Comparison · NCT02782104-1b7804c6
Esketamine Nasal Spray (IND Phase) vs Esketamine Nasal Spray (OP/MA Phase): Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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. Esketamine Nasal Spray (IND Phase) vs Esketamine Nasal Spray (OP/MA Phase): Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT02782104-1b7804c6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02782104-1b7804c6
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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 | 0.755 | 0.714 | 0.793 | wilson | |
| Risk in group 2 | 0.948 | 0.933 | 0.959 | wilson | |
| Risk difference, group 1 minus group 2 | -0.192 | -0.235 | -0.152 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.797 | 0.755 | 0.841 | log | |
| Odds ratio, group 1 over group 2 | 0.17 | 0.121 | 0.239 | log | |
| Number needed to treat, for one fewer participant with the outcome on Esketamine Nasal Spray (IND Phase) than on Esketamine Nasal Spray (OP/MA Phase) | 5.2 | 4.25 | 6.56 | from the risk difference interval |
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 | Esketamine Nasal Spray (IND Phase) | Participants who entered induction phase (IND) from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, NCT02422186, or ESKETINTRD3006 received esketamine nasal spray twice per week on Day 1 for 4 weeks as a flexible dose regimen (56 milligrams \[mg\] or 84 mg for participants less than \[\<\] 65 years; 28 mg, 56 mg or 84 mg for participants greater than or equal to \[\>=\] 65 years). | 346 | 458 | OG000 |
| Group 2 | Esketamine Nasal Spray (OP/MA Phase) | Participants who entered the OP/MA phase from the IND phase of study NCT02782104, continued on the same dose of esketamine from the IND phase, weekly. Participants who entered from studies NCT02417064, NCT02418585, NCT02493868, NCT02497287, or NCT02782104 were administered esketamine nasal spray, 56 mg or 84 mg, once weekly. Participants who entered study NCT02422186 received esketamine nasal spray (28 mg in Week 1; 28 or 56 mg in Week 2; and 28, 56 or 84 mg in Weeks 3 and 4) once weekly in optimization and maintenance phase (OP/MP). After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants was adjusted based upon efficacy and tolerability. | 1,052 | 1,110 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE occurring at or after the initial administration of study intervention up to end of study was considered as treatment-emergent.
- Time frame
- IND Phase: up to 4 weeks; OP/MA Phase: up to 78 months
- Population
- All enrolled analysis set included all participants who were eligible to enter this study and received at least 1 dose of intranasal study medication.
Source ClinicalTrials.gov
Trial
- Title
- A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression
- NCT number
- NCT02782104
- Phases
- PHASE3
- Conditions
- Depressive Disorder, Treatment-Resistant
- Interventions
- Esketamine Nasal Spray
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2024-02-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02782104?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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