Comparison · NCT03025789-sae
Inpatients vs Outpatients: 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. Inpatients vs Outpatients: serious adverse events. Trial comparisons, record NCT03025789-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03025789-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 | 0.0735 | 0.0404 | 0.13 | wilson | |
| Risk in group 2 | 0.105 | 0.0417 | 0.241 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0317 | -0.172 | 0.0533 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.699 | 0.232 | 2.1 | log | |
| Odds ratio, group 1 over group 2 | 0.675 | 0.199 | 2.28 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Inpatients than on Outpatients | 31.5 | 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 | Inpatients | Participants received fexinidazole orally for 10 days as inpatients (at the hospital)~Fexinidazole: Tablets of 600 mg; Participants with a weight between 20 and 34 kg received 1200 mg (2 tablets) for 4 days, then 600 mg (1 tablet) for 6 days (with food); Participants with a weight of 35 kg and above received 1800 mg (3 tablets) for 4 days, then 1200 mg (2 tablets) for 6 days (with food) | 10 | 136 | EG000 |
| Group 2 | Outpatients | Participants received fexinidazole orally for 10 days as outpatients (at home)~Fexinidazole: Tablets of 600 mg; Participants with a weight between 20 and 34 kg received 1200 mg (2 tablets) for 4 days, then 600 mg (1 tablet) for 6 days (with food); Participants with a weight of 35 kg and above received 1800 mg (3 tablets) for 4 days, then 1200 mg (2 tablets) for 6 days (with food) | 4 | 38 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Per protocol, non-serious adverse events (AEs) were recorded as follows: for inpatients, from the first intake of fexinidazole (Day 1) until the end-of-hospitalization Visit (Day 13-18) and in outpatients, from the first intake of fexinidazole (Day 1) until the end-of-treatment Visit (Day 11). Treatment-emergent serious AEs were collected from the first intake of fexinidazole (Day 1) until the end of the follow-up (Month 18). The population of analysis corresponds to the mITT population.
Source ClinicalTrials.gov
Trial
- Title
- Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
- NCT number
- NCT03025789
- Phases
- PHASE3
- Conditions
- Trypanosomiasis, African, Sleeping Sickness, Trypanosomiasis; Gambian
- Interventions
- Fexinidazole
- Lead sponsor
- Drugs for Neglected Diseases
- Results first posted
- 2024-06-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03025789?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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