try to be [1:20%) were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, peripheral sensory neuropathy, cough and dyspnea. The overall incidence of serious adverse reactions was 42% for the DVd group compared with 34% for the Vd group. Serious adverse reactions with at least a 2% greater incidence in the DVd arm compared to the Vd arm were upper respiratory tract infection (DVd 5% vs Vd 2%), diarrhea and atrial fibrillation (DVd 2% vs Vd 0% for each). Adverse reactions resulted in discontinuations for 7% (n=18) of patients in the DVd arm versus 9% (n=22) in the Vd arm. Table 6: Adverse reactions reported in 10% of patients and with at least a 5% frequency greater in the DVd arm Study 4 Adverse Reaction DVd (N=243) % Vd (N=237) % Any Grade Grade 3 Grade 4 Any Grade Grade 3 Grade 4 Key: D=daratumumab, Vd=bortezomib-dexamethasone. * Infusion reaction includes terms determined by investigators to be related to infusion, see description of Infusion Reactions below. edema peripheral, edema, generalized edema, peripheral swelling upper respiratory tract infection, bronchitis, sinusitis, respiratory tract infection viral, rhinitis, pharyngitis, respiratory tract infection, metapneumovirus infection, tracheobronchitis, viral upper respiratory tract infection, laryngitis, respiratory syncytial virus infection, staphylococcal pharyngitis, tonsillitis, viral pharyngitis, acute sinusitis, nasopharyngitis, bronchiolitis, bronchitis viral, pharyngitis streptococcal, tracheitis, upper respiratory tract infection bacterial, bronchitis bacterial, epiglottitis, laryngitis viral, oropharyngeal candidiasis, respiratory moniliasis, viral rhinitis, acute tonsillitis, rhinovirus infection cough, productive cough, allergic cough dyspnea, dyspnea exertional Infusion reactions * 45 9 0 0 0 0 Gastrointestinal disorders Diarrhea 32 3] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturers Janssen Pharmaceuticals, Inc. Johnson & Johnson Drug Class CD38 monoclonal antibodies Related Drugs CD38 monoclonal antibodies daratumumab Multiple Myeloma dexamethasone , Decadron , Revlimid , cyclophosphamide , Cytoxan , Adriamycin , doxorubicin , Velcade , Doxil , vincristine , lenalidomide , Pomalyst , thalidomide , bortezomib , carfilzomib , Ninlaro , Kyprolis , melphalan , daratumumab , Thalomid , Dexasone , pomalidomide , carmustine , ixazomib , More... Darzalex Rating No Reviews - Be the first! 10 /10 No Reviews - Be the first! 10 Rate it! enough
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