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
125793171 12579317 1 I 20160509 20160713 20160721 20160721 EXP FR-JNJFOC-20160710587 PHARMACYCLICS 80.09 YR E F Y 0.00000 20160721 CN FR FR

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
125793171 12579317 1 SS IMBRUVICA IBRUTINIB 1 Oral N 0 CAPSULE
125793171 12579317 2 PS IMBRUVICA IBRUTINIB 1 Oral N 205552 CAPSULE
125793171 12579317 3 SS MABTHERA RITUXIMAB 1 Subcutaneous 0 UNSPECIFIED
125793171 12579317 4 SS MABTHERA RITUXIMAB 1 Subcutaneous 0 UNSPECIFIED
125793171 12579317 5 SS ALDARA IMIQUIMOD 1 Topical 1DOSE/DAY 0 1 DF CREAM
125793171 12579317 6 SS BACTRIM SULFAMETHOXAZOLETRIMETHOPRIM 1 Oral 0 UNSPECIFIED
125793171 12579317 7 SS ZELITREX VALACYCLOVIR HYDROCHLORIDE 1 Oral 0 UNSPECIFIED
125793171 12579317 8 SS OMEPRAZOLE. OMEPRAZOLE 1 Unknown 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125793171 12579317 1 Lymphoma
125793171 12579317 2 Mantle cell lymphoma
125793171 12579317 3 Lymphoma
125793171 12579317 4 Mantle cell lymphoma
125793171 12579317 5 Skin lesion
125793171 12579317 6 Product used for unknown indication
125793171 12579317 7 Product used for unknown indication
125793171 12579317 8 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
125793171 12579317 DE
125793171 12579317 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
125793171 12579317 Diarrhoea
125793171 12579317 Dizziness
125793171 12579317 Dry mouth
125793171 12579317 Fatigue
125793171 12579317 Headache
125793171 12579317 Insomnia
125793171 12579317 Nausea
125793171 12579317 Seizure
125793171 12579317 Tinnitus

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
125793171 12579317 1 201505 0
125793171 12579317 2 201505 0
125793171 12579317 3 201503 0
125793171 12579317 4 201503 0
125793171 12579317 5 20160503 20160524 0