Comparison · NCT02612337-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 NCT02612337-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02612337-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 | 0.0244 | 0.00671 | 0.0846 | wilson | |
| Risk in group 2 | 0.0241 | 0.00663 | 0.0837 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000294 | -0.0618 | 0.063 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.146 | 7.02 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.139 | 7.36 | log | |
| 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) | 3,400 | 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 received OTO-104. Subjects were included in this treatment group according to the actual treatment received regardless of their randomized assignment. | 2 | 82 | 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. | 2 | 83 | 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 to the Week 12 (Month 3) end of study visit. The Baseline visit occurred after the Lead-in period when no intervention was administered. Therefore, collection of adverse events started during dosing at the Baseline visit and lasted to the end of the study (Week 12 (Month 3).
Source ClinicalTrials.gov
Trial
- Title
- Study of OTO-104 in Subjects With Unilateral Meniere's Disease
- NCT number
- NCT02612337
- Phases
- PHASE3
- Conditions
- Meniere's Disease
- Interventions
- OTO-104, Placebo
- Lead sponsor
- Otonomy, Inc.
- Results first posted
- 2023-01-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02612337?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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