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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120925492 | 12092549 | 2 | F | 20130807 | 20160817 | 20160219 | 20160826 | EXP | JP-ALEXION PHARMACEUTICALS INC.-A201401690 | ALEXION | 76.00 | YR | M | Y | 73.00000 | KG | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120925492 | 12092549 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 120925492 | 12092549 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | A92094B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 120925492 | 12092549 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AA8443B01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 120925492 | 12092549 | 4 | C | PRIMOBOLAN /00044802/ | 2 | Oral | 15 MG, QD | 0 | 15 | MG | QD | ||||||||
| 120925492 | 12092549 | 5 | C | NESP | DARBEPOETIN ALFA | 1 | Intravenous (not otherwise specified) | 30 ?G, QD | 0 | 30 | UG | QD | |||||||
| 120925492 | 12092549 | 6 | C | NESP | DARBEPOETIN ALFA | 1 | Intravenous (not otherwise specified) | 180 ?G, QD | 0 | 180 | UG | QD | |||||||
| 120925492 | 12092549 | 7 | C | EXJADE | DEFERASIROX | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 0 | 600 | MG | /wk | |||||||
| 120925492 | 12092549 | 8 | C | EXJADE | DEFERASIROX | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 0 | 900 | MG | QOW | |||||||
| 120925492 | 12092549 | 9 | C | EXJADE | DEFERASIROX | 1 | Oral | UNK | 0 | ||||||||||
| 120925492 | 12092549 | 10 | C | EXJADE | DEFERASIROX | 1 | Oral | 500 MG, DAILY | 0 | 500 | MG | ||||||||
| 120925492 | 12092549 | 11 | C | FEBURIC | FEBUXOSTAT | 1 | Unknown | 10 MG, DAILY | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120925492 | 12092549 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 120925492 | 12092549 | 4 | Product used for unknown indication |
| 120925492 | 12092549 | 5 | Product used for unknown indication |
| 120925492 | 12092549 | 7 | Product used for unknown indication |
| 120925492 | 12092549 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120925492 | 12092549 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120925492 | 12092549 | Antibody test positive | |
| 120925492 | 12092549 | Decreased appetite | |
| 120925492 | 12092549 | Extravascular haemolysis | |
| 120925492 | 12092549 | Malaise | |
| 120925492 | 12092549 | Rash |
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 |
|---|---|---|---|---|---|---|
| 120925492 | 12092549 | 1 | 20100906 | 20100927 | 0 | |
| 120925492 | 12092549 | 2 | 20101006 | 0 | ||
| 120925492 | 12092549 | 4 | 20130721 | 20130810 | 0 | |
| 120925492 | 12092549 | 5 | 20120613 | 20150122 | 0 | |
| 120925492 | 12092549 | 6 | 20150528 | 0 | ||
| 120925492 | 12092549 | 7 | 20100906 | 20100927 | 0 | |
| 120925492 | 12092549 | 8 | 20101006 | 0 | ||
| 120925492 | 12092549 | 9 | 20140220 | 20140302 | 0 | |
| 120925492 | 12092549 | 10 | 20150529 | 0 | ||
| 120925492 | 12092549 | 11 | 20150319 | 0 |