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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108746986 | 10874698 | 6 | F | 20150202 | 20160908 | 20150227 | 20160915 | PER | US-ALEXION-A201500657 | ALEXION | 0.00 | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108746986 | 10874698 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | N | T3-AC1963B01 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 108746986 | 10874698 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | N | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 108746986 | 10874698 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | N | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108746986 | 10874698 | 1 | Haemolytic uraemic syndrome |
| 108746986 | 10874698 | 3 | Rash |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108746986 | 10874698 | Alopecia | |
| 108746986 | 10874698 | Blood urea increased | |
| 108746986 | 10874698 | Eosinophil count increased | |
| 108746986 | 10874698 | Fatigue | |
| 108746986 | 10874698 | Palpitations | |
| 108746986 | 10874698 | Rash | |
| 108746986 | 10874698 | Red blood cells urine positive | |
| 108746986 | 10874698 | Urticaria | |
| 108746986 | 10874698 | Vaginal infection |
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 |
|---|---|---|---|---|---|---|
| 108746986 | 10874698 | 2 | 20160702 | 20160831 | 0 |