Table 3 Overall safety profile and most common AEs with IRd induction and single-agent ixazomib maintenance

From: Ixazomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma: long-term follow-up including ixazomib maintenance

  All patients (N = 65) Patients who did not proceed to SCT (N = 42) Patients who received maintenance (N = 25)a
n (%)    AE onset in cycles 1–12 (IRd) AE onset in cycle 13+ (single-agent ixazomib)
Any grade ≥3 AE 51 (78) 36 (86) 17 (68) 12 (48)
Any serious AE 30 (46) 22 (52) 9 (36) 7 (28)
AE leading to any study drug dose reduction 37 (57) 27 (64) 19 (76) 2 (8)
AE leading to discontinuation of any of the study drugs 10 (15) 9 (21) 0 0
On-study deaths 2 (3) 2 (5) 0 0
Most common AEs (in >25% of the overall study population)
  Diarrhea 39 (60) 28 (67) 14 (56) 13 (52)
  Fatigue 39 (60) 27 (64) 18 (72) 2 (8)
  Nausea 36 (55) 24 (57) 12 (48) 8 (32)
  PN NECb 28 (43) 19 (45) 13 (52) 3 (12)
  Upper respiratory tract infection 28 (43) 19 (45) 9 (36) 9 (36)
  Constipation 26 (40) 17 (40) 13 (52) 2 (8)
  Vomiting 26 (40) 16 (38) 9 (36) 2 (8)
  Rashes eruptions and exanthemsb 23 (35) 15 (36) 11 (44) 3 (12)
  Back pain 22 (34) 14 (33) 7 (28) 5 (20)
  Peripheral edema 22 (34) 14 (33) 10 (40) 3 (12)
  Thrombocytopeniac 23 (35) 16 (38) 4 (16) 4 (16)
  Insomnia 21 (32) 14 (33) 8 (32) 1 (4)
  Cough 21 (32) 17 (40) 8 (32) 3 (12)
  Pain in extremity 20 (31) 15 (36) 5 (20) 9 (36)
  Dizziness 19 (29) 15 (36) 6 (24) 3 (12)
  Neutropeniac 20 (31) 12 (29) 5 (20) 0
  Pyrexia 18 (28) 13 (31) 6 (24) 2 (8)
  1. AE adverse event, NEC not elsewhere classified, PN peripheral neuropathy, SCT stem cell transplantation
  2. aData are split to represent AEs during IRd induction (cycles 1–12), and single-agent ixazomib maintenance; patients could have had a new-onset AE in both treatment periods
  3. bData represent higher-level terms
  4. cPooled terms