Table 3 Most common any grade or grade 3/4 TEAEs in the safety population.

From: Daratumumab/lenalidomide/dexamethasone in transplant-ineligible newly diagnosed myeloma: MAIA long-term outcomes

 

D-Rd (n = 364)

Rd (n = 365)

TEAE, n (%)

Any grade

Grade 3/4

Any grade

Grade 3/4

Hematologic

 Neutropenia

224 (61.5)

197 (54.1)

166 (45.5)

135 (37.0)

 Anemia

154 (42.3)

62 (17.0)

150 (41.1)

79 (21.6)

Nonhematologic

 Diarrhea

240 (65.9)

33 (9.1)

188 (51.5)

22 (6.0)

 Fatigue

164 (45.1)

33 (9.1)

114 (31.2)

17 (4.7)

 Constipation

157 (43.1)

6 (1.6)

137 (37.5)

2 (0.5)

 Peripheral edema

155 (42.6)

10 (2.7)

117 (32.1)

3 (0.8)

 Back pain

155 (42.6)

14 (3.8)

109 (29.9)

14 (3.8)

 Asthenia

136 (37.4)

19 (5.2)

101 (27.7)

18 (4.9)

 Nausea

133 (36.5)

7 (1.9)

88 (24.1)

2 (0.5)

 Insomnia

125 (34.3)

11 (3.0)

116 (31.8)

14 (3.8)

 Bronchitis

124 (34.1)

12 (3.3)

87 (23.8)

7 (1.9)

 Cough

123 (33.8)

2 (0.5)

65 (17.8)

0

 Dyspnea

119 (32.7)

12 (3.3)

63 (17.3)

4 (1.1)

 Pneumonia

113 (31.0)

71 (19.5)

66 (18.1)

39 (10.7)

 Weight decreased

112 (30.8)

10 (2.7)

69 (18.9)

11 (3.0)

 Peripheral sensory neuropathy

111 (30.5)

9 (2.5)

66 (18.1)

2 (0.5)

 Muscle spasms

111 (30.5)

2 (0.5)

86 (23.6)

5 (1.4)

  1. Any grade TEAEs and grade 3/4 TEAEs that are listed are those that occurred in ≥30% and ≥20% of patients in either group, respectively.
  2. TEAE treatment-emergent adverse event, D-Rd daratumumab plus lenalidomide/dexamethasone, Rd lenalidomide/dexamethasone.