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Table 4 Common AEs reported in ≥10% of the safety population in either the ixazomib-Rd or placebo-Rd arm, plus other AEs of clinical importance

From: Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: China Continuation study

AE Ixazomib-Rd (n = 57) Placebo-Rd (n = 58)
All grades Grade 3 Grade 4 All grades Grade 3 Grade 4
Common AEs, n (%)
 Thrombocytopeniaa 39 (68) 10 (18) 4 (7) 36 (62) 8 (14) 3 (5)
 Neutropeniab 28 (49) 11 (19) 3 (5) 29 (50) 11 (19) 1 (2)
 Anemiac 20 (35) 7 (12) 0 31 (53) 15 (26) 1 (2)
 Pneumoniad 20 (35) 10 (18) 1 (2) 15 (26) 10 (17) 0
 Upper respiratory tract infection 19 (33) 3 (5) 0 14 (24) 1 (2) 0
 Leukopenia 17 (30) 5 (9) 0 10 (17) 1 (2) 0
 Hepatotoxicitye 12 (21) 3 (5) 0 5 (9) 0 0
 Herpes zoster 12 (21) 4 (7) 0 2 (3) 0 0
 Weight decreased 11 (19) 0 0 9 (16) 0 0
 Diarrhea 10 (18) 1 (2) 0 4 (7) 0 0
 Rashf 10 (18) 0 0 12 (21) 0 0
 Cough 9 (16) 0 0 3 (5) 0 0
 Pyrexia 7 (12) 0 0 8 (14) 0 0
 Hypokalemia 7 (12) 3 (5) 1 (2) 2 (3) 0 0
 Bone pain 6 (11) 1 (2) 0 4 (7) 1 (2) 0
 Insomnia 6 (11) 0 0 6 (10) 0 0
 Lymphopenia 6 (11) 2 (4) 0 1 (2) 0 0
 Fatigue 5 (9) 1 (2) 0 7 (12) 0 0
 Hypoesthesia 4 (7) 0 0 7 (12) 0 0
 Hyperglycemia 2 (4) 0 0 6 (10) 1 (2) 0
Other AEs of clinical interest, n (%)
 Other gastrointestinal AEs
  Nausea 5 (9) 0 0 2 (3) 0 0
  Vomiting 5 (9) 0 0 2 (3) 0 0
 Peripheral neuropathiesg 4 (7) 0 0 6 (10) 0 0
 Cardiovascular AEs
  Cardiac arrhythmiash 3 (5) 1 (2) 0 2 (3) 0 0
  Heart failurei 1 (2) 0 0 3 (5) 1 (2) 1 (2)
  Hypotensionj 1 (2) 0 0 0 0 0
 Acute renal failurek 2 (4) 0 0 5 (9) 2 (3) 0
 New primary malignancy 0 0 0 1 (2) 0 1 (2)
  1. aPooled rate of preferred terms thrombocytopenia and platelet count decreased
  2. bPooled rate of preferred terms neutropenia and neutrophil count decreased
  3. cPooled rate of anemia and red blood cell analyses
  4. dPooled rate of pneumonia, lung infection, and bronchitis
  5. ePooled rate of eight preferred terms in the high-level terms of liver function analyses, tissue enzyme analyses, hepatic enzyme and function abnormalities, protein metabolism disorders, and peritoneal and retroperitoneal disorders; grade 3 events included 1 reversible elevation of alanine aminotransferase in a non-active hepatitis B-carrying patient, 1 hypoalbuminemia reported concurrently with progressive disease (and with no other liver function test abnormalities), and 1 transient increase in blood alkaline phosphatase in the context of development of complete response; no events were classed as serious adverse events or led to discontinuation
  6. fPooled rate of 19 rash-related preferred terms
  7. gModified high-level term of peripheral neuropathies not elsewhere classified
  8. hCardiac arrhythmias standardized MedDRA query (SMQ)
  9. iModified cardiac failure SMQ
  10. jModified vascular hypotensive disorder high-level term and vascular test high-level term
  11. kAcute renal failure SMQ