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
125414191 12541419 1 I 20131128 20131202 20160708 20160708 EXP PHHO2013US017187 NOVARTIS 53.10 YR F Y 87.30000 KG 20160708 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
125414191 12541419 1 PS LAPATINIB LAPATINIB 1 Oral 1000 MG, 1D 16000 MG 22059 1000 MG FILM-COATED TABLET QD
125414191 12541419 2 SS LAPATINIB LAPATINIB 1 Oral 750 MG, QD 16000 MG 22059 750 MG FILM-COATED TABLET QD
125414191 12541419 3 SS TRASTUZUMAB TRASTUZUMAB 1 Intravenous (not otherwise specified) 6 MG/KG, Q3W 0 6 MG/KG
125414191 12541419 4 SS ANASTROZOLE. ANASTROZOLE 1 Intravenous (not otherwise specified) 1 MG, UNK U 0 1 MG
125414191 12541419 5 C ONDANSETRON ONDANSETRON 1 Intravenous (not otherwise specified) 4 MG, PRN U 0 4 MG
125414191 12541419 6 C MORPHINE SULFATE. MORPHINE SULFATE 1 Intravenous (not otherwise specified) 4 MG, PRN U 0 4 MG
125414191 12541419 7 C MAALOX MAX ALUMINUM HYDROXIDEDIMETHICONEMAGNESIUM HYDROXIDE 1 Oral 30 ML, SINGLE U 0 30 ML 1X

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125414191 12541419 1 Breast cancer metastatic
125414191 12541419 3 Breast cancer metastatic
125414191 12541419 4 Breast cancer metastatic
125414191 12541419 5 Nausea
125414191 12541419 6 Abdominal pain
125414191 12541419 7 Nausea

Outcome of event

Event ID CASEID OUTC COD
125414191 12541419 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
125414191 12541419 Diarrhoea
125414191 12541419 Hypokalaemia

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
125414191 12541419 1 20131113 20131201 0
125414191 12541419 2 20131211 20140207 0
125414191 12541419 3 20131111 0
125414191 12541419 4 20131111 20140214 0
125414191 12541419 5 20131201 20131205 0
125414191 12541419 6 20131130 20131201 0
125414191 12541419 7 20131201 20131201 0