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
127633781 12763378 1 I 201503 20150410 20160920 20160920 EXP US-JNJFOC-20150411471 PHARMACYCLICS 70.00 YR E M Y 0.00000 20160920 MD US US

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
127633781 12763378 1 PS IBRUTINIB IBRUTINIB 1 Oral ON DAY 1-14 N 205552 560 MG CAPSULE QD
127633781 12763378 2 SS DEXAMETHASONE. DEXAMETHASONE 1 Oral DAY 1-5 0 10 MG/M**2 TABLET BID
127633781 12763378 3 SS CYTARABINE. CYTARABINE 1 Intravenous (not otherwise specified) 70 MG, CYCLE 2-6, DAY 1 AND 6, IT OR ICV 0 70 MG INTRAVENOUS INFUSION
127633781 12763378 4 SS ETOPOSIDE. ETOPOSIDE 1 Intravenous (not otherwise specified) OVER 30-60 MINUTES, ON DAY 2-5 0 50 MG/M**2 INTRAVENOUS INFUSION
127633781 12763378 5 SS DOXORUBICIN DOXORUBICIN 1 Intravenous (not otherwise specified) OVER 1 HOUR, DAY 2 0 50 MG/M**2 INTRAVENOUS INFUSION
127633781 12763378 6 SS RITUXIMAB RITUXIMAB 1 Intravenous (not otherwise specified) ON DAY 1-2 0 375 MG/M**2 INTRAVENOUS INFUSION
127633781 12763378 7 SS PEGFILGRASTIM PEGFILGRASTIM 1 Subcutaneous ON DAY 6 0 6 MG
127633781 12763378 8 SS TEMOZOLOMIDE. TEMOZOLOMIDE 1 Intravenous (not otherwise specified) 0 100 MG/M**2 INTRAVENOUS INFUSION

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127633781 12763378 1 Central nervous system lymphoma
127633781 12763378 2 Central nervous system lymphoma
127633781 12763378 3 Central nervous system lymphoma
127633781 12763378 4 Central nervous system lymphoma
127633781 12763378 5 Central nervous system lymphoma
127633781 12763378 6 Central nervous system lymphoma
127633781 12763378 7 Central nervous system lymphoma
127633781 12763378 8 Central nervous system lymphoma

Outcome of event

Event ID CASEID OUTC COD
127633781 12763378 LT
127633781 12763378 DE
127633781 12763378 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
127633781 12763378 Coma
127633781 12763378 Diarrhoea
127633781 12763378 Lung infection
127633781 12763378 Respiratory failure
127633781 12763378 Sepsis

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
127633781 12763378 1 20141015 0
127633781 12763378 2 20141015 0
127633781 12763378 4 20141016 0
127633781 12763378 5 20141016 0
127633781 12763378 6 20141015 0
127633781 12763378 7 20141016 0
127633781 12763378 8 20141016 0