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 Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219 (NCT02452866), a na phase 3 study. The primary outcome is Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02452866 |
| Phase | Phase 3 |
| Condition | Bacterial Vaginosis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 325 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Symbiomix Therapeutics |
| Results posted | Yes |
2. Clinical Question
Population
Women and postmenarchal adolescent girls with bacterial vaginosis were the intended population. The registry lists enrollment as 325. It does not report detailed eligibility criteria or explain how participants were selected.
Intervention
Participants received a single dose of SYM-1219, a granule formulation containing 2 grams of secnidazole. The record describes the study as prospective, open-label, and multi-center.
Comparator
There was no separate comparator group: the study is listed as single-group, with allocation recorded as NA. All participants in the described arm received SYM-1219. The registry record therefore does not provide a randomized control comparison.
Primary question
The primary endpoint concerns the number of participants with treatment-emergent adverse events and laboratory abnormalities. The outcome timeframe is 30days. The record describes safety evaluations in terms of adverse-event incidence, intensity, and type, as well as vital signs and clinical safety laboratory results.
In practical terms, the study was designed to characterize safety observations after treatment in the stated population. Its single-group, open-label design can describe events recorded among treated participants, but it cannot estimate a contrast against an untreated or differently treated group. The posted registry information does not provide outcome results for the full primary endpoint, including the number with laboratory abnormalities, or an analysis of the endpoint’s uncertainty.
3. Trial Design
This was a Phase 3, multi-center, prospective, open-label study of SYM-1219. The registry classifies it as a single-group study and lists allocation as NA and masking as NONE. It lists the intervention as SYM-1219, a drug, and describes a single dose containing 2 grams of secnidazole. The stated condition was bacterial vaginosis, and the intended population was women and postmenarchal adolescent girls with that condition.
The registry lists enrollment as 325, while the safety-event listing gives 321 participants at risk for serious and other adverse events. Those figures serve different roles in the record: enrollment is the listed study enrollment, while the at-risk figures accompany the event counts. The registry does not explain the relationship between those figures, identify the analyzed population for each outcome, or report why the at-risk number differs from enrollment.
The listed study start was 2015-06, and primary completion was 2015-10. The study status is COMPLETED. The sponsor is Symbiomix Therapeutics. The registry record does not report a protocol-based sample-size justification, detailed recruitment or follow-up procedures, or a statistical analysis plan. It also does not report whether any interim analyses were planned or conducted.
Because the study has no separate control arm and is open-label, its design supports a descriptive account of events observed among treated participants. It does not offer a like-for-like treatment comparison. In particular, the posted safety counts cannot distinguish events attributable to treatment from events that might also occur in the absence of treatment. That limitation follows from the design and is not resolved by the study’s Phase 3 designation.
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 | SYM-1219 |
|---|---|
| STARTED | 325 |
| COMPLETED | 321 |
| NOT COMPLETED | 4 |
Analysis population for the primary outcome, as defined in the registry: Safety evaluations were based on the incidence, intensity, and type of AEs,vital signs, and clinical safety laboratory results.
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.
Population: Baseline Nugent score
| Characteristic | Unit | SYM-1219 2g |
|---|---|---|
| Participants analysed | 325 | |
| Age, Categorical: <=18 years | Participants | 2 |
| Age, Categorical: Between 18 and 65 years | Participants | 323 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 325 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 72 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 249 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities, measured over 30days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Numbers of Participants With Treatment Emergent Adverse Events and Laboratory Abnormalities.” Its unit is participants, and the registry classifies it as a count of participants. The timeframe is 30days. The endpoint is intended to capture how many participants experienced treatment-emergent adverse events or laboratory abnormalities, rather than to measure a change in a continuous clinical quantity.
Safety outcomes are used to characterize the types and frequency of adverse observations during a study. The registry says safety evaluations were based on the incidence, intensity, and type of adverse events, vital signs, and clinical safety laboratory results. This gives the endpoint a broad safety purpose, although the posted primary outcome description does not provide separate numerical results for each component.
The registry’s outcome description also refers to subjects with clinical cure at TOC/EOS, with clinical cure based on Amsel and normalization of Nugent score. The relationship between that wording and the stated safety endpoint is not explained in the registry record. It does not report a separate definition of treatment-emergent timing, the laboratory thresholds used, or the method for handling repeated events in the participant count. Those details matter when interpreting a participant-level count, because the count does not convey how many events an individual experienced or their duration.
The posted record does not give a primary-endpoint result for treatment-emergent adverse events and laboratory abnormalities as a combined outcome. The separate safety-event counts available in the record should therefore not be treated as a complete report of that primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available safety listing records 1 participant with a serious adverse event among 321 at risk, 63 participants with other adverse events among 321 at risk, and 0 deaths. It also lists “foot burn” and “loss of consciousness” among the top serious-event terms, each reported as 0.3%. These are descriptive registry entries. They do not constitute a comparison with another treatment or with no treatment.
The counts answer a limited question: what events were recorded in the listed safety group? They do not by themselves establish whether an event was caused by SYM-1219. In a single-group study, there is no concurrent control group to help separate treatment-associated events from background events, changes in the underlying condition, or other influences. Open-label conduct also means that masking was absent, as the record states; the registry does not describe how this may have affected event assessment or reporting.
The 321 at-risk figure is the denominator attached to the safety-event listing. The registry separately lists enrollment as 325, but does not explain the difference or identify why some enrolled participants are not included in the at-risk figure. It is therefore important not to treat the event listing as necessarily representing every enrolled participant, or to assume that all outcomes had the same analysis population.
The top serious-event terms are reported as terms with percentages, but the record does not provide their participant counts or clarify whether a participant could appear under more than one term. The percentages should be read as registry-reported figures, not as a basis for reconstructing event counts. The record also does not state the seriousness criteria, how relatedness to treatment was assessed, or how events were coded.
No confidence intervals, hypothesis tests, or formal analyses are listed for the safety outcomes. A confidence interval, in general, describes the statistical uncertainty around an estimate; without such an interval or an analysis method, the precision of these counts cannot be quantified from the registry record. The absence of a reported analysis does not establish that no analysis was performed elsewhere, but it means the registry entry does not allow readers to evaluate one.
The record lists one outcome measure and no analyses. It does not report a prespecified statistical plan, multiplicity procedure, missing-data method, or analysis populations beyond the brief safety-population description. Accordingly, interpretation should remain descriptive and limited to the reported event counts and terms.
9. Statistical Methods Explained
What kind of outcome is being counted?
The primary outcome is a count of participants with safety events or laboratory abnormalities. In general, this is a binary outcome at the participant level: each person is classified according to whether the event of interest occurred. A participant count is different from an event count. A person with repeated events may still contribute only once to a participant-level count, depending on the endpoint definition. The registry does not explain the detailed counting rules for this endpoint.
The safety listing distinguishes serious events from other adverse events and gives participants at risk for each category. Such counts are useful for describing the observed safety experience, but they are not a measure of event severity for the entire group, nor do they show how long an event lasted. The registry does not provide event-level timing, duration, or a full breakdown by intensity.
What does a denominator contribute?
A denominator defines the group among whom an event count was observed. The registry gives 321 participants at risk for the serious-event and other-event listings. This helps identify the population associated with those counts. It does not resolve how that population was assembled, whether all participants completed follow-up, or whether each participant had the same opportunity for observation. These matters are not reported in the registry record.
In general, a proportion or rate needs a clearly defined numerator, denominator, and observation period. The safety listing supplies participant counts and an at-risk figure, while the primary endpoint has a 30days timeframe. The record does not establish that every safety listing uses exactly that endpoint timeframe, so the timeframe should not be transferred to other results without clarification. No new proportions or rates are calculated in this interpretation.
Why is a control group important for inference?
General statistical explanation: a control group provides a reference for estimating how outcomes differ under alternative study conditions. A randomized comparison can reduce systematic differences between groups, subject to the conduct and analysis of the study. Here, the record describes a single-group study and lists allocation as NA. Consequently, the event counts describe observations in the treated group, not a treatment effect relative to a comparator.
A single-group safety study can still organize and report adverse observations. However, without a control group, differences in baseline risk, the natural course of illness, and other influences cannot be separated from treatment-associated patterns by a between-group estimate. This is a limitation of what the design can identify, not a claim about the cause of any particular event.
What can uncertainty measures tell readers?
In general, a confidence interval communicates the range of values reasonably compatible with an estimate under a specified statistical model. A wider interval indicates less precision; a narrower interval indicates greater precision, conditional on the model and data. The registry record does not list confidence intervals or a statistical model for the reported safety counts. Readers therefore cannot use the registry entry to judge the statistical precision of those counts beyond noting the observed numbers.
For binary outcomes, uncertainty depends on the observed count and the population at risk, among other features. If participants’ outcomes are correlated, for example because observations are clustered within study centers, a method that assumes independent observations may not represent uncertainty well. That is a general consideration for multi-center research; the registry does not report whether center-level clustering was assessed or how any such feature was handled.
What can the sample-size assumptions establish?
General planning calculations can illustrate how many participants per arm might be needed to detect a stated fraction of an observed effect under specified assumptions. The record’s planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says these calculations are planning illustrations based on the observed effect, not the trial’s own design. They are not observed power.
Those assumptions do not turn this single-group study into a two-arm comparison. Nor do planning calculations establish that the study was designed with a particular power or that a treatment effect was demonstrated. The registry does not report the study’s own sample-size justification, and no comparison effect or analysis is listed in the record. A planning illustration should therefore be understood as conditional on its stated assumptions, rather than as evidence about the study’s actual inferential strength.
More generally, the statistical plan determines how outcomes are defined, which participants are included, how missing observations are handled, and what estimates and uncertainty measures are reported. The registry record does not describe those methods in sufficient detail for an independent reconstruction. The posted counts can be interpreted descriptively, but they do not support additional adjusted or comparative conclusions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and no analyses. It does not report whether the study prespecified a hierarchy of outcomes, whether multiple safety comparisons or subgroups were considered, or whether any multiplicity adjustment was planned. Multiplicity is a general statistical concern when several hypotheses are tested: repeated testing can increase the chance of a nominally notable result arising by chance. The registry record does not provide enough detail to assess that issue for this study.
Missing-data methods are not reported in the registry record. The entry does not say how participants with incomplete follow-up, unavailable laboratory results, or missing safety assessments were handled. It also does not provide outcome-specific analysis populations or explain the relationship between the enrollment figure of 325 and the at-risk figure of 321 in the adverse-event listing. The counts should therefore be interpreted using the populations explicitly attached to them, without assuming a particular missing-data rule.
The record describes safety evaluations based on adverse-event incidence, intensity, and type, vital signs, and clinical safety laboratory results. It does not give a detailed analysis-population definition or say whether all enrolled participants were included in each safety evaluation. The endpoint description’s reference to clinical cure at TOC/EOS is not reconciled with the broader safety-population wording. These omissions limit reproducibility and make it difficult to determine exactly which observations contributed to each planned endpoint.
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 |
|---|---|---|---|
| SYM-1219 2g | 1 | 321 | 0.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SYM-1219 2g | 0 of 321 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| SYM-1219 2g | 63 of 321 |
Most frequent serious adverse event terms
| Event term | Organ system | SYM-1219 2g |
|---|---|---|
| foot burn | Injury, poisoning and procedural complications | 1 of 321 |
| loss of consciousness | Investigations | 1 of 321 |
Most frequent non-serious adverse event terms
| Event term | Organ system | SYM-1219 2g |
|---|---|---|
| Vulvovaginal mycotic infection | Infections and infestations | 18 of 321 |
| Urinary tract infection | Infections and infestations | 10 of 321 |
| Vulvovaginal candidiasis | Infections and infestations | 9 of 321 |
| Bacterial vaginosis | Infections and infestations | 3 of 321 |
| Nasopharyngitis | Infections and infestations | 2 of 321 |
| Vaginal mycosis | Infections and infestations | 2 of 321 |
| Upper respiratory | Infections and infestations | 2 of 321 |
| Genital herpes | Infections and infestations | 2 of 321 |
| headache | Nervous system disorders | 1 of 321 |
| dizziness | Nervous system disorders | 1 of 321 |
Serious events with the highest arm-level rate: foot burn (0.3%), loss of consciousness (0.3%).
The registry lists 1 participant with a serious adverse event among 321 at risk and 0 deaths. It reports “foot burn” and “loss of consciousness” as top serious-event terms, each at 0.3%. The separate listing for other adverse events reports 63 participants among 321 at risk. These figures describe the entries in the registry; they are not a comparison with an untreated group.
The serious-event count is a participant count, not necessarily a count of every serious event. The registry does not state whether the same participant could have experienced multiple serious events, and it does not give participant counts for the two named terms. The terms and percentages should therefore be read as reported, without inferring a precise number of affected participants from a percentage.
Seriousness is not the same as treatment causality. The registry does not report the criteria used to classify seriousness or provide an assessment of whether each event was related to SYM-1219. Nor does it provide detail on onset, duration, outcome, or follow-up for the listed serious events. The counts support a description of the safety record, but not a conclusion about why an event occurred or how its frequency would compare under another treatment.
12. What the Result Does, and Does Not, Mean
The record documents a completed, open-label, single-group safety study of SYM-1219 in women and postmenarchal adolescent girls with bacterial vaginosis. The intervention was a single dose of a granule formulation containing 2 grams of secnidazole. The posted adverse-event entries include 1 participant with a serious adverse event, 63 participants with other adverse events, and 0 deaths, each event listing using 321 participants at risk. The two top serious-event terms are reported as “foot burn” and “loss of consciousness,” each at 0.3%.
These observations describe what the registry reports for the treated group. They do not establish that SYM-1219 caused or prevented any particular event. Because there is no comparator group, the study cannot estimate how the listed event experience differs from an alternative treatment or from no treatment. The open-label design also means that masking was absent, although the registry does not explain how event ascertainment was conducted.
The posted information does not provide a complete numerical result for the named primary endpoint, which includes treatment-emergent adverse events and laboratory abnormalities. Nor does it report confidence intervals or a formal analysis for the safety counts. The registry’s brief description of safety evaluations mentions vital signs and laboratory results, but numerical results for those components are not reported in the record.
These limits do not make descriptive safety information irrelevant. They define what it can support: a record of observed events in the listed group, not a causal estimate or a comparative benefit-risk conclusion. The registry entry also does not report enough detail to resolve the difference between enrollment and the number at risk, or to assess missing observations and the precision of the estimates. No conclusion beyond the scope of the recorded counts should be drawn from them.
13. Why This Trial Matters Statistically
Safety studies need clear outcome definitions, denominators, and analysis populations. This record makes the basic design explicit: a prospective, multi-center, open-label, single-group study, with a primary endpoint focused on treatment-emergent adverse events and laboratory abnormalities. It also gives an at-risk figure for the adverse-event listings. Those details help readers distinguish a descriptive safety account from a controlled comparison.
The design is statistically important because the study has no comparator arm. Event counts in a treated group can show what was recorded during study observation, but cannot by themselves quantify an excess or reduction relative to another treatment. This distinction is essential when interpreting safety data: an event observed after treatment is not automatically an event caused by treatment.
The record also illustrates why endpoint reporting should include more than a title. The primary endpoint names adverse events and laboratory abnormalities, while the available safety listing separates serious and other adverse events. The registry does not give a complete result for the primary endpoint, detailed counting rules, confidence intervals, or the methods used to handle incomplete information. Without those elements, readers cannot fully assess precision or reproduce the intended analysis.
Finally, the enrollment figure and the at-risk figure are not the same, and the record does not explain their relationship. Explicit accounting of participant flow and analysis populations would help readers understand which observations underpin each safety result. These are general reporting considerations, and they matter particularly when the available evidence is descriptive rather than comparative.
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 trial-specific limitation is the single-group design. With no control arm, the adverse-event counts do not estimate a difference between SYM-1219 and another treatment or no treatment. The open-label design means participants and study personnel were not masked, according to the registry. The record does not describe procedures used to limit potential effects of that design on event reporting or assessment.
The registry lists enrollment as 325 and the safety listings as having 321 participants at risk. It does not explain the relationship between these figures, report a participant-flow account, or state why the at-risk population differs from enrollment. The record also does not explain whether each outcome used the same analysis population or how missing observations were handled.
Although the primary endpoint includes treatment-emergent adverse events and laboratory abnormalities, the registry does not report a complete numerical result for that endpoint. The listed serious and other adverse-event counts do not cover every endpoint component. Laboratory findings, vital signs, event intensity, timing, duration, relatedness, and detailed coding rules are not reported in the available record.
No confidence intervals, hypothesis tests, or statistical analysis methods are listed. The registry gives no sample-size justification for the trial, and does not report interim analyses or a statistical plan. The brief endpoint description also refers to clinical cure at TOC/EOS, but the relationship between that wording and the stated safety endpoint is not explained. Together, these reporting gaps restrict independent assessment of precision, completeness, and reproducibility.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219 — NCT02452866.
- Registry record last updated 2021-04-13; status last verified 2020-12.
- Results first posted 2021-04-13.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02452866 is listed as a completed Phase 3, prospective, multi-center, open-label, single-group study sponsored by Symbiomix Therapeutics. The study evaluated a single dose of SYM-1219, a granule formulation containing 2 grams of secnidazole, in women and postmenarchal adolescent girls with bacterial vaginosis. The registry lists enrollment as 325, a start of 2015-06, and primary completion in 2015-10.
The primary endpoint concerns participants with treatment-emergent adverse events and laboratory abnormalities over 30days. The adverse-event listing reports 1 participant with a serious adverse event, 63 with other adverse events, and 0 deaths among 321 at risk. “Foot burn” and “loss of consciousness” are listed as top serious-event terms, each at 0.3%. The registry does not report a formal analysis, confidence intervals, a detailed missing-data method, or a complete numerical result for the primary endpoint.