Table 2.
TEAEs occurring in ≥5% of patients
| Dose group | High‐dose group (n = 50) | Low‐dose group (n = 51) | Placebo‐to‐high‐dose control group* (n = 50) | |
|---|---|---|---|---|
| High dose for 24 weeks | Low dose for 24 weeks | Placebo for 12 weeks* | High‐dose for 12 weeks* | |
| TEAE | n (%) [case] | n (%) [case] | n (%) [case] | n (%) [case] |
| Cough | 9 (18.0) [11] | 9 (17.6) [17] | 6 (12.0) [9] | 7 (14.0) [10] |
| Nasopharyngitis | 6 (12.0) [10] | 10 (19.6) [17] | 2 (4.0) [2] | 8 (14.0) [9] |
| Pyrexia | 4 (8.0) [4] | 6 (11.8) [8] | 2 (4.0) [2] | 7 (14.0) [7] |
| Diarrhea | 4 (8.0) [4] | 6 (11.8) [6] | 6 (12.0) [6] | 4 (8.0) [4] |
| COVID‐19 | 3 (6.0) [3] | 5 (9.8) [5] | 0 | 8 (16.0) [8] |
| Vomiting | 1 (2.0) [1] | 5 (9.8) [6] | 3 (6.0) [3] | 3 (6.0) [5] |
| Decreased appetite | 5 (10.0) [6] | 4 (7.8) [4] | 0 | 1 (2.0) [1] |
| Constipation | 3 (6.0) [4] | 4 (7.8) [4] | 1 (2.00) [1] | 1 (2.0) [1] |
*
Adverse events were counted based on the onset date of the adverse event.
Percentages were calculated using the number of patients in each group as the denominator. Several cases of adverse events could be collected from one patient.
TEAE, treatment‐emergent adverse event.