Comparison · NCT01511107-sae
Amoxicillin-Clavulanate, 10 Days vs Amoxicillin-Clavulanate, 5 Days: 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. Amoxicillin-Clavulanate, 10 Days vs Amoxicillin-Clavulanate, 5 Days: serious adverse events. Trial comparisons, record NCT01511107-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01511107-sae
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 | 0.0117 | 0.00398 | 0.0338 | wilson | |
| Risk in group 2 | 0.0194 | 0.00831 | 0.0446 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00771 | -0.034 | 0.017 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.602 | 0.145 | 2.49 | log | |
| Odds ratio, group 1 over group 2 | 0.598 | 0.141 | 2.53 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Amoxicillin-Clavulanate, 10 Days than on Amoxicillin-Clavulanate, 5 Days | 130 | 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 | Amoxicillin-Clavulanate, 10 Days | Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days. | 3 | 257 | EG000 |
| Group 2 | Amoxicillin-Clavulanate, 5 Days | Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10. | 5 | 258 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Parents were interviewed at each scheduled study visit (Day 1, Day 12-14, Day 16-30, 6 week), at the Day 4-6 phone call, at interim illness visits through May 31st, and at the final September visit to determine if their child had any adverse events.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
- NCT number
- NCT01511107
- Phases
- PHASE2
- Conditions
- Acute Otitis Media
- Interventions
- Amoxicillin-Clavulanate, 10 days, Amoxicillin-Clavulanate, 5 days
- Lead sponsor
- Alejandro Hoberman
- Results first posted
- 2017-02-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01511107?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/NCT01511107-sae