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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125704231 | 12570423 | 1 | I | 20060101 | 20160627 | 20160719 | 20160719 | EXP | MX-NOVOPROD-498672 | NOVO NORDISK | 23.00 | YR | A | M | Y | 59.00000 | KG | 20160719 | OT | MX | MX |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125704231 | 12570423 | 1 | PS | NOVOSEVEN RT | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Unknown | UNK | U | UNKNOWN | 103665 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | |||||||
125704231 | 12570423 | 2 | SS | NOVOSEVEN RT | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Unknown | 270 ?G/KG | U | UNKNOWN | 103665 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125704231 | 12570423 | 1 | Factor VIII deficiency |
125704231 | 12570423 | 2 | Prophylaxis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125704231 | 12570423 | DE |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125704231 | 12570423 | Cerebral haemorrhage | |
125704231 | 12570423 | Hydrocephalus | |
125704231 | 12570423 | Off label use |
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 |
---|---|---|---|---|---|---|
125704231 | 12570423 | 1 | 20060101 | 0 | ||
125704231 | 12570423 | 2 | 20160624 | 20160626 | 0 |