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 The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy (NCT01369641), a randomized na study. The primary outcome is Efficacy of Intratympanic Sodium Thiosulfate (STS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01369641 |
| Phase | NA |
| Condition | Cancer |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | Double |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
| Results posted | Yes |
2. Clinical Question
Population
Patients receiving systemic cisplatin therapy for cancer were the intended population. The registry record lists an enrollment of 1 and describes the study as a pilot. It does not report further eligibility details or a fuller description of the enrolled participant.
Intervention
The intervention was intratympanic sodium thiosulfate (STS). The record describes pressure equalization tube insertion as a procedure and says the experimental ear would receive STS treatments. The number and timing of STS administrations are not reported in the registry record.
Comparator
The comparator was a placebo ear, with saline listed as the placebo intervention. The record says ears would be randomized so that one ear received STS and the comparator ear received placebo. It does not report which ear was assigned to which treatment for the enrolled participant.
Primary question
The stated question was whether intratympanic STS could reduce the degree or incidence of hearing loss in patients receiving systemic cisplatin therapy. Hearing was to be assessed with pure-tone and speech audiometry and distortion product otoacoustic emissions (DPOAE). No analyzed hearing outcome or estimate of the treatment contrast is reported in the registry record.
The self-controlled approach makes each participant’s ears the intended comparison: an STS-treated ear is compared with a placebo ear in the same person. In general, comparisons within a person can reduce the influence of characteristics shared by both ears, but they still require clear outcome definitions and appropriate analysis of the paired observations. The registry record does not report a statistical analysis plan or any results that would show how the intended comparison was analyzed.
3. Trial Design
The registry record describes a pilot, randomized, self-controlled study of intratympanic STS in patients receiving cisplatin therapy. Allocation is listed as randomized, masking as double, and the model as single group. The intervention descriptions specify random assignment of ears: the experimental ear would receive STS, while the comparator ear would receive placebo. The record does not explain how the double masking was implemented or reconcile the single-group model label with the ear-level comparator description.
The listed interventions include STS, saline placebo, cisplatin, and insertion of pressure equalization (PE) tubes. The record does not state the timing or details of those procedures and treatments beyond identifying the interventions and describing the ear assignments. It also does not report the randomization procedure or how allocation was concealed.
Enrollment is listed as 1. The study status is terminated. The recorded start date is 2011-08-24, and primary completion is listed as 2013-03-10. The reason for termination is not reported in the registry record. The listed phase is NA.
The planned hearing assessments included pure-tone and speech audiometry before cisplatin therapy, again at three weeks, 6 weeks, and 12 weeks, and every 6 months thereafter for up to one year. DPOAE is also named as an assessment method, but its schedule is not reported in the registry record. The primary outcome timeframe is through 1 year post-treatment. No outcome analysis is reported, so the registry record does not establish whether the planned assessments were completed.
The registry record does not report a sample-size justification, a detailed protocol, or a statistical analysis plan. Its enrollment and termination information describe the study record, but do not explain why recruitment ended or what informed the design.
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 | Sodium Thiosulfate (STS) Ear & Placebo Ear |
|---|---|
| STARTED | 1 |
| COMPLETED | 0 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Sodium Thiosulfate (STS) Ear & Placebo Ear |
|---|---|
| Withdrawal by Subject | 1 |
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 | Sodium Thiosulfate (STS) Ear & Placebo Ear |
|---|---|---|
| Participants analysed | 1 | |
| Age, Continuous | years | 69.26 (SD 0) |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 1 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Efficacy of Intratympanic Sodium Thiosulfate (STS), measured over Through 1 year post-treatment.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Efficacy of Intratympanic Sodium Thiosulfate (STS).” Its description says the study aimed to assess whether intratympanic STS reduced the degree or incidence of hearing loss in patients receiving systemic cisplatin therapy. Hearing was to be assessed using pure-tone and speech audiometry and DPOAE. The outcome timeframe is through 1 year post-treatment.
The registry record specifies that pure-tone and speech audiometry were planned before cisplatin therapy, at three weeks, 6 weeks, and 12 weeks, and every 6 months thereafter for up to one year. Repeated hearing assessments can describe changes over time, while comparison of the two ears is intended to relate those changes to the assigned ear treatment. In general, hearing measures can be useful outcomes when the research question concerns hearing change, but their interpretation depends on prespecified measurement rules and a clear definition of what counts as a meaningful change.
The registry record does not state an operational threshold for hearing loss, how audiometric findings would be combined, or which time point or summary measure would define the main comparison. It gives no unit, parameter, or dispersion for the primary outcome, and no analyzed outcome values are reported. DPOAE is named, but its assessment schedule and role in the primary outcome are not specified. Accordingly, the endpoint description establishes the intended subject of measurement, not an observed estimate of STS’s effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized ear-level comparison, but it does not report an analyzed hearing result. The primary outcome is listed with a timeframe through 1 year post-treatment, and the study status is terminated. Enrollment is listed as 1, while the number of reported analyses is 0. There is therefore no posted estimate of the difference in hearing outcomes between the STS ear and the placebo ear, and no confidence interval or inferential test for that comparison.
This absence of an analysis is not evidence that the treatments had equal outcomes, nor does it establish that either ear improved or worsened. Without reported hearing measurements and an analysis, the direction and size of any difference cannot be assessed. The registry record also does not report whether all intended assessments were completed, so it cannot establish the extent of available outcome data.
In general, a confidence interval describes the range of values compatible with the observed data under the statistical model. Its width reflects precision as well as the estimated effect. No confidence interval is reported for this study, so precision cannot be evaluated. Likewise, a p-value tests compatibility with a specified null hypothesis under an analysis model; no p-value or tested contrast is reported. Neither statistical significance nor its absence can be inferred from the enrollment or study status alone.
The within-person design has a clear intended comparison: the two ears of a participant are assigned to different conditions. General advantages of paired designs include reducing the effect of person-level characteristics shared by both ears. However, the statistical information in a paired comparison depends on the within-person difference, not simply on the number of ears considered separately. With enrollment listed as 1 and no results reported, there is no basis in the registry record for estimating the distribution or precision of paired differences.
The record gives planning assumptions for an illustrative sample-size calculation: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect expressed as a stated fraction of the observed effect. No resulting sample-size values or observed effect estimates are reported in the registry record. These assumptions do not supply an efficacy result or establish that the study had adequate power. Any such sample-size illustration is for planning, not observed power.
The record’s limited outcome reporting supports a description of the intended question and design, but not a conclusion about the treatment contrast. The study’s termination reason, analysis approach, and any results outside the registry record are not reported in the registry record.
9. Statistical Methods Explained
The registry record combines an ear-level randomized comparison with design labels that include a single-group model. It describes an experimental ear receiving STS and a comparator ear receiving placebo, while listing allocation as randomized and masking as double. The model label and the ear assignment description are both recorded; the registry does not explain how they relate. The analysis plan and the implementation of masking are not reported in the registry record.
What does a self-controlled comparison mean?
In general, a self-controlled design compares outcomes from different conditions within the same participant. Here, the intended contrast is between an ear assigned STS and an ear assigned placebo in a participant receiving cisplatin. Each participant serves as their own comparison for characteristics shared by their ears. A paired analysis generally focuses on the difference within each participant, rather than treating each ear as an unrelated observation.
This approach depends on having outcomes measured in both ears at comparable times and on a suitable definition of the paired contrast. General considerations include whether treatment effects in one ear could affect the other ear, whether the same measurement procedures are used for both ears, and whether changes over time are handled consistently. These are considerations for paired designs; the registry record does not report how they were addressed in this study.
How should the outcome schedule be understood?
The primary outcome description identifies pure-tone and speech audiometry before cisplatin therapy, at three weeks, 6 weeks, and 12 weeks, and every 6 months thereafter for up to one year. These repeated measurements could be used to describe hearing at individual visits or change across visits. In general, repeated observations from the same person are related, so an analysis should account for that dependence rather than treating each measurement as independent.
The registry record does not specify which visit or summary over visits was the principal basis for the treatment comparison. It also does not define a hearing-loss threshold, state whether the endpoint is a continuous measure or a categorized outcome, or explain how pure-tone, speech, and DPOAE findings would be combined. DPOAE is named as an assessment method, but its timing is not reported in the registry record. These omissions prevent a reader from reconstructing the intended endpoint calculation.
What can the sample-size assumptions tell readers?
The record describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. Those are assumptions for a planning calculation, not evidence about the study’s observed outcomes. No sample-size illustration values or observed effect estimate are reported in the registry record.
In general, a sample-size calculation estimates how much information may be needed to detect an effect under specified assumptions. Its result depends on the assumed effect, variability, allocation, test, and analysis model. Here, the listed assumptions do not explain whether a calculation accounts for the within-person ear pairing. The sample-size justification and a detailed statistical plan are not reported in the registry record. A planning illustration should not be described as observed power, which cannot substitute for an analysis of collected outcomes.
Why does over-dispersion matter in general?
Over-dispersion occurs when outcome variability is greater than a statistical model assumes. In general, if that extra variability is ignored, standard errors may be too small and confidence intervals too narrow, making results appear more precise than they are. The registry record does not identify a particular outcome distribution or report a model assessment for over-dispersion. This concept is therefore general statistical context, not a finding about this study.
More broadly, inference requires a defined estimand, a prespecified approach to paired observations and repeated measurements, and a transparent account of uncertainty. The record provides the clinical intent and parts of the assessment schedule, but does not report the analysis choices or any numerical efficacy result. The reported enrollment of 1 and zero listed analyses leave no posted estimate from which to judge the size or precision of the intended comparison.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description names several hearing assessment methods and repeated assessment times. When a study evaluates multiple measures, time points, or contrasts, general statistical practice is to specify which analysis is primary and how other tests will be interpreted. Testing multiple hypotheses without an appropriate plan can increase the chance of a seemingly notable result arising by chance. The registry record does not report a multiplicity strategy, a hierarchy of outcomes, or whether any adjustment was planned.
The registry lists one outcome measure and zero analyses. It does not provide analyzed outcomes, so the record does not show whether multiple statistical tests were performed or how they were handled. The absence of a reported adjustment should not be interpreted as proof that no adjustment was used; the analysis plan is not reported in the registry record.
Missing-data handling and analysis populations are also not reported in the registry record. It does not state whether outcome measurements were missing, how missing assessments would be addressed, or whether an intention-to-treat, per-protocol, or other population was defined. Nor does it describe exclusions or rules for incomplete paired observations.
In general, missingness can matter especially in a paired design because a within-person comparison needs usable outcome information from both assigned conditions. How missing observations are handled can affect both the analysis population and the estimate. The registry record does not provide enough information to determine whether missingness occurred or how it could affect interpretation. These reporting gaps limit reproducibility and prevent assessment of the analysis choices, but they do not establish that any particular bias occurred.
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 |
|---|---|---|---|
| Sodium Thiosulfate (STS) Ear & Placebo Ear | 0 | 1 | 0.0% |
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 |
|---|---|
| Sodium Thiosulfate (STS) Ear & Placebo Ear | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sodium Thiosulfate (STS) Ear & Placebo Ear |
|---|---|---|
| Ear infaction and tympanic perforation | General disorders | 1 of 1 |
The adverse-event record lists a group titled “Sodium Thiosulfate (STS) Ear & Placebo Ear.” For this group, 1 participant was listed as at risk. The record lists 0 participants affected by serious adverse events and 1 participant affected by other adverse events. The number of deaths is not reported in the registry record.
These are participant counts in a group combining the STS ear and placebo ear, not separate event counts by ear assignment. The registry record does not identify which treatment condition was associated with the reported other adverse event, describe the event term, or report a causal assessment. No serious adverse-event terms are listed. The figures therefore describe what the safety record reports, but do not establish whether an event was caused by STS, placebo, cisplatin, or another factor.
In general, adverse-event counts require context about definitions, observation periods, severity, and attribution. The registry record does not give further safety detail or a separate safety analysis. With enrollment listed as 1, these counts are descriptive of the recorded group and should not be treated as a precise estimate of event frequency in a broader population.
12. What the Result Does, and Does Not, Mean
The record establishes that a pilot study was intended to compare intratympanic STS with placebo using randomized ear assignments in patients receiving cisplatin therapy. It also records enrollment of 1, a terminated status, one primary outcome measure, and zero analyses. Those details describe the scope and reporting status of the study; they do not answer whether hearing outcomes differed between the assigned ears.
No analyzed hearing measurements, treatment-effect estimate, confidence interval, or p-value is reported in the registry record. Consequently, the size, direction, and precision of any treatment contrast are unknown from this record. The absence of a reported result should not be interpreted as a finding of no effect, and the study’s termination should not be interpreted as evidence for or against the intervention.
In general, a pilot study can explore feasibility and help inform later research, but its interpretation depends on the actual data and the design objectives. The registry record does not report a feasibility outcome, recruitment rationale, or sample-size justification. It therefore does not establish what the pilot was intended to demonstrate beyond the stated hearing question.
The intended self-controlled comparison is conceptually distinct from comparing separate groups of participants. A within-person design can control for characteristics shared across a participant’s ears, but it still needs clearly defined outcomes, complete paired measurements, and an analysis suited to the paired structure. The record does not report those analytic details or whether the planned measurements were completed.
The result that can be stated is limited: the registry record documents the design and safety counts, but no efficacy analysis. Any broader claim about hearing outcomes, clinical benefit, or the absence of benefit would go beyond the posted results.
13. Why This Trial Matters Statistically
This study raises a useful statistical design question: how to evaluate a localized intervention when each participant contributes an intervention ear and a comparator ear. In general, such a self-controlled comparison can reduce the influence of participant-level factors shared by both ears. It also creates a paired-data structure, which calls for analysis that respects the relationship between the two observations.
The study also planned repeated hearing assessments during cisplatin therapy and through follow-up. Repeated measurement can describe the course of an outcome, but it raises analytic choices about which time point or summary addresses the main question and how measurements within a participant are handled. The registry record does not report these choices, so the design illustrates why outcome definitions and analysis plans are important to interpretation.
The recorded enrollment of 1 and zero analyses make the limitations of registry reporting especially visible. Design labels and an outcome description can explain what investigators intended to study, but they cannot replace an outcome estimate and a measure of its precision. The record does not provide results from which to evaluate the planned ear-level contrast.
Finally, the record lists a sample-size planning illustration with specified assumptions but no reported numerical illustration or observed effect estimate. In general, planning calculations depend on assumptions that should match the design and target analysis. A planning calculation is not evidence that a study detected an effect and is not observed power. The distinction matters when interpreting small or terminated studies: design intent, observed data, and statistical evidence are separate things.
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 most direct limitation is that the registry record lists enrollment of 1 and zero analyses. No primary outcome values, between-ear contrast, uncertainty interval, or inferential test is reported. The reason for termination is not reported in the registry record, so the circumstances behind the study’s termination cannot be assessed.
The endpoint description identifies hearing-loss degree or incidence and names pure-tone and speech audiometry and DPOAE, but it does not define a hearing-loss threshold, specify the primary summary measure, or explain how the different assessment methods relate to one another. The schedule for audiometry is given, while the timing of DPOAE assessment is not reported in the registry record.
The design has multiple labels: randomized allocation, double masking, and a single-group model, alongside a description of randomized ear assignments to STS and placebo. The registry record does not explain the relationship among these labels, the masking procedure, or the randomization method. The analysis plan does not describe how paired ears or repeated observations would be handled.
Missing-data procedures, analysis populations, multiplicity handling, and a sample-size justification are not reported in the registry record. It is not possible to tell whether planned assessments were completed or whether any outcome data were missing. The safety record combines the STS and placebo ears, does not name the reported other adverse event, and does not report a death count. These limitations restrict interpretation to the recorded design and descriptive safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Effect of Sodium Thiosulfate Eardrops on Hearing Loss in Patients Who Receive Cisplatin Therapy — NCT01369641.
- Registry record last updated 2025-05-16; status last verified 2025-05.
- Results first posted 2014-05-01.
- 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
NCT01369641 is a pilot, randomized, self-controlled study of intratympanic sodium thiosulfate for patients receiving systemic cisplatin therapy. The registry record describes an STS ear and a placebo ear, lists allocation as randomized and masking as double, and labels the model single group. Enrollment is listed as 1, and the status is terminated.
The primary outcome aimed to assess degree or incidence of hearing loss through 1 year post-treatment using pure-tone and speech audiometry and DPOAE. The record lists zero analyses and does not report an efficacy estimate or the reason for termination. Its safety figures list 1 participant at risk, 0 affected by serious adverse events, and 1 affected by other adverse events in the combined STS-ear-and-placebo-ear group. The death count is not reported in the registry record.