Comparison · NCT02056431-sae
IVR Intervention Group vs IVR Control Group: 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. IVR Intervention Group vs IVR Control Group: serious adverse events. Trial comparisons, record NCT02056431-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02056431-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 | 0.228 | 0.197 | 0.264 | wilson | |
| Risk in group 2 | 0.224 | 0.194 | 0.257 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00475 | -0.0411 | 0.051 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.833 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.79 | 1.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on IVR Intervention Group than on IVR Control Group | 210 | 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 | IVR Intervention Group | Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.~IVR Intervention Group: Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians. | 138 | 604 | EG000 |
| Group 2 | IVR Control Group | Participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education. | 149 | 666 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data were collected for each participant from the time of enrollment through 8 months.
Source ClinicalTrials.gov
Trial
- Title
- Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
- NCT number
- NCT02056431
- Phases
- NA
- Conditions
- Diabetic Peripheral Neuropathy
- Interventions
- IVR Intervention Group
- Lead sponsor
- Kaiser Permanente
- Results first posted
- 2018-02-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02056431?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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