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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125470051 | 12547005 | 1 | I | 20160528 | 20160701 | 20160711 | 20160711 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201605039 | ALEXION | 53.82 | YR | F | Y | 0.00000 | 20160711 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125470051 | 12547005 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, QW | 3600 | MG | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||
| 125470051 | 12547005 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, POST EACH PE SESION | 3600 | MG | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||
| 125470051 | 12547005 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, UNK | 3600 | MG | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125470051 | 12547005 | 1 | Antiphospholipid syndrome |
| 125470051 | 12547005 | 2 | Off label use |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125470051 | 12547005 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125470051 | 12547005 | Allodynia | |
| 125470051 | 12547005 | Bacterial infection | |
| 125470051 | 12547005 | Drug ineffective | |
| 125470051 | 12547005 | Off label use | |
| 125470051 | 12547005 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 125470051 | 12547005 | 1 | 20160528 | 20160619 | 0 | |
| 125470051 | 12547005 | 2 | 20150601 | 20160605 | 0 | |
| 125470051 | 12547005 | 3 | 20160626 | 0 |