Comparison · NCT02612337-21624d7e
OTO-104 (Safety Analysis Set) vs Placebo (Safety Analysis Set): Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)
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): Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3). Trial comparisons, record NCT02612337-21624d7e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02612337-21624d7e
On this page
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 | 0.0488 | 0.0191 | 0.119 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000347 | 0.0442 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0488 | -0.00447 | 0.119 | 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 treat, for one more participant with the outcome on OTO-104 (Safety Analysis Set) than on Placebo (Safety Analysis Set) | 20.5 | 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. | 4 | 82 | OG000 |
| 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 | 83 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3)
- Description
Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection at the Baseline visit persisted at the end of study visit (Week 12 \[Month 3\]).
- Time frame
- 3 months
- Population
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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02612337-21624d7e