Table 3.
Adverse events | Microparticles group (n = 40) | Placebo group (n = 39) | ||||||
---|---|---|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
Pyrexia | 7 (18%) | 2 (5%) | 1 (3%) | 0 | 5 (13%) | 2(5%) | 0 | 0 |
Vomiting | 4 (10%) | 0 | 1 (3%) | 0 | 4 (10%) | 1 (3%) | 0 | 0 |
Fatigue | 4 (10%) | 0 | 0 | 0 | 3 (8%) | 1(3%) | 1 (3%) | 0 |
Nausea | 3 (8%) | 1 (3%) | 0 | 0 | 5 (13%) | 3 (8%) | 1 (3%) | 0 |
Thoracalgia | 2 (5%) | 1 (3%) | 0 | 0 | 0 | 0 | 0 | 0 |
Chest stuffiness | 0 | 0 | 0 | 0 | 4 (10%) | 1 (3%) | 0 | 0 |
Leukopenia | 3 (8%) | 1 (3%) | 0 | 0 | 5 (13%) | 3 (8%) | 1 (3%) | 0 |
Infection | 0 | 1 (3%) | 0 | 0 | 0 | 1 (3%) | 2 (5%) | 0 |
Thrombus | 0 | 0 | 0 | 0 | 0 | 1 (3%) | 0 | 0 |
Atrial Fibrillation | 0 | 0 | 0 | 0 | 0 | 1 (3%) | 0 | 0 |
Pain | 0 | 2 (5%) | 0 | 0 | 0 | 2 (5%) | 0 | 0 |
Hypertension | 0 | 1(3%) | 0 | 0 | 0 | 1 (3%) | 1 (3%) | 0 |
Anemia | 3 (8%) | 2 (5%) | 0 | 0 | 2 (5%) | 1 (3%) | 0 | 0 |
Abnormal liver function | 1 (3%) | 4 (10%) | 1 (3%) | 0 | 4 (10%) | 0 | 0 | 0 |
Constipation | 1 (3%) | 1 (3%) | 0 | 0 | 2 (5%) | 0 | 0 | 0 |
Hypoproteinemia | 3 (8%) | 1 (3%) | 0 | 0 | 2 (5%) | 1 (3%) | 0 | 0 |
Cough | 1 (3%) | 0 | 0 | 0 | 0 | 1 (3%) | 1 (3%) | 0 |
Dyspnoea | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3%) | 0 |
Urine leukocytosis | 0 | 1 (3%) | 0 | 0 | 0 | 0 | 0 | 0 |
Erythra | 1 (3%) | 1 (3%) | 0 | 0 | 0 | 1 (3%) | 0 | 0 |