Table 6 Most common grade 3/4 (≥10% of patients) TEAEs and TEAEs with an outcome of death (>1 patient; safety population)a.

From: Daratumumab plus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: frailty subgroup analysis of MAIA

 

Non-frailb

Frail

 

Fit (19.9%c; n = 145/729)

Intermediate (34.3%c; n = 250/729)

Total–non-frailb (54.2%c; n = 395/729)

Frail (45.8%c; n = 334/729)

 

D-Rd (18.7%d; n = 68/364)

Rd (21.1%e; n = 77/365)

D-Rd (35.2%d; n = 128/364)

Rd (33.4%e; n = 122/365)

D-Rd (53.8%d; n = 196/364)

Rd (54.5%e; n = 199/365)

D-Rd (46.2%d; n = 168/364)

Rd (45.5%e; n = 166/365)

Total number of patients with grade 3/4 TEAE, n (%)

58 (85.3)

61 (79.2)

117 (91.4)

104 (85.2)

175 (89.3)

165 (82.9)

159 (94.6)

148 (89.2)

Hematologic, n (%)

        

 Neutropenia

30 (44.1)

22 (28.6)

59 (46.1)

52 (42.6)

89 (45.4)

74 (37.2)

97 (57.7)

55 (33.1)

 Lymphopenia

7 (10.3)

7 (9.1)

18 (14.1)

14 (11.5)

25 (12.8)

21 (10.6)

31 (18.5)

18 (10.8)

 Leukopenia

7 (10.3)

2 (2.6)

11 (8.6)

10 (8.2)

18 (9.2)

12 (6.0)

22 (13.1)

9 (5.4)

 Anemia

4 (5.9)

11 (14.3)

17 (13.3)

24 (19.7)

21 (10.7)

35 (17.6)

28 (16.7)

40 (24.1)

 Thrombocytopenia

4 (5.9)

3 (3.9)

8 (6.3)

12 (9.8)

12 (6.1)

15 (7.5)

17 (10.1)

18 (10.8)

Non-hematologic, n (%)

        

 Infections

16 (23.5)

22 (28.6)

46 (35.9)

30 (24.6)

62 (31.6)

52 (26.1)

70 (41.7)

46 (27.7)

  Pneumonia

7 (10.3)

5 (6.5)

13 (10.2)

11 (9.0)

20 (10.2)

16 (8.0)

33 (19.6)

17 (10.2)

 Cataract

10 (14.7)

8 (10.4)

11 (8.6)

9 (7.4)

21 (10.7)

17 (8.5)

13 (7.7)

19 (11.4)

 Pulmonary embolism

8 (11.8)

5 (6.5)

6 (4.7)

9 (7.4)

14 (7.1)

14 (7.0)

7 (4.2)

5 (3.0)

 Hypokalemia

7 (10.3)

5 (6.5)

12 (9.4)

10 (8.2)

19 (9.7)

15 (7.5)

18 (10.7)

20 (12.0)

 Hyperglycemia

2 (2.9)

2 (2.6)

13 (10.2)

4 (3.3)

15 (7.7)

6 (3.0)

12 (7.1)

8 (4.8)

Total number of patients with TEAE with outcome of death, n (%)

1 (1.5)

3 (3.9)

6 (4.7)

4 (3.3)

7 (3.6)

7 (3.5)

20 (11.9)

20 (12.0)

 General physical health deterioration

0

0

0

1 (0.8)

0

1 (0.5)

2 (1.2)

1 (0.6)

 Pneumonia

0

0

0

0

0

0

2 (1.2)

3 (1.8)

 Myocardial infarction

0

0

0

2 (1.6)

0

2 (1.0)

1 (0.6)

1 (0.6)

 Cardiac arrest

0

0

0

0

0

0

1 (0.6)

2 (1.2)

 Sepsis

0

0

0

0

0

0

0

3 (1.8)

  1. TEAE treatment emergent adverse event, D-Rd daratumumab plus lenalidomide/dexamethasone, Rd lenalidomide/dexamethasone.
  2. aPercentages in the table were calculated using the number of patients in each treatment cohort per frailty subgroup of the safety population (fit: D-Rd, n = 68; Rd, n = 77; intermediate: D-Rd, n = 128; Rd, n = 122; total–non-frail: D-Rd, n = 196; Rd, n = 199; frail: D-Rd, n = 168; Rd, n = 166) as the denominator, unless otherwise indicated.
  3. bNon-frail subgroup consists of fit and intermediate patients.
  4. cPercentage was calculated using the number of patients in the safety population as the denominator.
  5. dPercentage was calculated using the number of patients in the D-Rd cohort of the safety population as the denominator.
  6. ePercentage was calculated using the number of patients in the Rd cohort of the safety population as the denominator.
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