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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123178042 | 12317804 | 2 | F | 20160406 | 20160901 | 20160429 | 20160912 | EXP | JP-ALEXION PHARMACEUTICALS INC-A201603089 | ALEXION | 66.00 | YR | M | Y | 56.00000 | KG | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123178042 | 12317804 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 123178042 | 12317804 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE3116D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 123178042 | 12317804 | 3 | C | NEORAL | CYCLOSPORINE | 1 | Oral | 100 MG, BID | 0 | 100 | MG | BID | |||||||
| 123178042 | 12317804 | 4 | C | TANATRIL | IMIDAPRIL | 1 | Unknown | 0 | |||||||||||
| 123178042 | 12317804 | 5 | C | ARTIST | CARVEDILOL | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123178042 | 12317804 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 123178042 | 12317804 | 3 | Product used for unknown indication |
| 123178042 | 12317804 | 4 | Product used for unknown indication |
| 123178042 | 12317804 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123178042 | 12317804 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123178042 | 12317804 | Haemolysis | |
| 123178042 | 12317804 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 123178042 | 12317804 | 1 | 20131023 | 20131113 | 0 | |
| 123178042 | 12317804 | 2 | 20131120 | 0 | ||
| 123178042 | 12317804 | 3 | 20140305 | 0 |