Table 2 Summary of safety outcomes by age (<65 years and ≥65 years).

From: Daratumumab plus lenalidomide maintenance in newly diagnosed multiple myeloma after transplant: AURIGA subgroup analyses

 

D-R

R

 

<65 years (n = 59)

≥65 years (n = 37)

<65 years (n = 58)

≥65 years (n = 40)

Any grade TEAEs, n (%)

58 (98.3)

37 (100)

58 (100)

39 (97.5)

 Most commona

  Neutropeniab

40 (67.8)

22 (59.5)

36 (62.1)

24 (60.0)

  Diarrhea

33 (55.9)

26 (70.3)

31 (53.4)

23 (57.5)

  Fatigue

31 (52.5)

13 (35.1)

25 (43.1)

21 (52.5)

  URTI

26 (44.1)

14 (37.8)

12 (20.7)

14 (35.0)

  Cough

23 (39.0)

14 (37.8)

26 (44.8)

10 (25.0)

  Back pain

22 (37.3)

9 (24.3)

12 (20.7)

8 (20.0)

  Hypokalemia

20 (33.9)

13 (35.1)

24 (41.4)

12 (30.0)

  Arthralgia

20 (33.9)

12 (32.4)

20 (34.5)

16 (40.0)

  Leukopenia

19 (32.2)

6 (16.2)

17 (29.3)

12 (30.0)

  Nasal congestion

19 (32.2)

6 (16.2)

14 (24.1)

5 (12.5)

  Headache

18 (30.5)

6 (16.2)

9 (15.5)

8 (20.0)

  Nausea

14 (23.7)

12 (32.4)

17 (29.3)

9 (22.5)

  Thrombocytopenia

13 (22.0)

10 (27.0)

11 (19.0)

17 (42.5)

Grade 3/4 TEAEs, n (%)

45 (76.3)

26 (70.3)

37 (63.8)

29 (72.5)

 Most commonc

  Neutropeniab

26 (44.1)

19 (51.4)

25 (43.1)

16 (40.0)

  Lymphopenia

7 (11.9)

3 (8.1)

3 (5.2)

2 (5.0)

  Hypertension

6 (10.2)

1 (2.7)

3 (5.2)

1 (2.5)

  Leukopenia

6 (10.2)

3 (8.1)

2 (3.4)

4 (10.0)

  Hypokalemia

4 (6.8)

3 (8.1)

2 (3.4)

4 (10.0)

  Pneumonia

1 (1.7)

4 (10.8)

1 (1.7)

3 (7.5)

Grade 3/4 cytopenias, n (%)

31 (52.5)

21 (56.8)

27 (46.6)

19 (47.5)

Grade 3/4 infections, n (%)

11 (18.6)

7 (18.9)

6 (10.3)

7 (17.5)

COVID-19 events, n (%)

 Any grade

19 (32.2)

9 (24.3)

22 (37.9)

7 (17.5)

 Grade 3/4

1 (1.7)

0

3 (5.2)

0

Serious TEAEs, n (%)

14 (23.7)

15 (40.5)

7 (12.1)

15 (37.5)

 Most commond

  Pneumonia

1 (1.7)

3 (8.1)

1 (1.7)

3 (7.5)

TEAEs leading to discontinuation of any treatment component,e n (%)

7 (11.9)

7 (18.9)

4 (6.9)

4 (10.0)

Death due to TEAEs, n (%)

0

2 (5.4)

0

1 (2.5)

  1. D-R daratumumab/lenalidomide, R lenalidomide, TEAE treatment-emergent adverse event, URTI upper respiratory tract infection.
  2. aDefined as ≥30% of patients in either treatment group or age subgroup.
  3. bPreferred term grouping.
  4. cDefined as ≥10% of patients in either treatment group or age subgroup.
  5. dDefined as occurring in ≥3 patients in either treatment group or age subgroup.
  6. eIncludes patients who had TEAEs with an action of “drug withdrawn” taken for ≥1 component of study treatment on the “adverse event” complete report form page.
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