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
100442016 10044201 6 F 201309 20150326 20140328 20150331 EXP US-ROCHE-1277849 ROCHE 2.00 DY M Y 2.72000 KG 20150331 N 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
100442016 10044201 1 PS Omalizumab OMALIZUMAB 1 TRANSPLACENTAL D 5369 QOW
100442016 10044201 2 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 3 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 4 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 5 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 6 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 7 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 8 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 9 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 10 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 11 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 12 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 13 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 14 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 15 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 16 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 17 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 18 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 19 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 20 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW
100442016 10044201 21 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 22 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 23 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 24 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY D 5369 225 MG QOW
100442016 10044201 25 SS Omalizumab OMALIZUMAB 1 TRANSMAMMARY PARENT ROUTE OF ADMINISTRATION: SUBCUTANEOUS D 5369 225 MG QOW

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
100442016 10044201 1 Product used for unknown indication

Outcome of event

Event ID CASEID OUTC COD
100442016 10044201 CA
100442016 10044201 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
100442016 10044201 Candida infection
100442016 10044201 Conjunctivitis
100442016 10044201 Ear infection
100442016 10044201 Exposure during breast feeding
100442016 10044201 Failure to thrive
100442016 10044201 Foetal exposure during pregnancy
100442016 10044201 Gastroenteritis
100442016 10044201 Movement disorder
100442016 10044201 Nasopharyngitis
100442016 10044201 Sinusitis
100442016 10044201 Torticollis
100442016 10044201 Upper respiratory tract infection

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
100442016 10044201 1 20121105 20130829 0
100442016 10044201 2 20130909 0
100442016 10044201 3 20130923 0
100442016 10044201 4 20131007 0
100442016 10044201 5 20131021 0
100442016 10044201 6 20131104 0
100442016 10044201 7 20131118 0
100442016 10044201 8 20131202 0
100442016 10044201 9 20131216 0
100442016 10044201 10 20131230 0
100442016 10044201 11 20140113 0
100442016 10044201 12 20140204 0
100442016 10044201 13 20140313 0
100442016 10044201 14 20140327 0
100442016 10044201 15 20140410 0
100442016 10044201 16 20140424 0
100442016 10044201 17 20140508 0
100442016 10044201 18 20140522 0
100442016 10044201 19 20140605 0
100442016 10044201 20 20140619 0
100442016 10044201 21 20140703 0
100442016 10044201 22 20140717 0
100442016 10044201 23 20140731 0
100442016 10044201 24 20140814 0
100442016 10044201 25 20140828 0