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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124447943 | 12444794 | 3 | F | 20160413 | 20160919 | 20160607 | 20160926 | EXP | US-ALEXION PHARMACEUTICALS INC-A201603959 | ALEXION | 21.56 | YR | F | Y | 118.82000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124447943 | 12444794 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, EVERY 12 DAYS | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 124447943 | 12444794 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 1200 MG, Q2W | 125166 | 1200 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124447943 | 12444794 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124447943 | 12444794 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124447943 | 12444794 | Blood lactate dehydrogenase increased | |
| 124447943 | 12444794 | Exposure during pregnancy | |
| 124447943 | 12444794 | Haemolysis | |
| 124447943 | 12444794 | Incorrect dose administered | |
| 124447943 | 12444794 | Neutropenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |