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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117913823 | 11791382 | 3 | F | 20130716 | 20160809 | 20151201 | 20160815 | EXP | JP-ALEXION PHARMACEUTICALS INC-A201503335 | ALEXION | 79.00 | YR | F | Y | 49.00000 | KG | 20160815 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117913823 | 11791382 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 2400 | MG | A92094B01 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||
| 117913823 | 11791382 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 2400 | MG | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 117913823 | 11791382 | 3 | C | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 15 MG, QD | 0 | 15 | MG | QD | |||||||
| 117913823 | 11791382 | 4 | C | WARFARIN | WARFARIN | 1 | Unknown | 1 MG, QD | 1049 | MG | 0 | 1 | MG | QD | |||||
| 117913823 | 11791382 | 5 | C | FERROMIA | FERROUS CITRATE | 1 | Unknown | 100 MG, QD | 277100 | MG | 0 | 100 | MG | QD | |||||
| 117913823 | 11791382 | 6 | C | FOLIAMIN | FOLIC ACID | 1 | Oral | 3 DF, DAILY | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117913823 | 11791382 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 117913823 | 11791382 | 3 | Paroxysmal nocturnal haemoglobinuria |
| 117913823 | 11791382 | 4 | Paroxysmal nocturnal haemoglobinuria |
| 117913823 | 11791382 | 5 | Paroxysmal nocturnal haemoglobinuria |
| 117913823 | 11791382 | 6 | Paroxysmal nocturnal haemoglobinuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117913823 | 11791382 | OT |
| 117913823 | 11791382 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117913823 | 11791382 | Enteritis infectious | |
| 117913823 | 11791382 | Haemolysis | |
| 117913823 | 11791382 | Ischaemic enteritis | |
| 117913823 | 11791382 | Thrombosis |
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 |
|---|---|---|---|---|---|---|
| 117913823 | 11791382 | 1 | 20130617 | 20130708 | 0 | |
| 117913823 | 11791382 | 2 | 20130716 | 0 | ||
| 117913823 | 11791382 | 3 | 20090413 | 0 | ||
| 117913823 | 11791382 | 4 | 20100902 | 20150608 | 0 | |
| 117913823 | 11791382 | 5 | 20051215 | 20130826 | 0 | |
| 117913823 | 11791382 | 6 | 20090409 | 0 |