS | PREDNISOLON | PREDNISOLONE | 1 | Y | 0 | |||||||||||
| 125900243 | 12590024 | 4 | SS | KLACID | CLARITHROMYCIN | 1 | Oral | Y | 0 | 500 | MG | ||||||||
| 125900243 | 12590024 | 5 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 125900243 | 12590024 | 6 | C | HUMINSULIN | INSULIN HUMAN | 1 | Unknown | 0 | |||||||||||
| 125900243 | 12590024 | 7 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Oral | 20 MG | 0 | 20 | MG | QD | |||||||
| 125900243 | 12590024 | 8 | C | METOPROLOL. | METOPROLOL | 1 | Oral | 47.5 MG | 0 | 47.5 | MG | QD | |||||||
| 125900243 | 12590024 | 9 | C | FUROSEMID | FUROSEMIDE | 1 | Oral | DAILY DOSE: 2-1-0 | 0 | 20 | MG | ||||||||
| 125900243 | 12590024 | 10 | C | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 40 MG | 0 | 40 | MG | QD | |||||||
| 125900243 | 12590024 | 11 | C | AUGMENTAN | AMOXICILLINCLAVULANATE POTASSIUM | 1 | Oral | 2 ANZ | 0 | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125900243 | 12590024 | 1 | Deep vein thrombosis |
| 125900243 | 12590024 | 2 | Polymyalgia rheumatica |
| 125900243 | 12590024 | 3 | Uveitis |
| 125900243 | 12590024 | 4 | Pneumonia |
| 125900243 | 12590024 | 5 | Diabetes mellitus |
| 125900243 | 12590024 | 6 | Diabetes mellitus |
| 125900243 | 12590024 | 7 | Coronary artery disease |
| 125900243 | 12590024 | 8 | Coronary artery disease |
| 125900243 | 12590024 | 9 | Cardiac failure |
| 125900243 | 12590024 | 10 | Anaemia |
| 125900243 | 12590024 | 11 | Pneumonia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125900243 | 12590024 | LT |
| 125900243 | 12590024 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125900243 | 12590024 | Gastrointestinal haemorrhage | |
| 125900243 | 12590024 | Granulomatosis with polyangiitis | |
| 125900243 | 12590024 | Haemoglobin decreased | |
| 125900243 | 12590024 | Haemoptysis | |
| 125900243 | 12590024 | Melaena | |
| 125900243 | 12590024 | Pulmonary haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 125900243 | 12590024 | 1 | 201606 | 0 |