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Table 2 Treatment-emergent adverse events, discontinuation, and deaths at 18 months from randomization (safety population)

From: Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study

 

KRd (n = 392)

Rd (n = 389)

Patients with any-grade AE, n (%)

379 (96.7)

372 (95.6)

Grade ≥ 3 AE, n (%)

315 (80.4)

293 (75.3)

Serious AEs, n (%)

211 (53.8)

180 (46.3)

AE leading to treatment discontinuation, n (%)

83 (21.2)

81 (20.8)

AE leading to death, n (%)

25 (6.4)

29 (7.5)

Any-grade AEs of interest, n (%)

 Anemia

157 (40.1)

147 (37.8)

 Thrombocytopenia

107 (27.3)

84 (21.6)

 Neutropenia

137 (34.9)

126 (32.4)

 Hypertension

51 (13.0)

23 (5.9)

 Dyspnea (HLT)

82 (20.9)

67 (17.2)

 Peripheral neuropathy (SMQN)

59 (15.1)

55 (14.1)

 Cardiac failure (SMQN)

23 (5.9)

13 (3.3)

 Acute renal failure (SMQN)

26 (6.6)

24 (6.2)

Grade ≥ 3 AEs of interest, n (%)

 Anemia

69 (17.6)

65 (16.7)

 Thrombocytopenia

63 (16.1)

47 (12.1)

 Neutropenia

111 (28.3)

99 (25.4)

 Hypertension

16 (4.1)

5 (1.3)

 Dyspnea

10 (2.6)

6 (1.5)

 Peripheral neuropathy (SMQN)

9 (2.3)

9 (2.3)

 Cardiac failure (SMQN)

14 (3.6)

5 (1.3)

 Acute renal failure (SMQN)

9 (2.3)

12 (3.1)

  1. AE adverse event, HLT high-level term, KRd carfilzomib, lenalidomide, and dexamethasone, Rd lenalidomide and dexamethasone, SMQN standardized Medical Dictionary for Regulatory Activities query, narrow scope