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
125839011 12583901 1 I 20160712 20160722 20160722 EXP DK-JNJFOC-20160712077 JANSSEN GLINTBORG B, HOJGAARD P, HETLAND ML, KROGH NS, KOLLERUP G, JENSEN J, ET AL. IMPACT OF TOBACCO SMOKING ON RESPONSE TO TUMOUR NECROSIS FACTOR-ALPHA INHIBITOR TREATMENT IN PATIENTS WITH ANKYLOSING SPONDYLITIS: RESULTS FROM THE DANISH NATIONWIDE DANBIO REGISTRY. RHEUMATOLOGY (OXFORD) 2016;55 (4):659-668. 0.00 Y 0.00000 20160722 MD DK DK

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
125839011 12583901 1 PS INFLIXIMAB, RECOMBINANT INFLIXIMAB 1 Intravenous (not otherwise specified) U UNKNOWN 103772 LYOPHILIZED POWDER
125839011 12583901 2 SS GOLIMUMAB GOLIMUMAB 1 Subcutaneous U UNKNOWN 125289 SOLUTION FOR INJECTION
125839011 12583901 3 SS ADALIMUMAB ADALIMUMAB 1 Unknown 0 UNSPECIFIED
125839011 12583901 4 SS ETANERCEPT ETANERCEPT 1 Unknown 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125839011 12583901 1 Ankylosing spondylitis
125839011 12583901 2 Ankylosing spondylitis
125839011 12583901 3 Ankylosing spondylitis
125839011 12583901 4 Ankylosing spondylitis

Outcome of event

Event ID CASEID OUTC COD
125839011 12583901 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125839011 12583901 Drug ineffective
125839011 12583901 Infection
125839011 12583901 Neoplasm malignant

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

no results found

Therapies reported

no results found