This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303) (NCT03734991), a randomized phase 3 study. The primary outcome is Clinical Cure (Complete Resolution of Signs and Symptoms).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03734991 |
| Phase | Phase 3 |
| Condition | Candida Vulvovaginitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 376 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Scynexis, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Female subjects 12 years and older with acute vulvovaginal candidiasis were eligible. The primary endpoint population is described as mITT, but the registry record does not report how that population was defined.
Intervention
Oral ibrexafungerp (SCY-078), given as 300 mg orally every 12 hrs for 1 day (2 doses in 1 day).
Comparator
Matching placebo.
Primary question
The study assessed clinical cure, defined as complete resolution of signs and symptoms, at the test-of-cure visit during Day 8-14. The registry record does not report one extracted comparison of the primary outcome or an estimate of the difference between groups.
In practical statistical terms, the question concerns the proportion of participants meeting the stated clinical-cure definition in each randomized group at the test-of-cure assessment. The recorded primary endpoint is a participant count, while its description says it is measured by the percentage of subjects with clinical cure. Those descriptions identify a binary outcome at the participant level: each participant either meets the cure definition for the assessment or does not. No group-specific primary-outcome counts, percentages, effect estimate, confidence interval, or p-value are reported in the registry record.
The study also listed mycological eradication, a combined clinical-cure and mycological-eradication responder outcome, complete clinical response at follow-up, and overall treatment-emergent adverse events among its secondary outcomes. These outcomes concern different clinical or safety events, so their results should not be treated as substitutes for the primary endpoint. The registry record identifies five outcome measures overall but does not provide the statistical analyses for a single primary-outcome comparison.
3. Trial Design
VANISH 303 is recorded as a Phase 3, randomized, multicenter, parallel-group, placebo-controlled study. The registry lists enrollment of 376 and a completed status. Its brief description identifies female subjects 12 years and older with acute vulvovaginal candidiasis. The recorded condition is Candida vulvovaginitis.
Participants were assigned to oral ibrexafungerp (SCY-078) or matching placebo. The ibrexafungerp regimen is described as 300 mg orally every 12 hrs for 1 day (2 doses in 1 day). A parallel design means that participants are assigned to one group and assessed in that group, rather than receiving both study regimens in sequence. Random allocation is intended, in general, to make assigned groups comparable on average with respect to measured and unmeasured baseline characteristics; it does not guarantee exact balance in any particular trial.
The registry's masking entry is triple, while the study description calls the trial double-blind. The registry record does not explain the difference between those descriptions or identify which people were masked. The study is described as multicenter, but the number and locations of centers are not reported in the registry record.
The recorded study start is 2019-01-04 and primary completion is 2019-08-21. These dates describe the registry timeline, not the timing of any individual participant's test-of-cure visit. The primary endpoint is clinical cure at the test-of-cure visit during Day 8-14, in the mITT population. The registry record does not report the mITT definition, details of the randomization procedure, or a protocol-based sample-size justification. The actual trial enrollment should not be interpreted as a sample-size calculation for a particular target effect without those details.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| STARTED | 249 | 127 |
| Withdrawn Before Treatment | 2 | 3 |
| Withdrawn Before TOC | 59 | 41 |
| Completed the TOC Visit | 188 | 83 |
| Withdrawn At or After the TOC Visit | 5 | 3 |
| COMPLETED | 183 | 80 |
| NOT COMPLETED | 66 | 47 |
Reasons for not completing this period:
| Reason | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|
| Adverse Event | 4 | 0 |
| Lost to Follow-up | 4 | 0 |
| Physician Decision | 0 | 1 |
| Pregnancy | 1 | 0 |
| Withdrawal by Subject | 6 | 3 |
| Lack of efficacy and or/use of antifungal therapy | 49 | 41 |
| Other | 2 | 2 |
Analysis population for the primary outcome, as defined in the registry: mITT
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Ibrexafungerp (SCY-078) | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 247 | 124 | 371 | |
| Age, Categorical: <=18 years | Participants | 0 | 1 | 1 |
| Age, Categorical: Between 18 and 65 years | Participants | 244 | 120 | 364 |
| Age, Categorical: >=65 years | Participants | 3 | 3 | 6 |
| Age, Continuous | years | 34.5 (SD 11.22) | 35.8 (SD 12.47) | 34.9 (SD 11.63) |
| Sex: Female, Male: Female | Participants | 247 | 124 | 371 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 64 | 25 | 89 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 183 | 99 | 282 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): Asian | Participants | 4 | 0 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 101 | 51 | 152 |
| Race (NIH/OMB): White | Participants | 132 | 71 | 203 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 8 | 2 | 10 |
| Region of Enrollment: United States | participants | 247 | 124 | 371 |
6. Primary Endpoint
The registry lists the primary outcome as Clinical Cure (Complete Resolution of Signs and Symptoms), measured over Day 8-14.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is clinical cure, defined as complete resolution of signs and symptoms, assessed at the test-of-cure visit during Day 8-14. It is described as the percentage of subjects with clinical cure and is recorded as a count of participants in the mITT population. The endpoint therefore focuses on whether each participant meets a prespecified clinical state at the assessment, rather than on a continuous measurement such as a symptom score.
In general, a binary endpoint can be clinically interpretable because it expresses the frequency of a defined event in a group. A test-of-cure assessment also establishes a common evaluation period for participants, which is important because outcomes can vary with the timing of measurement. The endpoint's usefulness depends on a clear definition, consistent assessment, and transparent reporting of the population included in the analysis.
The record identifies the clinical-cure definition and timeframe but does not report the criteria used to classify each sign or symptom, who assessed them, or how missing test-of-cure assessments were handled. It also does not give group-level clinical-cure counts or percentages. As a result, the endpoint can be described, but the posted results do not allow readers to quantify the primary outcome or its precision for either randomized group.
Mycological eradication and combined responder outcomes were listed separately as secondary outcomes. They represent distinct outcome definitions and should not be conflated with clinical cure alone. The registry record does not report their results in the information available for this analysis.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the trial's main design features and identifies clinical cure at the test-of-cure visit as its primary endpoint. It does not, however, report a single primary-outcome comparison. The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. Thus no single treatment contrast for the primary endpoint can be interpreted from the available result information.
In particular, group-specific clinical-cure counts or percentages, a between-group effect estimate, a confidence interval, and a p-value are not reported in the registry record. Without these quantities, readers cannot determine the magnitude or precision of the primary-outcome contrast from the posted results. The absence of an extracted comparison is not evidence that the groups had the same outcome, and it is not evidence that a difference was statistically significant or clinically important.
Enrollment is listed as 376. The safety information separately gives participants at risk for adverse events as 247 in the ibrexafungerp group and 124 in the placebo group. Those denominators belong to the safety information and should not be assumed to be the numbers analyzed for the primary endpoint. The mITT population is named for the primary endpoint, but its definition and analyzed group sizes are not reported in the registry record.
Because there is no primary effect estimate or interval, the precision of a treatment contrast cannot be assessed. In general, a confidence interval describes a range of values compatible with the data under the analysis assumptions; a narrow interval conveys more precision than a wide one. No such interval is reported for the primary endpoint. Likewise, a p-value would address compatibility with a specified null hypothesis under a statistical model, but no primary-outcome p-value is reported.
The listed secondary outcomes include mycological eradication, a clinical-cure and mycological-eradication responder outcome, complete clinical response at follow-up, and overall treatment-emergent adverse events. Their presence indicates that the study considered more than one outcome domain, but the record does not report the analysis results or a multiplicity procedure. These missing details limit interpretation of any claims about which outcomes were emphasized or how statistical error across outcomes was addressed.
Accordingly, the defensible reading is descriptive: the study randomized participants to ibrexafungerp or matching placebo, specified a clinical-cure endpoint and several secondary outcomes, and posted selected safety counts. The primary efficacy effect and its statistical uncertainty are not reported in the registry record. The trial design alone cannot establish the direction, size, or certainty of a treatment difference.
9. Statistical Methods Explained
What kind of outcome is clinical cure?
The endpoint is binary at the participant level: complete resolution of signs and symptoms is the event of interest, assessed at the test-of-cure visit. The registry describes the endpoint as a percentage while also recording it as a count of participants. In general, a binary outcome can be summarized by the number of participants meeting the event definition and the number assessed, with the corresponding proportion calculated for each group. A comparison may then be expressed using a difference in proportions, a ratio of proportions, or another prespecified effect measure. The registry record does not report which effect measure was planned or an estimate from the primary analysis.
What does randomization contribute?
The study is recorded as randomized and parallel-group. In general, random allocation helps reduce systematic differences in prognostic characteristics between groups at assignment. Its purpose is to support a fair comparison of outcomes, not to ensure that all baseline characteristics are identical. Interpretation still depends on how randomization was implemented, whether assignments were concealed, how participants were followed, and how outcomes were analyzed. These procedural details are not reported in the registry record.
Why does masking matter?
Masking is intended, in general, to limit the influence of knowledge about assigned treatment on participant experience, clinical management, outcome assessment, or reporting. The registry records triple masking, while the study description calls the study double-blind. It does not explain the discrepancy or specify the masked roles. The record therefore supports noting that masking was intended, but not a more detailed account of its implementation.
How should precision be assessed?
A point estimate describes the observed effect under a chosen statistical measure; a confidence interval adds information about uncertainty in that estimate. In general, the interval is interpreted in the context of the analysis model and the data, not as a guarantee that the true effect lies within its limits. A p-value, if reported, addresses the compatibility of data with a specified null model and is not a measure of clinical importance. Neither a primary-outcome point estimate nor a confidence interval or p-value is reported in the registry record. Statistical significance and precision therefore cannot be assessed for the primary comparison from the posted information.
What does over-dispersion mean in general?
Over-dispersion is a general concern for count data when observed variability exceeds what a statistical model assumes. It can make standard errors too small if the extra variation is ignored, which can in turn make confidence intervals too narrow and tests appear more decisive than warranted. That concept is not a reported feature of this endpoint: clinical cure is recorded as a participant count and described as a percentage, not as a recurrent event count or a rate. The registry record does not report a model or a dispersion parameter for the primary outcome.
What can be inferred from the planning assumptions?
The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. In general, such an illustration asks how many participants per arm might be needed under its assumptions to detect a specified effect with a chosen power. It is a planning calculation, not observed power and not a report of the trial's original design justification. The registry record says that the illustration is not the trial's own design. It also does not report a protocol-based sample-size justification. Because the primary outcome has several categories or time points and was not reduced to one comparison, no single primary effect is available for an interpretation of a planning illustration as a target for this endpoint.
What do the analysis population labels imply?
The primary outcome is assigned to the mITT population. In general, analysis populations determine which randomized participants contribute data and can materially affect the estimand being described. The abbreviation alone does not establish which participants were included, what deviations were permitted, or how participants without a post-baseline measurement were handled. The registry record does not define mITT or report the primary analysis denominators. The safety group sizes are listed separately and should not be substituted for primary-outcome analysis sizes.
What is not available about the statistical plan?
The registry record does not report the primary-outcome model, the planned effect measure, confidence-interval method, missing-data approach, or multiplicity adjustment. It also does not report interim analyses or a detailed statistical analysis plan. These omissions do not prove that such methods were absent from the trial protocol; they mean that the registry record does not describe them. Without these details and the numerical primary results, the statistical analysis cannot be independently reconstructed from the registry information alone.
10. Multiplicity, Missing Data and Analysis Populations
The study lists a primary clinical-cure outcome and several secondary outcomes: mycological eradication, a combined clinical-cure and mycological-eradication responder outcome, complete clinical response at follow-up, and overall treatment-emergent adverse events. Testing or interpreting several outcomes can raise a multiplicity issue. In general, the more questions assessed, the greater the chance of at least one apparently unusual result if each is tested without adjustment. A prespecified testing hierarchy or adjustment can address that concern, but the registry record does not report a multiplicity procedure or explain how outcomes were prioritized.
The record identifies the primary population as mITT but does not define it, give its group sizes, or describe exclusions from it. The handling of participants without an endpoint assessment, missing values, protocol deviations, and withdrawal is not reported in the registry record. These details matter because an analysis population and missing-data method determine which observations contribute to the estimated outcome and what comparison the estimate represents.
The record also indicates that the primary outcome has several categories or time points and was not reduced to one comparison. No single primary contrast or associated estimate is reported. The registry lists five outcome measures and zero analyses in the posted information. The absence of a reported analysis does not establish that no analysis was performed; it means the registry record does not provide those results. These reporting gaps prevent an assessment of multiplicity control, missing-data sensitivity, and the relationship between the named primary endpoint and any detailed analysis plan.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ibrexafungerp (SCY-078) | 1 | 247 | 0.4% |
| Placebo | 2 | 124 | 1.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Ibrexafungerp (SCY-078) | 0 of 247 |
| Placebo | 0 of 124 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ibrexafungerp (SCY-078) | 117 of 247 |
| Placebo | 34 of 124 |
Most frequent serious adverse event terms
| Event term | Organ system | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|---|
| Hypokalaemia | Investigations | 0 of 247 | 1 of 124 |
| Diabetes mellitus | Metabolism and nutrition disorders | 0 of 247 | 1 of 124 |
| Pneumonia and bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | 1 of 247 | 0 of 124 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ibrexafungerp (SCY-078) | Placebo |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 63 of 247 | 8 of 124 |
| Nausea | Gastrointestinal disorders | 40 of 247 | 7 of 124 |
| Headache | Nervous system disorders | 23 of 247 | 11 of 124 |
| Bacterial vaginosis | Infections and infestations | 13 of 247 | 10 of 124 |
| Abdominal pain | Gastrointestinal disorders | 17 of 247 | 3 of 124 |
| Abdominal discomfort | Gastrointestinal disorders | 14 of 247 | 2 of 124 |
Serious events with the highest arm-level rate: hypokalaemia (0.8%), diabetes mellitus (0.8%), pneumonia and bronchial hyperreactivity (0.4%).
The safety information lists participants at risk as 247 for ibrexafungerp and 124 for placebo. Serious adverse events are recorded for 1 participant in the ibrexafungerp group and 2 participants in the placebo group. Deaths are recorded as 0 in each group. The record also gives other adverse-event counts of 117 and 34, respectively. These counts should be read using their listed group denominators and the safety population information; the registry record does not explain every detail of event collection or the relationship between the safety set and enrollment.
The listed serious-event terms are hypokalaemia at 0.8%, diabetes mellitus at 0.8%, and pneumonia and bronchial hyperreactivity at 0.4%. These percentages are reported for the terms, but the registry information does not assign each listed term to a treatment group. They should not be read as evidence that a particular event occurred only in one group or as a comparative risk estimate.
Adverse-event counts describe events recorded during the study; by themselves, they do not establish that the study treatment caused an event. The registry record does not report a comparative safety analysis, confidence intervals, or a detailed account of event severity and relatedness. The counts are therefore descriptive and should not be used to infer a precise difference in safety between groups.
12. What the Result Does, and Does Not, Mean
The record establishes that VANISH 303 was a randomized, parallel-group, placebo-controlled Phase 3 study of oral ibrexafungerp for acute vulvovaginal candidiasis. It identifies the regimen, the clinical-cure definition, the assessment window, and a number of secondary outcomes. It also provides selected safety counts. Those details describe the trial's intended comparison and some of the outcomes recorded.
They do not establish the size or direction of a primary clinical-cure difference. The registry record does not report the primary endpoint counts or percentages by group, a comparative effect estimate, a confidence interval, or a p-value. It is therefore not possible to judge from the posted primary results how different the groups were, how precisely a difference was estimated, or whether a prespecified statistical criterion was met. The lack of a reported comparison should not be interpreted as no effect, nor as evidence of an effect.
Likewise, the listed serious adverse-event counts and selected event terms are descriptive. Counts can identify what was recorded in each group, but they do not by themselves establish causation or provide a precise comparison. The registry record does not report the methods needed to assess adjusted or comparative safety estimates.
In general, the interpretation of a trial requires both its design and its outcome estimates. Randomization and masking can support a credible comparison, but they cannot replace the numerical results and analysis details. The registry record does not define the mITT population, describe missing-data handling, or report multiplicity procedures. These omissions constrain conclusions about what population the primary endpoint represents and how uncertainty across multiple outcomes was addressed.
The careful conclusion is limited: the trial was designed to compare ibrexafungerp with matching placebo on clinical cure at the test-of-cure visit during Day 8-14, among participants described as mITT, and it posted selected safety information. The primary comparative result and the information needed to evaluate its precision are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a clearly named endpoint and a reportable treatment effect. Clinical cure is defined as complete resolution of signs and symptoms, and the endpoint is tied to a specified test-of-cure period. That makes the intended outcome recognizable. Yet without group-level results and a comparative estimate, the central statistical question remains unanswered by the registry information: the size and precision of the difference between randomized groups cannot be assessed.
The record also illustrates why analysis populations and outcome timing matter. The primary endpoint is assigned to an mITT population and assessed during Day 8-14, but the population definition and the handling of missing assessments are not described. Those details determine who contributes to the estimate and how the endpoint is operationalized. A label alone is not enough to reproduce or fully evaluate an analysis.
Several secondary outcomes are listed alongside the primary endpoint. In general, multiple outcomes can create choices about emphasis and statistical error control. The registry record does not report a multiplicity strategy or detailed testing hierarchy, so readers cannot evaluate how the study planned to interpret results across its outcomes.
Finally, the available safety counts demonstrate the difference between descriptive reporting and comparative inference. Serious adverse-event counts and selected terms offer a record of observed events, but no comparative safety estimate or uncertainty measure is provided. Overall, the record supports a description of trial structure and selected safety observations, while showing how omissions in outcome and methods reporting limit statistical interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this trial from the registry record is that no single primary-outcome comparison is reported. Although clinical cure is defined and its assessment period is specified, group-level results and a comparative estimate are absent. The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. Consequently, the magnitude and precision of the primary result cannot be evaluated.
The primary analysis population is named as mITT, but its definition and analyzed group sizes are not reported. The registry also does not describe missing-data handling, the number of participants with an observed test-of-cure assessment, or how deviations from assigned treatment were addressed. These issues make it difficult to determine precisely which participant experiences the primary result would represent.
Statistical methods are incompletely described. The primary effect measure, confidence-interval method, outcome model, and multiplicity procedure are not reported in the registry record. Nor are interim analyses or a detailed analysis plan. The record's planning illustration assumptions are not a substitute for the trial's own design justification, which is not reported.
The masking information is not fully reconciled: the registry entry says triple masking, while the study description calls the trial double-blind. The registry record does not explain this difference. Safety reporting is also limited to listed counts and selected serious-event terms; the record does not provide a comparative analysis or assign every listed term to a treatment group. These limitations concern reporting and interpretation and should not be taken to establish that details or analyses were absent from the study's other records.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303) — NCT03734991.
- Registry record last updated 2021-09-08; status last verified 2021-08.
- Results first posted 2021-09-08.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
VANISH 303 (NCT03734991) is recorded as a completed Phase 3, randomized, multicenter, parallel-group, placebo-controlled trial with enrollment of 376. It compared oral ibrexafungerp (SCY-078), 300 mg orally every 12 hrs for 1 day (2 doses in 1 day), with matching placebo in female subjects 12 years and older with acute vulvovaginal candidiasis.
The primary endpoint was clinical cure, defined as complete resolution of signs and symptoms at the test-of-cure visit during Day 8-14, in the mITT population. Secondary outcomes included mycological eradication, combined clinical cure and mycological eradication, complete clinical response at follow-up, and overall treatment-emergent adverse events. The registry record does not report a single primary-outcome comparison, its effect estimate, or its uncertainty. Selected safety counts are reported, but a comparative safety analysis and several key analysis details are not reported in the registry record.