Table II.
Evaluation of safety in the rerandomized PP and PA groups
| Period | High-PP (n = 70) |
High-PA (n = 38) |
Low-PP (n = 89) |
Low-PA (n = 43) |
||||
|---|---|---|---|---|---|---|---|---|
| Dose-finding period (2015, placebo) | ||||||||
| Serious AE, no. (%) | 1 | 1.4 | — | — | 2 | 2.2 | 2 | 4.7 |
| Serious ADR, no. (%) | — | — | — | — | — | — | — | — |
| All AEs, no. (%) | 56 | 80.0 | 28 | 73.7 | 62 | 69.7 | 37 | 86.0 |
| Mild | 55 | 78.6 | 24 | 63.2 | 59 | 66.3 | 32 | 74.4 |
| Moderate | — | — | 4 | 10.5 | 3 | 3.4 | 5 | 11.6 |
| Severe | 1 | 1.4 | — | — | — | — | — | — |
| All ADRs, no. (%) | 13 | 18.6 | 4 | 10.5 | 17 | 19.1 | 9 | 20.9 |
| Mild | 13 | 18.6 | 4 | 10.5 | 17 | 19.1 | 9 | 20.9 |
| Moderate | — | — | — | — | — | — | — | — |
| Severe | — | — | — | — | — | — | — | — |
| Long-term treatment period (2016–2017) | ||||||||
| Serious AE, no. (%) | — | — | — | — | 3 | 3.4 | — | — |
| Serious ADR, no. (%) | — | — | — | — | — | — | — | — |
| All AEs, no. (%) | 55 | 78.6 | 28 | 73.7 | 64 | 71.9 | 36 | 83.7 |
| Mild | 53 | 75.7 | 27 | 71.1 | 56 | 62.9 | 34 | 79.1 |
| Moderate | 2 | 2.9 | 1 | 2.6 | 8 | 9.0 | 2 | 4.7 |
| Severe | — | — | — | — | — | — | — | — |
| All ADRs, no. (%) | 2 | 2.9 | 7 | 18.4 | 5 | 5.6 | 9 | 20.9 |
| Mild | 2 | 2.9 | 7 | 18.4 | 5 | 5.6 | 9 | 20.9 |
| Moderate | — | — | — | — | — | — | — | — |
| Severe | — | — | — | — | — | — | — | — |
| High-PP (n = 64) |
High-PA (n = 36) |
Low-PP (n = 81) |
Low-PA (n = 39) |
|||||
|---|---|---|---|---|---|---|---|---|
| Observation period (2018–2019) | ||||||||
| Serious AE, no. (%) | 2 | 3.1 | 2 | 5.6 | 2 | 2.5 | 1 | 2.6 |
| Serious ADR, no. (%) | — | — | — | — | — | — | — | — |
| All AEs, no. (%) | 47 | 73.4 | 26 | 72.2 | 58 | 71.6 | 29 | 74.4 |
| Mild | 42 | 65.6 | 25 | 69.4 | 52 | 64.2 | 27 | 69.2 |
| Moderate | 5 | 7.8 | 1 | 2.8 | 6 | 7.4 | 2 | 5.1 |
| Severe | — | — | — | — | — | — | — | — |
| All ADRs, no. (%) | — | — | — | — | — | — | — | — |
| Mild | — | — | — | — | — | — | — | — |
| Moderate | — | — | — | — | — | — | — | — |
| Severe | — | — | — | — | — | — | — | — |
High and low refer to patients who experienced exacerbated/unaltered or decreased rhinitis symptoms, respectively, during the peak JCY pollen dispersal period in 2015 while taking placebo.