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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126476011 | 12647601 | 1 | I | 20160808 | 20160812 | 20160812 | EXP | DE-B.I. PHARMACEUTICALS,INC./RIDGEFIELD-2016-BI-52021BI | BOEHRINGER INGELHEIM | ALHASHEM H,AVENDANO C,HAYES B,WINTERS M,KESSELRING L. PERSISTENT LIFE-THREATENING HEMORRHAGE AFTER ADMINISTRATION OF IDARUCIZUMAB. AMERICAN JOURNAL OF EMERGENCY MEDICINE 2016 JAN 01;. | 65.00 | YR | M | Y | 0.00000 | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126476011 | 12647601 | 1 | PS | PRADAXA | DABIGATRAN ETEXILATE MESYLATE | 1 | Oral | U | 22512 | ||||||||||
| 126476011 | 12647601 | 2 | SS | PRAXBIND | IDARUCIZUMAB | 1 | Unknown | U | 761025 | 5 | G |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126476011 | 12647601 | 1 | Atrial fibrillation |
| 126476011 | 12647601 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126476011 | 12647601 | LT |
| 126476011 | 12647601 | OT |
| 126476011 | 12647601 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126476011 | 12647601 | Apparent death | |
| 126476011 | 12647601 | Asthenia | |
| 126476011 | 12647601 | Dyspnoea | |
| 126476011 | 12647601 | Faeces discoloured | |
| 126476011 | 12647601 | Gastrointestinal haemorrhage | |
| 126476011 | 12647601 | Haemorrhage | |
| 126476011 | 12647601 | Hypotension | |
| 126476011 | 12647601 | Melaena | |
| 126476011 | 12647601 | Pallor | |
| 126476011 | 12647601 | Tachycardia | |
| 126476011 | 12647601 | Therapeutic embolisation |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |