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Comparison · NCT03974178-deaths

Patients With Stage 1 r-HAT vs Patients With Stage 2 r-HAT: deaths from any cause

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. Patients With Stage 1 r-HAT vs Patients With Stage 2 r-HAT: deaths from any cause. Trial comparisons, record NCT03974178-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03974178-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.278wilson
Risk in group 20.02860.005060.145wilson
Risk difference, group 1 minus group 2-0.0286-0.1450.25newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer death from any cause on Patients With Stage 1 r-HAT than on Patients With Stage 2 r-HAT35from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Patients With Stage 1 r-HATPatients with stage 1 r-HAT were patients without trypanosomes in the cerebrospinal fluid (CSF) but with trypanosomes in the blood and/or lymph and CSF white blood cells (WBC) ≤5 cells/µL.010EG000
Group 2Patients With Stage 2 r-HATPatients with stage 2 r-HAT were patients with trypanosomes in the CSF (and/or in blood/lymph) and/or CSF WBC \>5 cells/µL.135EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Non-serious treatment-emergent adverse events (AEs) were recorded from the first intake of fexinidazole (Day 1) until the End-of-Hospitalization Visit (Day 12-18). Treatment-emergent AEs considered as serious or related to fexinidazole treatment were collected from the first intake of fexinidazole (Day 1) until the End-of-Study Visit (Month 12). The population of analysis includes all patients who received at least one dose of fexinidazole.

Source ClinicalTrials.gov

Trial

Title
Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense
NCT number
NCT03974178
Phases
PHASE2, PHASE3
Conditions
Trypanosomiasis, African, Sleeping Sickness, Trypanosoma Brucei Rhodesiense; Infection
Interventions
Fexinidazole
Lead sponsor
Drugs for Neglected Diseases
Results first posted
2025-01-30

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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