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
125298651 12529865 1 I 20160627 20160706 20160706 EXP US-ABBVIE-16K-163-1663301-00 ABBVIE 56.00 YR Y 0.00000 20160706 CN 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
125298651 12529865 1 PS HUMIRA ADALIMUMAB 1 Subcutaneous U UNKNOWN 125057 SOLUTION FOR INJECTION
125298651 12529865 2 SS HUMIRA ADALIMUMAB 1 U UNKNOWN 125057
125298651 12529865 3 SS REMICADE INFLIXIMAB 1 Unknown U UNKNOWN 0
125298651 12529865 4 SS REMICADE INFLIXIMAB 1 U UNKNOWN 0
125298651 12529865 5 SS IMURAN AZATHIOPRINE 1 Unknown U UNKNOWN 0
125298651 12529865 6 SS IMURAN AZATHIOPRINE 1 U UNKNOWN 0
125298651 12529865 7 C ORENCIA ABATACEPT 1 0
125298651 12529865 8 C VEDOLIZUMAB VEDOLIZUMAB 1 0
125298651 12529865 9 C VEDOLIZUMAB VEDOLIZUMAB 1 0
125298651 12529865 10 C PREDNISONE. PREDNISONE 1 0
125298651 12529865 11 C PREDNISONE. PREDNISONE 1 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125298651 12529865 1 Crohn's disease
125298651 12529865 2 Colitis
125298651 12529865 3 Crohn's disease
125298651 12529865 4 Colitis
125298651 12529865 5 Crohn's disease
125298651 12529865 6 Colitis
125298651 12529865 7 Colitis
125298651 12529865 8 Crohn's disease
125298651 12529865 9 Colitis
125298651 12529865 10 Crohn's disease
125298651 12529865 11 Colitis

Outcome of event

Event ID CASEID OUTC COD
125298651 12529865 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125298651 12529865 Colostomy
125298651 12529865 Drug specific antibody present
125298651 12529865 Gastrointestinal haemorrhage
125298651 12529865 Nausea
125298651 12529865 Post procedural complication
125298651 12529865 Procedural complication
125298651 12529865 Pyoderma gangrenosum
125298651 12529865 Stomal hernia
125298651 12529865 Wound dehiscence

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

no results found

Therapies reported

no results found