Table 4.
Most common adverse events in the clarithromycin and placebo group
| 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%) |
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
aThe group psychiatric symptoms encompass anxiety, agitation, depression and psychosis