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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120808194 | 12080819 | 4 | F | 20160823 | 20160216 | 20160826 | EXP | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-08779DE | BOEHRINGER INGELHEIM | THORBORG C,HORN E,MOFID H,LANGER F. REVERSAL BY THE SPECIFIC ANTIDOTE, IDARUCIZUMAB, OF ELEVATED DABIGATRAN EXPOSURE IN A PATIENT WITH RECTAL PERFORATION AND PARALYTIC ILEUS. BRITISH JOURNAL OF ANAESTHESIA 2016;117:3:407-409. | 79.00 | YR | F | Y | 50.00000 | KG | 20160826 | OT | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120808194 | 12080819 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Unknown | 220 MG | U | 22512 | 110 | MG | BID | ||||||
| 120808194 | 12080819 | 2 | SS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | U | 22512 | |||||||||||
| 120808194 | 12080819 | 3 | SS | PRAXBIND | IDARUCIZUMAB | 1 | Unknown | U | 761025 | ||||||||||
| 120808194 | 12080819 | 4 | C | CLOPIDOGREL | CLOPIDOGREL BISULFATE | 1 | Unknown | 75 MG | 0 | 75 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120808194 | 12080819 | 1 | Cerebrovascular accident prophylaxis |
| 120808194 | 12080819 | 2 | Atrial fibrillation |
| 120808194 | 12080819 | 3 | Haemorrhage |
| 120808194 | 12080819 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120808194 | 12080819 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120808194 | 12080819 | Activated partial thromboplastin time prolonged | |
| 120808194 | 12080819 | Anaemia | |
| 120808194 | 12080819 | Coagulation factor increased | |
| 120808194 | 12080819 | Coagulation time prolonged | |
| 120808194 | 12080819 | Coagulopathy | |
| 120808194 | 12080819 | Creatinine renal clearance decreased | |
| 120808194 | 12080819 | Haemorrhage | |
| 120808194 | 12080819 | Ileus paralytic | |
| 120808194 | 12080819 | Peritonitis | |
| 120808194 | 12080819 | Prothrombin time prolonged | |
| 120808194 | 12080819 | Rectal perforation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |