Trial Outcomes & Findings for Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM) (NCT NCT00152464)
NCT ID: NCT00152464
Last Updated: 2019-01-22
Results Overview
The time to onset of asthma was defined as the period elapsed between the randomization visit (V2) and the date of onset of asthma. Instead of the median the first Quartile is reported since the median (50%) was not reached.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
514 participants
Primary outcome timeframe
During the treatment period (18 months)
Results posted on
2019-01-22
Participant Flow
The study started to enroll patients in March 2002 and concluded in March 2006.
Participant Flow refers to the Intent-to-treat (ITT) population. 514 subjects were initially randomized, 4 subjects withdrew consent before first study drug intake.
Participant milestones
| Measure |
Placebo (PBO)
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
255
|
|
Overall Study
COMPLETED
|
215
|
219
|
|
Overall Study
NOT COMPLETED
|
40
|
36
|
Reasons for withdrawal
| Measure |
Placebo (PBO)
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
21
|
22
|
|
Overall Study
Atopic dermatitis poorly controlled
|
0
|
1
|
|
Overall Study
Eczema deterioration
|
0
|
1
|
|
Overall Study
Parent decision
|
1
|
1
|
|
Overall Study
Investigator decision
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Eczema poorly controlled
|
1
|
0
|
|
Overall Study
Patient relocated
|
1
|
0
|
Baseline Characteristics
Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)
Baseline characteristics by cohort
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
Total Title
n=510 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
255 Participants
n=5 Participants
|
255 Participants
n=7 Participants
|
510 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
19.42 months
STANDARD_DEVIATION 3.86 • n=5 Participants
|
19.28 months
STANDARD_DEVIATION 3.94 • n=7 Participants
|
19.35 months
STANDARD_DEVIATION 3.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the treatment period (18 months)Population: Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
The time to onset of asthma was defined as the period elapsed between the randomization visit (V2) and the date of onset of asthma. Instead of the median the first Quartile is reported since the median (50%) was not reached.
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Time to Onset of Asthma During the Treatment Period
|
NA months
Interval 9.5 to
Median not reached due to insufficient number of events.
|
NA months
Interval 10.3 to
Median not reached due to insufficient number of events.
|
SECONDARY outcome
Timeframe: During the treatment period (18 months)Population: Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am and each wheezing event occurring at any time together with the treatment for these symptoms.
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Percentage of Days With Symptoms of Either Wheezing or Nocturnal Cough
|
3.5 percentage of days
Standard Deviation 6.26
|
2.85 percentage of days
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: During the treatment period (18 months)Population: Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
The caring person was to note on the diary card each each wheezing event occurring at any time.
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Percentage of Days With Symptoms of Wheezing
|
1.31 percentage of days
Standard Deviation 3.00
|
0.88 percentage of days
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: During the treatment period (18 months)Population: Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
The caring person was to note on the diary card each nocturnal cough event with sleep disturbances occurring from 7:00 pm to 7:00 am
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Percentage of Days With Symptoms of Nocturnal Cough
|
2.72 percentage of days
Standard Deviation 5.24
|
2.33 percentage of days
Standard Deviation 4.30
|
SECONDARY outcome
Timeframe: During the treatment period (18 months)Population: Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Percentage of Subjects Using Asthma Medication
Beta 2 Mimetics
|
33.3 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Subjects Using Asthma Medication
Cromoglycates
|
0.8 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Subjects Using Asthma Medication
Inhaled Corticoids
|
18.8 percentage of participants
|
15.3 percentage of participants
|
|
Percentage of Subjects Using Asthma Medication
Systemic Corticoids
|
18.4 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Subjects Using Asthma Medication
Leukotriene antagonists
|
2.7 percentage of participants
|
3.5 percentage of participants
|
SECONDARY outcome
Timeframe: During the treatment period (18 months)Population: 255 subject were included in the Intention-to-treat (ITT) set. Number of participants analyzed is given for each individual category.
The following asthma medications were taken into consideration: Beta 2-mimetics, cromoglycates, inhaled corticoids, systemic corticoids, leukotriene antagonists
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Percentage of Days of Use of Asthma Medication
Leukotriene antagonists
|
0.30 percentage of days
Standard Deviation 2.19
|
0.34 percentage of days
Standard Deviation 3.23
|
|
Percentage of Days of Use of Asthma Medication
Beta 2 Mimetics
|
2.36 percentage of days
Standard Deviation 9.31
|
1.37 percentage of days
Standard Deviation 4.47
|
|
Percentage of Days of Use of Asthma Medication
Cromoglycates
|
0.03 percentage of days
Standard Deviation 0.37
|
0.09 percentage of days
Standard Deviation 1.24
|
|
Percentage of Days of Use of Asthma Medication
Inhaled Corticoids
|
3.60 percentage of days
Standard Deviation 12.03
|
1.98 percentage of days
Standard Deviation 7.49
|
|
Percentage of Days of Use of Asthma Medication
Systemic Corticoids
|
0.31 percentage of days
Standard Deviation 1.02
|
0.13 percentage of days
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: During the treatment period (18 months)Population: Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
The following medications for Atopic Dermatitis were taken into consideration: Topical corticosteroids/ Local Steroids Class A, non-steroidal anti-inflammatory (NSAI) creams, tar/ Local Steroids Class B/ Local Steroids Class C/ Topical tacrolimus/ Topical pimecrolimus/ Systemic H1 anti-histamines/ Local antibiotics or antiseptics
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Percentage of Subjects Using Medication for Atopic Dermatitis
Topical corticosteroids
|
61.6 percentage of subjects
|
63.9 percentage of subjects
|
|
Percentage of Subjects Using Medication for Atopic Dermatitis
Local Steroids Class A, NSAI creams, tar
|
31.4 percentage of subjects
|
33.3 percentage of subjects
|
|
Percentage of Subjects Using Medication for Atopic Dermatitis
Local Steroids Class B
|
28.6 percentage of subjects
|
27.1 percentage of subjects
|
|
Percentage of Subjects Using Medication for Atopic Dermatitis
Local Steroids Class C
|
33.7 percentage of subjects
|
37.3 percentage of subjects
|
|
Percentage of Subjects Using Medication for Atopic Dermatitis
Topical tacrolimus
|
0.8 percentage of subjects
|
1.2 percentage of subjects
|
|
Percentage of Subjects Using Medication for Atopic Dermatitis
Topical pimecrolimus
|
2.4 percentage of subjects
|
5.5 percentage of subjects
|
|
Percentage of Subjects Using Medication for Atopic Dermatitis
Systemic H1 anti-histamines
|
22.0 percentage of subjects
|
19.6 percentage of subjects
|
|
Percentage of Subjects Using Medication for Atopic Dermatitis
Local antibiotics or antiseptics
|
12.9 percentage of subjects
|
11.0 percentage of subjects
|
SECONDARY outcome
Timeframe: During the treatment period (18 months)Population: 255 subject were included in the Intention-to-treat (ITT) set. Number of participants analyzed is given for each individual category.
The following medications for Atopic Dermatitis were taken into consideration: Emollients, local antihistamines; Local steroids class (LSC) A, non-steroidal anti-inflammatory (NSAI) creams, tar; Local steroids class B; Local steroids class C; Local antibiotics or antiseptics; Oral H1 anti-histamines (a-h); Local antibiotics (ABs) or antiseptics
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Percentage of Days of Use of Medication for Atopic Dermatitis
Topical corticosteroids
|
32.42 percentage of days
Standard Deviation 42.96
|
31.84 percentage of days
Standard Deviation 42.70
|
|
Percentage of Days of Use of Medication for Atopic Dermatitis
LSC A, NSAI creams, tar
|
15.40 percentage of days
Standard Deviation 33.69
|
18.64 percentage of days
Standard Deviation 37.30
|
|
Percentage of Days of Use of Medication for Atopic Dermatitis
LSC B
|
14.23 percentage of days
Standard Deviation 32.19
|
12.30 percentage of days
Standard Deviation 30.49
|
|
Percentage of Days of Use of Medication for Atopic Dermatitis
LSC C
|
9.82 percentage of days
Standard Deviation 24.98
|
8.27 percentage of days
Standard Deviation 22.16
|
|
Percentage of Days of Use of Medication for Atopic Dermatitis
Topical tacrolimus
|
0.36 percentage of days
Standard Deviation 5.41
|
0.02 percentage of days
Standard Deviation 0.21
|
|
Percentage of Days of Use of Medication for Atopic Dermatitis
Topical pimecrolimus
|
0.52 percentage of days
Standard Deviation 5.62
|
0.31 percentage of days
Standard Deviation 2.31
|
|
Percentage of Days of Use of Medication for Atopic Dermatitis
Local ABs or antiseptics
|
2.99 percentage of days
Standard Deviation 15.00
|
2.63 percentage of days
Standard Deviation 15.37
|
|
Percentage of Days of Use of Medication for Atopic Dermatitis
Systemic H1 a-h
|
3.80 percentage of days
Standard Deviation 14.28
|
1.95 percentage of days
Standard Deviation 8.84
|
SECONDARY outcome
Timeframe: During the treatment period (18 months)Population: Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger.
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Percentage of Subjects With Urticaria
|
41.6 percentage of participants
|
27.5 percentage of participants
|
SECONDARY outcome
Timeframe: During the treatment period (18 months)Population: Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
Urticaria was defined as typical hives or areas of skin swelling, redness and itching distinctly different from the child's usual inflamed skin lesions of Atopic Dermatitis (AD), associated with an infection or food allergen ingestion/contact or other trigger.
Outcome measures
| Measure |
Placebo (PBO)
n=255 Participants
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 Participants
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Number of Episodes of Urticaria Per Subject
|
1.71 Number of episodes
Standard Deviation 4.05
|
0.71 Number of episodes
Standard Deviation 1.83
|
Adverse Events
Placebo (PBO)
Serious events: 37 serious events
Other events: 240 other events
Deaths: 0 deaths
Levocetirizine (LCTZ)
Serious events: 31 serious events
Other events: 239 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (PBO)
n=255 participants at risk
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 participants at risk
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Immune system disorders
Food allergy
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Bronchitis chronic
|
1.2%
3/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Bronchopneumonia
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
1.6%
4/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Eczema infected
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
5/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.78%
2/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Haemophilus infection
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.78%
2/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Pyelonephritis acute
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Skin infection
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Subcutaneous abscess
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Investigations
Hepatic enzyme increased
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Investigations
Weight increased
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
1.6%
4/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.78%
2/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
1.6%
4/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.5%
19/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
4.7%
12/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.4%
6/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
1.2%
3/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.2%
3/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
0.39%
1/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
Other adverse events
| Measure |
Placebo (PBO)
n=255 participants at risk
Placebo was administered as oral drops twice daily.
|
Levocetirizine (LCTZ)
n=255 participants at risk
0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
16.1%
41/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
19.2%
49/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
8/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
5.5%
14/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.1%
41/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
18.8%
48/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Teething
|
8.2%
21/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
8.6%
22/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
29/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
12.2%
31/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
General disorders
Pyrexia
|
27.8%
71/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
33.3%
85/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
5.1%
13/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
2.4%
6/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
20.4%
52/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
17.3%
44/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Bronchitis acute
|
5.1%
13/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
4.7%
12/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Ear infection
|
15.3%
39/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
14.9%
38/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
21.6%
55/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
22.4%
57/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Influenza
|
7.1%
18/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
9.8%
25/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Laryngitis
|
3.5%
9/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
7.5%
19/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
29.0%
74/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
31.0%
79/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Otitis media
|
15.7%
40/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
14.1%
36/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
20.8%
53/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
22.7%
58/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
7.1%
18/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
5.9%
15/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Rhinitis
|
27.8%
71/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
28.6%
73/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Tonsillitis
|
11.0%
28/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
8.2%
21/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
49.4%
126/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
51.4%
131/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Varicella
|
13.3%
34/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
11.8%
30/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
9.4%
24/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
9.8%
25/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.3%
67/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
22.4%
57/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.5%
19/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
9.4%
24/255 • Adverse events were collected from Visit 1 until during the treatment phase (up to month 18).
Adverse Events refer to the Intention-to-treat (ITT) population, consisting of all randomized subjects who took at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60