Comparison · NCT02717442-sae
OTO-104 (Safety Analysis Set) vs Placebo (Safety Analysis Set): 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. OTO-104 (Safety Analysis Set) vs Placebo (Safety Analysis Set): serious adverse events. Trial comparisons, record NCT02717442-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02717442-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 | 0.0233 | 0.0064 | 0.0809 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0418 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0233 | -0.0218 | 0.0809 | 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 OTO-104 (Safety Analysis Set) than on Placebo (Safety Analysis Set) | 43 | 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 | OTO-104 (Safety Analysis Set) | All subjects who receivedOTO-104. Subjects were included in this treatment group according to the actual treatment received regardless of their randomized assignment. | 2 | 86 | EG000 |
| Group 2 | Placebo (Safety Analysis Set) | All subjects who received Placebo. Subjects were included in this treatment group according to the actual treatment received regardless of their randomized assignment. | 0 | 88 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Reported or observed during or after dosing with the study drug at the Baseline visit up until the Week 12 (3 Months) end of study visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in, which is why adverse events were collected starting at the Baseline visit during dosing up until the final visit.
Source ClinicalTrials.gov
Trial
- Title
- Study of OTO-104 in Subjects With Unilateral Meniere's Disease
- NCT number
- NCT02717442
- Phases
- PHASE3
- Conditions
- Meniere's Disease
- Interventions
- OTO-104, Placebo
- Lead sponsor
- Otonomy, Inc.
- Results first posted
- 2023-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02717442?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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