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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115638796 | 11563879 | 6 | F | 20151118 | 20160815 | 20150928 | 20160823 | EXP | US-ALEXION-A201503557 | ALEXION | 0.00 | F | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115638796 | 11563879 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | T3-AE0884B01R | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 115638796 | 11563879 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | T3-AE1224B01 | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 115638796 | 11563879 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK, QW | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115638796 | 11563879 | 1 | Haemolytic uraemic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115638796 | 11563879 | HO |
| 115638796 | 11563879 | LT |
| 115638796 | 11563879 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115638796 | 11563879 | Acute kidney injury | |
| 115638796 | 11563879 | Blood creatinine increased | |
| 115638796 | 11563879 | Exposure during pregnancy | |
| 115638796 | 11563879 | Fatigue | |
| 115638796 | 11563879 | Heart valve incompetence | |
| 115638796 | 11563879 | Pulmonary hypertension | |
| 115638796 | 11563879 | Thrombocytopenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |