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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127802541 | 12780254 | 1 | I | 20160915 | 20160926 | 20160926 | EXP | RO-NOVOPROD-510981 | NOVO NORDISK | 11.00 | YR | C | M | Y | 48.00000 | KG | 20160926 | MD | RO | RO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127802541 | 12780254 | 1 | PS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 8 MG, QD (2MG EVERY 6 HOURS) | UNKNOWN | 103665 | 8 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QD | |||||
| 127802541 | 12780254 | 2 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 5 MG/DOSE (10 ADMINISTRATION) | UNKNOWN | 103665 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127802541 | 12780254 | 1 | Haemophilia A with anti factor VIII |
| 127802541 | 12780254 | 2 | Haemorrhage |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127802541 | 12780254 | OT |
| 127802541 | 12780254 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127802541 | 12780254 | Condition aggravated | |
| 127802541 | 12780254 | Drug ineffective | |
| 127802541 | 12780254 | Intra-abdominal haematoma |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |