Comparison · NCT00619801-sae
Levocetirizine 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
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ConductScience Library. Levocetirizine vs Placebo: serious adverse events. Trial comparisons, record NCT00619801-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00619801-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 | 0.00877 | 0.00155 | 0.048 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0611 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00877 | -0.0528 | 0.048 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Levocetirizine than on Placebo | 114 | 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 | Levocetirizine | Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). | 1 | 114 | EG001 |
| Group 2 | Placebo | Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). | 0 | 59 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2).
Source ClinicalTrials.gov
Trial
- Title
- Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
- NCT number
- NCT00619801
- Phases
- PHASE3
- Conditions
- Allergic Rhinitis, Chronic Urticaria
- Interventions
- Levocetirizine, Placebo
- Lead sponsor
- UCB Pharma
- Results first posted
- 2009-09-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00619801?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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