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
126432731 12643273 1 I 20160808 20160811 20160811 EXP CN-ROCHE-1810583 ROCHE LI H, SHAO B, YAN Y, SONG G, LIU X, WANG J AND LIANG X. EFFICACY AND SAFETY OF TRASTUZUMAB COMBINED WITH CHEMOTHERAPY FOR FIRST-LINE TREATMENT AND BEYOND PROGRESSION OF HER2-OVEREXPRESSING ADVANCED BREAST CANCER. CHINESE JOURNAL OF CANCER RESEARCH = CHUNG-KUO YEN CHENG YEN CHIU 2016 JUN;28 (3):330-338. 0.00 F Y 0.00000 20160811 MD CN 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
126432731 12643273 1 PS Trastuzumab TRASTUZUMAB 1 Intravenous (not otherwise specified) 103792 SOLUTION FOR INFUSION
126432731 12643273 2 SS CAPECITABINE. CAPECITABINE 1 Unknown DAY 1 AND DAY 14 U 20896 1000 MG/M**2 TABLET BID
126432731 12643273 3 SS PACLITAXEL. PACLITAXEL 1 Unknown DAY 1 OR SAME DOSE DIVIDED IN DAY 1 AND THE EIGHTH DAY U 0 175 MG/M**2 Q3W
126432731 12643273 4 SS DOCETAXEL. DOCETAXEL 1 Unknown U 0
126432731 12643273 5 SS VINORELBINE VINORELBINEVINORELBINE TARTRATE 1 Unknown DAY 1 AND DAY 8 U 0 30 MG/M**2 Q3W
126432731 12643273 6 SS GEMCITABINE GEMCITABINEGEMCITABINE HYDROCHLORIDE 1 Unknown DAY 1 AND DAY 8 U 0 1000 MG/M**2 Q3W

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
126432731 12643273 1 HER-2 positive breast cancer
126432731 12643273 2 HER-2 positive breast cancer
126432731 12643273 3 HER-2 positive breast cancer
126432731 12643273 4 HER-2 positive breast cancer
126432731 12643273 5 HER-2 positive breast cancer
126432731 12643273 6 HER-2 positive breast cancer

Outcome of event

Event ID CASEID OUTC COD
126432731 12643273 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
126432731 12643273 Angina pectoris
126432731 12643273 Blood creatinine increased
126432731 12643273 Chills
126432731 12643273 Extremity necrosis
126432731 12643273 Haematotoxicity
126432731 12643273 Hepatic failure
126432731 12643273 Metastases to central nervous system
126432731 12643273 Pyrexia
126432731 12643273 Thrombosis
126432731 12643273 Traumatic lung injury

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

no results found

Therapies reported

no results found