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
| 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) |
aPooled rate of preferred terms thrombocytopenia and platelet count decreased
bPooled rate of preferred terms neutropenia and neutrophil count decreased
cPooled rate of anemia and red blood cell analyses
dPooled rate of pneumonia, lung infection, and bronchitis
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
fPooled rate of 19 rash-related preferred terms
gModified high-level term of peripheral neuropathies not elsewhere classified
hCardiac arrhythmias standardized MedDRA query (SMQ)
iModified cardiac failure SMQ
jModified vascular hypotensive disorder high-level term and vascular test high-level term
kAcute renal failure SMQ