Table 3 Overall safety profile and drug doses in the clarithromycin group and placebo group
Clarithromycin group, No = 27 | Placebo group, No = 31 | |
|---|---|---|
120/180 days follow-up—% | 77.8% (63.6%; 95.2%) | 90.3% (80.5%; 100%) |
Treatment cycles—no. (%) | ||
1 | 1 (3.7%) | 2 (6.4%) |
2 | 3 (11.1%) | 1 (3.2%) |
3 | 16 (59.3%) | 19 (61.2%) |
4 | 7 (25.9%) | 9 (29.0%) |
Any adverse event—no. (%) | 26 (96.3%) | 28 (90.3%) |
Any ≥ 3 adverse event—no. (%) | 16 (59.3%) | 12 (38.7%) |
Any serious adverse event—no. (%) | 16 (59.3%) | 10 (32.3%) |
Adverse event resulting in dose reduction of study drug—no. (%) | 9 (33.3%) | 3 (9.7%)a |
Adverse event resulting in dose reduction of bortezomib—no. (%) | 9 (33.3%) | 4 (12.9%)b |
Adverse event resulting in dose reduction of dexamethasone—no. (%) | 9 (33.3%) | 3 (9.7%)a |
Adverse event resulting in dose reduction of cyclophosphamide—no. (%) | 4 (14.8%) | 1 (3.2%)b |