Comparison · NCT03643562-sae
Treatment Naive vs Previously Treated: 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. Treatment Naive vs Previously Treated: serious adverse events. Trial comparisons, record NCT03643562-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03643562-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 | 0.556 | 0.267 | 0.811 | wilson | |
| Risk in group 2 | 0.5 | 0.29 | 0.71 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0556 | -0.301 | 0.386 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.11 | 0.528 | 2.34 | log | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.251 | 6.23 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Treatment Naive than on Previously Treated | 18 | 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 | Treatment Naive | Treatment-naive participants received prescribed adrabetadex by IT injection via LP every 2 weeks. Treatment with adrabetadex continued until the clinician considered adrabetadex to be no longer beneficial to the participant, the participant withdrew from the study, adrabetadex received marketing authorization in the United States, or the development program was discontinued. | 5 | 9 | EG000 |
| Group 2 | Previously Treated | Previously-treated participants received prescribed adrabetadex by IT injection via LP every 2 weeks. Treatment with adrabetadex continued until the clinician considered adrabetadex to be no longer beneficial to the participant, the participant withdrew from the study, adrabetadex received marketing authorization in the United States, or the development program was discontinued. | 9 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to Week 134
Source ClinicalTrials.gov
Trial
- Title
- Niemann-Pick Type C Treatment With Adrabetadex for Symptoms of Brain and Nervous System
- NCT number
- NCT03643562
- Phases
- PHASE3
- Conditions
- Niemann-Pick Type C Disease
- Interventions
- Adrabetadex
- Lead sponsor
- Mandos LLC
- Results first posted
- 2024-01-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03643562?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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