Table 2 Toxicities according to study periods: induction therapy, high-dose melphalan and maintenance therapy.

From: Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age

Events

S1 n/%

S2 n/%

S3 n/%

p

Induction therapy

N = 349

N = 108

N = 141

 

 Any AE/SAE

205/58.7

78/72.2

96/68.1

0.02

 Infections and infestations (≥2°, SOC)

56/16.0

24/22.2

30/21.3

0.20

 Blood and lymphatic system disorders (≥3°, SOC)

66/18.9

28/25.9

35/24.8

0.16

 Gastrointestinal disorders (≥3°, SOC)

16/4.6

8/7.4

18/12.8

0.008

 Cardiac disorders (≥2°, SOC)

4/1.1

3/2.8

3/2.1

0.40

 Renal and urinary disorders (≥3°, SOC)

11/3.2

2/1.9

4/2.8

0.89

 Neuropathy (≥2°, specific term)

25/7.2

9/8.3

8/5.7

0.70

 Thromboembolic events (≥2°, specific term)

9/2.6

5/4.6

6/4.3

0.44

 Leukocyto- and/or neutropenia (≥3°, specific term)

73/20.9

35/32.4

32/22.7

0.05

 Thrombocytopenia (≥3°, specific term)

14/4.0

7/6.5

8/5.7

0.45

 Anemia (≥3°, specific term)

15/4.3

6/5.6

7/5.0

0.80

 Any SAE

74/21.2

41/38.0

57/40.4

<0.001

 SAE due to infections and infestations (SOC)

20/5.7

16/14.8

14/9.9

0.01

First MEL200/ASCT

N = 302

N = 96

N = 123

 

 Any SAE

43/14.2

16/16.7

42/34.1

<0.001

 SAE due to infections and infestations (SOC)

22/7.3

10/10.4

19/15.4

0.04

Second MEL200/ASCT

N = 104

N = 22

N = 29

 

 Any SAE

20/19.2

6/27.3

9/31.0

0.33

 SAE due to infections and infestations (SOC)

11/10.6

4/18.2

3/10.3

0.52

Lenalidomide maintenance

N = 273

N = 87

N = 107

 

 Any AE/SAE

188/68.9

62/71.3

78/72.9

0.74

 Infections and infestations (≥2°, SOC)

118/43.2

37/42.5

57/53.3

0.18

 Blood and lymphatic system disorders (≥3°, SOC)

92/33.7

27/31.0

37/34.6

0.88

 Gastrointestinal disorders (≥3°, SOC)

13/4.8

6/6.9

11/10.3

0.13

 Cardiac disorders (≥2°, SOC)

1/0.4

0/0.0

3/2.8

0.07

 Renal and urinary disorders (≥3°, SOC)

2/0.7

1/1.1

2/1.9

0.48

 Neuropathy (≥2°, specific term)

12/4.4

3/3.4

4/3.7

1.0

 Thromboembolic events (≥2°, specific term)

7/2.6

6/6.9

5/4.7

0.14

 Leukocyto- and/or neutropenia (≥3°, specific term)

92/33.7

29/33.3

30/28.0

0.56

 Thrombocytopenia (≥3°, specific term)

23/8.4

7/8.0

18/16.8

0.05

 Anemia (≥3°, specific term)

5/1.8

2/2.3

2/1.9

0.90

 Any SAE

81/29.7

30/34.5

50/46.7

0.01

 SAE due to infections and infestations (SOC)

48/17.6

13/14.9

31/29.0

0.02

  1. Detailed listing of (serious) adverse events according to treatment phases: induction therapy, MEL200/ASCT and maintenance therapy with respect to the three age groups ≤60 years (S1), 61–65 years (S2) and 66–70 years (S3). Adverse events were recorded applying the NCI CTCAE criteria (version 4.0, ≥2° for infections, cardiac disorders, neuropathy or thromboembolic events or if an serious adverse event occurred, otherwise, only if ≥3°) and systematically analyzed using the MedDRA terminology. For MEL200/ASCT, only SAE were available. Specific AE/SOC terms are presented if considered relevant and may subsummarize different primary terms according to MedDRA.
  2. Bold p values are statistically significant.
  3. AE adverse event, SAE serious AE, NCI CTCAE National Cancer Institute Common Terminology Criteria for Adverse Events, SOC System Organ Class (according to MedDRA terminology).
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