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
122440433 12244043 3 F 20110308 20160707 20160406 20160714 EXP JP-ALEXION-A201200945 ALEXION 47.00 YR M Y 74.00000 KG 20160714 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
122440433 12244043 1 PS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 600 MG, QW 125166 600 MG CONCENTRATE FOR SOLUTION FOR INFUSION /wk
122440433 12244043 2 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 900 MG, Q2W AE3116D01 125166 900 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
122440433 12244043 3 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 35 MG, QD 1050 MG 0 35 MG QD
122440433 12244043 4 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 2.5 MG, UNK 1050 MG 0 2.5 MG
122440433 12244043 5 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 2.5 MG, UNK 1050 MG 0 2.5 MG
122440433 12244043 6 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 2.5 MG, QOD 1050 MG 0 2.5 MG QOD
122440433 12244043 7 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 5 MG, UNK 1050 MG 0 5 MG
122440433 12244043 8 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 5 MG, UNK 1050 MG 0 5 MG
122440433 12244043 9 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 20 MG, UNK 1050 MG 0 20 MG
122440433 12244043 10 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 10 MG, UNK 1050 MG 0 10 MG
122440433 12244043 11 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 5 MG, UNK 1050 MG 0 5 MG
122440433 12244043 12 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Unknown 2.5 MG, QD 1050 MG 0 2.5 MG QD
122440433 12244043 13 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 5 MG, QD 1050 MG 0 5 MG QD
122440433 12244043 14 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 5 MG, QD 1050 MG 0 5 MG QD
122440433 12244043 15 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 UNK 1050 MG 0
122440433 12244043 16 C PREDNISOLONE. PREDNISOLONE 1 Unknown 4 MG, QD 0 4 MG TABLET QD
122440433 12244043 17 C PREDNISOLONE. PREDNISOLONE 1 Unknown 1 MG, QD 0 1 MG TABLET QD
122440433 12244043 18 C PREDNISOLONE. PREDNISOLONE 1 Unknown 1 MG, QOD 0 1 MG TABLET QOD
122440433 12244043 19 C PREDNISOLONE. PREDNISOLONE 1 Oral 4 MG, UNK 0 4 MG TABLET
122440433 12244043 20 C PREDNISOLONE. PREDNISOLONE 1 Oral 4 MG, UNK 0 4 MG TABLET
122440433 12244043 21 C PREDNISOLONE. PREDNISOLONE 1 Oral 3 MG, UNK 0 3 MG TABLET
122440433 12244043 22 C PREDNISOLONE. PREDNISOLONE 1 Oral 2 MG, UNK 0 2 MG TABLET
122440433 12244043 23 C PREDNISOLONE. PREDNISOLONE 1 Oral 1 MG, UNK 0 1 MG TABLET
122440433 12244043 24 C PREDNISOLONE. PREDNISOLONE 1 Oral 1 MG, UNK 0 1 MG TABLET
122440433 12244043 25 C PREDNISOLONE. PREDNISOLONE 1 Oral 4 MG, UNK 0 4 MG TABLET
122440433 12244043 26 C PREDNISOLONE. PREDNISOLONE 1 Oral 3 MG, UNK 0 3 MG TABLET
122440433 12244043 27 C PREDNISOLONE. PREDNISOLONE 1 Oral 2 MG, UNK 0 2 MG TABLET
122440433 12244043 28 C PREDNISOLONE. PREDNISOLONE 1 4 MG, QD 0 4 MG TABLET QD
122440433 12244043 29 C PREDNISOLONE. PREDNISOLONE 1 Oral 1 MG, QD 0 1 MG TABLET QD
122440433 12244043 30 C PREDNISOLONE. PREDNISOLONE 1 Oral 3 G, QD 0 3 G TABLET QD
122440433 12244043 31 C PREDNISOLONE. PREDNISOLONE 1 Oral 2 G, QD 0 2 G TABLET QD
122440433 12244043 32 C PREDNISOLONE. PREDNISOLONE 1 Oral 4 G, QD 0 4 G TABLET QD
122440433 12244043 33 C PREDNISOLONE. PREDNISOLONE 1 Oral 3 G, QD 0 3 G TABLET QD
122440433 12244043 34 C GASTER FAMOTIDINE 1 Oral 20 MG, UNK 0 20 MG
122440433 12244043 35 C BASEN /01290601/ VOGLIBOSE 1 Oral 0.6 MG, UNK 0 .6 MG
122440433 12244043 36 C NORVASC AMLODIPINE BESYLATE 1 Oral 5 MG, UNK 0 5 MG
122440433 12244043 37 C ACTONEL RISEDRONATE SODIUM 1 Oral 17.5 MG, QD 0 17.5 MG QD
122440433 12244043 38 C LIMETHASONE DEXAMETHASONE PALMITATEGLYCERINLECITHINSOYBEAN OIL 1 Intravenous (not otherwise specified) 2.5 MG, QW 0 2.5 MG INJECTION /wk
122440433 12244043 39 C VOGLIBOSE VOGLIBOSE 1 Oral 0.6 MG, QD 0 .6 MG QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
122440433 12244043 1 Paroxysmal nocturnal haemoglobinuria
122440433 12244043 3 Product used for unknown indication
122440433 12244043 16 Product used for unknown indication
122440433 12244043 34 Product used for unknown indication
122440433 12244043 35 Product used for unknown indication
122440433 12244043 36 Product used for unknown indication
122440433 12244043 37 Product used for unknown indication
122440433 12244043 38 Product used for unknown indication
122440433 12244043 39 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
122440433 12244043 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
122440433 12244043 Cholelithiasis
122440433 12244043 Hepatic function abnormal
122440433 12244043 Hyperbilirubinaemia
122440433 12244043 Nasopharyngitis
122440433 12244043 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
122440433 12244043 1 20110107 20110128 0
122440433 12244043 2 20110204 0
122440433 12244043 3 20051205 20060103 0
122440433 12244043 4 20120203 20120329 0
122440433 12244043 5 20120428 20120622 0
122440433 12244043 6 20120623 20120706 0
122440433 12244043 7 20120914 20120928 0
122440433 12244043 8 20121027 20121221 0
122440433 12244043 9 20131206 20131213 0
122440433 12244043 10 20131214 20131220 0
122440433 12244043 11 20131221 20131228 0
122440433 12244043 12 20131229 20140117 0
122440433 12244043 13 20141121 20150425 0
122440433 12244043 14 20160213 20160226 0
122440433 12244043 16 200601 20110121 0
122440433 12244043 17 20120330 20120427 0
122440433 12244043 18 20120707 20120720 0
122440433 12244043 19 20120929 20121026 0
122440433 12244043 20 20121222 20130118 0
122440433 12244043 21 20130119 20130215 0
122440433 12244043 22 20130215 20130621 0
122440433 12244043 23 20130622 20131205 0
122440433 12244043 24 20140118 20140619 0
122440433 12244043 25 20140620 20140703 0
122440433 12244043 26 20140704 20140717 0
122440433 12244043 27 20140718 20140731 0
122440433 12244043 28 20150426 20150925 0
122440433 12244043 29 20140801 20141120 0
122440433 12244043 30 20150926 20160114 0
122440433 12244043 31 20160115 20160212 0
122440433 12244043 32 20160227 20160331 0
122440433 12244043 33 20160401 0
122440433 12244043 34 20060329 20110217 0
122440433 12244043 35 20060427 0
122440433 12244043 36 20100324 20120817 0
122440433 12244043 37 20090525 20110127 0
122440433 12244043 38 20120608 20120831 0
122440433 12244043 39 20140801 0