Comparison · NCT03087955-sae
Late-stage HAT vs Early- and Intermediate-stage HAT: 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. Late-stage HAT vs Early- and Intermediate-stage HAT: serious adverse events. Trial comparisons, record NCT03087955-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03087955-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 | 0.108 | 0.0693 | 0.164 | wilson | |
| Risk in group 2 | 0.0732 | 0.0252 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0346 | -0.0925 | 0.108 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.47 | 0.456 | 4.76 | log | |
| Odds ratio, group 1 over group 2 | 1.53 | 0.428 | 5.47 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Late-stage HAT than on Early- and Intermediate-stage HAT | 28.9 | 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 | Late-stage HAT | Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph and/or cerebrospinal fluid (CSF) at the investigational center. If testing for parasites in CSF was negative, the CSF white blood cell count, measured at the investigational center, had to be above 20 cells/µL for classification as late-stage HAT. Participants received 960 mg acoziborole as a single oral dose. | 18 | 167 | EG000 |
| Group 2 | Early- and Intermediate-stage HAT | Participants with confirmation of HAT by detection of the parasite in the blood and/or lymph at the investigational center. Parasites had to be absent from the CSF. The CSF white blood cell count, measured at the investigational center, had to be between 6 and 20 cells/µL for classification as intermediate stage HAT and equal to or below 5 cells/µL for classification as early-stage HAT. Participants received 960 mg acoziborole as a single oral dose. | 3 | 41 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Non-serious AEs were recorded from the time of administration of acoziborole on Day 1 until the 6 month follow-up visit. Serious AEs were collected from the time of providing written informed consent until the end of the follow-up (Month 18). TEAEs were defined as any AEs occurring on or after the date of study-drug administration or worsening in intensity on or after the date of study-drug administration.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due to T.b. Gambiense
- NCT number
- NCT03087955
- Phases
- PHASE2, PHASE3
- Conditions
- Trypanosomiasis, African, Gambiense Trypanosomiasis, Sleeping Sickness
- Interventions
- Acoziborole
- Lead sponsor
- Drugs for Neglected Diseases
- Results first posted
- 2025-09-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03087955?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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