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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127802591 | 12780259 | 1 | I | 20160915 | 20160926 | 20160926 | EXP | RO-NOVOPROD-510996 | NOVO NORDISK | 11.00 | YR | C | M | Y | 43.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127802591 | 12780259 | 1 | PS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 8 MG, QD (2 MG EVERY 6 HOUR) | UNKNOWN | 103665 | 8 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QD | |||||
| 127802591 | 12780259 | 2 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | INCREASED 4 MG PER ADMINISTRATION | UNKNOWN | 103665 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | ||||||||
| 127802591 | 12780259 | 3 | C | CEFTRIAXONUM | 2 | Intravenous (not otherwise specified) | 1.5 MG, BID | 0 | 1.5 | MG | BID | ||||||||
| 127802591 | 12780259 | 4 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | 500 MG, BID | 0 | 500 | MG | BID | |||||||
| 127802591 | 12780259 | 5 | C | DEXAMETAZONA /00016001/ | 2 | 6 MG, BID | 0 | 6 | MG | BID | |||||||||
| 127802591 | 12780259 | 6 | C | DEXAMETAZONA /00016001/ | 2 | 8 MG, BID | 0 | 8 | MG | BID | |||||||||
| 127802591 | 12780259 | 7 | C | DEXAMETAZONA /00016001/ | 2 | UNK | 0 | ||||||||||||
| 127802591 | 12780259 | 8 | C | NOSPA /00359202/ | 2 | 0 | |||||||||||||
| 127802591 | 12780259 | 9 | C | ALGOCALMIN | METAMIZOLE SODIUM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127802591 | 12780259 | 1 | Haemophilia A with anti factor VIII |
| 127802591 | 12780259 | 2 | Haematuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127802591 | 12780259 | OT |
| 127802591 | 12780259 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127802591 | 12780259 | Drug ineffective | |
| 127802591 | 12780259 | Haematuria |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |