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
125870982 12587098 2 F 20141230 20160801 20160725 20160808 EXP PHHO2015DE001493 NOVARTIS 65.00 YR F Y 84.00000 KG 20160808 OT DE DE

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
125870982 12587098 1 PS EVEROLIMUS EVEROLIMUS 1 Oral 0.75 MG, BID 50 MG Y 21560 .75 MG TABLET BID
125870982 12587098 2 SS TACROLIMUS. TACROLIMUS 1 Oral 2 + 1.5MG 0 3.5 MG
125870982 12587098 3 SS TACROLIMUS. TACROLIMUS 1 Oral 0.75 MG, BID 0 .75 MG BID
125870982 12587098 4 SS TACROLIMUS. TACROLIMUS 1 Oral 0.5 MG, BID (0.50-0-0.50-0) 0 .5 MG BID
125870982 12587098 5 SS TACROLIMUS. TACROLIMUS 1 Oral 2.5 MG, QD (1-0-1.5-0) 0 2.5 MG QD
125870982 12587098 6 SS TACROLIMUS. TACROLIMUS 1 Oral 1.5 MG, BID 0 1.5 MG BID
125870982 12587098 7 SS TACROLIMUS. TACROLIMUS 1 Oral UNK 0
125870982 12587098 8 SS SIMULECT BASILIXIMAB 1 Intravenous (not otherwise specified) 20 MG U 0 20 MG 1X
125870982 12587098 9 SS AZATHIOPRINE. AZATHIOPRINE 1 Oral 150 MG, QD (150-0-0) Y 0 150 MG QD
125870982 12587098 10 SS DECORTIN H PREDNISOLONE 1 Oral 15 MG, QD 330 MG 0 15 MG QD
125870982 12587098 11 SS DECORTIN H PREDNISOLONE 1 Oral 0.75 MG, BID 330 MG 0 .75 MG BID
125870982 12587098 12 SS DECORTIN H PREDNISOLONE 1 Oral 5 MG, QD (5-0-0-0) 330 MG 0 5 MG QD
125870982 12587098 13 SS DECORTIN H PREDNISOLONE 1 Oral UNK 330 MG 0
125870982 12587098 14 SS DECORTIN H PREDNISOLONE 1 Oral 5 MG, QD 330 MG 0 5 MG QD
125870982 12587098 15 C CELLCEPT MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE 1 Oral 0.75 MG, BID U 0 .75 MG BID
125870982 12587098 16 C CELLCEPT MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL HYDROCHLORIDE 1 Oral 500 MG, BID (500 -0-500-0) U 0 500 MG BID
125870982 12587098 17 C CONCOR BISOPROLOL FUMARATE 1 Oral 5 MG, QD (1-0-0-0) 0 5 MG QD
125870982 12587098 18 C ATORVASTATIN ATORVASTATIN 1 Oral 80 MG, QD 0 80 MG QD
125870982 12587098 19 C LEVEMIR INSULIN DETEMIR 1 Subcutaneous IE (12-0-12-0-0) U 0
125870982 12587098 20 C LEVEMIR INSULIN DETEMIR 1 Subcutaneous IE (14-0-12-0-0) U 0
125870982 12587098 21 C KEPINOL SULFAMETHOXAZOLETRIMETHOPRIM 1 Unknown 480 MG, QD (1-0-0-0-0) U 0 480 MG QD
125870982 12587098 22 C ACTRAPID INSULIN HUMAN 1 Subcutaneous AS NEEDED 0
125870982 12587098 23 C CARMEN LERCANIDIPINE 1 Unknown 10 MG, BID (10-0-10-0) 0 10 MG BID
125870982 12587098 24 C CANDESARTAN CANDESARTAN 1 Oral 8 MG, BID 0 8 MG BID
125870982 12587098 25 C DELIX RAMIPRIL 1 Unknown 2.5 MG, BID (1-0-1-0-0) U 0 2.5 MG BID
125870982 12587098 26 C TOREM TORSEMIDE 1 Unknown 10 MG, BID (1-1-0-0) 0 10 MG BID
125870982 12587098 27 C ROCALTROL CALCITRIOL 1 Unknown 0.25 UG, QD (0-1-0-0-0) U 0 .25 UG QD
125870982 12587098 28 C VALCYTE VALGANCICLOVIR HYDROCHLORIDE 1 Unknown 450 MG, QD (1-0-0-0-0) U 0 450 MG QD
125870982 12587098 29 C OMEP OMEPRAZOLE 1 Unknown 40 MG, TID (1-1-1-0-0) U 0 40 MG TID
125870982 12587098 30 C ARANESP DARBEPOETIN ALFA 1 Unknown 40 UG, UNK (0-0-0-0-0) U 0 40 UG
125870982 12587098 31 C SPIRONOLACTONE. SPIRONOLACTONE 1 Oral 25 MG, ONCE/SINGLE 0 25 MG 1X
125870982 12587098 32 C CLEXANE ENOXAPARIN SODIUM 1 Subcutaneous 40 MG, QD (1-0-0-0-0) U 0 40 MG QD
125870982 12587098 33 C ROCEPHIN CEFTRIAXONE SODIUM 1 Intravenous (not otherwise specified) 2 G, QD (1-0-0-0-0) U 0 2 G QD
125870982 12587098 34 C ASS ^HEXAL^ ASPIRIN 1 Oral 100 MG, QD (1-0-0-0) 0 100 MG QD
125870982 12587098 35 C PANTOZOL PANTOPRAZOLE SODIUM 1 Unknown 40 MG, BID 0 40 MG BID
125870982 12587098 36 C BISOPROLOL BISOPROLOL 1 Oral 5 MG, QD (5-0-0) 0 5 MG QD
125870982 12587098 37 C RAMIPRIL. RAMIPRIL 1 Oral 2.5 MG, BID (2.5-0-2.5MG) 0 2.5 MG BID
125870982 12587098 38 C VIGANTOLETTEN CHOLECALCIFEROL 1 Unknown 1000 IE (1-0-0-0) U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125870982 12587098 1 Renal transplant
125870982 12587098 2 Renal transplant
125870982 12587098 8 Renal transplant
125870982 12587098 9 Renal transplant
125870982 12587098 10 Renal transplant
125870982 12587098 15 Renal transplant
125870982 12587098 17 Hypertension
125870982 12587098 18 Hyperlipidaemia
125870982 12587098 19 Diabetes mellitus
125870982 12587098 21 Product used for unknown indication
125870982 12587098 22 Diabetes mellitus
125870982 12587098 23 Hypertension
125870982 12587098 24 Hypertension
125870982 12587098 25 Product used for unknown indication
125870982 12587098 26 Oedema peripheral
125870982 12587098 27 Product used for unknown indication
125870982 12587098 28 Product used for unknown indication
125870982 12587098 29 Product used for unknown indication
125870982 12587098 30 Product used for unknown indication
125870982 12587098 31 Product used for unknown indication
125870982 12587098 32 Product used for unknown indication
125870982 12587098 33 Product used for unknown indication
125870982 12587098 34 Thrombosis prophylaxis
125870982 12587098 35 Prophylaxis
125870982 12587098 36 Hypertension
125870982 12587098 37 Hypertension
125870982 12587098 38 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
125870982 12587098 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
125870982 12587098 Candida infection
125870982 12587098 Hypokalaemia
125870982 12587098 Pulmonary oedema
125870982 12587098 Transplant failure
125870982 12587098 Ureteral necrosis
125870982 12587098 Urinary tract infection
125870982 12587098 Urosepsis
125870982 12587098 Wound dehiscence

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
125870982 12587098 1 20141225 20150126 0
125870982 12587098 2 20141225 0
125870982 12587098 6 20151115 0
125870982 12587098 7 20151117 0
125870982 12587098 8 20141224 0
125870982 12587098 9 20150519 20151115 0
125870982 12587098 10 20141225 0
125870982 12587098 13 20150515 0
125870982 12587098 15 20150127 0