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Table 4 Most common adverse events in the clarithromycin and placebo group

From: A randomized placebo-controlled phase II study of clarithromycin or placebo combined with VCD induction therapy prior to high-dose melphalan with stem cell support in patients with newly diagnosed multiple myeloma

 

Clarithromycin group, No = 27

Placebo group, No = 31

Any grade

Grade 3 or 4

Any grade

Grade 3 or 4

Hematologic events

 Thrombocytopenia

11 (40.7%)

2 (7.4%)

7 (22.6%)

0

 Anemia

12 (44.4%)

2 (7.4%)

11 (35.5%)

0

 Neutropenia

11 (40.7%)

1 (3.7%)

13 (41.9%)

0

Gastrointestinal events

 Typhlitis and perforation of colon

2 (7.4%)

2 (7.4%)

1 (3.2%)

1 (3.2%)

 Paralytic ileus

2 (7.4%)

2 (7.4%)

0

0

 Constipation

6 (22.2%)

1 (3.7%)

5 (16.1%)

0

 Diarrhea

4 (14.8%)

3 (11.1%)

5 (16.1%)

1 (3.2%)

 Dyspepsia

3 (11.1%)

0

1 (3.2%)

0

 Nausea

5 (18.5%)

0

6 (19.4%)

0

Infections

 Respiratory tract infection

5 (18.5%)

2 (7.4%)

8 (25.8%)

5 (16.1%)

 Urinary tract infection

3 (11.1%)

1 (3.7%)

5 (16.1%)

1 (3.2%)

 Septicemia

5 (18.5%)

5 (18.5%)

1 (3.2%)

1 (3.2%)

 Other infections

6 (22.2%)

4 (14.8%)

9 (29.0%)

5 (16.1)

 Oral candidiasis

7 (25.9%)

1 (3.7%)

1 (3.2%)

0

Nervous system disorders

 Peripheral sensory neuropathy

15 (55.6%)

0

8 (25.8%)

0

 Dizziness

4 (14.8%)

1 (3.7%)

3 (9.7%)

0

Other conditions

 Peripheral edema

11 (40.7%)

1 (3.7%)

7 (22.6%)

1 (3.2%)

 Hypotension

4 (14.8%)

2 (7.4%)

1 (3.2%)

0

 Fatigue

4 (14.8%)

1 (3.7%)

3 (9.7%)

0

 Rash

2 (7.4%)

0

4 (12.9%)

0

 Insomnia

2 (7.4%)

0

6 (19.4%)

0

 Weight loss

3 (11.1%)

0

1 (3.2%)

0

 Mucositis

2 (7.4%)

0

4 (12.9%)

0

 Psychiatric symptomsa

5 (18.5%)

1 (3.7%)

2 (6.5%)

1 (3.2%)

  1. The table included adverse event of any grade that occurred in more than 10% in any of the treatment groups or adverse events grade 3 or more that occurred in more than 5% in any of the treatment groups
  2. aThe group psychiatric symptoms encompass anxiety, agitation, depression and psychosis