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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126651521 | 12665152 | 1 | I | 20160812 | 20160818 | 20160818 | EXP | CA-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-53378CN | BOEHRINGER INGELHEIM | 0.00 | E | M | Y | 0.00000 | 20160818 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126651521 | 12665152 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 300 MG | N | 22512 | 150 | MG | BID | ||||||
| 126651521 | 12665152 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | N | 22512 | |||||||||||
| 126651521 | 12665152 | 3 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | N | 22512 | |||||||||||
| 126651521 | 12665152 | 4 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126651521 | 12665152 | 1 | Cerebrovascular accident prophylaxis |
| 126651521 | 12665152 | 2 | Atrial fibrillation |
| 126651521 | 12665152 | 3 | Anticoagulant therapy |
| 126651521 | 12665152 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126651521 | 12665152 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126651521 | 12665152 | Activated partial thromboplastin time prolonged | |
| 126651521 | 12665152 | Acute kidney injury | |
| 126651521 | 12665152 | Blood creatinine increased | |
| 126651521 | 12665152 | Coagulopathy | |
| 126651521 | 12665152 | International normalised ratio abnormal | |
| 126651521 | 12665152 | Lactic acidosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |