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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123576675 | 12357667 | 5 | F | 20120113 | 20160916 | 20160512 | 20160923 | EXP | GB-ALEXION PHARMACEUTICALS INC-A201603369 | ALEXION | 48.80 | YR | M | Y | 0.00000 | 20160923 | OT | GB | GB |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
123576675 | 12357667 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
123576675 | 12357667 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004302 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
123576675 | 12357667 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P000470 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
123576675 | 12357667 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0004801 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
123576675 | 12357667 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0005002 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
123576675 | 12357667 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | P0005002R | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
123576675 | 12357667 | 7 | C | PENICILLIN /00000901/ | PENICILLIN G | 1 | Unknown | UNK | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
123576675 | 12357667 | 1 | Paroxysmal nocturnal haemoglobinuria |
123576675 | 12357667 | 7 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
123576675 | 12357667 | HO |
123576675 | 12357667 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
123576675 | 12357667 | Haemolysis | |
123576675 | 12357667 | Incorrect dose administered | |
123576675 | 12357667 | Lower respiratory tract infection |
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 |
---|---|---|---|---|---|---|
123576675 | 12357667 | 2 | 20120113 | 0 | ||
123576675 | 12357667 | 3 | 20120113 | 0 | ||
123576675 | 12357667 | 4 | 20120113 | 0 | ||
123576675 | 12357667 | 5 | 20120113 | 0 | ||
123576675 | 12357667 | 6 | 20120113 | 0 |