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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126693991 | 12669399 | 1 | I | 20160808 | 20160819 | 20160819 | EXP | DE-NOVOPROD-505966 | NOVO NORDISK | MICHAELA STEMBERGER AND ET.ALL.,. SUCCESSFUL BLEEDING CONTROL WITH RECOMBINANT PORCINE FACTOR VIII IN REDUCED LOADING DOSES IN TWO PATIENTS WITH ACQUIRED HAEMOPHILIA A AND FAILURE OF BYPASSING AGENT THERAPY. HAEMOPHILIA. 2016;1-3 | 77.00 | YR | E | M | Y | 0.00000 | 20160819 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126693991 | 12669399 | 1 | PS | NOVOSEVEN | COAGULATION FACTOR VIIA RECOMBINANT HUMAN | 1 | Unknown | 90 ?G/KG | Y | U | UNKNOWN | 103665 | POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | ||||||
| 126693991 | 12669399 | 2 | C | PREDNISOLONE. | PREDNISOLONE | 1 | Oral | 100 MG, QD | 0 | 100 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126693991 | 12669399 | 1 | Acquired haemophilia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126693991 | 12669399 | LT |
| 126693991 | 12669399 | HO |
| 126693991 | 12669399 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126693991 | 12669399 | Drug ineffective | |
| 126693991 | 12669399 | Haematuria | |
| 126693991 | 12669399 | Renal colic | |
| 126693991 | 12669399 | Thrombosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |