Comparison · NCT04145219-sae
HDM SLIT-tablet (12 SQ-HDM) vs Placebo SLIT-tablet: 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. HDM SLIT-tablet (12 SQ-HDM) vs Placebo SLIT-tablet: serious adverse events. Trial comparisons, record NCT04145219-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04145219-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 | 0.022 | 0.0136 | 0.0354 | wilson | |
| Risk in group 2 | 0.00821 | 0.00377 | 0.0178 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0138 | 0.00105 | 0.028 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.68 | 1.06 | 6.81 | log | |
| Odds ratio, group 1 over group 2 | 2.72 | 1.06 | 6.99 | log | |
| Number needed to harm, for one more participant with a serious adverse event on HDM SLIT-tablet (12 SQ-HDM) than on Placebo SLIT-tablet | 72.5 | 35.8 | 956 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | HDM SLIT-tablet (12 SQ-HDM) | Rhinitis/rhinoconjunctivitis rescue medication and asthma controller/reliever medication as needed, plus daily house dust mite sublingual allergy immunotherapy tablet (HDM-SLIT tablet, 12 SQ-HDM dose). | 16 | 727 | EG000 |
| Group 2 | Placebo SLIT-tablet | Rhinitis/rhinoconjunctivitis rescue medication and asthma controller/reliever medication as needed, plus daily placebo sublingual allergy immunotherapy tablet (Placebo SLIT-tablet). | 6 | 731 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AEs) were collected from consent until the last follow-up phone contact with the participant (from V1 to TC3 (telephone call 3), for approximately 54-59 weeks).
Source ClinicalTrials.gov
Trial
- Title
- House Dust Mite Allergy Trial In Children
- NCT number
- NCT04145219
- Phases
- PHASE3
- Conditions
- Allergic Rhinitis Due to Dermatophagoides Farinae, Allergic Rhinitis Due to Dermatophagoides Pteronyssinus, Allergic Rhinitis Due to House Dust Mite
- Interventions
- Sublingual allergy immunotherapy tablet, Placebo
- Lead sponsor
- ALK-Abelló A/S
- Results first posted
- 2024-06-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04145219?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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