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Table 3 Primary, Secondary, and Exploratory Outcome Variables (Intent-to-Treat Analysis)

From: Review of Desloratadine Data Using the ARIA Guidelines

 

5-mg DL

Placebo

P

 

Baseline LS (m ± SEM)

Days 1-15 LS (m ± SEM)

Baseline LS (m ± SEM)

Days 1-15 LS (m ± SEM)

 

AM/PM T5SS reflective

8.71 ± 0.15

-3.19 ± 0.22

8.49 ± 0.15

-2.29 ± 0.22

<0.001

RQLQ total score (at end point)

2.96 ± 0.08

-1.10 ± 0.10

2.80 ± 0.08

-0.73 ± 0.10

<0.001

AM/PM T5SS instantaneous

8.30 ± 0.17

-2.86 ± 0.20

8.17 ± 0.17

-1.90 ± 0.20

<0.001

AM/PM rhinorrhea reflective

1.81 ± -0.04

-0.58 ± 0.05

1.75 ± 0.04

-0.38 ± 0.05

<0.001

AM/PM nasal congestion reflective

1.96 ± 0.04

-0.56 ± 0.05

1.87 ± 0.04

-0.43 ± 0.05

0.013

AM/PM sneezing reflective

1.65 ± 0.04

-0.64 ± 0.05

1.61 ± 0.04

-0.42 ± 0.05

<0.011

AM/PM nasal itching reflective

1.7 ± 0.04

-0.67 ± 0.05

1.65 ± 0.04

-0.43 ± 0.05

<0.001

AM/PM eye itching reflective

1.38 ± 0.06

-0.58 ± 0.05

1.45 ± 0.06

-0.46 ± 0.05

0.047

AM/PM rhinorrhea instantaneous

1.76 ± 0.05

-0.54 ± 0.05

1.72 ± 0.05

-0.33 ± 0.05

<0.001

AM/PM nasal congestion instantaneous

1.94 ± 0.05

-0.52 ± 0.05

1.87 ± 0.05

-0.39 ± 0.05

0.009

AM/PM sneezing instantaneous

1.56 ± 0.05

-0.59 ± 0.05

1.51 ± 0.05

-0.36 ± 0.05

<0.001

AM/PM nasal itching instantaneous

1.65 ± 0.05

-0.63 ± 0.05

1.61 ± 0.05

-0.37 ± 0.05

<0.001

AM/PM eye itching instantaneous

1.38 ± 0.06

-0.58 ± 0.05

1.46 ± 0.06

-0.45 ± 0.05

0.023

Sleep interference

1.37 ± 0.06

-0.39 ± 0.05

1.38 ± 0.06

-0.27 ± 0.05

0.039

Activity interference

1.72 ± 0.05

-0.60 ± 0.06

1.66 ± 0.05

-0.40 ± 0.06

<0.001

Symptom severity reflective (VAS)

57.4 ± 1.36

-17.2 ± 1.50

56.76 ± 1.35

-10.9 ± 1.49

<0.001

Patient's evaluation of response WPAI-AS

NA

3.24 ± -0.10

NA

3.66 ± - 0.10

<0.001

overall work impairment

46.38 ± 2.35

-15.0 ± 2.78

41.37 ± 2.27

-5.7 ± 2.69

0.002

activity impairment

48.24 ± 1.85

-15.3 ± 2.20

46.04 ± 1.87

-9.2 ± 2.22

0.007

  1. AM, morning; PM, evening; DL, desloratadine; LS, least significant. LS means, SEM (SEM of the LS means) are obtained from an ANOVA model with treatment and site effects.