Comparison · NCT02716818-sae
Chronocort® vs Standard Glucocorticoid Therapy: 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. Chronocort® vs Standard Glucocorticoid Therapy: serious adverse events. Trial comparisons, record NCT02716818-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02716818-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 | 0.115 | 0.0567 | 0.218 | wilson | |
| Risk in group 2 | 0.082 | 0.0355 | 0.178 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0328 | -0.0794 | 0.146 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.4 | 0.47 | 4.17 | log | |
| Odds ratio, group 1 over group 2 | 1.45 | 0.434 | 4.85 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Chronocort® than on Standard Glucocorticoid Therapy | 30.5 | 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 | Chronocort® | Chronocort® will be provided as 5mg, 10mg and 20mg capsules for oral administration. The starting dose for each subject will be based on the subjects previous glucocorticoid therapy dose and then dose titrated to effect.~Chronocort®: Chronocort® is a patented oral modified release formulation of hydrocortisone which is intended to mimic, or closely match, the serum levels of endogenous cortisol. | 7 | 61 | EG000 |
| Group 2 | Standard Glucocorticoid Therapy | Subjects in this arm will continue their previous oral glucocorticoid therapy, titrated to effect. Standard glucocorticoid therapy may consist of:~1. Hydrocortisone only~2. Prednisone or prednisolone, alone or in combination with hydrocortisone~3. Dexamethasone, alone or in combination with any other glucocorticoid | 5 | 61 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event information was collected from the point of enrolment to completion of the study (6 months).
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia
- NCT number
- NCT02716818
- Phases
- PHASE3
- Conditions
- Congenital Adrenal Hyperplasia
- Interventions
- Chronocort®, standard glucocorticoid therapy
- Lead sponsor
- Neurocrine UK Limited
- Results first posted
- 2019-09-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02716818?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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