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
106852706 10685270 6 F 20141116 20160906 20141231 20160909 EXP JP-ASTELLAS-2014JP027262AA ASTELLAS NIITSU Y, TAKEUCHI Y, WATANABE S, ITO K, KINNO K, SAWADA Y, ET AL.. A CASE OF PROSTATE CANCER THAT STATUS EPILEPTICUS WAS NOTED AFTER THE ADMINISTRATION OF ENZALUTAMIDE. JAPANESE JOURNAL OF UROLOGICAL SURGERY. 2016;29 (7):1194 83.86 YR M Y 55.00000 KG 20160909 CN 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
106852706 10685270 1 PS XTANDI ENZALUTAMIDE 1 Oral 6240 MG 203415 160 MG CAPSULE QD
106852706 10685270 2 SS CRAVIT LEVOFLOXACIN 1 Oral 1000 MG 0 500 MG TABLET QD
106852706 10685270 3 SS CRAVIT LEVOFLOXACIN 1 Oral 1000 MG 0 250 MG TABLET QD
106852706 10685270 4 C NEXIUM ESOMEPRAZOLE MAGNESIUM 1 Oral U 0 20 MG CAPSULE QD
106852706 10685270 5 C SENNOSIDE /00571901/ SENNOSIDES A AND B 1 Oral U 0 12 MG TABLET QD
106852706 10685270 6 C ADONA /00056903/ CARBAZOCHROME SODIUM SULFONATE 1 Oral UNK UNK, AS NEEDED U 0 TABLET
106852706 10685270 7 C TRANSAMIN TRANEXAMIC ACID 1 Oral UNK UNK, AS NEEDED U 0 CAPSULE

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
106852706 10685270 1 Hormone-refractory prostate cancer
106852706 10685270 2 Urinary tract infection
106852706 10685270 4 Gastrooesophageal reflux disease
106852706 10685270 5 Constipation
106852706 10685270 6 Haematuria
106852706 10685270 7 Haematuria

Outcome of event

Event ID CASEID OUTC COD
106852706 10685270 OT
106852706 10685270 HO
106852706 10685270 LT

Reactions reported

Event ID CASEID DRUG REC ACT PT
106852706 10685270 Haematuria
106852706 10685270 Seizure
106852706 10685270 Urinary tract infection
106852706 10685270 Vomiting

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
106852706 10685270 1 20141016 20141125 0
106852706 10685270 2 20141116 20141117 0
106852706 10685270 3 20141118 201411 0
106852706 10685270 4 20140801 0
106852706 10685270 5 20140903 0
106852706 10685270 6 20141123 0
106852706 10685270 7 20141123 0