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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123951173 | 12395117 | 3 | F | 2016 | 20160714 | 20160523 | 20160725 | EXP | US-ALEXION PHARMACEUTICALS INC-A201603573 | ALEXION | 0.00 | F | Y | 0.00000 | 20160725 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123951173 | 12395117 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
123951173 | 12395117 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK, Q12D | Y | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
123951173 | 12395117 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
123951173 | 12395117 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
123951173 | 12395117 | Blood urine present | |
123951173 | 12395117 | Chest pain | |
123951173 | 12395117 | Decreased appetite | |
123951173 | 12395117 | Fatigue | |
123951173 | 12395117 | Haemochromatosis | |
123951173 | 12395117 | Haemolysis | |
123951173 | 12395117 | Serum ferritin increased | |
123951173 | 12395117 | Weight decreased |
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 |
---|---|---|---|---|---|---|
123951173 | 12395117 | 2 | 201605 | 20160706 | 0 |