Comparison · NCT01802385-sae
Sertraline 400mg 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
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ConductScience Library. Sertraline 400mg vs Placebo: serious adverse events. Trial comparisons, record NCT01802385-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01802385-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 | 0.616 | 0.551 | 0.676 | wilson | |
| Risk in group 2 | 0.524 | 0.46 | 0.587 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0919 | 0.00147 | 0.18 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.18 | 1 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 1.46 | 1.01 | 2.11 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sertraline 400mg than on Placebo | 10.9 | 5.55 | 682 | 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 | Sertraline 400mg | Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day plus adjunctive sertraline therapy at 400mg/day for 2 weeks, then 200mg for 12 weeks, and then tapered over 3 weeks.~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks. | 141 | 229 | EG001 |
| Group 2 | Placebo | Standard cryptococcal meningitis therapy with amphotericin (0.7-1.0 mg/kg/day) + fluconazole (800-1200mg/day).~Sertraline: Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks. | 121 | 231 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 18 weeks
Source ClinicalTrials.gov
Trial
- Title
- Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
- NCT number
- NCT01802385
- Phases
- PHASE3
- Conditions
- Cryptococcal Meningitis, Fungal Meningitis
- Interventions
- Sertraline
- Lead sponsor
- University of Minnesota
- Results first posted
- 2020-01-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01802385?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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