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
124631573 12463157 3 F 20160302 20160811 20160614 20160816 EXP US-ROCHE-1771433 ROCHE 47.00 YR F Y 78.30000 KG 20160816 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
124631573 12463157 1 PS Pertuzumab PERTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 1 DAY 1 ?LOADING DOSE 125409 840 MG SOLUTION FOR INFUSION
124631573 12463157 2 SS Pertuzumab PERTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 2-6 DAY 1?MOST RECENT DOSE ADMINISTERED: 26/FEB/2016 AND 08/APR/2016 (CYCLE 4, 420 MG)?MAINTE 125409 420 MG SOLUTION FOR INFUSION Q3W
124631573 12463157 3 SS Trastuzumab TRASTUZUMAB 1 Intravenous (not otherwise specified) LOADING DOSE ON DAY 1 CYCLE 1 103792 8 MG/KG SOLUTION FOR INFUSION
124631573 12463157 4 SS Trastuzumab TRASTUZUMAB 1 Intravenous (not otherwise specified) CYCLE 2-6 DAY 1?MAINTENANCE DOSE?MOST RECENT DOSE ADMINISTERED: 26/FEB/2016, 08/APR/2016 (CYCLE 4, 4 103792 6 MG/KG SOLUTION FOR INFUSION Q3W
124631573 12463157 5 SS DOCETAXEL. DOCETAXEL 1 Intravenous (not otherwise specified) CYCLE 1 DAY 1?CYCLE 2-6 DAY 1 RECEIVED ON 26 /FEB/2016 AND CYCLE 4 ON 08/APR/2016 (138MG) 0 75 MG/M**2 Q3W
124631573 12463157 6 SS CARBOPLATIN. CARBOPLATIN 1 Intravenous (not otherwise specified) AUC=6 MG/ML/MIN IV OVER 30-60 MIN ON DAY 1 Q3 WEEKS?CYCLE 2-6 DAY 1 RECEIVED ON 26 /FEB/2016 AND CYC 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
124631573 12463157 1 Breast cancer
124631573 12463157 3 Breast cancer
124631573 12463157 5 Breast cancer
124631573 12463157 6 Breast cancer

Outcome of event

Event ID CASEID OUTC COD
124631573 12463157 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
124631573 12463157 Enterocolitis infectious
124631573 12463157 Hypokalaemia
124631573 12463157 Nausea
124631573 12463157 Vomiting

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
124631573 12463157 1 20160205 0
124631573 12463157 3 20160205 0
124631573 12463157 5 20160205 0
124631573 12463157 6 20160205 0