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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124150342 | 12415034 | 2 | F | 20131204 | 20160909 | 20160530 | 20160916 | PER | US-ALEXION-A201603783 | ALEXION | 49.61 | YR | M | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124150342 | 12415034 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, Q2W | Y | T3-AE7318B01 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 124150342 | 12415034 | 2 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124150342 | 12415034 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 124150342 | 12415034 | 2 | Premedication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124150342 | 12415034 | Inappropriate schedule of drug administration | |
| 124150342 | 12415034 | Pain |
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 |
|---|---|---|---|---|---|---|
| 124150342 | 12415034 | 1 | 20131204 | 20160902 | 0 |