Table 5 Characteristics of treatment emergent adverse events.
Loratadine (n = 68) | Placebo (n = 69) | |
|---|---|---|
Number of participants reporting ≥ 1 AEs (%) | 7 (10) | 4 (6) |
Number of AEs reported | 12 | 5 |
Serious (%) | ||
No | 12 (100) | 5 (100) |
Yes | 0 (0) | 0 (0) |
Severity of AE (%) | ||
Mild | 4 (33) | 2 (40) |
Moderate | 8 (67) | 3 (60) |
Severe | 0 (0) | 0 (0) |
Possible relationship to study medication (%) | ||
Not possibly related | 11 (92) | 5 (100) |
Possibly related | 1 (8) | 0 (0) |