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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121971006 | 12197100 | 6 | F | 20160309 | 20160719 | 20160321 | 20160802 | EXP | US-ALEXION-A201601827 | ALEXION | 61.57 | YR | F | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121971006 | 12197100 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | T2-AE1229B01 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121971006 | 12197100 | 1 | Haemolytic uraemic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121971006 | 12197100 | OT |
| 121971006 | 12197100 | HO |
| 121971006 | 12197100 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121971006 | 12197100 | Blood creatinine increased | |
| 121971006 | 12197100 | Chest pain | |
| 121971006 | 12197100 | Drug ineffective | |
| 121971006 | 12197100 | Hepatic failure | |
| 121971006 | 12197100 | Hypotension | |
| 121971006 | 12197100 | Laboratory test abnormal | |
| 121971006 | 12197100 | Neoplasm | |
| 121971006 | 12197100 | Ovarian cancer recurrent |
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 |
|---|---|---|---|---|---|---|
| 121971006 | 12197100 | 1 | 20150708 | 20160225 | 0 |