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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124962182 | 12496218 | 2 | F | 20160714 | 20160624 | 20160725 | EXP | JP-ALEXION-A201604558 | ALEXION | 18.00 | YR | M | Y | 41.70000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124962182 | 12496218 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | U | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||
| 124962182 | 12496218 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 124962182 | 12496218 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | U | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 124962182 | 12496218 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | U | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124962182 | 12496218 | 1 | Haemolytic uraemic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124962182 | 12496218 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124962182 | 12496218 | Condition aggravated | |
| 124962182 | 12496218 | Immunodeficiency congenital |
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 |
|---|---|---|---|---|---|---|
| 124962182 | 12496218 | 1 | 20140922 | 20140929 | 0 | |
| 124962182 | 12496218 | 2 | 20141006 | 20141020 | 0 | |
| 124962182 | 12496218 | 3 | 20141103 | 20150302 | 0 | |
| 124962182 | 12496218 | 4 | 20150316 | 20160516 | 0 |