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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123456262 | 12345626 | 2 | F | 201604 | 20160907 | 20160509 | 20160913 | PER | US-ALEXION-A201603263 | ALEXION | 0.00 | M | Y | 0.00000 | 20160913 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123456262 | 12345626 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | Y | T2-AE5434B02 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 123456262 | 12345626 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK UNK, QMONTH | Y | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | /month | |||||||
| 123456262 | 12345626 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q7 WEEKS | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 123456262 | 12345626 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q8WEEKS | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123456262 | 12345626 | 1 | Haemolytic uraemic syndrome |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123456262 | 12345626 | Inappropriate schedule of drug administration | |
| 123456262 | 12345626 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 123456262 | 12345626 | 4 | 20160726 | 0 |