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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126924871 | 12692487 | 1 | I | 20150304 | 20150626 | 20160829 | 20160829 | EXP | JP-ALEXION-A201502457 | ALEXION | 0.00 | Y | 0.00000 | 20160829 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126924871 | 12692487 | 1 | PS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 600 MG, QW | 10500 | MG | 125166 | 600 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /wk | ||||
126924871 | 12692487 | 2 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 10500 | MG | AC4114B02 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||
126924871 | 12692487 | 3 | SS | SOLIRIS | ECULIZUMAB | 1 | Intravenous (not otherwise specified) | 900 MG, Q2W | 10500 | MG | AC6839D01 | 125166 | 900 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | QOW | |||
126924871 | 12692487 | 4 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 150 MG, DAILY | 0 | ||||||||||
126924871 | 12692487 | 5 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 100 MG, DAILY | 0 | ||||||||||
126924871 | 12692487 | 6 | SS | NEORAL | CYCLOSPORINE | 1 | Unknown | 150 MG, DAILY | 0 | ||||||||||
126924871 | 12692487 | 7 | SS | NEORAL | CYCLOSPORINE | 1 | Unknown | 140MG DAILY | 0 | ||||||||||
126924871 | 12692487 | 8 | SS | NEORAL | CYCLOSPORINE | 1 | Unknown | 180 MG DAILY | 0 | 180 | MG | ||||||||
126924871 | 12692487 | 9 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 300 MG, DAILY | 0 | ||||||||||
126924871 | 12692487 | 10 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 320 MG, DAILY | 0 | ||||||||||
126924871 | 12692487 | 11 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 300MG DAILY | 0 | ||||||||||
126924871 | 12692487 | 12 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 250 MG, DAILY | 0 | ||||||||||
126924871 | 12692487 | 13 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 300 MG, DAILY | 0 | ||||||||||
126924871 | 12692487 | 14 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 350 MG, DAILY | 0 | ||||||||||
126924871 | 12692487 | 15 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 400 MG, DAILY | 0 | ||||||||||
126924871 | 12692487 | 16 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | 450 MG, DAILY | 0 | 450 | MG | ||||||||
126924871 | 12692487 | 17 | SS | NEORAL | CYCLOSPORINE | 1 | Oral | UNK | 0 | ||||||||||
126924871 | 12692487 | 18 | SS | ATG /00575401/ | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | 125 MG, DAILY | Y | 0 | 125 | MG | |||||||
126924871 | 12692487 | 19 | SS | ATG /00575401/ | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | UNK | Y | 0 | |||||||||
126924871 | 12692487 | 20 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Unknown | UNK | 0 | ||||||||||
126924871 | 12692487 | 21 | C | NESP | DARBEPOETIN ALFA | 1 | Subcutaneous | 120 MG, Q2W | 0 | 120 | MG | QOW | |||||||
126924871 | 12692487 | 22 | C | ORGARAN | DANAPAROID SODIUM | 1 | Subcutaneous | 2500 IU, DAILY | 0 | 2500 | IU | ||||||||
126924871 | 12692487 | 23 | C | FERROUS CITRATE | FERROUS CITRATE | 1 | Oral | 50 MG, DAILY | 0 | 50 | MG | ||||||||
126924871 | 12692487 | 24 | C | FOLIAMIN | FOLIC ACID | 1 | Oral | 5 MG, DAILY | 0 | 5 | MG | ||||||||
126924871 | 12692487 | 25 | C | FOLIAMIN | FOLIC ACID | 1 | Oral | 15 MG DAILY | 0 | 15 | MG | ||||||||
126924871 | 12692487 | 26 | C | BONZOL /00428701/ | 2 | Unknown | 200 MG, DAILY | 0 | 200 | MG | |||||||||
126924871 | 12692487 | 27 | C | BONZOL /00428701/ | 2 | Unknown | 100 MG, DAILY | 0 | 100 | MG | |||||||||
126924871 | 12692487 | 28 | C | WARFARIN | WARFARIN | 1 | Oral | 2 MG, DAILY | 0 | 2 | MG | ||||||||
126924871 | 12692487 | 29 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Oral | 20 MG, DAILY | 0 | 20 | MG | ||||||||
126924871 | 12692487 | 30 | C | G-CSF | GRANULOCYTE COLONY-STIMULATING FACTOR NOS | 1 | Unknown | UNK | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126924871 | 12692487 | 1 | Paroxysmal nocturnal haemoglobinuria |
126924871 | 12692487 | 4 | Paroxysmal nocturnal haemoglobinuria |
126924871 | 12692487 | 5 | Immunosuppression |
126924871 | 12692487 | 6 | Pancytopenia |
126924871 | 12692487 | 18 | Pancytopenia |
126924871 | 12692487 | 20 | Product used for unknown indication |
126924871 | 12692487 | 21 | Product used for unknown indication |
126924871 | 12692487 | 22 | Product used for unknown indication |
126924871 | 12692487 | 23 | Product used for unknown indication |
126924871 | 12692487 | 24 | Paroxysmal nocturnal haemoglobinuria |
126924871 | 12692487 | 26 | Paroxysmal nocturnal haemoglobinuria |
126924871 | 12692487 | 28 | Paroxysmal nocturnal haemoglobinuria |
126924871 | 12692487 | 29 | Product used for unknown indication |
126924871 | 12692487 | 30 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126924871 | 12692487 | OT |
126924871 | 12692487 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126924871 | 12692487 | Anaemia | |
126924871 | 12692487 | Herpes zoster | |
126924871 | 12692487 | Immunosuppressant drug therapy | |
126924871 | 12692487 | Pancytopenia |
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 |
---|---|---|---|---|---|---|
126924871 | 12692487 | 1 | 20140716 | 20140806 | 0 | |
126924871 | 12692487 | 2 | 20140813 | 0 | ||
126924871 | 12692487 | 4 | 20140604 | 20140924 | 0 | |
126924871 | 12692487 | 5 | 20140925 | 20141203 | 0 | |
126924871 | 12692487 | 6 | 20141204 | 20150204 | 0 | |
126924871 | 12692487 | 7 | 20150205 | 20150218 | 0 | |
126924871 | 12692487 | 8 | 20150219 | 20150331 | 0 | |
126924871 | 12692487 | 9 | 20150401 | 20150402 | 0 | |
126924871 | 12692487 | 10 | 20150403 | 20150413 | 0 | |
126924871 | 12692487 | 11 | 20150414 | 20150421 | 0 | |
126924871 | 12692487 | 12 | 20150422 | 20151013 | 0 | |
126924871 | 12692487 | 13 | 20151014 | 20151110 | 0 | |
126924871 | 12692487 | 14 | 20151111 | 20151221 | 0 | |
126924871 | 12692487 | 15 | 20151222 | 20160119 | 0 | |
126924871 | 12692487 | 16 | 20160120 | 0 | ||
126924871 | 12692487 | 18 | 20150330 | 20150403 | 0 | |
126924871 | 12692487 | 19 | 201503 | 20150403 | 0 | |
126924871 | 12692487 | 21 | 20160217 | 0 | ||
126924871 | 12692487 | 22 | 20150401 | 20150406 | 0 | |
126924871 | 12692487 | 23 | 20151125 | 20151222 | 0 | |
126924871 | 12692487 | 24 | 20130206 | 20140813 | 0 | |
126924871 | 12692487 | 25 | 20150722 | 0 | ||
126924871 | 12692487 | 26 | 20140723 | 20140805 | 0 | |
126924871 | 12692487 | 27 | 20140806 | 20140910 | 0 | |
126924871 | 12692487 | 28 | 20130206 | 20141217 | 0 | |
126924871 | 12692487 | 29 | 20150327 | 0 | ||
126924871 | 12692487 | 30 | 201503 | 201504 | 0 |