Comparison · NCT03559192-0eaaaf3a
Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) vs Double-blind Treatment + Withdrawal Period: Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period
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. Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) vs Double-blind Treatment + Withdrawal Period: Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period. Trial comparisons, record NCT03559192-0eaaaf3a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03559192-0eaaaf3a
On this page
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 | 0.471 | 0.368 | 0.576 | wilson | |
| Risk in group 2 | 0.357 | 0.263 | 0.464 | wilson | |
| Risk difference, group 1 minus group 2 | 0.113 | -0.0345 | 0.255 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 0.915 | 1.9 | log | |
| Odds ratio, group 1 over group 2 | 1.6 | 0.863 | 2.97 | log | |
Number needed to treat, for one more participant with the outcome on Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) than on Double-blind Treatment + Withdrawal Period: Placebo | 8.81 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Double-blind Treatment + Withdrawal Period: JNJ-67953964 10 Milligrams (mg) | Participants who were responders (30% or more improvement on the MADRS total score during the placebo run-in were responders) or non-responders to lead-in placebo group were re-randomized to receive 10 mg JNJ-67953964 capsules (2\*5 mg JNJ-67953964 capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to SSRI/SNRI treatment. Participants who completed the double-blind treatment period prior to the end of Week 11 entered the withdrawal period where they were treated with placebo for 2 weeks. | 40 | 85 | OG001 |
| Group 2 | Double-blind Treatment + Withdrawal Period: Placebo | Participants who were responders (30 percent \[%\]) or more improvement on the Montgomery-Asberg Depression Rating Scale (MADRS) total score during the placebo run-in) or non-responders to lead-in placebo group were re-randomized to receive placebo matching to JNJ-67953964 capsules (2 placebo capsules) once daily during double-blind treatment period (up to 6 weeks after lead-in period) in addition to Selective serotonin reuptake inhibitors /Serotonin and norepinephrine reuptake inhibitors (SSRI/SNRI) treatment. Participants who completed the double-blind treatment period prior to the end of Week 11 entered the withdrawal period where they were treated with placebo for 2 weeks. | 30 | 84 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) During DB Treatment Period
- Description
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. TEAEs were AEs with onset during the treatment period that has worsened since baseline.
- Time frame
- Up to Week 6
- Population
- The full safety analysis set included all enrolled participants who received at least 1 dose of study medication in the treatment period.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression
- NCT number
- NCT03559192
- Phases
- PHASE2
- Conditions
- Depressive Disorder, Major
- Interventions
- JNJ-67953964, Placebo
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2023-06-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03559192?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03559192-0eaaaf3a