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
126209354 12620935 4 F 20141023 20160902 20160804 20160915 EXP IT-SUN PHARMACEUTICAL INDUSTRIES LTD-2016RR-121442 RANBAXY 76.38 YR F Y 73.00000 KG 20160915 OT 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
126209354 12620935 1 PS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Intravenous (not otherwise specified) 800 MG/M2, CYCLICAL Y U 78433 800 MG/M**2
126209354 12620935 2 SS PACLITAXEL. PACLITAXEL 1 Unknown 60 MG/M2, UNK Y U 0 60 MG/M**2
126209354 12620935 3 SS HERCEPTIN TRASTUZUMAB 1 Intravenous (not otherwise specified) 6 ?G/KG, CYCLICAL U U 0 6 UG/KG
126209354 12620935 4 SS KADCYLA ADO-TRASTUZUMAB EMTANSINE 1 Intravenous (not otherwise specified) 3.6 MG/KG CYCLICAL Y U L01XC14 0 3.6 MG/KG
126209354 12620935 5 C PARIET RABEPRAZOLE SODIUM 1 Unknown UNK U U 0
126209354 12620935 6 C RYTMONORM PROPAFENONE 1 Unknown UNK U U 0
126209354 12620935 7 C MICARDIS TELMISARTAN 1 Unknown UNK U U 0

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126209354 12620935 1 Breast cancer
126209354 12620935 2 Breast cancer
126209354 12620935 3 Breast cancer
126209354 12620935 4 Breast cancer
126209354 12620935 5 Gastritis
126209354 12620935 6 Hypertension
126209354 12620935 7 Hypertension

Outcome of event

Event ID CASEID OUTC COD
126209354 12620935 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
126209354 12620935 Diarrhoea
126209354 12620935 Dyspnoea exertional
126209354 12620935 Ejection fraction decreased
126209354 12620935 Myalgia
126209354 12620935 Thrombocytopenia
126209354 12620935 Vocal cord paralysis

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

no results found

Therapies reported

no results found