Comparison · NCT00074802-sae
Paroxetine Continuation vs Paroxetine With CBT Augmentation: 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. Paroxetine Continuation vs Paroxetine With CBT Augmentation: serious adverse events. Trial comparisons, record NCT00074802-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00074802-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 | 0.0345 | 0.00611 | 0.172 | wilson | |
| Risk in group 2 | 0 | 0 | 0.107 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0345 | -0.0764 | 0.172 | 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 Paroxetine Continuation than on Paroxetine With CBT Augmentation | 29 | 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 | Paroxetine Continuation | Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. | 1 | 29 | EG000 |
| Group 2 | Paroxetine With CBT Augmentation | Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.~Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.~Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions. | 0 | 32 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (AEs) were assessed from the beginning of the open trial phase of the study and throughout the randomized phase in which patients received paroxetine with or without CBT. Data presented in the Serious Adverse Events (SAE) and AE tables refer to events occurring during the randomized phase (Weeks 12, 16, 20, 24, and 28).
Source ClinicalTrials.gov
Trial
- Title
- Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
- NCT number
- NCT00074802
- Phases
- PHASE3
- Conditions
- Social Anxiety Disorder
- Interventions
- Paroxetine, Cognitive behavioral therapy (CBT)
- Lead sponsor
- Temple University
- Results first posted
- 2017-06-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00074802?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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