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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123023373 | 12302337 | 3 | F | 20160822 | 20160425 | 20160829 | EXP | US-ALEXION PHARMACEUTICALS INC-A201602938 | ALEXION | 0.00 | F | Y | 0.00000 | 20160829 | CN | US | US |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123023373 | 12302337 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | T3-AE5434B02 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
123023373 | 12302337 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | U | T3-AE7318B01 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
123023373 | 12302337 | 3 | SS | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | UNK, FOR 3 MONTHS | Y | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
123023373 | 12302337 | 1 | Paroxysmal nocturnal haemoglobinuria |
123023373 | 12302337 | 3 | White blood cell count decreased |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
123023373 | 12302337 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
123023373 | 12302337 | Dizziness | |
123023373 | 12302337 | Haemoglobin decreased | |
123023373 | 12302337 | Reticulocyte count increased | |
123023373 | 12302337 | Viral infection | |
123023373 | 12302337 | White blood cell count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |