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
111593162 11159316 2 F 201103 20160902 20150603 20160909 EXP JP-ALEXION-A201501938 ALEXION 5.00 YR F Y 13.00000 KG 20160909 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
111593162 11159316 1 PS SOLIRIS ECULIZUMAB 1 Intravenous (not otherwise specified) 600 MG, SINGLE Y A6839D01 125166 600 MG CONCENTRATE FOR SOLUTION FOR INFUSION QD
111593162 11159316 2 C CEFTAZIDIME. CEFTAZIDIME 1 Unknown 1.5 G, TID 0 1.5 G TID
111593162 11159316 3 C CLAFORAN CEFOTAXIME SODIUM 1 Unknown 1000 MG, BID 0 1000 MG BID
111593162 11159316 4 C SEPAMIT-R NIFEDIPINE 1 Oral 6 MG, TID 0 6 MG TID
111593162 11159316 5 C SEPAMIT-R NIFEDIPINE 1 Oral 0.9 G, TID 0 .9 G TID
111593162 11159316 6 C MICARDIS TELMISARTAN 1 Oral 8 MG, QD 0 8 MG TABLET QD
111593162 11159316 7 C MICARDIS TELMISARTAN 1 Oral 10 MG, QD 0 10 MG TABLET QD
111593162 11159316 8 C CARDENALIN DOXAZOSIN MESYLATE 1 Oral 0.3 MG, QD 0 .3 MG QD
111593162 11159316 9 C URALYT U /01675401/ POTASSIUM CITRATETRISODIUM CITRATE DIHYDRATE 1 Oral 2 G, BID 0 2 G BID
111593162 11159316 10 C URALYT U /01675401/ POTASSIUM CITRATETRISODIUM CITRATE DIHYDRATE 1 Oral 3 G, TID 0 3 G TID
111593162 11159316 11 C NEORAL CYCLOSPORINE 1 Oral 20 MG, BID 0 20 MG BID
111593162 11159316 12 C NEORAL CYCLOSPORINE 1 Oral 60 MG, BID 0 60 MG BID
111593162 11159316 13 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 Oral 10 MG, QD 0 10 MG QD
111593162 11159316 14 C PREDONINE PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE 1 0
111593162 11159316 15 C BIOTIN BIOTIN 1 Oral 1.25 G, BID 0 1.25 G BID
111593162 11159316 16 C L CARTIN FF LEVOCARNITINE 1 Oral 100 MG, BID 0 100 MG TABLET BID
111593162 11159316 17 C PHENOBAL /00023201/ PHENOBARBITAL 1 Oral 35 MG, BID 0 35 MG BID
111593162 11159316 18 C TRESIBA INSULIN DEGLUDEC 1 Subcutaneous 3 IU, QD 0 3 IU INJECTION QD
111593162 11159316 19 C NOVORAPID INSULIN ASPART 1 Subcutaneous 4.5 UNIT, 5TH PER DAY 0 INJECTION
111593162 11159316 20 C VENILON HUMAN IMMUNOGLOBULIN G 1 Intravenous drip 5 G, QMONTH 0 5 G INJECTION /month
111593162 11159316 21 C BIOLACTIS LACTOBACILLUS CASEI 1 Oral 1 G, QD 0 1 G QD
111593162 11159316 22 C BIOLACTIS LACTOBACILLUS CASEI 1 Oral 2 G, TID 0 2 G TID
111593162 11159316 23 C SINGULAIR MONTELUKAST SODIUM 1 Oral 4 MG, QD 0 4 MG QD
111593162 11159316 24 C ALFAROL ALFACALCIDOL 1 Oral 0.25 ?G, QD 0 .25 UG CAPSULE QD
111593162 11159316 25 C PROMAC /00024401/ NITROFURANTOIN 1 Oral 0.5 G, QD 0 .5 G QD
111593162 11159316 26 C RIBALL ALLOPURINOL 1 Oral 0.1 G, TID 0 .1 G GRANULE TID
111593162 11159316 27 C ALINAMIN /00257802/ 2 Oral 100 MG, BID 0 100 MG BID

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
111593162 11159316 1 Haemolytic uraemic syndrome
111593162 11159316 2 Product used for unknown indication
111593162 11159316 3 Product used for unknown indication
111593162 11159316 4 Haemolytic uraemic syndrome
111593162 11159316 5 Hypertension
111593162 11159316 6 Haemolytic uraemic syndrome
111593162 11159316 7 Hypertension
111593162 11159316 8 Haemolytic uraemic syndrome
111593162 11159316 9 Renal failure
111593162 11159316 11 Immunodeficiency
111593162 11159316 13 Haemolytic uraemic syndrome
111593162 11159316 14 Immunodeficiency
111593162 11159316 15 Prophylaxis
111593162 11159316 16 Prophylaxis
111593162 11159316 17 Haemolytic uraemic syndrome
111593162 11159316 18 Diabetes mellitus
111593162 11159316 19 Diabetes mellitus
111593162 11159316 20 Immunodeficiency
111593162 11159316 21 Prophylaxis
111593162 11159316 23 Asthma prophylaxis
111593162 11159316 24 Renal failure
111593162 11159316 25 Gastritis prophylaxis
111593162 11159316 26 Hyperlipidaemia
111593162 11159316 27 Vitamin B1 deficiency

Outcome of event

Event ID CASEID OUTC COD
111593162 11159316 DE
111593162 11159316 OT
111593162 11159316 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
111593162 11159316 Bone marrow failure
111593162 11159316 Immunodeficiency
111593162 11159316 Renal impairment
111593162 11159316 Staphylococcal infection
111593162 11159316 Thrombotic microangiopathy

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
111593162 11159316 1 20150319 20150319 0
111593162 11159316 2 20150306 20150317 0
111593162 11159316 3 20150325 20150330 0
111593162 11159316 4 20140401 20150224 0
111593162 11159316 5 20150225 20150518 0
111593162 11159316 6 20140401 20150224 0
111593162 11159316 7 20150225 20150518 0
111593162 11159316 8 20141229 20150518 0
111593162 11159316 9 20140401 20150223 0
111593162 11159316 10 20150224 20150421 0
111593162 11159316 11 20130827 20150411 0
111593162 11159316 12 20150412 20150518 0
111593162 11159316 13 20140405 20150518 0
111593162 11159316 15 20150309 20150429 0
111593162 11159316 16 20150317 20150518 0
111593162 11159316 17 20150101 20150518 0
111593162 11159316 18 20141111 0
111593162 11159316 19 20121010 20141110 0
111593162 11159316 20 20140501 20150518 0
111593162 11159316 21 20130827 20150223 0
111593162 11159316 22 20150224 20150518 0
111593162 11159316 23 20120726 20150518 0
111593162 11159316 24 20130827 20150421 0
111593162 11159316 25 20120229 20150414 0
111593162 11159316 26 20150225 20150518 0
111593162 11159316 27 20150309 20150421 0