Comparison · NCT02348632-sae
JZP-110 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
Cite this record
ConductScience Library. JZP-110 vs Placebo: serious adverse events. Trial comparisons, record NCT02348632-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02348632-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 | 0.042 | 0.029 | 0.0604 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0263 | wilson | |
| Risk difference, group 1 minus group 2 | 0.042 | 0.0126 | 0.0604 | 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, for one more participant with a serious adverse event on JZP-110 than on Placebo | 23.8 | 16.6 | 79.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | JZP-110 | Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase. | 27 | 643 | EG000 |
| Group 2 | Placebo | JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving. | 0 | 142 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The Safety Population consisted of all subjects who received at least 1 dose of study medication. Adverse events are reported across the entire study (e.g., the open-label and randomized withdrawal periods combined).
Source ClinicalTrials.gov
Trial
- Title
- "A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
- NCT number
- NCT02348632
- Phases
- PHASE3
- Conditions
- Narcolepsy, Obstructive Sleep Apnea
- Interventions
- JZP-110
- Lead sponsor
- Jazz Pharmaceuticals
- Results first posted
- 2019-06-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02348632?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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