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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113271713 | 11327171 | 3 | F | 20140303 | 20160908 | 20150731 | 20160915 | EXP | US-ALEXION PHARMACEUTICALS INC-A201502770 | ALEXION | 35.89 | YR | M | Y | 0.00000 | 20160915 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113271713 | 11327171 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | N | T2-AB5117C | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||
| 113271713 | 11327171 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | N | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 113271713 | 11327171 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, UNK | N | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 113271713 | 11327171 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, UNK | N | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 113271713 | 11327171 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | N | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 113271713 | 11327171 | 6 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113271713 | 11327171 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 113271713 | 11327171 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113271713 | 11327171 | OT |
| 113271713 | 11327171 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113271713 | 11327171 | Anaemia | |
| 113271713 | 11327171 | Blood creatinine increased | |
| 113271713 | 11327171 | Fatigue | |
| 113271713 | 11327171 | Incorrect dose administered | |
| 113271713 | 11327171 | Intravascular haemolysis | |
| 113271713 | 11327171 | Jaundice | |
| 113271713 | 11327171 | Platelet count decreased | |
| 113271713 | 11327171 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 113271713 | 11327171 | 1 | 20140226 | 0 | ||
| 113271713 | 11327171 | 2 | 20140303 | 0 | ||
| 113271713 | 11327171 | 3 | 20140326 | 20150325 | 0 | |
| 113271713 | 11327171 | 4 | 20150717 | 0 | ||
| 113271713 | 11327171 | 5 | 20140313 | 20160822 | 0 |