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
127295531 12729553 1 I 20160902 20160909 20160909 EXP IL-JNJFOC-20160905610 JANSSEN BAZ RC, SHAIN KH, ALSINA M, BRAYER J, RASHAL T, COOKSEY J, ET AL. PHASE I TRIAL OF THE COMBINATION OF SELINEXOR (SEL), LIPOSOMAL DOXORUBICIN (DOX) AND DEXAMETHASONE (DEX) FOR RELAPSED AND REFRACTORY MULTIPLE MYELOMA (RRMM). JOURNAL OF CLINICAL ONCOLOGY 2016;34 (SUPPL 15):8013. 0.00 Y 0.00000 20160909 OT IL IL

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
127295531 12729553 1 PS DOXORUBICIN HYDROCHLORIDE. DOXORUBICIN HYDROCHLORIDE 1 Intravenous (not otherwise specified) U U 50718 20 MG/M**2 LIPOSOME INJECTION
127295531 12729553 2 SS SELINEXOR SELINEXOR 1 Unknown U 0 UNSPECIFIED
127295531 12729553 3 SS SELINEXOR SELINEXOR 1 Unknown U 0 UNSPECIFIED
127295531 12729553 4 SS SELINEXOR SELINEXOR 1 Unknown U 0 UNSPECIFIED
127295531 12729553 5 SS DEXAMETHASONE. DEXAMETHASONE 1 Unknown U 0 UNSPECIFIED
127295531 12729553 6 SS DEXAMETHASONE. DEXAMETHASONE 1 Unknown U 0 UNSPECIFIED
127295531 12729553 7 SS DEXAMETHASONE. DEXAMETHASONE 1 Unknown U 0 UNSPECIFIED

Indications of drugs used

Event ID CASEID INDI DRUG SEQ INDI PT
127295531 12729553 1 Plasma cell myeloma
127295531 12729553 2 Plasma cell myeloma
127295531 12729553 3 Plasma cell myeloma
127295531 12729553 4 Plasma cell myeloma
127295531 12729553 5 Plasma cell myeloma
127295531 12729553 6 Plasma cell myeloma
127295531 12729553 7 Plasma cell myeloma

Outcome of event

Event ID CASEID OUTC COD
127295531 12729553 OT

Reactions reported

Event ID CASEID DRUG REC ACT PT
127295531 12729553 Anaemia
127295531 12729553 Diarrhoea
127295531 12729553 Fatigue
127295531 12729553 Hyperglycaemia
127295531 12729553 Hyponatraemia
127295531 12729553 Nausea
127295531 12729553 Neutropenia
127295531 12729553 Thrombocytopenia
127295531 12729553 Vomiting

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

no results found

Therapies reported

no results found