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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126975232 | 12697523 | 2 | F | 20160915 | 20160830 | 20160922 | EXP | PK-NOVOPROD-506618 | NOVO NORDISK | M.BORHANY ET AL.. A NEW REPORT OF FVII-INHIBITOR IN A PATIENT SUFFERING FROM SEVERE CONGENITAL FVII DEFICIENCY. HAEMOPHILIA. 2015;21:E322-E338 | 11.00 | YR | C | F | Y | 0.00000 | 20160922 | MD | PK | PK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126975232 | 12697523 | 1 | PS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Unknown | 15 ?G/KG SIX HOURLY FOR 2 WEEKS | UNKNOWN | 103665 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | ||||||||
| 126975232 | 12697523 | 2 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Unknown | 30 ?G/KG SIX HOURLY FOR 2 WEEKS | UNKNOWN | 103665 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | ||||||||
| 126975232 | 12697523 | 3 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | 103665 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126975232 | 12697523 | 1 | Factor VII deficiency |
| 126975232 | 12697523 | 2 | Procedural haemorrhage |
| 126975232 | 12697523 | 3 | Haemarthrosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126975232 | 12697523 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126975232 | 12697523 | Anti factor VII antibody positive | |
| 126975232 | 12697523 | Drug ineffective | |
| 126975232 | 12697523 | Haemoglobin decreased | |
| 126975232 | 12697523 | Haemorrhage |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |