Comparison · NCT02437383-sae
Propranolol ER vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Propranolol ER vs Placebo: serious adverse events. Trial comparisons, record NCT02437383-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02437383-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 | 0.04 | 0.0157 | 0.0984 | wilson | |
| Risk in group 2 | 0.01 | 0.00177 | 0.0545 | wilson | |
| Risk difference, group 1 minus group 2 | 0.03 | -0.0207 | 0.0889 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4 | 0.455 | 35.2 | log | |
| Odds ratio, group 1 over group 2 | 4.13 | 0.453 | 37.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Propranolol ER than on Placebo | 33.3 | 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 | Propranolol ER | Propranolol hydrochloride extended release (ER) capsules; 60 mg (Visit 1 and Visit 4); 120 mg (Visit 2 and Visit 3) given orally as: 60 mg once/day (Visit 1 and Visit 4) and 60 mg twice/day (Visit 2 and Visit 3).~Propranolol ER: Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4. | 4 | 100 | EG000 |
| Group 2 | Placebo | Capsules, identical in appearance to active comparator (propranolol), to be administered orally in exactly the same manner as propranolol at Visit 1 (once/day), Visit 2 (twice/day), Visit 3 (twice/day), and Visit 4 (once/day).~Placebo: Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules | 1 | 100 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From obtaining informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation.
Source ClinicalTrials.gov
Trial
- Title
- Study of Orofacial Pain and PropRANOlol
- NCT number
- NCT02437383
- Phases
- PHASE2
- Conditions
- Temporomandibular Disorders
- Interventions
- Propranolol ER, Placebo
- Lead sponsor
- University of North Carolina, Chapel Hill
- Results first posted
- 2019-05-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02437383?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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