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
127174391 12717439 1 I 20160902 20160906 20160906 EXP GB-JNJFOC-20160904194 JANSSEN BANERJEE SN, OZA AM, HAMILTON EP, HASAN J, LEARY A, MOORE KN, ET AL. A RANDOMIZED, OPEN-LABEL, PHASE II STUDY OF ANTI-NAPI2B ANTIBODY-DRUG CONJUGATE (ADC) LIFASTUZUMAB (LIFA) VEDOTIN (DNIB0600A) COMPARED TO PEGYLATED LIPOSOMAL DOXORUBICIN (PLD) IN PATIENTS (PTS) WITH PLATINUM-RESISTANT OVARIAN CANCER (PROC). JOURNAL OF CLINICAL ONCOLOGY 2016;34 (15):5569. 0.00 Y 0.00000 20160906 MD GB GB

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
127174391 12717439 1 PS DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) EVERY 4 WEEKS U 50718 40 MG/M**2 LIPOSOME INJECTION

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127174391 12717439 1 Ovarian cancer

Outcome of event

Event ID CASEID OUTC COD
127174391 12717439 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127174391 12717439 Adverse event
127174391 12717439 Neuropathy peripheral

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

no results found

Therapies reported

no results found