Comparison · NCT03688555-sae
ACT-774312 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. ACT-774312 vs Placebo: serious adverse events. Trial comparisons, record NCT03688555-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03688555-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 | 0.0000000000000000555 | 0.354 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.561 | 0.354 | 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 | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | ACT-774312 | Participants received ACT-774312 400 mg twice daily in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray. | 0 | 7 | EG000 |
| Group 2 | Placebo | Participants received matching placebo hard gelatin capsules twice daily in the morning and evening with or without food for 12 weeks. In addition, participants also continued with their standard background therapy of mometasone furoate nasal spray. | 0 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment-emergent adverse events were all adverse events that occurred after first study treatment administration on Day 1 through to last study treatment administration on Day 84, and in the post-treatment period up to the end-of-study visit on Day 112.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis
- NCT number
- NCT03688555
- Phases
- PHASE2
- Conditions
- Bilateral Nasal Polyposis
- Interventions
- ACT-774312, Placebo
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Results first posted
- 2022-02-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03688555?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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