Comparison · NCT00946998-sae
Sertraline 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. Sertraline vs Placebo: serious adverse events. Trial comparisons, record NCT00946998-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00946998-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 | 0.134 | 0.08 | 0.216 | wilson | |
| Risk in group 2 | 0.135 | 0.0809 | 0.218 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0014 | -0.1 | 0.097 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.99 | 0.484 | 2.02 | log | |
| Odds ratio, group 1 over group 2 | 0.988 | 0.432 | 2.26 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sertraline than on Placebo | 716 | 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 | Sertraline | Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~Sertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d | 13 | 97 | EG000 |
| Group 2 | Placebo | Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode~placebo: Placebo tablet will be identical and matched to sertraline tablet. | 13 | 96 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 12 weeks of randomized study duration.
Source ClinicalTrials.gov
Trial
- Title
- Chronic Kidney Disease Antidepressant Sertraline Trial
- NCT number
- NCT00946998
- Phases
- PHASE3
- Conditions
- Chronic Kidney Disease, Depression
- Interventions
- Sertraline, placebo
- Lead sponsor
- VA Office of Research and Development
- Results first posted
- 2018-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00946998?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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