The Safety Rates Drug Report

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Drug     Injury     Quarter    

Person who experienced the adverse event (patient)

Event ID CASE I F COD FOLL SEQ IMAGE EVENT DT MFR DT FDA DT REPT COD MFR NUM MFR SNDR AGE AGE COD GNDR COD E SUB WT WT COD REPT DT OCCP COD DEATH DT TO MFR CONFID REPORTER COUNTRY
5120029 5849089 F 7 5120029-8 20040101 20060915 20060929 EXP 2005JP001398 ASTELLAS PHARMA US, INC. 64 YR M N 68 KG 20060922 MD JAPAN

Drug(s) used by person

Event ID DRUG SEQ ROLE COD DRUGNAME VAL VBM ROUTE DOSE VBM DECHAL RECHAL LOT NUM EXP DT NDA NUM
5120029 1007726843 PS PROGRAF 1 ORAL 1.00 MG, BID, ORAL N D 50708
5120029 1007747175 SS PYRIDOSTIGMINE BROMIDE 1 ORAL 120.00 MG, UID/QD, ORAL N D
5120029 1007747203 SS BUFFERIN 1 D D

Indications of drugs used

Event ID DRUG SEQ INDI PT
5120029 1007726843 MYASTHENIA GRAVIS

Outcome of event

Event ID OUTC COD
5120029 HO
5120029 OT

Reactions reported

Event ID PT
5120029 BIOPSY KIDNEY ABNORMAL
5120029 BLOOD URINE PRESENT
5120029 DEHYDRATION
5120029 DIABETES MELLITUS
5120029 DIARRHOEA
5120029 GLYCOSYLATED HAEMOGLOBIN INCREASED
5120029 HYPERPLASIA
5120029 INFLAMMATION
5120029 KIDNEY FIBROSIS
5120029 MUSCLE SPASMS
5120029 ORAL INTAKE REDUCED
5120029 RENAL IMPAIRMENT
5120029 RENAL TUBULAR ATROPHY
5120029 SEGMENTED HYALINIZING VASCULITIS
5120029 TUBULOINTERSTITIAL NEPHRITIS
5120029 URINARY CASTS

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

Event ID RPSR COD
5120029 FGN
5120029 HP
5120029 LIT
5120029 OTH

Therapies reported

Event ID DRUG SEQ START DT END DT DUR DUR COD
5120029 1007726843 20020723 20041222
5120029 1007747175 20020701 20041222