Skip to main content

Table 4 Primary, Secondary Outcome Variables (Intent-to-Treat Analysis)

From: Review of Desloratadine Data Using the ARIA Guidelines

 

5-mg DL

Placebo

 

Baseline LS (m ± SEM)

LS

(m ± SEM)

Baseline LS (m ± SEM)

LS

(m ± SEM)

P

AM/PM T5SS reflective (days 1-29)

9.63 ± 0.13

-3.76 ± 0.22

9.55 ± 0.21

-2.87 ± 0.21

<0.001

RQLQ total score

 

day 29

3.30 ± 10.08

-1.35 ± 0.10

3.15 ± 0.08

-0.95 ± 0.10

<0.001

day 85

 

-1.66 ± 0.11

 

-1.39 ± 0.12

0.023

AM/PM T5SS reflective

 

-4.50 ± 0.23

 

-3.61 ± 0.23

<0.001

(days 1-85)

 

AM/PM T5SS instantaneous

 

days 1-29

9.35 ± 0.15

-3.41 ± 0.22

9.23 ± 0.14

-2.52 ± 0.22

<0.001

days 1-85

 

-4.11 ± 0.24

 

-3.22 ± 0.23

<0.001

AM/PM rhinorrhea reflective

 

days 1-29

2.10 ± 0.04

-0.81 ± 0.05

2.08 ± 0.04

-0.62 ± 0.05

<0.001

days 1-85

 

-0.98 ± 0.05

 

-0.77 ± 0.05

<0.001

AM/PM nasal congestion reflective

 

days 1-29

2.13 ± 0.04

-0.69 ± 0.05

2.1 ± 0.04

-0.53 ± 0.05

0.002

days 1-85

 

-0.87 ± 0.05

 

-0.70 ± 0.05

0.002

AM/PM sneezing reflective

 

days 1-29

1.88 ± 0.04

-0.83 ± 0.05

1.84 ± 0.04

-0.62 ± 0.05

<0.001

days 1-85

 

-0.96 ± 0.05

 

-0.76 ± 0.05

<0.001

AM/PM nasal itching reflective

 

days 1-29

1.89 ± 0.04

-0.77 ± 0.05

1.88 ± 0.04

-0.58 ± 0.05

<0.001

days 1-85

 

-0.91 ± 0.05

 

-0.65 ± 0.05

0.002

AM/PM eye itching reflective

 

days 1-29

1.62 ± 0.05

-0.67 ± 0.05

1.64 ± 0.05

-0.52 ± 0.05

0.006

days 1-85

 

-0.78 ± 0.05

 

-0.65 ± 0.05

0.016

Sleep interference

 

2-29 days

1.58 ± 0.05

-0.54 ± 0.06

1.59 ± 0.05

-0.42 ± 0.05

0.022

2-85 days

 

-0.65 ± 0.06

 

-0.52 ± 0.06

0.023

Activity interference

 

1-29 days

1.89 ± 0.04

−0.69 ± 0.05

1.89 ± 0.04

-0.46 ± 0.05

<0.001

1-85 days

 

-0.82 ± -0.06

 

-0.60 ± -0.06

<0.001

Symptom severity reflective (VAS)

 

days 2-29

61.2 ± 1.20

-19.7 ± 1.52

59.80 ± 1.19

-12.7 ± 1.50

<0.001

days 2-85

 

-25.7 ± 1.64

 

-18.0 ± 1.61

<0.001

Patient's evaluation of response (day 85)

NA

2.70 ± 0.10

NA

3.11 ± 0.10

<0.001

  1. LS, least significant. means, SEM (SE of the LS means) are obtained from an ANOVA model with treatment and site effects. NA, not applicable.