herapy in the KRd arm occurred in 27/392 (7%) patients compared with 27/389 (7%) patients who died due to adverse events within 30 days of the last dose of any Rd therapy. The most common cause of deaths occurring in patients (%) in the two arms (KRd versus Rd) included cardiac 10 (3%) versus 7 (2%), infection 9 (2%) versus 10 (3%), renal 0 (0%) versus 1 (< 1%), and other adverse reactions 9 (2%) versus 10 (3%). Serious adverse reactions were reported in 60% of the patients in the KRd arm and 54% of the patients in the Rd arm. The most common serious adverse reactions reported in the KRd arm as compared with the Rd arm were pneumonia (14% versus 11%), respiratory tract infection (4% versus 1.5%), pyrexia (4% versus 2%), and pulmonary embolism (3% versus 2%). Discontinuation due to any adverse reaction occurred in 26% in the KRd arm versus 25% in the Rd arm. Adverse reactions leading to discontinuation of Kyprolis occurred in 12% of patients and the most common reactions included pneumonia (1%), myocardial infarction (0.8%), and upper respiratory tract infection (0.8%).
Common Adverse Reactions (≥ 10%)
The adverse reactions in the first 12 cycles of therapy that occurred at a rate of 10% or greater in the KRd arm are presented in Table 8.
Table 8: Most Common Adverse Reactions (≥ 10% in the KRd Arm) Occurring in Cycles 1–12 (20/27 mg/m2 Regimen In Combination with Lenalidomide and Dexamethasone)
KRd = Kyprolis, lenalidomide, and dexamethasone; Rd = lenalidomide and dexamethasone
Pneumonia includes pneumonia and bronchopneumonia.
Peripheral neuropathies includes peripheral neuropathy, peripheral sensory neuropathy, and peripheral motor neuropathy.
Dyspnea includes dyspnea and dyspnea exertional.
Embolic and thrombotic events, venous include deep vein thrombosis, pulmonary embolism, thrombophlebitis superficial, thrombophlebitis, venous thrombosis limb, post thrombotic syndrome, venous thrombosis.
Hypertension includes hypertension, hypertensive crisis.
There were 274 (70%) patients in the KRd arm who received treatment beyond Cycle 12. There were no new clinically relevant adverse reactions that emerged in the later treatment cycles.
Adverse Reactions Occurring at a Frequency of < 10%
Blood and lymphatic system disorders: febrile neutropenia, lymphopenia
Cardiac disorders: cardiac arrest, cardiac failure, cardiac failure congestive, myocardial infarction, myocardial ischemia, pericardial effusion
Eye disorders: cataract, vision blurred
Gastrointestinal disorders: abdominal pain, abdominal pain upper, dyspepsia, toothache
General disorders and administration site conditions: chills, infusion site reaction, multi-organ failure, pain
Infections and infestations: influenza, sepsis, urinary tract infection, viral infection
Metabolism and nutrition disorders: dehydration, hyperkalemia, hyperuricemia, hypoalbuminemia, hyponatremia, tumor lysis syndrome
Musculoskeletal and connective tissue disorders: muscular weakness, myalgia
Nervous system disorders: hypoesthesia, paresthesia, deafness
Psychiatric disorders: anxiety, delirium
Renal and urinary disorders: renal failure, renal failure acute, renal impairment
Respiratory, thoracic and mediastinal disorders: dysphonia, epistaxis, oropharyngeal pain, pulmonary embolism, pulmonary edema
Skin and subcutaneous tissue disorders: erythema, hyperhidrosis, pruritus
Vascular disorders: deep vein thr |
