The Safety Rates Drug Report

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Drug     Injury     Quarter    

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