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
127138901 12713890 1 I 20160829 20160905 20160905 EXP JP-AMGEN-JPNSP2016116459 AMGEN MURAYAMA T. A RANDOMIZED, DOUBLE-BLIND TRIAL OF PEGFILGRASTIM VERSUS FILGRASTIM FOR THE MANAGEMENT OF NEUTROPENIA DURING CHASE(R) CHEMOTHERAPY FOR MALIGNANT LYMPHOMA. BRITISH JOURNAL OF HAEMATOLOGY. 2016;174 (4):563-570 0.00 Y 0.00000 20160904 MD 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
127138901 12713890 1 PS pegfilgrastim PEGFILGRASTIM 1 Subcutaneous 3.6 MG, UNK U 125031 3.6 MG UNKNOWN FORMULATION
127138901 12713890 2 SS filgrastim FILGRASTIM 1 Unknown 50 MUG/M2, UNK U 0 50 UG/M**2 UNKNOWN FORMULATION
127138901 12713890 3 SS DEXAMETHASONE. DEXAMETHASONE 1 Intravenous (not otherwise specified) 40 MG, UNK (ON DAY 1-3) 0 40 MG
127138901 12713890 4 SS ETOPOSIDE. ETOPOSIDE 1 Intravenous (not otherwise specified) 100 MG/M2, UNK 0 100 MG/M**2
127138901 12713890 5 SS CYTARABINE. CYTARABINE 1 Intravenous (not otherwise specified) 2000 MG/M2, UNK (ON DAY 2-3) 0 2000 MG/M**2
127138901 12713890 6 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Intravenous (not otherwise specified) 1200 MG/M2, UNK 0 1200 MG/M**2
127138901 12713890 7 SS RITUXIMAB RITUXIMAB 1 Unknown UNK 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127138901 12713890 1 Neutropenia
127138901 12713890 2 Neutropenia
127138901 12713890 3 Lymphoma
127138901 12713890 4 Lymphoma
127138901 12713890 5 Lymphoma
127138901 12713890 6 Lymphoma
127138901 12713890 7 Lymphoma

Outcome of event

Event ID CASEID OUTC COD
127138901 12713890 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127138901 12713890 Febrile neutropenia

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

no results found

Therapies reported

no results found