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
93954263 9395426 3 F 20160908 20130711 20160916 EXP CN-ASTELLAS-2013US007132 ASTELLAS WU S, LUO H, WANG L, ZHANG X, XIA B, XIE C ET AL. PHASE III RANDOMIZED STUDY OF ELECTIVE NODAL IRRADIATION PLUS ERLOTINIB COMBINED WITH CHEMOTHERAPY FOR ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ABSTRACT NUMBER: 4048). JOURNAL OF CLINICAL ONCOLOGY. 2016;34 (15 SUPPL):NO INFORMATION 47.00 YR M Y 0.00000 20160916 CN GB CN

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
93954263 9395426 1 PS Erlotinib ERLOTINIB 1 Oral U 21743 150 MG TABLET QD
93954263 9395426 2 SS CISPLATIN. CISPLATIN 1 Intravenous (not otherwise specified) 20 MG/M2, DAY 1-3 EVERY 4 WEEKS FOR 2 CYCLES U 0 20 MG/M**2 FORMULATION UNKNOWN
93954263 9395426 3 SS PACLITAXEL. PACLITAXEL 1 Intravenous (not otherwise specified) 135 MG/M2, DAY 1 EVERY 4 WEEKS FOR TWO CYCLES U 0 135 MG/M**2 FORMULATION UNKNOWN

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
93954263 9395426 1 Oesophageal squamous cell carcinoma
93954263 9395426 2 Oesophageal squamous cell carcinoma
93954263 9395426 3 Oesophageal squamous cell carcinoma

Outcome of event

Event ID CASEID OUTC COD
93954263 9395426 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
93954263 9395426 Haematotoxicity
93954263 9395426 Rash

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

no results found

Therapies reported

no results found