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 Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer (NCT01137071), a na phase 2 study. The primary outcome is 1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01137071 |
| Phase | Phase 2 |
| Condition | Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Recepta Biopharma |
| Results posted | Yes |
2. Clinical Question
Population
Women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube adenocarcinoma who achieved a second complete response. The trial record lists 29 participants enrolled. For the primary endpoint, it describes an intention-to-treat population of 29 considered for analysis.
Intervention
Hu3S193, a monoclonal antibody, was studied as consolidation therapy. The intervention description specifies a dose of 30mg/m2 every other week for 12 infusions over 23 weeks. It says this regimen would be administered to 51 patients, while the registry lists enrollment as 29; the number who actually received the planned regimen is not reported in the registry record.
Comparator
There was no comparison group. The trial is listed as single-group, with allocation marked NA and masking listed as none. Results therefore describe participants in the Hu3S193 study group; they do not provide a like-for-like comparison with another treatment or with no consolidation therapy.
Primary question
The primary outcome concerns time from the start of rescue platinum-based chemotherapy until documented disease progression or death from any cause. The registry calls the endpoint a “1-year PFS2 Rate,” but reports a median time of 11.8 months, with a 95% confidence interval of 10.6 to 13.9 months. It does not report a one-year proportion in the primary result.
3. Trial Design
This was a phase II trial of Hu3S193 consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube adenocarcinoma who achieved a second complete response. The registry identifies the study model as single-group, allocation as NA and masking as none. There is no randomized or concurrent control group in the record, so the design provides no direct estimate of how outcomes differed from those under another treatment or no consolidation therapy.
The intervention was a monoclonal antibody, Hu3S193. Its description specifies a dose of 30mg/m2 every other week, for 12 infusions over a total of 23 weeks. That description also states that the regimen would be administered to 51 patients. The registry lists enrollment as 29. These figures do not match; the number who actually started or completed the regimen is not reported in the registry record.
The trial began in 2011-04, and primary completion is listed as 2015-06. The status is terminated. The reason for termination, whether the planned follow-up was completed, and whether the intervention schedule changed are not reported in the registry record. The primary endpoint is assessed from the start of rescue platinum-based chemotherapy, rather than from the start of Hu3S193 treatment. The interval between consolidation therapy and rescue chemotherapy is not reported.
The registry lists secondary outcomes including one-year disease progression-free survival, two-year overall survival, vital signs and adverse events. The primary result reported is a median time to progression or death after rescue chemotherapy. The record does not provide enough detail to establish how the trial's termination, treatment exposure or follow-up affected the reported outcome. Interpretation should therefore remain specific to the endpoint and analysis population described in the registry.
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.
Before assignment: Patients were considered included in the study on the day of the first investigational product administration after investigator assured that patients met all the inclusion criterions and none of the exclusion criterions.
Overall Study
| Stage | hu3S193 |
|---|---|
| STARTED | 29 |
| COMPLETED | 15 |
| NOT COMPLETED | 14 |
Reasons for not completing this period:
| Reason | hu3S193 |
|---|---|
| Disease Progression | 11 |
| Withdrawal by Subject | 2 |
| Wrongly Included | 1 |
Analysis population for the primary outcome, as defined in the registry: In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).
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: A total of 37 patients were screened for this study of whom 29 were considered eligible and included in the study (baseline participants).
| Characteristic | Unit | Monoclonal Antibody hu3S193 |
|---|---|---|
| Participants analysed | 29 | |
| Age, Continuous | Years | 55.69 (29 to 67) |
| Gender: Female | Participants | 29 |
| Gender: Male | Participants | 0 |
| Race/Ethnicity, Customized: White | participants | 24 |
| Race/Ethnicity, Customized: Black | participants | 1 |
| Race/Ethnicity, Customized: Yellow | participants | 0 |
| Race/Ethnicity, Customized: Brown | participants | 4 |
| Race/Ethnicity, Customized: Other | participants | 0 |
| Region of Enrollment: Brazil | participants | 29 |
6. Primary Endpoint
The registry lists the primary outcome as 1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy, measured over 1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint measures the time from the beginning of rescue platinum-based chemotherapy until documented disease progression or death from any cause. The record defines progression as the appearance of any new measurable or non-measurable lesion under RECIST criteria; the progression date is the date on which a new lesion is documented. Participants who had not experienced progression or death during the relevant observation period could be censored.
Time-to-event outcomes are used when the timing of an event matters and participants may have different lengths of follow-up. A median time-to-event result describes the point by which half of the observed event-time distribution has had the event, subject to the method used to handle censoring. It is not the same measure as the proportion of participants who remain progression-free at a fixed time.
Although the registry title for the primary outcome refers to a “1-year PFS2 Rate,” the result is presented as a median in months, not as a one-year rate. The registry reports a median of 11.8 months, with a 95% confidence interval of 10.6 to 13.9 months. It does not report a one-year proportion for this primary result. The endpoint begins at rescue chemotherapy, so it describes the period after that treatment begins; it is not a direct measure of time from Hu3S193 initiation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
Among the intention-to-treat population described for the primary analysis, 29 participants were considered. The registry states that 25 experienced disease progression or death and 4 were censored. The reported median time from the start of rescue platinum-based chemotherapy to progression or death was 11.8 months. Its 95% confidence interval extends from 10.6 to 13.9 months. The interval communicates uncertainty around the estimated median; it does not mean that individual participants' event times fell within those limits.
The endpoint is a time-to-event measure, and the reported result is a median in months. It should not be read as the fraction of participants who were progression-free at one year. Despite the primary outcome title referring to a “1-year PFS2 Rate,” no one-year proportion is reported in the primary result. The estimate is also anchored to the beginning of rescue platinum-based chemotherapy, not to Hu3S193 treatment. This timing matters when describing what period the result covers.
The 4 censored participants are not counted as having had the event in the registry's description. Censoring indicates that their event status was not observed through the relevant analysis time; the reason and timing are not reported in the registry record. Censored observations can contribute information to a time-to-event analysis, but the registry does not describe the estimator or the assumptions used to account for censoring. The extent to which censoring might affect interpretation cannot be assessed from the reported details alone.
This is a single-group result, not a treatment contrast. The value of 11.8 months describes the observed outcome in the analyzed group under the registry's endpoint definition. Without a concurrent comparison group, it cannot establish what would have happened to similar participants without Hu3S193 or under another treatment. It also does not isolate the contribution of Hu3S193 from other care or from features of the participants and their disease course.
The record lists the trial as terminated and enrollment as 29, while the intervention description refers to a regimen for 51 patients. The reason for termination, actual treatment exposure and the relationship between the planned and analyzed populations are not reported. These details limit assessment of how closely the analyzed group followed the described treatment plan. The result is therefore best interpreted as a registry-reported median for the stated analysis population, with a confidence interval expressing statistical uncertainty, rather than as proof of a causal treatment effect.
9. Statistical Methods Explained
What does a median time-to-event estimate describe?
A time-to-event endpoint records the time until an event of interest occurs. Here, the event is disease progression or death from any cause, and the clock starts at the beginning of rescue platinum-based chemotherapy. A median time-to-event estimate marks the middle of the estimated event-time distribution. It summarizes timing, rather than stating how many participants had the event by a particular calendar point.
The registry reports the median as 11.8 months and gives a 95% confidence interval of 10.6 to 13.9 months. A confidence interval conveys uncertainty in the estimated value under the analysis approach. It is not a range containing the event times of most participants, nor does it guarantee that the underlying value lies within the interval. The registry does not state the method used to calculate the median or its confidence interval.
Why does censoring matter?
In a time-to-event study, some participants may not have a recorded event by the time their follow-up ends or the analysis is made. Their event time is then censored: it is known only that the event had not been observed up to a particular point. Censored participants are not equivalent to participants who experienced the event, and they are not necessarily missing all outcome information. Standard time-to-event methods can use the follow-up they contribute without treating them as if their event occurred at the end of observation.
The registry reports 25 participants with progression or death and 4 censored among the 29 considered for the primary analysis. It does not report the censoring dates, reasons for censoring, follow-up duration for each participant, or method used to account for censoring. These omissions make it difficult to assess whether censoring was informative—that is, related to a participant's underlying chance of progression or death. That relationship can matter to the interpretation of time-to-event estimates.
What does the endpoint name imply, and what is actually reported?
The primary outcome title refers to a “1-year PFS2 Rate,” but the result is expressed as a median time in months. A rate or proportion at a fixed time would ordinarily describe the share of participants meeting a specified status at that time. A median time-to-event result instead summarizes the distribution of event times. The registry's definition makes the starting point the beginning of rescue platinum-based chemotherapy, with progression or death as the event. The primary result does not state a one-year proportion, so the title should not be mistaken for a reported one-year percentage.
General statistical interpretation distinguishes the endpoint's definition from the estimator used to summarize it. The definition says what event and time origin count; the estimator describes how observed and censored follow-up are combined to calculate the median. The definition is available, but the specific estimator, confidence-interval method and any analysis assumptions are not reported in the registry record. It would therefore be inappropriate to attribute a particular estimation procedure to this trial.
What can and cannot be inferred from a single-group result?
A single-group study can describe outcomes observed among participants who entered the study and were included in an analysis. It cannot directly estimate a between-group treatment difference when no comparison arm is present. A difference from an external expectation would not be a randomized treatment contrast, and no such comparison is reported. Participant selection, disease history, other care and follow-up could all affect observed outcomes, but the registry record does not quantify their effects.
The record identifies the analysis population as intention-to-treat and says 29 participants were considered for the PFS2 analysis. The detailed definition of that population, including how it relates to treatment initiation or adherence, is not reported. The intervention description specifies 12 infusions across 23 weeks, but the number who received each infusion and the number who completed the schedule are not reported. Accordingly, the endpoint result should not be treated as an estimate among confirmed completers of the regimen.
What information is available about statistical testing?
The registry lists no analysis entries. It does not report a hypothesis test, p-value, adjusted analysis, hazard ratio or model specification for the primary result. Without a comparison group, a treatment-effect estimate contrasting Hu3S193 with another group is not available from the primary result. Details such as stratification, covariate adjustment, interim analyses, sample-size justification and multiplicity procedures are not reported in the registry record. Their absence from the record does not establish whether they were used; it means they cannot be evaluated from the reported information.
For general context, statistical precision and causal interpretation are different issues. A confidence interval describes uncertainty around an estimate under an analysis, while a controlled design is needed to support a direct comparison of treatment groups. A confidence interval around a single-group median does not, on its own, resolve the lack of a comparator. The reported interval should therefore be read as precision information for the median in the analyzed group, not as evidence of a treatment effect.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 58 outcome measures and no analysis entries. It names secondary outcomes that include one-year disease progression-free survival, two-year overall survival, vital signs and adverse events. The primary outcome title refers to a one-year PFS2 rate, while the primary result is reported as a median time in months. The registry does not explain the relationship between that title and the reported median.
When a study assesses multiple outcomes, multiplicity can affect how often apparently notable findings occur by chance. Statistical plans may address this through prespecified outcome hierarchies or adjustments, but the multiplicity approach for this trial is not reported in the registry record. The registry also does not identify which of the listed outcomes were designated for formal hypothesis testing, or provide a complete set of results for those outcomes. No claims about multiplicity control or statistical significance can therefore be made from the registry information described.
The primary analysis is described as intention-to-treat, with 29 participants considered, 25 experiencing progression or death and 4 censored. The detailed analysis-population definition and the reasons or timing of censoring are not reported. Censoring is part of time-to-event data handling and is not, by itself, proof that outcome data were simply omitted. The method used to account for censored observations, the amount of follow-up and any sensitivity analyses are not reported in the registry record.
There is also an enrollment inconsistency relevant to analysis populations: the registry lists enrollment as 29, while the intervention description says the regimen would be administered to 51 patients. The number who received treatment, the number eligible for the primary analysis and how those groups relate are not explained beyond the stated analysis population. The record does not report a missing-data plan or an analysis of the effect of missing or incomplete observations.
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 |
|---|---|---|---|
| hu3S193 | 3 | 29 | 10.3% |
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 |
|---|---|
| hu3S193 | 28 of 29 |
Most frequent serious adverse event terms
| Event term | Organ system | hu3S193 |
|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | 1 of 29 |
| Vomiting | Gastrointestinal disorders | 1 of 29 |
| Hip fracture | Musculoskeletal and connective tissue disorders | 1 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | hu3S193 |
|---|---|---|
| Nausea | Gastrointestinal disorders | 19 of 29 |
| Vomiting | Gastrointestinal disorders | 17 of 29 |
| Abdominal pain | Gastrointestinal disorders | 9 of 29 |
| Hypersensitivity | Immune system disorders | 9 of 29 |
| Headache | Nervous system disorders | 9 of 29 |
| Influenza like illness | General disorders | 8 of 29 |
| Constipation | Gastrointestinal disorders | 7 of 29 |
| Diarrhoea | Gastrointestinal disorders | 6 of 29 |
| Cough | Respiratory, thoracic and mediastinal disorders | 6 of 29 |
| Neutrophil count decreased | Investigations | 5 of 29 |
Serious events with the highest arm-level rate: intestinal obstruction (3.4%), vomiting (3.4%), hip fracture (3.4%).
The registry lists one Hu3S193 group, with 29 participants at risk for serious adverse events and 3 affected. It also lists 29 at risk for other adverse events and 28 affected. These are registry counts for the categories shown; they do not indicate whether an event was caused by Hu3S193. The record does not provide a comparison group that could establish whether these counts differed from another treatment or background risk.
The serious adverse event terms listed are intestinal obstruction, vomiting and hip fracture, each with a reported value of 3.4%. The registry does not provide further detail in this record about event timing, severity beyond the serious classification, recurrence, management or attribution. It is not possible to determine from these figures whether the listed terms occurred in separate participants or to infer additional counts from their percentages.
The deaths field is not populated, so deaths as a safety outcome are not reported in the registry record. “Not reported” should not be interpreted as no deaths. Likewise, the number of participants at risk is not the same as the number exposed for a particular duration, and the registry does not provide exposure-adjusted event rates. These safety figures describe the entries in the record; they do not establish a causal relationship or comparative safety profile.
12. What the Result Does, and Does Not, Mean
The primary result describes the time from the beginning of rescue platinum-based chemotherapy to progression or death among the participants considered for the PFS2 analysis. The reported median is 11.8 months, with a 95% confidence interval of 10.6 to 13.9 months. The registry states that 25 participants experienced the event and 4 were censored in the analysis population of 29. These details provide a descriptive account of the observed time-to-event outcome and its reported precision.
The result does not give a one-year progression-free proportion, despite the wording of the primary outcome title. It also does not estimate time from the start of Hu3S193 treatment, because the endpoint's time origin is the start of rescue platinum-based chemotherapy. The number who received or completed the described Hu3S193 schedule is not reported in the registry record.
Because the trial is single-group, the result cannot show how outcomes would have differed under another treatment or without Hu3S193. It cannot isolate the effect of the antibody from other care, participant characteristics, disease history or the course of follow-up. No treatment comparison, hazard ratio or p-value is reported for the primary result. The confidence interval expresses uncertainty in the median estimate under the method used, but the estimation method itself is not reported.
The record's status is terminated. It does not state why the trial ended or how termination affected recruitment, treatment exposure or follow-up. The enrollment figure of 29 does not match the intervention description's statement that the regimen would be administered to 51 patients. The record does not reconcile these figures. Taken together, the posted information supports a cautious description of the reported outcome in the analyzed group, not a conclusion about whether Hu3S193 changed outcomes or how it compares with other approaches.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint wording and endpoint results need to be read together. The primary outcome title refers to a one-year PFS2 rate, while the posted primary result is a median time in months. Those quantities answer different questions: a fixed-time proportion describes status at a specified time, whereas a median summarizes the timing of events across follow-up. The result should be described using the measure actually reported, rather than inferred from the title.
The time origin also determines the clinical period represented by an endpoint. Here, PFS2 is defined from the beginning of rescue platinum-based chemotherapy until progression or death. Although Hu3S193 is the intervention under study, the reported primary interval is not measured from the start of Hu3S193. Clear distinction between treatment timing and endpoint timing helps prevent a descriptive outcome from being attributed to the wrong phase of care.
The study's single-group structure is central to statistical interpretation. A median and confidence interval can describe outcomes and precision within the analyzed group, but without a comparison group they do not estimate a treatment contrast. This distinction remains important even when the endpoint is clearly defined and the event count is reported.
The registry also illustrates the value of transparent reporting about analysis populations, censoring, treatment exposure and trial status. It identifies the number considered for the primary analysis and the number censored, but does not describe censoring reasons or methods. Its enrollment and intervention-description figures do not align, and the reason for termination is not reported. These gaps limit readers' ability to connect the stated regimen, the participants treated and the final analysis. They are reporting limitations, not evidence by themselves of a particular trial conduct problem.
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.
Several limitations are specific to the registry information for this trial. It is listed as a single-group study with no masking, so the primary result has no concurrent control-group estimate. Differences from another treatment or from outcomes without consolidation therapy cannot be assessed directly. The result is descriptive and should not be interpreted as a causal estimate of Hu3S193's effect.
The primary outcome title refers to a one-year PFS2 rate, but the reported result is a median time of 11.8 months. The endpoint is defined from the start of rescue platinum-based chemotherapy, not Hu3S193 initiation. The registry does not report a one-year proportion for the primary result or explain the discrepancy between the outcome title and result format.
The registry lists enrollment as 29, while the intervention description refers to administering the regimen to 51 patients. It does not report how many received any Hu3S193, how many completed the planned schedule, or why the stated figures differ. The study is marked terminated, but the reason and its consequences for recruitment or follow-up are not reported.
The primary analysis description includes 4 censored participants, but does not give censoring reasons, timing, follow-up duration or the statistical method used to calculate the median and confidence interval. The record does not specify the detailed intention-to-treat definition, missing-data procedures, statistical testing plan or multiplicity approach. These omissions prevent a fuller assessment of analysis assumptions and robustness. Safety reporting also lacks details on event timing, attribution and the deaths field, which is not populated.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer — NCT01137071.
- Registry record last updated 2017-02-23; status last verified 2017-01.
- Results first posted 2016-12-29.
- 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
This phase II trial studied monoclonal antibody Hu3S193 as consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube adenocarcinoma who achieved a second complete response. It is listed as single-group, with no masking, enrollment of 29 and status terminated. The intervention description specifies 30mg/m2 every other week for 12 infusions over 23 weeks, but says the regimen would be administered to 51 patients; the registry does not reconcile the figures.
The primary endpoint is time from the beginning of rescue platinum-based chemotherapy until disease progression or death. In the intention-to-treat population of 29 considered for analysis, the registry reports 25 events and 4 censored participants. The median time was 11.8 months, with a 95% confidence interval of 10.6 to 13.9 months. A one-year proportion is not reported for this primary result. The record does not report a comparator, the analysis method, the reason for termination or the number who received or completed the planned intervention.