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
127765981 12776598 1 I 20160912 20160923 20160923 EXP JP-TEVA-694193ISR TEVA NANNO S, NAKANE T, OKAMURA H, NISHIMOTO M, KOH H, NAKAMAE H, ET AL. DISSEMINATED HORMOGRAPHIELLA ASPERGILLATA INFECTION WITH INVOLVEMENT OF THE LUNG, BRAIN, AND SMALL INTESTINE FOLLOWING ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION: CASE REPORT AND LITERATURE REVIEW. TRANSPL-INFECT-DIS 2016;18(4):611-616. 51.00 YR M Y 0.00000 20160923 OT 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
127765981 12776598 1 PS MYCOPHENOLATE MOFETIL. MYCOPHENOLATE MOFETIL 1 Unknown 1500 MILLIGRAM DAILY; D 65457 1500 MG QD
127765981 12776598 2 SS TACROLIMUS. TACROLIMUS 1 Unknown .03 MG/KG DAILY; D 90402 .03 MG/KG QD
127765981 12776598 3 SS Melphalan MELPHALAN 1 Unknown 40 MG/M2 X 2 DAYS; CONDITIONING REGIMEN U 0 40 MG/M**2
127765981 12776598 4 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Unknown 30 MG/M2 X 5 DAYS;CONDITIONING REGIMEN AND 30MG/M2 FOR 1 DAY U 0 30 MG/M**2
127765981 12776598 5 SS FLUDARABINE FLUDARABINE PHOSPHATE 1 Unknown 30MG/M2 FOR 1 DAY; 1 DAY REDUCED-INTENSITY CONDITIONING REGIMEN U 0
127765981 12776598 6 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Unknown 2000 MG/M2 X 1 DAY; REDUCED-INTENSITY CONDITIONING REGIMEN U 0 200 MG/M**2
127765981 12776598 7 C lenograstim LENOGRASTIM 1 Unknown FROM DAY 5 AFTER TRANSPLANTATION U 0
127765981 12776598 8 C ITRACONAZOLE. ITRACONAZOLE 1 Unknown FROM DAY 5 AFTER TRANSPLANTATION U 0
127765981 12776598 9 C aciclovir ACYCLOVIR 1 Unknown U 0
127765981 12776598 10 C LEVOFLOXACIN. LEVOFLOXACIN 1 Unknown U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127765981 12776598 1 Prophylaxis against graft versus host disease
127765981 12776598 2 Prophylaxis against graft versus host disease
127765981 12776598 8 Antifungal prophylaxis
127765981 12776598 9 Antiviral prophylaxis
127765981 12776598 10 Antibiotic prophylaxis

Outcome of event

Event ID CASEID OUTC COD
127765981 12776598 OT
127765981 12776598 DE

Reactions reported

Event ID CASEID DRUG REC ACT PT
127765981 12776598 Brain abscess
127765981 12776598 Fungal infection
127765981 12776598 Histiocytosis haematophagic
127765981 12776598 Pneumonia

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

no results found

Therapies reported

no results found