Comparison · NCT03672292-sae
SCY-078 Plus Voriconazole vs Voriconazole Mono-therapy: 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. SCY-078 Plus Voriconazole vs Voriconazole Mono-therapy: serious adverse events. Trial comparisons, record NCT03672292-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03672292-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 | 0.6 | 0.313 | 0.832 | wilson | |
| Risk in group 2 | 0.417 | 0.193 | 0.68 | wilson | |
| Risk difference, group 1 minus group 2 | 0.183 | -0.207 | 0.505 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.44 | 0.622 | 3.33 | log | |
| Odds ratio, group 1 over group 2 | 2.1 | 0.381 | 11.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SCY-078 Plus Voriconazole than on Voriconazole Mono-therapy | 5.45 | 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 | SCY-078 Plus Voriconazole | Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).~PLUS Oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks~SCY-078: Oral tablets of SCY-078~Voriconazole: Voriconazole IV vials or oral tablets | 6 | 10 | EG000 |
| Group 2 | Voriconazole Mono-therapy | Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).~PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given QD from Day 3 onwards).~Treatment duration = minimum 6 weeks/Max 13 weeks~Voriconazole: Voriconazole IV vials or oral tablets~Oral Placebo Tablets: Oral Placebo Tablets matching SCY-078 | 5 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Through study completion, an average of 19 weeks
Source ClinicalTrials.gov
Trial
- Title
- Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
- NCT number
- NCT03672292
- Phases
- PHASE2
- Conditions
- Invasive Pulmonary Aspergillosis
- Interventions
- SCY-078, Voriconazole, Oral Placebo Tablets
- Lead sponsor
- Scynexis, Inc.
- Results first posted
- 2024-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03672292?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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