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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116507543 | 11650754 | 3 | F | 20130904 | 20160915 | 20151021 | 20160926 | EXP | JP-ALEXION-A201401745 | ALEXION | 72.00 | YR | M | Y | 56.00000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116507543 | 11650754 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600-300 MG, QW | Y | 125166 | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | |||||||
| 116507543 | 11650754 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, Q2W | Y | AA8793B02 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 116507543 | 11650754 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, SINGLE | Y | AA8793B02 | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | ||||
| 116507543 | 11650754 | 4 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, SINGLE | Y | 125166 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QD | |||||
| 116507543 | 11650754 | 5 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | Y | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 116507543 | 11650754 | 6 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, Q2W | Y | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||||
| 116507543 | 11650754 | 7 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 300 MG, Q2W | Y | AD6547B01 | 125166 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | ||||
| 116507543 | 11650754 | 8 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 20 MG, DAILY | Y | 0 | 20 | MG | QD | ||||||
| 116507543 | 11650754 | 9 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | 15-7MG, DAILY | Y | 0 | QD | ||||||||
| 116507543 | 11650754 | 10 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | 7-1 MG DAILY | Y | 0 | ||||||||||
| 116507543 | 11650754 | 11 | C | NEORAL | CYCLOSPORINE | 1 | Oral | 50 MG, UNK | 0 | 50 | MG | ||||||||
| 116507543 | 11650754 | 12 | C | NEORAL | CYCLOSPORINE | 1 | Oral | 40 MG, UNK | 0 | 40 | MG | ||||||||
| 116507543 | 11650754 | 13 | C | NEORAL | CYCLOSPORINE | 1 | Oral | 200 MG, QD | 0 | 200 | MG | QD | |||||||
| 116507543 | 11650754 | 14 | C | NESP | DARBEPOETIN ALFA | 1 | Intravenous (not otherwise specified) | 120 ?G, Q2W | 0 | 120 | UG | INJECTION | QOW | ||||||
| 116507543 | 11650754 | 15 | C | BUFFERIN /00009201/ | ASPIRINDIHYDROXYALUMINUM AMINOACETATE ANHYDROUSMAGNESIUM CARBONATE | 1 | Intravenous (not otherwise specified) | 81 MG, DAILY | 0 | 81 | MG | INJECTION | |||||||
| 116507543 | 11650754 | 16 | C | MICARDIS | TELMISARTAN | 1 | Oral | 20 MG, DAILY | 0 | 20 | MG | ||||||||
| 116507543 | 11650754 | 17 | C | BAKTAR | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 1 G, TIW | 0 | 1 | G | TIW | |||||||
| 116507543 | 11650754 | 18 | C | FEBURIC | FEBUXOSTAT | 1 | Unknown | 10-20 MG, DAILY | 0 | ||||||||||
| 116507543 | 11650754 | 19 | C | PARIET | RABEPRAZOLE SODIUM | 1 | Oral | 10 MG, DAILY | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116507543 | 11650754 | 1 | Paroxysmal nocturnal haemoglobinuria |
| 116507543 | 11650754 | 8 | Haemolysis |
| 116507543 | 11650754 | 11 | Paroxysmal nocturnal haemoglobinuria |
| 116507543 | 11650754 | 14 | Paroxysmal nocturnal haemoglobinuria |
| 116507543 | 11650754 | 15 | Paroxysmal nocturnal haemoglobinuria |
| 116507543 | 11650754 | 16 | Product used for unknown indication |
| 116507543 | 11650754 | 17 | Product used for unknown indication |
| 116507543 | 11650754 | 18 | Product used for unknown indication |
| 116507543 | 11650754 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116507543 | 11650754 | LT |
| 116507543 | 11650754 | HO |
| 116507543 | 11650754 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116507543 | 11650754 | Acute myeloid leukaemia | |
| 116507543 | 11650754 | Anaemia | |
| 116507543 | 11650754 | Diabetes mellitus | |
| 116507543 | 11650754 | Drug ineffective | |
| 116507543 | 11650754 | Gastrointestinal haemorrhage | |
| 116507543 | 11650754 | Haemolysis | |
| 116507543 | 11650754 | Inappropriate schedule of drug administration | |
| 116507543 | 11650754 | Incorrect dose administered | |
| 116507543 | 11650754 | Platelet count decreased | |
| 116507543 | 11650754 | Renal failure | |
| 116507543 | 11650754 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 116507543 | 11650754 | 1 | 20130904 | 20131002 | 0 | |
| 116507543 | 11650754 | 2 | 20131009 | 20140423 | 0 | |
| 116507543 | 11650754 | 3 | 20140507 | 20140507 | 0 | |
| 116507543 | 11650754 | 4 | 20140508 | 20140508 | 0 | |
| 116507543 | 11650754 | 5 | 20140521 | 20150814 | 0 | |
| 116507543 | 11650754 | 6 | 20150828 | 20150925 | 0 | |
| 116507543 | 11650754 | 7 | 20151009 | 20151023 | 0 | |
| 116507543 | 11650754 | 8 | 20140507 | 20140514 | 0 | |
| 116507543 | 11650754 | 9 | 20140515 | 0 | ||
| 116507543 | 11650754 | 11 | 200801 | 0 | ||
| 116507543 | 11650754 | 13 | 20160112 | 0 | ||
| 116507543 | 11650754 | 14 | 20130422 | 20151225 | 0 | |
| 116507543 | 11650754 | 15 | 20120924 | 20150925 | 0 | |
| 116507543 | 11650754 | 16 | 20130903 | 20151211 | 0 | |
| 116507543 | 11650754 | 17 | 200810 | 0 | ||
| 116507543 | 11650754 | 18 | 20130927 | 0 | ||
| 116507543 | 11650754 | 19 | 20150408 | 0 |