|
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
