Comparison · NCT00092118-sae
Montelukast 10 mg vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Montelukast 10 mg vs Placebo: serious adverse events. Trial comparisons, record NCT00092118-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00092118-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00399 | 0.00155 | 0.0102 | wilson | |
| Risk in group 2 | 0.00101 | 0.000178 | 0.0057 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00298 | -0.0023 | 0.00926 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.95 | 0.443 | 35.3 | log | |
| Odds ratio, group 1 over group 2 | 3.96 | 0.442 | 35.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Montelukast 10 mg than on Placebo | 335 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Montelukast 10 mg | Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks. | 4 | 1,002 | EG001 |
| Group 2 | Placebo | Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks. | 1 | 990 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy.
Source ClinicalTrials.gov
Trial
- Title
- The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
- NCT number
- NCT00092118
- Phases
- PHASE3
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Montelukast, Comparator: Placebo
- Lead sponsor
- Organon and Co
- Results first posted
- 2010-07-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00092118?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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