Trial Outcomes & Findings for Montelukast Back to School Asthma Study (0476-340) (NCT NCT00461032)
NCT ID: NCT00461032
Last Updated: 2022-02-02
Results Overview
A day of worsening asthma is a day with: increase from baseline in β-agonist use (\> 70% and a min increase of 2 puffs); \> 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1162 participants
Primary outcome timeframe
8 Week treatment period initiated at the beginning of a school year
Results posted on
2022-02-02
Participant Flow
Participants were randomized at 165 sites in the US and Canada. Therapy period: June to November 2006 (including screening period).
Participants who were hospitalized for asthma in the 4 weeks prior to randomization or who required excluded medications were excluded from randomization.
Participant milestones
| Measure |
Placebo
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
|
Montelukast 5 mg
Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
582
|
580
|
|
Overall Study
COMPLETED
|
545
|
536
|
|
Overall Study
NOT COMPLETED
|
37
|
44
|
Reasons for withdrawal
| Measure |
Placebo
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
|
Montelukast 5 mg
Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
|
Overall Study
Lack of Efficacy
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
12
|
|
Overall Study
Protocol Violation
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
15
|
|
Overall Study
Patient Moved or Relocated
|
2
|
1
|
|
Overall Study
Other
|
7
|
5
|
Baseline Characteristics
Montelukast Back to School Asthma Study (0476-340)
Baseline characteristics by cohort
| Measure |
Placebo
n=582 Participants
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
|
Montelukast 5 mg
n=580 Participants
Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
|
Total
n=1162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.9 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
9.9 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
9.9 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
236 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
461 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
346 Participants
n=5 Participants
|
355 Participants
n=7 Participants
|
701 Participants
n=5 Participants
|
|
Daytime Asthma Symptom Score
|
1.32 Units on a Scale
STANDARD_DEVIATION 1.81 • n=5 Participants
|
1.35 Units on a Scale
STANDARD_DEVIATION 1.94 • n=7 Participants
|
1.34 Units on a Scale
STANDARD_DEVIATION 1.88 • n=5 Participants
|
|
β-Agonist Use
|
0.62 puffs/day
STANDARD_DEVIATION 1.11 • n=5 Participants
|
0.54 puffs/day
STANDARD_DEVIATION 0.94 • n=7 Participants
|
0.58 puffs/day
STANDARD_DEVIATION 1.03 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 Week treatment period initiated at the beginning of a school yearPopulation: The primary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. The percent of worsening asthma days was calculated from at least 7 days of diary data. Missing diary data were not imputed.
A day of worsening asthma is a day with: increase from baseline in β-agonist use (\> 70% and a min increase of 2 puffs); \> 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.
Outcome measures
| Measure |
Placebo
n=499 Participants
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
|
Montelukast 5 mg
n=499 Participants
Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
|
|---|---|---|
|
Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
|
27.23 Percentage of Days
Interval 24.25 to 30.0
|
24.26 Percentage of Days
Interval 21.52 to 27.01
|
SECONDARY outcome
Timeframe: 8 Week treatment period initiated at the beginning of a school yearPopulation: The analysis was based on the FAS population. This included all randomized participants who received at least 1 dose of study medication and had a valid efficacy measurement. Occurrence of one or more health care utilization was derived from the available diary data and was set to missing if no diary data were available.
Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.
Outcome measures
| Measure |
Placebo
n=476 Participants
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
|
Montelukast 5 mg
n=466 Participants
Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
|
|---|---|---|
|
Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)
Participants requiring Health Care Utilization
|
70 Participants
|
55 Participants
|
|
Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)
Participants not requiring Health Care Utilization
|
406 Participants
|
411 Participants
|
SECONDARY outcome
Timeframe: 8 Week treatment period initiated at the beginning of a school yearPopulation: The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had valid efficacy measurement for at least 7 days of diary data.
Outcome measures
| Measure |
Placebo
n=491 Participants
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
|
Montelukast 5 mg
n=495 Participants
Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
|
|---|---|---|
|
Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
|
7.02 Percentage of Days
Interval 5.8 to 8.23
|
6.04 Percentage of Days
Interval 4.84 to 7.24
|
SECONDARY outcome
Timeframe: 8 Week treatment period initiated at the beginning of a school yearPopulation: The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. Variables that were measured as the average over the treatment period were defined from at least 7 days of evaluable diary data.
Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.
Outcome measures
| Measure |
Placebo
n=491 Participants
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
|
Montelukast 5 mg
n=496 Participants
Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
|
|---|---|---|
|
Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
|
17.4 Percentage of Days
Interval 15.33 to 19.47
|
16.03 Percentage of Days
Interval 13.99 to 18.07
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 189 other events
Deaths: 0 deaths
Montelukast 5 mg
Serious events: 4 serious events
Other events: 191 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=566 participants at risk
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
|
Montelukast 5 mg
n=566 participants at risk
Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
Other adverse events
| Measure |
Placebo
n=566 participants at risk
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
|
Montelukast 5 mg
n=566 participants at risk
Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Congenital, familial and genetic disorders
Lymphangioma
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Ear and labyrinth disorders
Ear pain
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Eye disorders
Conjunctivitis
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Constipation
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.71%
4/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Toothache
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Gastrointestinal disorders
Vomiting
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.88%
5/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
General disorders
Chest discomfort
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
General disorders
Chest pain
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
General disorders
Fatigue
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
General disorders
Malaise
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
General disorders
Pyrexia
|
0.88%
5/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
1.6%
9/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Acute sinusitis
|
0.71%
4/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Body tinea
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Bronchitis
|
1.1%
6/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Bronchitis acute
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Cellulitis
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Ear infection
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Eye infection
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Folliculitis
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
6/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
1.4%
8/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Herpes simplex
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Hordeolum
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Impetigo
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Influenza
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
24/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
5.5%
31/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Otitis externa
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Otitis media
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
1.2%
7/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Otitis media acute
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Pharyngitis
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.2%
7/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
1.6%
9/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Pneumonia
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Pneumonia viral
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Rhinitis
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Sinusitis
|
1.9%
11/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
2.7%
15/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Skin infection
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Subcutaneous abscess
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Tonsillitis
|
0.71%
4/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
45/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
5.5%
31/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Urinary tract infection
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Varicella
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Viral infection
|
1.8%
10/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.88%
5/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.9%
11/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
1.2%
7/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Investigations
Weight decreased
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Nervous system disorders
Headache
|
1.2%
7/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
1.4%
8/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Nervous system disorders
Lethargy
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Nervous system disorders
Migraine
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Nervous system disorders
Sinus headache
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Psychiatric disorders
Sleep terror
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Reproductive system and breast disorders
Nipple swelling
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.9%
28/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
3.7%
21/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
11/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
1.4%
8/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.6%
9/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
2.3%
13/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
6/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.71%
4/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.35%
2/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.71%
4/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.53%
3/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.71%
4/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.18%
1/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
0.00%
0/566 • Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo \& 566 montelukast) is the number that received treatment. 16 placebo \& 14 montelukast randomized participants did not receive treatment. Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER