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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126601231 | 12660123 | 1 | I | 201602 | 20160810 | 20160817 | 20160817 | EXP | US-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-52575BP | BOEHRINGER INGELHEIM | 58.54 | YR | M | Y | 113.40000 | KG | 20160817 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126601231 | 12660123 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | 300 MG | Y | 22512 | 150 | MG | BID | ||||||
| 126601231 | 12660123 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Y | 22512 | |||||||||||
| 126601231 | 12660123 | 3 | SS | INSULIN DETEMIR | INSULIN DETEMIR | 1 | Subcutaneous | FLEXPEN; FORMULATION: SOLUTION FOR INJECTION; STRENGTH: 0.0024 MOL/L; DOSE PER APPLICATION AND DAILY | Y | 0 | QD | ||||||||
| 126601231 | 12660123 | 4 | C | FISH OIL | FISH OIL | 1 | Unknown | 0 | |||||||||||
| 126601231 | 12660123 | 5 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | 0 | |||||||||||
| 126601231 | 12660123 | 6 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | |||||||||||
| 126601231 | 12660123 | 7 | C | MULTIVITAMIN | VITAMINS | 1 | Unknown | 0 | |||||||||||
| 126601231 | 12660123 | 8 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | 0 | |||||||||||
| 126601231 | 12660123 | 9 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126601231 | 12660123 | 1 | Deep vein thrombosis |
| 126601231 | 12660123 | 2 | Pulmonary embolism |
| 126601231 | 12660123 | 3 | Diabetes mellitus inadequate control |
| 126601231 | 12660123 | 4 | Product used for unknown indication |
| 126601231 | 12660123 | 5 | Product used for unknown indication |
| 126601231 | 12660123 | 6 | Product used for unknown indication |
| 126601231 | 12660123 | 7 | Product used for unknown indication |
| 126601231 | 12660123 | 8 | Product used for unknown indication |
| 126601231 | 12660123 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126601231 | 12660123 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126601231 | 12660123 | Abdominal pain | |
| 126601231 | 12660123 | Constipation | |
| 126601231 | 12660123 | Dehydration | |
| 126601231 | 12660123 | Dyspnoea | |
| 126601231 | 12660123 | Frequent bowel movements | |
| 126601231 | 12660123 | Gastric haemorrhage | |
| 126601231 | 12660123 | Hyperglycaemia | |
| 126601231 | 12660123 | Rectal 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 |
|---|---|---|---|---|---|---|
| 126601231 | 12660123 | 1 | 201606 | 0 | ||
| 126601231 | 12660123 | 3 | 2015 | 201604 | 0 |