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
121788074 12178807 4 F 20150919 20160728 20160315 20160728 EXP MX-ROCHE-1639787 ROCHE 55.93 YR F Y 72.50000 KG 20160728 MD MX MX

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
121788074 12178807 1 PS Pertuzumab PERTUZUMAB 1 Intravenous (not otherwise specified) LOADING DOSE 1147117,1149553 125409 840 MG 1X
121788074 12178807 2 SS Pertuzumab PERTUZUMAB 1 Intravenous (not otherwise specified) MAINTENANCE DOSE?DATE OF MOST RECENT DOSE OF PERTUZUMAB PRIOR TO AE ONSET: 17/SEP/2015?DATE OF MOST 1147117,1149553 125409 420 MG SOLUTION FOR INFUSION Q3W
121788074 12178807 3 SS Trastuzumab TRASTUZUMAB 1 Intravenous (not otherwise specified) LOADING DOSE 1145825 103792 8 MG/KG SOLUTION FOR INFUSION 1X
121788074 12178807 4 SS Trastuzumab TRASTUZUMAB 1 Intravenous (not otherwise specified) MAINTENANCE DOSE?DATE OF MOST RECENT DOSE OF TRASTUZUMAB PRIOR TO AE ONSET: 17/SEP/2015?DATE OF MOST 1145825 103792 480 MG SOLUTION FOR INFUSION Q3W
121788074 12178807 5 SS DOCETAXEL. DOCETAXEL 1 Intravenous (not otherwise specified) DATE OF MOST RECENT DOSE OF TAXANE PRIOR TO AE ONSET: 17/SEP/2015?DATE OF MOST RECENT DOSE OF TAXANE 0 91 MG Q3W
121788074 12178807 6 SS CYCLOPHOSPHAMIDE. CYCLOPHOSPHAMIDE 1 Unknown 0
121788074 12178807 7 SS DOXORUBICIN DOXORUBICIN 1 Unknown 0
121788074 12178807 8 C METFORMIN METFORMIN HYDROCHLORIDE 1 Unknown 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
121788074 12178807 1 HER-2 positive breast cancer
121788074 12178807 3 HER-2 positive breast cancer
121788074 12178807 5 HER-2 positive breast cancer
121788074 12178807 6 HER-2 positive breast cancer
121788074 12178807 7 HER-2 positive breast cancer
121788074 12178807 8 Type 2 diabetes mellitus

Outcome of event

Event ID CASEID OUTC COD
121788074 12178807 HO
121788074 12178807 LT

Reactions reported

Event ID CASEID DRUG REC ACT PT
121788074 12178807 Dehydration

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
121788074 12178807 1 20150827 0
121788074 12178807 2 20150917 0
121788074 12178807 3 20150827 0
121788074 12178807 4 20150917 0
121788074 12178807 5 20150827 0
121788074 12178807 6 20150529 0
121788074 12178807 7 20150529 0
121788074 12178807 8 201408 0