Comparison · NCT04581629-sae
Period 1: Encaleret vs Periods 2 and 3: Encaleret: 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. Period 1: Encaleret vs Periods 2 and 3: Encaleret: serious adverse events. Trial comparisons, record NCT04581629-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04581629-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 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk in group 2 | 0 | 0 | 0.228 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.228 | 0.39 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Period 1: Encaleret | In Period 1 (5 days), participants received an ascending dose of oral encaleret once daily (QD) for the first 3 days (Day 1: 30 mg QD, Day 2: 10, 60 or 90 mg QD, Day 3: 20, 40, 60, 90, 120 or 180 mg QD). Participants then received an individualized dose of oral encaleret twice daily (BID) for 2 days (Day 4 and Day 5: 10 to 180 mg BID). | 0 | 6 | EG000 |
| Group 2 | Periods 2 and 3: Encaleret | In Period 2 (5 days), participants received encaleret BID for 5 days at dose levels based on responses from Period 1. On Day 1 and Day 2, participants received 10 to 240 mg BID. On Day 3 to Day 5, participants received 10 to 360 mg BID.~In Period 3 (24 weeks), participants received encaleret for an additional 24 weeks. Participants received encaleret at an initial dose based on tolerance and response to the encaleret dose at the end of Period 2 | 0 | 13 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 16 months
Source ClinicalTrials.gov
Trial
- Title
- Safety, Tolerability, and Efficacy of Encaleret in Participants With Autosomal Dominant Hypocalcemia (ADH) Type 1
- NCT number
- NCT04581629
- Phases
- PHASE2
- Conditions
- Autosomal Dominant Hypocalcemia (ADH), Autosomal Dominant Hypocalcemia Type 1 (ADH1)
- Interventions
- Encaleret
- Lead sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company
- Results first posted
- 2024-11-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04581629?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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