Table 2 Clinical adverse reactions within 96 weeks follow-up
High dose (n = 24) | Low dose (n = 24) | Placebo (n = 24) | P value | |
|---|---|---|---|---|
Adverse reactions | 12 (50.0%) | 8 (33.3%) | 11 (45.8%) | 0.479 |
Skin disorders | 1 (4.2%) | 1 (4.2%) | 2 (8.3%) | 0.712 |
Hematological disorder | 0 | 0 | 1 (4.2%) | 0.363 |
Otolaryngology disorder | 1 (4.2%) | 1 (4.2%) | 1 (4.2%) | >0.999 |
Respiratory system disorder | 0 | 1 (4.2%) | 1 (4.2%) | 0.598 |
Cardiac disorders | 2 (8.3%) | 1 (4.2%) | 0 | 0.352 |
Gastrointestinal disorders | 2 (8.3%) | 1 (4.2%) | 0 | 0.352 |
Endocrine system disorders | 0 | 0 | 0 | – |
Urogenital system disorders | 0 | 0 | 0 | – |
Skeletal musculature disorders | 0 | 0 | 1 (4.2%) | 0.363 |
Neuropsychiatric disorders | 0 | 0 | 0 | – |
Others (fever, fatigue, insomnia, and so on) | 6 (25.0%) | 3 (12.5%) | 5 (20.8%) | 0.538 |
