Comparison · NCT06414512-sae
Low Dose Flucytosine vs Control: 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. Low Dose Flucytosine vs Control: serious adverse events. Trial comparisons, record NCT06414512-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06414512-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 | 0.646 | 0.504 | 0.766 | wilson | |
| Risk in group 2 | 0.772 | 0.703 | 0.828 | wilson | |
| Risk difference, group 1 minus group 2 | -0.126 | -0.278 | 0.0119 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.837 | 0.668 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.539 | 0.27 | 1.08 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Low Dose Flucytosine than on Control | 7.93 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Low Dose Flucytosine | HIV-infected persons in Uganda with cryptococcal meningitis~Flucytosine: Participants in the trial will receive 60mg/kg/day of 5-FC in 3 divided doses for 10 days. Single-dose liposomal amphotericin (10mg/kg) is preferred, if available. Amphotericin B 0.7-1.0 mg/kg/day may be used if needed. | 31 | 48 | EG001 |
| Group 2 | Control | Historical controls drawn from the AMBITION trial will be used as a comparison group, selected weighted by inclusion/exclusion criteria, baseline characteristics and therapies received.~AMBITION trial control: Induction therapy for control group participants followed the 2018 WHO cryptococcal guidelines with 7 days of 5-FC 100mg/kg/day and 7 days of IV Amphotericin deoxycholate followed by 1200mg fluconazole/day for 7 days. | 132 | 171 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 16 weeks
Source ClinicalTrials.gov
Trial
- Title
- Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis
- NCT number
- NCT06414512
- Phases
- PHASE2
- Conditions
- Cryptococcal Meningitis
- Interventions
- AMBITION trial control, Flucytosine
- Lead sponsor
- University of Minnesota
- Results first posted
- 2025-08-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06414512?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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