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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126528181 | 12652818 | 1 | I | 20160803 | 20160803 | 20160815 | 20160815 | EXP | JP-NOVOPROD-504489 | NOVO NORDISK | 79.00 | YR | E | F | Y | 53.00000 | KG | 20160815 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126528181 | 12652818 | 1 | PS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 15 MG, QD | UNKNOWN | 103665 | 15 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | QD | |||||
| 126528181 | 12652818 | 2 | SS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Intravenous (not otherwise specified) | 15 MG, BID | UNKNOWN | 103665 | 15 | MG | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | BID | |||||
| 126528181 | 12652818 | 3 | C | CONCENTRATED RED CELLS | HUMAN RED BLOOD CELL | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 126528181 | 12652818 | 4 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 50 MG, QD | 0 | 50 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126528181 | 12652818 | 1 | Acquired haemophilia |
| 126528181 | 12652818 | 2 | Muscle haemorrhage |
| 126528181 | 12652818 | 3 | Acquired haemophilia |
| 126528181 | 12652818 | 4 | Acquired haemophilia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126528181 | 12652818 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126528181 | 12652818 | Shock haemorrhagic |
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 |
|---|---|---|---|---|---|---|
| 126528181 | 12652818 | 1 | 20160731 | 0 | ||
| 126528181 | 12652818 | 2 | 20160801 | 0 | ||
| 126528181 | 12652818 | 3 | 20160731 | 20160801 | 0 | |
| 126528181 | 12652818 | 4 | 20160725 | 0 |