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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126127891 | 12612789 | 1 | I | 20150610 | 20160722 | 20160801 | 20160801 | EXP | JP-ALXN-A201605424AA | ALEXION | 33.00 | YR | F | Y | 47.00000 | KG | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126127891 | 12612789 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||||
| 126127891 | 12612789 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AC6839D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126127891 | 12612789 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AC6841D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126127891 | 12612789 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | AE3116D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 126127891 | 12612789 | 5 | C | FOLIAMIN | FOLIC ACID | 1 | Unknown | 15 MG, QD | 0 | 15 | MG | QD | |||||||
| 126127891 | 12612789 | 6 | C | METHYCOBAL | METHYLCOBALAMIN | 1 | Unknown | 1500 ?G, QD | 0 | 1500 | UG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126127891 | 12612789 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 126127891 | 12612789 | 5 | Product used for unknown indication |
| 126127891 | 12612789 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126127891 | 12612789 | OT |
| 126127891 | 12612789 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126127891 | 12612789 | Blood bilirubin increased | |
| 126127891 | 12612789 | Haemolysis | |
| 126127891 | 12612789 | Infection | |
| 126127891 | 12612789 | Jaundice | |
| 126127891 | 12612789 | Nasopharyngitis | |
| 126127891 | 12612789 | Seasonal allergy | |
| 126127891 | 12612789 | Upper respiratory tract infection | |
| 126127891 | 12612789 | Upper respiratory tract inflammation |
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 |
|---|---|---|---|---|---|---|
| 126127891 | 12612789 | 1 | 20101214 | 20110104 | 0 | |
| 126127891 | 12612789 | 2 | 20110111 | 0 | ||
| 126127891 | 12612789 | 5 | 20090702 | 0 | ||
| 126127891 | 12612789 | 6 | 20140423 | 0 |