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Table 2 TCS, DSS, and DMS during the entire and peak grass pollen season in the Canadian subgroup in all three trials

From: The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children

 

Pooled adult-pediatric 2009 trials

Adult-pediatric 2012 trial

 

Placebo

Grass SLIT-T

Placebo

Grass SLIT-T

TCS entire season

  

  n

54

42

122

122

  Mean (SE/SD)*

5.37 (0.68)

3.32 (0.65)

4.96 (4.22)

3.34 (2.93)

  Median

3.88

1.46

4.11

2.58

  Difference (95% CI)**

 

-2.06 (-3.72, -0.39)

 

-1.53 (-2.1, -0.3)

  Relative difference*

 

-38%

 

-37%

  p value

 

.016

 

.005

DSS entire season

   

  n

54

42

122

122

  Mean (SE/SD)*

4.31 (0.50)

2.69 (0.51)

3.48 (2.91)

2.59 (2.16)

  Median

3.18

1.38

2.96

2.00

  Difference (95% CI)**

 

-1.63 (-2.89, -0.36)

 

-0.95 (-1.3, -0.0)

  Relative difference

 

-38%

 

-32%

  p value

 

.013

 

.027

DMS entire season

   

  n

54

42

122

122

  Mean (SE/SD)*

1.09 (0.32)

0.67 (0.23)

1.30 (0.36)

0.62 (0.20)

  Median

0.12

0.00

0.65

0.00

  Difference (95% CI)**

 

-0.42 (-1.12, 0.28)

 

-0.68 (-1.20, -0.16)

  Relative difference

 

-39%

 

-52%

  p value

 

.238

 

.011

TCSPeak season

  

  n

52

42

120

119

  Mean (SE/SD)*

5.73 (0.78)

3.17 (0.62)

5.50 (4.93)

3.70 (3.40)

  Median

3.93

1.47

4.48

3.13

  Difference (95% CI)**

 

-2.56 (-4.32, -0.81)

 

-1.35 (-2.3, -0.2)

  Relative difference

 

-45%

 

-30%

  p value

 

.005

 

.014

DSS peak season

   

  n

52

42

120

119

  Mean (SE/SD)*

4.64 (0.59)

2.77 (0.51)

3.73 (3.29)

2.85 (2.37)

  Median

3.33

1.21

2.93

2.43

  Difference (95% CI)**

 

-1.87 (-3.24, -0.50)

 

-0.50 (-1.3, 0.1)

  Relative difference

 

-40%

 

-17%

  p value

 

.008

 

.109

DMS peak season

   

  n

52

42

120

119

  Mean (SE/SD)*

1.14 (0.35)

0.46 (0.21)

1.77 (2.61)

0.85 (1.87)

  Median

0.00

0.00

0.55

0.00

  Difference (95% CI)**

 

-0.68 (-1.42, 0.05)

 

-1.13 (-1.94, -0.33)

  Relative difference

 

-60%

 

-54%

  p value

 

.068

 

.006

  1. *Adjusted means (SE) for the pooled adult-pediatric 2009 trials; raw means (SD) for the adult-pediatric 2012 trial.
  2. **For the pooled adult-pediatric 2009 trials, analysis of variance model was used with asthma status, treatment group, and site as fixed effects and adjusting for different error variation for each treatment group. For the adult-pediatric 2012 trial, the point estimate of the difference was based on the median; the 95% CI for the median difference was based on the Hodges-Lehmann estimator for TCS and DSS. For DMS in this trial, a zero-inflated log-normal model was used with asthma status, treatment group, age category and pollen region as fixed effects. Absolute and relative treatment differences are estimated based on this model, and confidence intervals are estimated based on the model using the delta method.
  3. DMS, daily medication score; DSS, daily symptom score; SD, standard deviation, SE, standard error; TCS, total combined score.