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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1015019811 | 10150198 | 11 | F | 20140227 | 20150922 | 20140502 | 20150930 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201401403 | ALEXION | 0.00 | Y | 0.00000 | 20150930 | N | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1015019811 | 10150198 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | D | T2-AB5117C | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 1015019811 | 10150198 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | D | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 1015019811 | 10150198 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, UNK | D | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 1015019811 | 10150198 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK, Q12D | D | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 1015019811 | 10150198 | 5 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | Unknown | UNK | D | 0 | |||||||||
| 1015019811 | 10150198 | 6 | C | STEROID ANTIBACTERIALS | UNSPECIFIED INGREDIENT | 1 | Unknown | UNK | D | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1015019811 | 10150198 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 1015019811 | 10150198 | 5 | Product used for unknown indication |
| 1015019811 | 10150198 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1015019811 | 10150198 | HO |
| 1015019811 | 10150198 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1015019811 | 10150198 | Cardiomegaly | |
| 1015019811 | 10150198 | Cellulitis | |
| 1015019811 | 10150198 | Dyspnoea | |
| 1015019811 | 10150198 | Haemoglobin decreased | |
| 1015019811 | 10150198 | Haemolysis | |
| 1015019811 | 10150198 | Platelet count decreased | |
| 1015019811 | 10150198 | Thrombocytopenia |
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 |
|---|---|---|---|---|---|---|
| 1015019811 | 10150198 | 1 | 20130912 | 0 | ||
| 1015019811 | 10150198 | 2 | 20140423 | 0 | ||
| 1015019811 | 10150198 | 4 | 20150724 | 0 |