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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125418062 | 12541806 | 2 | F | 20160629 | 20160711 | 20160708 | 20160721 | EXP | JP-BAXALTA-2016BXJ004710 | BAXALTA | 67.00 | YR | M | Y | 75.00000 | KG | 20160720 | PH | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125418062 | 12541806 | 1 | PS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Intravenous (not otherwise specified) | 4000 IU, 3X A DAY | 140 | 4000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | TID | ||||||
| 125418062 | 12541806 | 2 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | 4000 IU, ONCE | 140 | 4000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | 1X |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125418062 | 12541806 | 1 | Acquired haemophilia |
| 125418062 | 12541806 | 2 | Haemostasis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125418062 | 12541806 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125418062 | 12541806 | Angina pectoris | |
| 125418062 | 12541806 | Myocardial infarction |
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 |
|---|---|---|---|---|---|---|
| 125418062 | 12541806 | 1 | 20160415 | 0 | ||
| 125418062 | 12541806 | 2 | 20160711 | 20160711 | 0 |