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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