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
122818533 12281853 3 F 20140708 20160725 20160419 20160801 EXP JP-ALEXION-A201501222 ALEXION 65.00 YR M Y 76.00000 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
122818533 12281853 1 PS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 600 MG, QW 125166 600 MG CONCENTRATE FOR SOLUTION FOR INFUSION /wk
122818533 12281853 2 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 900 MG, Q2W A90993D01 125166 900 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
122818533 12281853 3 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 900 MG, Q2W AB6695B01 125166 900 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
122818533 12281853 4 SS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 900 MG, Q2W AD6547B01 125166 900 MG CONCENTRATE FOR SOLUTION FOR INFUSION QOW
122818533 12281853 5 SS SOLIRIS ECULIZUMAB 1 UNK 125166 CONCENTRATE FOR SOLUTION FOR INFUSION
122818533 12281853 6 C ENDOXAN /00021101/ CYCLOPHOSPHAMIDE 1 Unknown 100 MG, DAILY 21100 MG 0 100 MG QD
122818533 12281853 7 C BACTRAMIN SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 1 DF, TIW 0 TABLET TIW
122818533 12281853 8 C TRAZENTA LINAGLIPTIN 1 Oral 5 MG, QD 0 5 MG TABLET QD
122818533 12281853 9 C SUREPOST REPAGLINIDE 1 Oral 1.5 MG, DAILY 0 1.5 MG TABLET QD
122818533 12281853 10 C WARFARIN WARFARIN 1 Oral 1-2MG, QD 0 TABLET QD
122818533 12281853 11 C ADALAT NIFEDIPINE 1 Oral 20-40MG, QD 0 TABLET QD
122818533 12281853 12 C NU-LOTAN LOSARTAN POTASSIUM 1 Oral 50 MG, QD 0 50 MG TABLET QD
122818533 12281853 13 C CARVEDILOL. CARVEDILOL 1 Oral 10 MG, QD 0 10 MG TABLET QD
122818533 12281853 14 C HYDREA HYDROXYUREA 1 Oral 500-1000MG, DAILY 0 CAPSULE QD
122818533 12281853 15 C TAKEPRON LANSOPRAZOLE 1 Oral 15 MG, QD 0 15 MG TABLET QD
122818533 12281853 16 C FUROSEMIDE. FUROSEMIDE 1 Oral 20-40 MG, QD 0 TABLET QD
122818533 12281853 17 C FEBURIC FEBUXOSTAT 1 Oral 10-20MG, QD 0 TABLET QD
122818533 12281853 18 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 10-35 MG, QOD 0 TABLET QOD
122818533 12281853 19 C MAGMITT MAGNESIUM OXIDE 1 Oral 330-990 MG, DAILY 0 TABLET QD
122818533 12281853 20 C REBAMIPIDE REBAMIPIDE 1 Oral 300 MG, DAILY 0 300 MG TABLET QD
122818533 12281853 21 C CRAVIT LEVOFLOXACIN 1 Ophthalmic 5 ML, PRN 0 5 ML EYE DROPS /yr
122818533 12281853 22 C CRAVIT LEVOFLOXACIN 1 Oral 250 MG, QD 0 250 MG EYE DROPS QD
122818533 12281853 23 C DICLOD DICLOFENAC SODIUM 1 Ophthalmic 5 ML, PRN 0 5 ML EYE DROPS /yr
122818533 12281853 24 C RINDERON /00008501/ BETAMETHASONE 1 Nasal 5 ML, PRN 0 5 ML /yr
122818533 12281853 25 C LOXOPROFEN LOXOPROFEN 1 Oral UNK, PRN 0 TABLET /yr
122818533 12281853 26 C FLUMETHOLON FLUOROMETHOLONE 1 Ophthalmic 10 ML, PRN 0 10 ML EYE DROPS /yr
122818533 12281853 27 C LIXIANA EDOXABAN TOSILATE MONOHYDRATE 1 Oral 60 MG, QD 0 60 MG TABLET QD
122818533 12281853 28 C MAGCOROL P 2 Unknown UNK, PRN 0 /yr
122818533 12281853 29 C INAVIR /07146202/ 2 40 MG, QD 0 40 MG QD
122818533 12281853 30 C VITAMEDIN /00274301/ 2 Intravenous (not otherwise specified) UNK, QD 0 INJECTION QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
122818533 12281853 1 Paroxysmal nocturnal haemoglobinuria
122818533 12281853 6 Paroxysmal nocturnal haemoglobinuria
122818533 12281853 7 Product used for unknown indication
122818533 12281853 8 Product used for unknown indication
122818533 12281853 9 Product used for unknown indication
122818533 12281853 10 Paroxysmal nocturnal haemoglobinuria
122818533 12281853 11 Product used for unknown indication
122818533 12281853 12 Product used for unknown indication
122818533 12281853 13 Product used for unknown indication
122818533 12281853 14 Product used for unknown indication
122818533 12281853 15 Product used for unknown indication
122818533 12281853 16 Product used for unknown indication
122818533 12281853 17 Product used for unknown indication
122818533 12281853 18 Paroxysmal nocturnal haemoglobinuria
122818533 12281853 19 Product used for unknown indication
122818533 12281853 20 Product used for unknown indication
122818533 12281853 21 Product used for unknown indication
122818533 12281853 23 Product used for unknown indication
122818533 12281853 24 Product used for unknown indication
122818533 12281853 25 Product used for unknown indication
122818533 12281853 26 Product used for unknown indication
122818533 12281853 27 Product used for unknown indication
122818533 12281853 28 Product used for unknown indication
122818533 12281853 29 Product used for unknown indication
122818533 12281853 30 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
122818533 12281853 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
122818533 12281853 Drug ineffective
122818533 12281853 Renal impairment
122818533 12281853 Small intestinal ulcer haemorrhage

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
122818533 12281853 1 20120626 20120724 0
122818533 12281853 2 20120807 0
122818533 12281853 6 20131210 20150312 0
122818533 12281853 8 20150401 20150511 0
122818533 12281853 9 20150401 20160118 0
122818533 12281853 10 20120412 20151011 0
122818533 12281853 11 20120326 0
122818533 12281853 12 20120325 0
122818533 12281853 14 20121225 20160131 0
122818533 12281853 15 20120329 0
122818533 12281853 17 20150401 20160331 0
122818533 12281853 18 20140304 0
122818533 12281853 19 20150401 20160331 0
122818533 12281853 20 20150706 20150719 0
122818533 12281853 21 20150203 0
122818533 12281853 22 20150803 0
122818533 12281853 23 20150707 20150728 0
122818533 12281853 24 20150707 20150707 0
122818533 12281853 25 20150710 20160331 0
122818533 12281853 26 20150710 20150728 0
122818533 12281853 27 20151005 20151101 0
122818533 12281853 28 20160119 20160119 0
122818533 12281853 29 20160222 20160222 0
122818533 12281853 30 20160315 20160315 0