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
127262161 12726216 1 I 20160902 20160908 20160908 EXP DE-MYLANLABS-2016M1037918 MYLAN MIHM J, LEYKING S, DIRKS J, SMOLA S, FLISER D, SESTER U, ET AL. IMMUNE-BASED GUIDANCE OF FOSCARNET TREATMENT DURATION IN A TRANSPLANT RECIPIENT WITH GANCICLOVIR-RESISTANT CYTOMEGALOVIRUS INFECTION. J-CLIN-VIROL 2016;82:5-8. 0.00 Y 0.00000 20160908 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
127262161 12726216 1 SS VALGANCICLOVIR. VALGANCICLOVIR 1 Unknown Y U 0
127262161 12726216 2 PS TACROLIMUS. TACROLIMUS 1 Unknown U U 90596
127262161 12726216 3 SS GANCICLOVIR. GANCICLOVIR 1 Intravenous (not otherwise specified) U U 0
127262161 12726216 4 C PREDNISOLONE. PREDNISOLONE 1 Unknown U U 0
127262161 12726216 5 C MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 Unknown 1000G [SIC] Y U 0
127262161 12726216 6 C ACICLOVIR ACYCLOVIR 1 Unknown U U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127262161 12726216 1 Prophylaxis
127262161 12726216 2 Immunosuppressant drug therapy
127262161 12726216 3 Cytomegalovirus infection
127262161 12726216 4 Immunosuppressant drug therapy
127262161 12726216 5 Immunosuppressant drug therapy

Outcome of event

Event ID CASEID OUTC COD
127262161 12726216 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127262161 12726216 Blood creatinine increased
127262161 12726216 Cytomegalovirus infection
127262161 12726216 Pathogen resistance

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found