Comparison · NCT03110575-b6640933
TNX-102 SL - TNX-102 SL vs Placebo - TNX-102 SL: Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed a Double-blinded lead-in Study
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. TNX-102 SL - TNX-102 SL vs Placebo - TNX-102 SL: Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed a Double-blinded lead-in Study. Trial comparisons, record NCT03110575-b6640933. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03110575-b6640933
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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 | 0.43 | 0.334 | 0.532 | wilson | |
| Risk in group 2 | 0.639 | 0.54 | 0.728 | wilson | |
| Risk difference, group 1 minus group 2 | -0.209 | -0.34 | -0.0672 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.673 | 0.51 | 0.888 | log | |
| Odds ratio, group 1 over group 2 | 0.426 | 0.238 | 0.763 | log | |
| Number needed to treat, for one fewer participant with the outcome on TNX-102 SL - TNX-102 SL than on Placebo - TNX-102 SL | 4.78 | 2.94 | 14.9 | 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 | TNX-102 SL - TNX-102 SL | The patients in this group received TNX-102 SL 5.6 mg in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303. | 40 | 93 | OG001 |
| Group 2 | Placebo - TNX-102 SL | The patients in this group received placebo in the lead-in double blind study TNX-CY-P301, then received TNX-102 SL 5.6 mg in this open label study TNX-CY-P303. | 62 | 97 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Incidence of Newly Emergent Adverse Events of TNX-102 SL Tablets Taken Daily at Bedtime Over an Additional 12 Weeks in Patients With PTSD Who Have Completed a Double-blinded lead-in Study
- Description
- Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class.
- Time frame
- 12 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- 12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients
- NCT number
- NCT03110575
- Phases
- PHASE3
- Conditions
- PTSD
- Interventions
- TNX-102 SL
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Results first posted
- 2025-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03110575?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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