Comparison · NCT00812812-sae
Paroxetine 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. Paroxetine vs Placebo: serious adverse events. Trial comparisons, record NCT00812812-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00812812-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 | 0 | 0.117 | wilson | |
| Risk in group 2 | 0 | 0 | 0.125 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.125 | 0.117 | 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 | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Paroxetine | Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day. | 0 | 29 | EG001 |
| Group 2 | Placebo | Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks). | 0 | 27 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Serious adverse events (SAEs) and non-serious AEs were collected during the treatment (8 weeks at maximum) and taper phases (3 weeks at maximum). SAEs were also collected during the follow-up phase (2 weeks after the last dose of investigational product).
Source ClinicalTrials.gov
Trial
- Title
- Paxil Japanese Post Marketing Paediatric Study in Depression (Double-blind, Placebo Controlled Study)
- NCT number
- NCT00812812
- Phases
- PHASE4
- Conditions
- Depressive Disorder
- Interventions
- paroxetine 10mg tablet, paroxetine 20mg tablet, matched placebo to paroxetine 10mg, matched placebo to paroxetine 20mg
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2011-10-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00812812?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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