The Safety Rates Drug Report

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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
110923303 11092330 3 F 20160908 20150506 20160913 EXP IT-ROCHE-1572353 ROCHE , CREMOLINI C, LOUPAKIS F, BARBARA C, DARGENIO F, MIRAGLIO E, MASI G, SALVATORE L, MARCUCCI L, ANTONUZZO L, CHIARA S, BANZI C, SCHIRRIPA M, AMOROSO D, BONETTI A, MARTIGNETTI A, PARIS M, BONI L, TOMCIKOVA D AND FALCONE A LACTATE DEHYDROGENASE (LDH) LEVELS TO PREDICT BENEFIT FROM THE CONTINUATION OF BEVACIZUMAB (BEV) BEYOND PROGRESSION IN METASTATIC COLORECTAL CANCER (MCRC): SUBGROUP ANALYSIS OF THE RANDOMIZED BEBYP STUDY [ABS NO:E15127]. JOURNAL OF CLINICAL ONCOLOGY 2016 MAY;34 (SUP15):-. 0.00 Y 0.00000 20160914 MD IT IT

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
110923303 11092330 1 PS Bevacizumab BEVACIZUMAB 1 Unknown U 125085
110923303 11092330 2 SS FOLINIC ACID LEUCOVORIN 1 Unknown U 0
110923303 11092330 3 SS FLUOROURACIL. FLUOROURACIL 1 Unknown U 0
110923303 11092330 4 SS OXALIPLATIN. OXALIPLATIN 1 Unknown U 0
110923303 11092330 5 SS IRINOTECAN IRINOTECAN 1 Unknown U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
110923303 11092330 1 Colorectal cancer metastatic
110923303 11092330 2 Colorectal cancer metastatic
110923303 11092330 3 Colorectal cancer metastatic
110923303 11092330 4 Colorectal cancer metastatic
110923303 11092330 5 Colorectal cancer metastatic

Outcome of event

Event ID CASEID OUTC COD
110923303 11092330 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
110923303 11092330 Arterial thrombosis
110923303 11092330 Diarrhoea
110923303 11092330 Febrile neutropenia
110923303 11092330 Haematuria
110923303 11092330 Hypertension
110923303 11092330 Neurotoxicity
110923303 11092330 Neutropenia
110923303 11092330 Stomatitis
110923303 11092330 Thrombocytopenia
110923303 11092330 Venous thrombosis
110923303 11092330 Vomiting

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

no results found

Therapies reported

no results found