Table 2.
Symptom and medication scores at week 44–52, primary evaluation period (FAS)
| Score | 300 IR (n = 315) | 500 IR (n = 296) | Placebo (n = 316) |
|---|---|---|---|
| Average Adjusted Symptom Score (AASS, primary variable) | 5.00 ± 0.21*** | 5.32 ± 0.22*** | 6.11 ± 0.21 |
| Difference from. Placebo | |||
| Least squares mean difference | −1.11 ± 0.20*** | −0.80 ± 0.20*** | |
| Relative least squares mean difference | −18.2% | −13.1% | |
| Average Rhinitis Total Symptom Score (ARTSS) | 4.96 ± 0.21*** | 5.25 ± 0.21*** | 6.03 ± 0.21 |
| Average Medication Score | 0.04 ± 0.02* | 0.07 ± 0.02 | 0.07 ± 0.02 |
| Average Combined Score | 0.62 ± 0.03*** | 0.67 ± 0.03*** | 0.77 ± 0.03 |
| Average Total Rhinoconjunctivitis Symptom Score | 6.48 ± 0.29*** | 6.91 ± 0.30** | 7.79 ± 0.29 |
| Individual nasal and ocular symptom scores | |||
| Sneezing | 1.13 ± 0.05** | 1.14 ± 0.05** | 1.27 ± 0.05 |
| Rhinorrhea | 1.43 ± 0.07*** | 1.52 ± 0.07*** | 1.74 ± 0.07 |
| Nasal congestion | 1.22 ± 0.07*** | 1.35 ± 0.07*** | 1.58 ± 0.07 |
| Nasal pruritus | 1.18 ± 0.06*** | 1.23 ± 0.06*** | 1.43 ± 0.06 |
| Itchy eyes | 0.92 ± 0.06 | 0.97 ± 0.06 | 1.03 ± 0.06 |
| Watering eyes | 0.59 ± 0.05* | 0.68 ± 0.06 | 0.72 ± 0.05 |
| Troubles with daily life | 1.02 ± 0.06*** | 1.11 ± 0.06** | 1.28 ± 0.06 |
The data are presented as the least squares mean ± standard error.
The relative least squares mean difference: {(Active − Placebo)/Placebo} × 100.
The mixed‐effects model for repeated measures (MMRM) includes the terms for the treatment group, time, and treatment‐by‐time as fixed effects; and the baseline value, age, gender, sensitization status with autumn allergies, rescue medication use during the pretreatment period, and prior drug for the target disease as covariates.
***P < 0.001, **P < 0.01, *P < 0.05 compared with placebo.