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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126049482 | 12604948 | 2 | F | 20160711 | 20160727 | 20160728 | 20160805 | EXP | BR-BAXALTA-2016BLT005314 | BAXALTA | 21.33 | YR | M | Y | 66.00000 | KG | 20160805 | OT | BR | BR |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126049482 | 12604948 | 1 | PS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Unknown | 5000 IU, 1X A DAY, ON DEMAND | VNF2Q096 | 140 | 5000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | QD | |||||
126049482 | 12604948 | 2 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Unknown | 7000 IU, IN HOSPITAL, ON DEMAND | 140 | 7000 | IU | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION | |||||||
126049482 | 12604948 | 3 | SS | FEIBA | ANTI-INHIBITOR COAGULANT COMPLEX | 1 | Unknown | BEGAN ON DEMAND | 140 | POWDER AND SOLVENT FOR SOLUTION FOR INFUSION |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126049482 | 12604948 | 1 | Haemorrhage |
126049482 | 12604948 | 2 | Joint swelling |
126049482 | 12604948 | 3 | Limb discomfort |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126049482 | 12604948 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126049482 | 12604948 | Drug ineffective | |
126049482 | 12604948 | Osteoarthritis |
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 |
---|---|---|---|---|---|---|
126049482 | 12604948 | 1 | 20160711 | 20160713 | 0 | |
126049482 | 12604948 | 2 | 20160714 | 20160718 | 0 | |
126049482 | 12604948 | 3 | 2006 | 0 |