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 Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer (NCT00771810), a randomized phase 2 study. The primary outcome is Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00771810 |
| Phase | Phase 2 |
| Condition | Thrombocytopenia, Neutropenia, Lymphopenia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 34 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Tarix Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Women receiving combination gemcitabine and platinum therapy for ovarian, fallopian tube, or peritoneal carcinoma were eligible for the study described in the registry record. The listed enrollment was 34. The primary endpoint description identifies the intention-to-treat population for analysis, but eligibility details beyond the cancer type and chemotherapy setting are not reported in the registry record.
Intervention
TXA127 was given by daily injection under the skin alongside chemotherapy. The study compared two dose levels: 100 ug/kg/day and 300 ug/kg/day. The planned chemotherapy could be gemcitabine with carboplatin or gemcitabine with cisplatin, and the brief summary describes treatment for up to six cycles.
Comparator
The comparator was placebo given concurrently with combination gemcitabine and platinum-based chemotherapy. The registry describes a parallel-group randomized design and quadruple masking. Further details about who was masked and how the randomization sequence was generated are not reported in the registry record.
Primary question
The primary question was whether the mean percentage of chemotherapy cycles with platelet counts below 50,000/mm3 differed across the placebo and TXA127 dose groups during a maximum of six 3-week chemotherapy cycles. The posted outcome values are arm-level summaries. A formal primary comparison estimate or inferential test is not reported in the registry record.
The clinical rationale described in the record is prevention or reduction of chemotherapy-associated thrombocytopenia, particularly low platelet levels that can lead to excess bleeding. The study also assessed safety and other blood-count and treatment-related outcomes. Its focus was not limited to platelet counts: the listed secondary outcomes include lymphopenia, neutropenia, anemia, mucositis, alopecia, chemotherapy dose intensity, and dose density.
The question therefore has two related parts: how often low platelet counts occurred across treatment cycles, and whether adding either TXA127 dose was associated with a different pattern than placebo. The posted primary outcome describes cycle-level frequency as a mean percentage, while several secondary outcomes count participants with an event at least once during the study timeframe. These are different summaries and should not be treated as interchangeable measures.
3. Trial Design
The registry describes a randomized, quadruple-masked, parallel-group phase II study sponsored by Tarix Pharmaceuticals. The study is marked completed. Its recorded start was 2008-10, and its primary completion was 2011-12. The listed enrollment was 34. The design compared concurrent placebo with two daily subcutaneous TXA127 dose levels during gemcitabine and platinum-based chemotherapy.
The chemotherapy setting included gemcitabine combined with carboplatin or cisplatin, as described in the study summary. Treatment was intended to continue concurrently for up to six chemotherapy cycles, each described in the primary outcome timeframe as 3 weeks. The registry does not report how participants were assigned among the three groups, whether chemotherapy regimens were balanced across groups, or whether treatment exposure and follow-up were similar by arm.
Group sizes in the posted primary outcome were 10 for placebo, 10 for TXA127 100 ug/kg, and 12 for TXA127 300ug/kg. The secondary platelet-count outcome reports participant denominators of 10, 11, and 13, respectively; other outcomes also have their own denominators. These endpoint-specific counts should be read as posted for each outcome, not as evidence about why denominators differ. The registry record does not explain the differences.
Quadruple masking indicates that the record classifies the study as masked at four levels, but it does not identify those roles or describe the procedures used to maintain masking. The method of sequence generation, allocation concealment, stratification, and any protocol amendments are not reported in the registry record. The record also does not report the planned sample-size justification or a statistical analysis plan. These omissions limit how fully the design can be reconstructed from the registry entry alone.
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 | Placebo | TXA127 100 ug/kg | TXA127 300 ug/kg |
|---|---|---|---|
| STARTED | 10 | 11 | 13 |
| COMPLETED | 5 | 6 | 6 |
| NOT COMPLETED | 5 | 5 | 7 |
Reasons for not completing this period:
| Reason | Placebo | TXA127 100 ug/kg | TXA127 300 ug/kg |
|---|---|---|---|
| Adverse Event | 3 | 0 | 2 |
| Lost to Follow-up | 0 | 0 | 1 |
| Physician Decision | 1 | 2 | 2 |
| Protocol Violation | 0 | 1 | 1 |
| Withdrawal by Subject | 1 | 2 | 0 |
| Other | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: The number of participants for analysis was the intention to treat population.
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 | Placebo | TXA127 100 ug/kg | TXA127 300ug/kg | Total |
|---|---|---|---|---|---|
| Participants analysed | 10 | 11 | 13 | 34 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 | 9 | 10 | 27 |
| Age, Categorical: >=65 years | Participants | 2 | 2 | 3 | 7 |
| Sex: Female, Male: Female | Participants | 10 | 11 | 13 | 34 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 10 | 11 | 13 | 34 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 2 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 8 | 9 | 11 | 28 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 | 2 |
| Region of Enrollment: United States | participants | 10 | 11 | 13 | 34 |
6. Primary Endpoint
The registry lists the primary outcome as Chemotherapy Cycles During Which the Platelet Count Measures Below 50,000/mm3, measured over During a maximum of six 3-week chemotherapy cycles.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | Percentage of cycles |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the mean percentage of chemotherapy cycles during which platelet counts measured below 50,000/mm3. It covers a maximum of six 3-week chemotherapy cycles. This endpoint summarizes how often a clinically relevant low platelet count occurred across treatment cycles, rather than simply recording whether a participant ever had a low count.
That cycle-based summary can reflect repeated episodes within a participant. A participant may contribute more than one cycle, so the cycles are not necessarily independent observations. The registry reports a mean and a full range for each arm, but does not report a standard deviation, standard error, confidence interval, or an inferential comparison for this primary endpoint. The range describes the spread from the lowest to highest posted participant-level percentage; it does not by itself establish how precisely the arm mean is estimated.
The endpoint is relevant to the study rationale because the brief summary identifies low platelet levels as a chemotherapy side effect associated with excess bleeding. However, the primary measure is a laboratory-count outcome, not a direct measure of bleeding, transfusion, chemotherapy interruption, or another patient-centered consequence. Those outcomes should not be inferred from a change, or lack of change, in the platelet-cycle summary.
The posted means were 20.0% of cycles with low counts in the placebo group, 11.7% with TXA127 100 ug/kg, and 21.5% with TXA127 300ug/kg. The full ranges were 0.0 to 67.0, 0.0 to 50.0, and 0.0 to 100.0, respectively. The registry identifies the intention-to-treat population for this analysis, but further details about handling cycles without an observed count are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary endpoint summaries do not show a consistent ordering across the three groups by TXA127 dose. The mean percentage of cycles with platelet counts below 50,000/mm3 was 20.0% with placebo, 11.7% with TXA127 100 ug/kg, and 21.5% with TXA127 300ug/kg. Thus, the lower posted mean was in the 100 ug/kg group, while the 300ug/kg group mean was slightly higher than the placebo mean. These are descriptive arm summaries, not a reported test of treatment differences.
The full ranges were broad: 0.0 to 67.0 for placebo, 0.0 to 50.0 for TXA127 100 ug/kg, and 0.0 to 100.0 for TXA127 300ug/kg. The endpoints of the ranges show that participant-level percentages varied within each group. Ranges do not convey how values were distributed between their endpoints and are not substitutes for an uncertainty interval around a mean. The registry does not report a confidence interval or standard error for the primary endpoint.
There is no reported primary comparison estimate, p-value, or adjusted analysis for the cycle-level endpoint. The registry record lists no reported analyses. Consequently, the arm means alone cannot establish whether the apparent differences are compatible with random variation, nor can they establish a causal effect. The reported intention-to-treat population is relevant, but the record does not give enough information to assess how all randomized participants and all eligible cycles entered the endpoint calculation.
Secondary binary outcomes offer additional, but limited, comparative information. For participants with platelet counts below 50,000/mm3, the posted counts were 5 of 10 with placebo, 4 of 11 with TXA127 100 ug/kg, and 6 of 13 with TXA127 300ug/kg. The unadjusted risk-difference calculations for the TXA127 groups have intervals that include zero, and their unadjusted p-values are 0.528 and 0.855. These calculations are not reported sponsor analyses. They are imprecise comparisons based on small endpoint groups, and should not replace a prespecified primary analysis.
The cycle-based endpoint and participant-based secondary endpoint answer different questions. The former summarizes the percentage of cycles affected; the latter counts participants who experienced at least one qualifying low count during the stated timeframe. A pattern in one need not match the other, particularly when participants have different numbers of observed cycles. The registry does not provide participant-level data or a detailed account of exposure and missing cycles to clarify this relationship.
Overall, the posted primary results describe different arm averages with substantial ranges, but do not establish a reliable treatment contrast. The registry record does not report the formal inferential analysis needed to quantify uncertainty for the primary endpoint. Results for secondary outcomes are exploratory context rather than confirmation of a primary treatment effect.
9. Statistical Methods Explained
The primary outcome is a continuous summary reported as a mean percentage of cycles. Each participant may contribute data from multiple chemotherapy cycles, so the outcome has a repeated-measures structure: measurements from the same participant can be related to one another. Treating all cycles as if they came from unrelated participants can understate uncertainty when within-participant values are correlated. General statistical principle: methods for repeated measurements account for that dependence, whereas an unadjusted average may not.
The record reports a full range for each primary arm rather than a standard deviation or uncertainty interval. A range gives the lowest and highest values and indicates how far apart those extremes are. It does not show whether most observations cluster near the mean or near one endpoint. It is also sensitive to extreme values. General statistical principle: an interval estimate around a mean addresses uncertainty in the estimated average, while a range describes observed variability; the two have different meanings. No interval estimate for the primary arm means is reported in the registry record.
What do the secondary risk differences mean?
The secondary comparisons for binary outcomes use risk differences. A risk difference compares the proportion with an outcome in one group with the proportion in the placebo group; negative values in these TXA127 comparisons indicate a lower observed proportion in the TXA127 arm. For the participant-level platelet outcome, the posted risk differences were -0.136 for TXA127 100 ug/kg and -0.038 for TXA127 300ug/kg. Their respective intervals were -0.557 to 0.284 and -0.450 to 0.373. Both intervals include zero, meaning the posted data are compatible with no difference as well as with differences in either direction over the ranges represented by those intervals.
Those intervals are wide relative to the point estimates. That imprecision is expected to be a concern when group counts are small and outcomes are uncommon or variable. General statistical principle: an interval that spans zero for a risk difference does not establish that groups are equivalent; it indicates that the data do not pin down the direction and size of the difference precisely. No equivalence margin or noninferiority margin is reported in the registry record.
The unadjusted p-values for the participant-level platelet comparisons were 0.528 and 0.855. A p-value measures how incompatible the data are with a specified null model, conditional on assumptions of the analysis; it is not the probability that the null hypothesis is true, and it does not measure clinical importance. These particular comparisons are unadjusted recalculations from posted summary counts rather than reported sponsor analyses. No reported analysis details establish whether these calculations match the trial's planned methods.
Why do small event counts make comparisons unstable?
When group sizes and event counts are limited, changing the outcome status of a small number of participants can alter the estimated proportions appreciably. Confidence intervals for risk differences can therefore be broad, and different reasonable methods can yield different interval limits or p-values. General statistical principle: sparse data call for caution because the apparent size and direction of an effect may be sensitive to individual observations. The registry does not report whether exact, score-based, or other methods were used for any sponsor analysis.
Risk ratios and odds ratios are also listed for some secondary comparisons. They express contrasts on relative rather than absolute scales. A ratio near one corresponds to similar observed values on that scale, while values on either side represent opposite directions. The intervals for these measures are also broad in these small groups. For interpretation, the risk difference can be more directly connected to the absolute frequency contrast, while relative measures can appear large or small depending on the baseline frequency. Neither scale resolves the limitations of sparse data.
How should the planning illustrations be interpreted?
Planning illustrations use the observed effect as a starting point and show participants per arm for 80% power and 90% power at a two-sided significance level 0.05, with equal allocation and a normal approximation. Rows considering 75% or 50% of the observed effect represent planning for smaller effects than the observed estimate. They are hypothetical sample-size calculations, not evidence that the trial had a given probability of detecting an effect and not a report of the original design calculation.
Because the calculations are anchored to estimates from small groups, those estimates may be unstable. A planning result can become very large when the effect used is small, and can change substantially if the underlying event rates or target effect differ. The trial's own sample-size assumptions and justification are not reported in the registry record. The posted planning illustrations should therefore be read as conditional scenarios, not as a retrospective verdict on trial adequacy.
The record identifies the intention-to-treat population for the primary analysis, but does not report the exact statistical model, missing-data procedures, covariate adjustment, or handling of repeated cycles. It also does not report the analysis population definitions for every secondary outcome. General statistical principle: an analysis population and a method for incomplete observations affect which participants and measurements contribute to estimates, and are necessary for reproducing or fully evaluating a result.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a multiplicity strategy. It lists several secondary outcomes and multiple treatment comparisons, but does not state whether one outcome was designated as a key secondary endpoint, whether tests were ordered hierarchically, or whether p-values were adjusted for the number of comparisons. Without such information, secondary p-values should be viewed as unadjusted and exploratory rather than as a family of confirmatory tests.
Missing-data handling is also not reported in the registry record. The primary endpoint is described as an intention-to-treat analysis, but the record does not explain how participants without a post-baseline platelet measurement, participants who discontinued chemotherapy, or cycles without an evaluable count were handled. It does not describe imputation, exclusions, or sensitivity analyses. This absence does not demonstrate that data were missing; it means the registry entry does not explain their management.
Endpoint-specific denominators vary. For example, the primary arm summaries list 10, 10, and 12 participants, while the participant-level platelet outcome lists 10, 11, and 13. Other outcomes also have distinct denominators. The registry does not reconcile these differences or explain whether they reflect endpoint eligibility, data availability, or another reason. Denominators should therefore be read as outcome-specific, without assuming a cause for their variation.
The primary endpoint description names the intention-to-treat population, but the analysis population definitions for the secondary outcomes are not reported in the registry record. The record also does not report whether analyses were conducted according to randomized assignment, treatment received, or another population for those outcomes. These details matter because exclusions after randomization can affect the comparability created by random assignment.
The record lists no reported analyses and gives no statistical analysis plan, interim-analysis plan, or protocol-level decision rules. It is therefore not possible to determine from the registry whether the posted summaries were the prespecified analyses or whether additional analyses were conducted but not recorded. These gaps limit the strength of conclusions that can be drawn from isolated secondary comparisons and the completeness of the analysis history.
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 |
|---|---|---|---|
| Placebo | 3 | 10 | 30.0% |
| TXA127 100 ug/kg | 1 | 11 | 9.1% |
| TXA127 300 ug/kg | 3 | 13 | 23.1% |
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 |
|---|---|
| Placebo | 10 of 10 |
| TXA127 100 ug/kg | 11 of 11 |
| TXA127 300 ug/kg | 13 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | TXA127 100 ug/kg | TXA127 300 ug/kg |
|---|---|---|---|---|
| Female genital tract fistula | Gastrointestinal disorders | 1 of 10 | 0 of 11 | 1 of 13 |
| Abdonminal pain lower | Gastrointestinal disorders | 1 of 10 | 0 of 11 | 0 of 13 |
| Pyrexia | General disorders | 1 of 10 | 0 of 11 | 0 of 13 |
| Depressed mood | Psychiatric disorders | 1 of 10 | 0 of 11 | 0 of 13 |
| Ureteric obstruction | Renal and urinary disorders | 0 of 10 | 0 of 11 | 1 of 13 |
| Pleural effusion with dyspnoea | Respiratory, thoracic and mediastinal disorders | 0 of 10 | 0 of 11 | 1 of 13 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 0 of 10 | 0 of 11 | 1 of 13 |
| Hypertensive crisis | Vascular disorders | 0 of 10 | 1 of 11 | 0 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | TXA127 100 ug/kg | TXA127 300 ug/kg |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 7 of 10 | 7 of 11 | 9 of 13 |
| Fatigue | General disorders | 8 of 10 | 6 of 11 | 7 of 13 |
| Neutropenia | Blood and lymphatic system disorders | 7 of 10 | 5 of 11 | 8 of 13 |
| Constipation | Gastrointestinal disorders | 8 of 10 | 7 of 11 | 5 of 13 |
| Headache | Nervous system disorders | 7 of 10 | 5 of 11 | 5 of 13 |
| Vomiting | Gastrointestinal disorders | 6 of 10 | 4 of 11 | 5 of 13 |
| Thrombocytopenia | Blood and lymphatic system disorders | 5 of 10 | 5 of 11 | 2 of 13 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 10 | 5 of 11 | 5 of 13 |
| Anaemia | Blood and lymphatic system disorders | 2 of 10 | 4 of 11 | 5 of 13 |
| Abdominal pain | Gastrointestinal disorders | 5 of 10 | 4 of 11 | 1 of 13 |
Serious events with the highest arm-level rate: abdonminal pain lower (10.0%), female genital tract fistula (10.0%), pyrexia (10.0%), depressed mood (10.0%), hypertensive crisis (9.1%).
The safety summary reports participants with serious adverse events and participants with other adverse events by group. Serious adverse events were recorded for 3 participants in the placebo group, 1 participant in the TXA127 100 ug/kg group, and 3 participants in the TXA127 300 ug/kg group. The corresponding groups at risk were 10, 11, and 13. Other adverse events were recorded for all participants listed as at risk in each group: 10, 11, and 13, respectively.
These are descriptive counts, not evidence that an event was caused by the assigned study treatment. The registry does not report attribution, event timing, duration, recurrence, severity grading beyond the serious-event classification, or a comparative safety analysis. Death counts are not reported in the registry record.
The listed serious-event terms include “Abdonminal pain lower,” “Female genital tract fistula,” “Pyrexia,” “Depressed mood,” “Hypertensive crisis,” and “Ureteric obstruction,” with posted percentages ranging from 7.7% to 10.0%. The record does not provide enough detail to determine from these term-level entries whether each participant had one or more events, whether terms occurred in more than one group, or how the percentages were calculated across the full safety dataset. These figures should be read as registry safety summaries, not as a complete assessment of comparative risk.
12. What the Result Does, and Does Not, Mean
The posted primary results describe the average share of chemotherapy cycles with platelet counts below the specified threshold in each study group. The mean was 20.0% for placebo, 11.7% for TXA127 100 ug/kg, and 21.5% for TXA127 300ug/kg. The full ranges were wide, and the registry does not report an inferential comparison for this primary endpoint. The results therefore describe what was recorded in the groups but do not establish a treatment effect.
The outcome is a laboratory-based summary. It does not directly show whether participants experienced bleeding, required transfusions, had chemotherapy delayed, or benefited in another clinical way. Although the study rationale links low platelet counts with excess bleeding, that rationale does not make the platelet-count outcome a substitute for measuring bleeding or other consequences.
The results also do not establish that the two TXA127 doses have the same effect, or that either dose differs from placebo. A lack of a reported primary comparison is not evidence of equivalence. Likewise, a secondary comparison whose interval includes zero does not prove there is no difference. Small group counts and broad intervals leave substantial uncertainty about the direction and magnitude of some contrasts.
The study was randomized and masked according to the registry, which are important design features, but the entry does not report enough operational or analytic detail to evaluate all protections against bias. The allocation procedure, missing-data handling, and analysis methods for the primary outcome are not reported in the registry record. These limitations do not negate the posted observations; they constrain how strongly those observations support a causal interpretation.
Finally, the record describes a phase II study with listed enrollment of 34. Its results can characterize outcomes in this trial setting, but they should not be generalized automatically to other chemotherapy regimens, patient populations, or clinical decisions. The registry record alone does not establish the broader balance of benefit and harm or provide a basis for medical advice.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its primary endpoint combines repeated cycle-level observations with an arm-level mean. The distinction matters: percentages of affected cycles describe treatment-course burden, while participant counts describe whether a person experienced an event at least once. These measures may tell different stories, especially when participants contribute different numbers of cycles.
The three-arm design also illustrates why dose groups should not be assumed to form a monotonic trend. The posted primary mean for the lower dose was below the placebo mean, while the higher-dose mean was above the placebo mean. That pattern is descriptive and does not establish a dose relationship, particularly without a formal primary comparison and with broad participant-level ranges.
Small groups make precision a central issue. The primary endpoint groups contain 10, 10, and 12 participants, and secondary endpoint denominators vary. In this setting, individual observations can have substantial influence on summaries of event frequency. The secondary risk-difference intervals are broad, underscoring that a point estimate alone can give a misleading impression of certainty.
The registry also distinguishes evidence about an outcome from evidence about its clinical consequences. Platelet counts are relevant to the stated study rationale, but the primary endpoint does not itself measure bleeding or chemotherapy delivery. The trial lists other outcomes that could help contextualize those consequences, yet the record does not report a comprehensive analysis tying them together.
Finally, the entry demonstrates the value of transparent analysis reporting. The study design and arm-level summaries are available, but the primary inferential method, multiplicity approach, and missing-data procedures are not reported in the registry record. Those details are needed to assess precision, reproduce analyses, and judge how much weight to give secondary findings. The statistical lesson is to separate the observed summaries from the strength of the evidence they can support.
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 posted record. The primary outcome is reported as a mean and full range, without a standard deviation, standard error, or uncertainty interval. No formal comparison of the primary endpoint is reported. As a result, readers cannot evaluate a reported inferential estimate for the central outcome from the registry entry.
Group sizes are small, and the reported ranges include substantial variation. Small groups can yield unstable estimates, while a range alone does not show the distribution of values. The record does not provide participant-level observations, cycle counts by participant, or summaries of how many cycles contributed to each arm mean. Dependence among repeated cycles and differences in treatment exposure therefore cannot be evaluated.
Endpoint-specific denominators differ, and the registry does not explain why. The primary outcome identifies the intention-to-treat population, but the record does not provide corresponding analysis-population definitions for every secondary outcome. Missing-data procedures, reasons for missing observations, and sensitivity analyses are not reported in the registry record. These gaps make it difficult to assess whether the available observations represent the randomized groups comparably across outcomes.
The record does not report details of random-sequence generation, allocation concealment, masking roles, or adherence to assigned treatment. Nor does it provide a statistical analysis plan, multiplicity strategy, or sample-size justification. The secondary comparisons are unadjusted recalculations based on posted summary counts, not reported sponsor analyses; they should not be treated as prespecified confirmatory results.
Safety reporting is also limited to summary counts and selected serious-event terms. Causality, timing, recurrence, and death counts are not reported in the registry record. Taken together, these limitations constrain assessment of both treatment effect and comparative safety. They should be considered alongside, rather than substituted for, the descriptive results that are posted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer — NCT00771810.
- Registry record last updated 2017-11-13; status last verified 2017-10.
- Results first posted 2013-06-07.
- 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
The registry describes a completed randomized, quadruple-masked, parallel-group phase II study of TXA127 with gemcitabine and platinum-based chemotherapy for ovarian, fallopian tube, or peritoneal carcinoma. Listed enrollment was 34. The groups received concurrent placebo, TXA127 100 ug/kg/day, or TXA127 300 ug/kg/day.
The primary outcome was the mean percentage of chemotherapy cycles with platelet counts below 50,000/mm3 during a maximum of six 3-week cycles. Posted means were 20.0%, 11.7%, and 21.5%, respectively, with full ranges of 0.0 to 67.0, 0.0 to 50.0, and 0.0 to 100.0. A formal primary comparison is not reported in the registry record.
Secondary outcomes include participant-level platelet events and other blood-count and treatment-related outcomes. Their unadjusted comparisons are exploratory, and the record does not report multiplicity or missing-data methods. Safety summaries report serious adverse events in each group, but do not establish causality. Overall, the registry provides descriptive results with important uncertainties about precision and analysis methods.