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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112028836 | 11202883 | 6 | F | 20150519 | 20160825 | 20150619 | 20160901 | EXP | US-ALEXION PHARMACEUTICALS INC.-A201502192 | ALEXION | 0.00 | M | Y | 0.00000 | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112028836 | 11202883 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | UNK | Y | T2-AD5336B01,T3-AD5338B01 | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112028836 | 11202883 | 1 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112028836 | 11202883 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112028836 | 11202883 | Adverse drug reaction | |
| 112028836 | 11202883 | Burning sensation | |
| 112028836 | 11202883 | Chromaturia | |
| 112028836 | 11202883 | Drug ineffective | |
| 112028836 | 11202883 | Fatigue | |
| 112028836 | 11202883 | Haemoglobin decreased | |
| 112028836 | 11202883 | Malaise | |
| 112028836 | 11202883 | Myelodysplastic syndrome | |
| 112028836 | 11202883 | Rhinorrhoea | |
| 112028836 | 11202883 | Urine output increased | |
| 112028836 | 11202883 | White blood cell count abnormal |
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 |
|---|---|---|---|---|---|---|
| 112028836 | 11202883 | 1 | 20150714 | 0 |