Comparison · NCT03572049-sae
SUBA Itraconazole vs Conventional Itraconazole: 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. SUBA Itraconazole vs Conventional Itraconazole: serious adverse events. Trial comparisons, record NCT03572049-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03572049-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 | 0.0952 | 0.0377 | 0.221 | wilson | |
| Risk in group 2 | 0.261 | 0.156 | 0.403 | wilson | |
| Risk difference, group 1 minus group 2 | -0.166 | -0.319 | -0.00216 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.365 | 0.128 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.298 | 0.0878 | 1.01 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on SUBA Itraconazole than on Conventional Itraconazole | 6.04 | 3.14 | 464 | from the risk difference interval |
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 | SUBA Itraconazole | Stage 1: Day 1-3 two 65 mg capsules three times daily with food. Days 4-42 two 65 mg capsules twice daily with food.~Stage 2 : Days 43-180 two 65 mg capsules twice daily with food~SUBA itraconazole: SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food. | 4 | 42 | EG000 |
| Group 2 | Conventional Itraconazole | Stage 1: Day 1-3 two 100 mg capsules three times daily with food. Days 4-42 two 100 mg capsules twice daily with food.~Stage 2 : Days 43-180 two 100 mg capsules twice daily with food~Conventional itraconazole: Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food. | 12 | 46 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Data regarding all adverse events were collected over 180 days (approximately 6 months).
Source ClinicalTrials.gov
Trial
- Title
- Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole
- NCT number
- NCT03572049
- Phases
- PHASE2, PHASE3
- Conditions
- Invasive Fungal Infections
- Interventions
- SUBA itraconazole, Conventional itraconazole
- Lead sponsor
- University of Alabama at Birmingham
- Results first posted
- 2022-10-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03572049?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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