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
125965722 12596572 2 F 20091215 20160722 20160727 20160729 EXP JP-ROCHE-1607871 ROCHE ARUGA T, KUROI [****] AND SHINICHIRO HORIGUCHI, KOTOWARISHA] GOTO, TOMOYUKI ARIGA, YAMASHITA YEAR ET AL. P2 -2-71 ONE EXAMPLE (NEGATIVE PRIMARY ORIGIN HER2 WHERE T-DM1 WAS EFFECTIVE AND RELAPSE NEST HER2 POSITIVE MAMMARY CARCINOMA). THE 13TH JAPANESE MEDICAL PRACTICE ONCOLOGY ASSOCIATION SCIENCE MEETING (2015.7.16,17,18) SAPPORO CITY, HOKKAIDO 2015 JUL;:-. 9.00 DEC F Y 0.00000 20160729 MD JP JP

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
125965722 12596572 1 PS KADCYLA ADO-TRASTUZUMAB EMTANSINE 1 Intravenous drip 125427 3.6 MG/KG SOLUTION FOR INFUSION Q3W
125965722 12596572 2 SS KADCYLA ADO-TRASTUZUMAB EMTANSINE 1 Intravenous drip FREQUENCY IS UNCERTAIN?DOSE INTERRUPTED IN //2016 125427 148.8 MG SOLUTION FOR INFUSION
125965722 12596572 3 SS KADCYLA ADO-TRASTUZUMAB EMTANSINE 1 Intravenous drip DOSAGE IS UNCERTAIN 125427 SOLUTION FOR INFUSION
125965722 12596572 4 SS HERCEPTIN TRASTUZUMAB 1 Intravenous drip Y 103792 4 MG/KG SOLUTION FOR INFUSION QD
125965722 12596572 5 SS HERCEPTIN TRASTUZUMAB 1 Intravenous drip Y 103792 77 MG SOLUTION FOR INFUSION /wk
125965722 12596572 6 SS HERCEPTIN TRASTUZUMAB 1 Intravenous drip Y 103792 77 MG SOLUTION FOR INFUSION Q3W
125965722 12596572 7 SS HERCEPTIN TRASTUZUMAB 1 Intravenous drip Y 103792 85 MG SOLUTION FOR INFUSION Q3W
125965722 12596572 8 SS HERCEPTIN TRASTUZUMAB 1 Intravenous drip Y 103792 163 MG SOLUTION FOR INFUSION Q3W
125965722 12596572 9 SS HERCEPTIN TRASTUZUMAB 1 Intravenous drip Y 103792 213 MG SOLUTION FOR INFUSION Q3W
125965722 12596572 10 SS HERCEPTIN TRASTUZUMAB 1 Intravenous drip Y 103792 216 MG SOLUTION FOR INFUSION Q3W
125965722 12596572 11 SS HERCEPTIN TRASTUZUMAB 1 Intravenous drip Y 103792 216 MG SOLUTION FOR INFUSION Q3W
125965722 12596572 12 SS PACLITAXEL. PACLITAXEL 1 Intravenous drip DOSAGE IS UNCERTAIN.?MOST RECENT DOSE ON 08/JAN/2010. Y 0 100 MG
125965722 12596572 13 SS NAVELBINE VINORELBINE TARTRATE 1 Intravenous drip U 0 30 MG
125965722 12596572 14 C AROMASIN EXEMESTANE 1 Oral 0 25 MG
125965722 12596572 15 C XELODA CAPECITABINE 1 Oral 0 1800 MG TABLET
125965722 12596572 16 C XELODA CAPECITABINE 1 Oral 0 1800 MG TABLET
125965722 12596572 17 C TYKERB LAPATINIB DITOSYLATE 1 Oral 0 1250 MG
125965722 12596572 18 C DOCETAXEL. DOCETAXEL 1 Intravenous drip 0 60 MG
125965722 12596572 19 C GEMZAR GEMCITABINE HYDROCHLORIDE 1 Intravenous drip 0 1000 MG
125965722 12596572 20 C TULOBUTEROL TULOBUTEROL 1 Transdermal 0 2 MG QD
125965722 12596572 21 C AMBROXOL HYDROCHLORIDE AMBROXOL HYDROCHLORIDE 1 Oral 0 2 DF TABLET BID
125965722 12596572 22 C NEXIUM ESOMEPRAZOLE MAGNESIUM 1 Oral 0 1 DF CAPSULE QD
125965722 12596572 23 C SINGULAIR MONTELUKAST SODIUM 1 Oral 0 1 DF TABLET QD
125965722 12596572 24 C FLUTIDE DISKUS FLUTICASONE PROPIONATE 1 Respiratory (inhalation) 0 BID
125965722 12596572 25 C THEO-DUR THEOPHYLLINE ANHYDROUS 1 Oral 0 3 DF TABLET TID
125965722 12596572 26 C ACTONEL RISEDRONATE SODIUM 1 Oral 0 1 DF TABLET /wk
125965722 12596572 27 C BUFFERIN TABLETS (JAPAN) 2 Oral 0 1 DF TABLET QD
125965722 12596572 28 C TEPRENONE TEPRENONE 1 Oral 0 1 DF CAPSULE QD
125965722 12596572 29 C THYRADIN LEVOTHYROXINE 1 Oral 0 2 DF TABLET QD

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125965722 12596572 1 Breast cancer
125965722 12596572 4 Breast cancer
125965722 12596572 5 Breast cancer
125965722 12596572 6 Breast cancer
125965722 12596572 7 Breast cancer
125965722 12596572 8 Breast cancer
125965722 12596572 9 Breast cancer
125965722 12596572 10 Breast cancer
125965722 12596572 12 Breast cancer
125965722 12596572 13 Breast cancer
125965722 12596572 14 Breast cancer
125965722 12596572 15 Breast cancer
125965722 12596572 16 Breast cancer
125965722 12596572 17 Breast cancer
125965722 12596572 18 Breast cancer
125965722 12596572 19 Breast cancer
125965722 12596572 20 Asthma
125965722 12596572 21 Asthma
125965722 12596572 22 Gastritis
125965722 12596572 23 Asthma
125965722 12596572 24 Asthma
125965722 12596572 25 Asthma
125965722 12596572 26 Osteoporosis
125965722 12596572 28 Gastritis
125965722 12596572 29 Hypothyroidism

Outcome of event

Event ID CASEID OUTC COD
125965722 12596572 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125965722 12596572 Anaphylactic reaction
125965722 12596572 Febrile neutropenia
125965722 12596572 Interstitial lung disease
125965722 12596572 Nausea

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
125965722 12596572 1 20140218 20140603 0
125965722 12596572 2 20160315 0
125965722 12596572 3 20160621 0
125965722 12596572 4 20090219 20090219 0
125965722 12596572 5 20090226 20091214 0
125965722 12596572 6 20091215 20100108 0
125965722 12596572 7 20100109 20100628 0
125965722 12596572 8 20110301 20110804 0
125965722 12596572 9 20110805 20120813 0
125965722 12596572 10 20120814 20140217 0
125965722 12596572 11 20120814 20140217 0
125965722 12596572 12 20091215 0
125965722 12596572 13 20100109 20100628 0
125965722 12596572 14 20090219 20091214 0
125965722 12596572 15 20100629 20110228 0
125965722 12596572 16 20110301 20110804 0
125965722 12596572 17 20100629 20110228 0
125965722 12596572 18 20110805 20120813 0
125965722 12596572 19 20120814 20140217 0