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
1118307411 11183074 11 F 20150219 20160918 20150611 20160926 EXP PHHY2015IL022120 NOVARTIS 61.01 YR M Y 89.00000 KG 20160926 CN COUNTRY NOT SPECIFIED IL

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
1118307411 11183074 1 PS TASIGNA NILOTINIB 1 Oral 300 MG, BID U S0071, S0074, S0076 22068 300 MG CAPSULE BID
1118307411 11183074 2 C ENALADEX ENALAPRIL MALEATE 1 Unknown U 0
1118307411 11183074 3 C PLAVIX CLOPIDOGREL BISULFATE 1 Unknown U 0
1118307411 11183074 4 C CARDILOC BISOPROLOL FUMARATE 1 Unknown U 0
1118307411 11183074 5 C MICROPIRIN ASPIRIN 1 Unknown U 0
1118307411 11183074 6 C AMARYL GLIMEPIRIDE 1 Unknown 1 MG, QD 0 1 MG QD
1118307411 11183074 7 C AMARYL GLIMEPIRIDE 1 Unknown 1 MG, BID 0 1 MG BID
1118307411 11183074 8 C SIMVACOR SIMVASTATIN 1 Unknown U 0
1118307411 11183074 9 C BEZAFIBRATE BEZAFIBRATE 1 Unknown U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
1118307411 11183074 1 Chronic myeloid leukaemia
1118307411 11183074 2 Hypertension
1118307411 11183074 3 Product used for unknown indication
1118307411 11183074 4 Cardiac disorder
1118307411 11183074 5 Product used for unknown indication
1118307411 11183074 6 Type 2 diabetes mellitus
1118307411 11183074 8 Blood cholesterol increased
1118307411 11183074 9 Blood triglycerides abnormal

Outcome of event

Event ID CASEID OUTC COD
1118307411 11183074 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
1118307411 11183074 Asthenia
1118307411 11183074 Blood creatinine increased
1118307411 11183074 Blood glucose increased
1118307411 11183074 Blood triglycerides increased
1118307411 11183074 Diabetes mellitus inadequate control
1118307411 11183074 Eye haemorrhage
1118307411 11183074 Glycosylated haemoglobin increased
1118307411 11183074 Hyperhidrosis
1118307411 11183074 Proteinuria
1118307411 11183074 Vision blurred
1118307411 11183074 Weight increased

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
1118307411 11183074 1 20150201 0
1118307411 11183074 7 20160108 0