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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123920584 | 12392058 | 4 | F | 20160510 | 20160713 | 20160523 | 20160726 | EXP | BR-ALEXION PHARMACEUTICALS INC-A201603624 | ALEXION | 33.00 | YR | F | Y | 40.00000 | KG | 20160726 | OT | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123920584 | 12392058 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | Y | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 123920584 | 12392058 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, EVERY 15 DAYS | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123920584 | 12392058 | 1 | Haemolytic uraemic syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123920584 | 12392058 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123920584 | 12392058 | Arthritis infective | |
| 123920584 | 12392058 | Autoimmune disorder | |
| 123920584 | 12392058 | Behcet's syndrome | |
| 123920584 | 12392058 | Blood lactate dehydrogenase abnormal | |
| 123920584 | 12392058 | Drug ineffective | |
| 123920584 | 12392058 | Erythema | |
| 123920584 | 12392058 | Face oedema | |
| 123920584 | 12392058 | Haemoglobin decreased | |
| 123920584 | 12392058 | Haemolysis | |
| 123920584 | 12392058 | Haptoglobin increased | |
| 123920584 | 12392058 | Headache | |
| 123920584 | 12392058 | Hypersensitivity | |
| 123920584 | 12392058 | Oedema peripheral | |
| 123920584 | 12392058 | Oropharyngeal pain | |
| 123920584 | 12392058 | Papule | |
| 123920584 | 12392058 | Peripheral swelling | |
| 123920584 | 12392058 | Pneumonia | |
| 123920584 | 12392058 | Pyrexia | |
| 123920584 | 12392058 | Secretion discharge | |
| 123920584 | 12392058 | Sinusitis | |
| 123920584 | 12392058 | Total complement activity increased | |
| 123920584 | 12392058 | Vasculitis |
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 |
|---|---|---|---|---|---|---|
| 123920584 | 12392058 | 2 | 20150424 | 0 |