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
125353571 12535357 1 I 20160622 20160707 20160707 EXP CZ-ACCORD-042109 ACCORD MRAZOVA, I. BEVACIZUMAB IN TREATMENT OF METASTATIC BREAST CANCER. ACTA MEDICINAE, NO. 3/2016, P. 30-33. 0.00 F Y 0.00000 20160707 MD CZ CZ

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
125353571 12535357 1 PS CAPECITABINE. CAPECITABINE 1 Oral 202593
125353571 12535357 2 SS PACLITAXEL/PACLITAXEL LIPOSOME PACLITAXEL 1 JAN-MAR-2011, 5TH, 6TH, 7TH SERIES OF PACLITAXEL U 75436
125353571 12535357 3 C AVASTIN BEVACIZUMAB 1 1-MAR-2012, AT 15 MG/KG, APR AND OCT-2012, 5-8/2012 AT 15 MG/KG, SEP-2012 AT SAME DOSE 0
125353571 12535357 4 C HERCEPTIN TRASTUZUMAB 1 0 Q3W
125353571 12535357 5 C BONDRONAT IBANDRONIC ACID 1 Intravenous (not otherwise specified) SUBSEQUENTLY WITHDRAWN AFTERWARDS 0
125353571 12535357 6 C FASLODEX FULVESTRANT 1 Subcutaneous ONCE IN 28 DAYS 0 500 MG
125353571 12535357 7 C FEMARA LETROZOLE 1 0 TABLET
125353571 12535357 8 C XGEVA DENOSUMAB 1 THAN ON OCT-2013 AND ON NOV-2013 IT WAS DISCONTINUED 0
125353571 12535357 9 C ZOMETA ZOLEDRONIC ACID 1 Intravenous (not otherwise specified) 0
125353571 12535357 10 C TAMOXIFEN/TAMOXIFEN CITRATE 2 0 TABLET
125353571 12535357 11 C MEGAPLEX 2 0 TABLET
125353571 12535357 12 C NAVELBINE VINORELBINE TARTRATE 1 Intravenous (not otherwise specified) NOV-2013 23RD APPLICATIONS AND THAN SUBSEQUENTLY WITHDRAWN 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
125353571 12535357 1 Breast cancer
125353571 12535357 2 Breast cancer
125353571 12535357 3 Breast cancer metastatic
125353571 12535357 4 Breast cancer
125353571 12535357 5 Breast cancer
125353571 12535357 6 Back pain
125353571 12535357 7 Arthralgia
125353571 12535357 8 Breast cancer
125353571 12535357 9 Breast cancer

Outcome of event

Event ID CASEID OUTC COD
125353571 12535357 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
125353571 12535357 Neurotoxicity
125353571 12535357 Off label use
125353571 12535357 Palmar-plantar erythrodysaesthesia syndrome

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
125353571 12535357 1 201204 201209 0
125353571 12535357 2 201101 201103 0
125353571 12535357 3 201304 0
125353571 12535357 4 201008 0
125353571 12535357 5 20120301 0
125353571 12535357 6 201109 0
125353571 12535357 7 201104 201108 0
125353571 12535357 8 201311 201311 0
125353571 12535357 9 201204 201301 0
125353571 12535357 10 200707 0
125353571 12535357 11 201211 201212 0
125353571 12535357 12 201304 0