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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127613581 | 12761358 | 1 | I | 20160913 | 20160920 | 20160920 | EXP | JP-ALXN-A201606895AA | ALEXION | 86.00 | YR | F | Y | 39.00000 | KG | 20160920 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127613581 | 12761358 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 127613581 | 12761358 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 127613581 | 12761358 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||||
| 127613581 | 12761358 | 4 | C | BONZOL /00428701/ | 2 | Unknown | 200 MG, DAILY | 0 | 200 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127613581 | 12761358 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 127613581 | 12761358 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127613581 | 12761358 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127613581 | 12761358 | Femoral neck fracture | |
| 127613581 | 12761358 | Haemolysis |
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 |
|---|---|---|---|---|---|---|
| 127613581 | 12761358 | 1 | 20130227 | 20130320 | 0 | |
| 127613581 | 12761358 | 2 | 20130328 | 20150806 | 0 | |
| 127613581 | 12761358 | 3 | 20151215 | 0 | ||
| 127613581 | 12761358 | 4 | 20140227 | 20151228 | 0 |