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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125500302 | 12550030 | 2 | F | 20090224 | 20160802 | 20160712 | 20160810 | PER | US-ALEXION-A201604990 | ALEXION | 23.15 | YR | F | Y | 0.00000 | 20160810 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125500302 | 12550030 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 225600 | MG | Y | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125500302 | 12550030 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125500302 | 12550030 | Diarrhoea | |
| 125500302 | 12550030 | Gastrointestinal viral infection | |
| 125500302 | 12550030 | Headache | |
| 125500302 | 12550030 | Inappropriate schedule of drug administration | |
| 125500302 | 12550030 | Nausea | |
| 125500302 | 12550030 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125500302 | 12550030 | 1 | 20090224 | 20160621 | 0 |