Comparison · NCT02567825-sae
Surgical Management vs Non-Surgical Management: 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. Surgical Management vs Non-Surgical Management: serious adverse events. Trial comparisons, record NCT02567825-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02567825-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 | 0.00794 | 0.0661 | wilson | |
| Risk in group 2 | 0.0579 | 0.0283 | 0.115 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0346 | -0.0934 | 0.0175 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.402 | 0.106 | 1.52 | log | |
| Odds ratio, group 1 over group 2 | 0.388 | 0.0979 | 1.54 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Surgical Management than on Non-Surgical Management | 28.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Surgical Management | Tympanostomy Tube Placement Topical antimicrobial treatment of acute otitis media episodes with ofloxacin drops~Tympanostomy tube placement: As per routine care, tympanostomy tubes will be inserted under general anesthesia, using a small radial incision in the anteroinferior portion of the tympanic membrane; a Teflon® Armstrong-type tympanostomy tube will be used.~Ofloxacin Otic: Participants randomized to receive tympanostomy tubes will also be followed overtime for recurrences of AOM and treated with topical ofloxacin (Floxin® 0.3%, 5 mL) 5 drops into the affected ear twice daily for 10 days. Persistence of otorrhea after 7 days of treatment will be considered inadequate response, and children so affected will be prescribed empiric amoxicillin-clavulanate (90/6.4 mg/kg/day in two divided doses) followed by culture-directed therapy 48 hours later. | 3 | 129 | EG000 |
| Group 2 | Non-Surgical Management | Antimicrobial treatment of acute otitis media episodes with amoxicillin-clavulanate and/or ceftriaxone~Amoxicillin-Clavulanate and/or Ceftriaxone: Children randomized to nonsurgical management will receive stepwise therapy with amoxicillin-clavulanate (90/6.4 mg/kg in two divided doses for 10 days), and in the event of inadequate response, ceftriaxone (75 mg/kg intramuscularly, repeated in 48 hours), as recommended in the American Academy of Pediatrics guidelines. | 7 | 121 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The occurrence of adverse events (AEs) were recorded from Day 1 (enrollment) through Day 786. Parents were interviewed at each scheduled study visit, at interim illness visits, and at the end-of-study visit to determine if their child had any adverse events since the preceding visit. All recorded AEs were followed to adequate resolution.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
- NCT number
- NCT02567825
- Phases
- NA
- Conditions
- Acute Otitis Media
- Interventions
- Tympanostomy tube placement, Amoxicillin-Clavulanate and/or Ceftriaxone, Ofloxacin Otic
- Lead sponsor
- Alejandro Hoberman
- Results first posted
- 2021-12-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02567825?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
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GET https://conductscience.org/api/comparisons/v1/NCT02567825-sae