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
103592503 10359250 3 F 20160905 20140804 20160919 EXP SE-ROCHE-1440079 ROCHE LOMAN N, JOHANSSON I, BJOHLE J, FRISELL J, LEKBERG T, RYDEN L, VON WACHENFELDT A, BERGH J, HATSCHEK T AND HEDENFALK I PRELIMINARY TRANSLATIONAL RESULTS FROM PROMIX, A PHASE II TRIAL OF PREOPERATIVE CHEMOTHERAPY WITH THE ADDITION OF BEVACIZUMAB IN LARGE OPERABLE AND LOCALLY ADVANCED HER2-NEGATIVE BREAST CANCER. CANCER RESEARCH 2015 MAY 01;75 (9S1):-. 0.00 F Y 0.00000 20160919 MD SE SE

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
103592503 10359250 1 PS Bevacizumab BEVACIZUMAB 1 Unknown U 125085 15 MG/KG SOLUTION FOR INFUSION
103592503 10359250 2 SS DOCETAXEL. DOCETAXEL 1 Unknown U 0 75 MG/M**2
103592503 10359250 3 SS Epirubicin EPIRUBICIN 1 Unknown U 0 75 MG/M**2

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
103592503 10359250 1 Breast cancer
103592503 10359250 2 Breast cancer
103592503 10359250 3 Breast cancer

Outcome of event

Event ID CASEID OUTC COD
103592503 10359250 OT
103592503 10359250 HO

Reactions reported

Event ID CASEID DRUG REC ACT PT
103592503 10359250 Colitis
103592503 10359250 Fatigue
103592503 10359250 Haemorrhage
103592503 10359250 Hypersensitivity
103592503 10359250 Liver function test increased
103592503 10359250 Vomiting

Reporting Sources (this data is often not reported and may therefore be missing here)

no results found

Therapies reported

no results found