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 Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer (NCT00553059), a randomized phase 3 study. The primary outcome is Number of Participants With Total Protection in the Acute, Delayed and Overall Periods.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00553059 |
| Phase | Phase 3 |
| Condition | Chemotherapy-induced Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | Triple |
| Enrollment | 62 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
The clinical question is whether adding dronabinol to palonosetron and dexamethasone changes the number of participants achieving total protection from chemotherapy-induced nausea and vomiting, compared with palonosetron and dexamethasone plus placebo. The registry describes the chemotherapy as moderately emetogenic and the participants as patients receiving chemotherapy for cancer. The condition information also names unspecified adult solid tumors, protocol specific; further eligibility details are not reported in the registry record.
The intervention group received intravenous palonosetron hydrochloride and dexamethasone before chemotherapy, together with oral dronabinol. The comparison group received the same palonosetron and dexamethasone regimen with oral placebo instead of dronabinol. The oral treatments were scheduled three times a day for five days, starting before chemotherapy on day one. The primary outcome was total protection during the first five days of the first chemotherapy cycle. Total protection required no vomiting, no rescue therapy, and no nausea.
The primary outcome description separates assessment into acute, delayed, and overall periods. The acute period is 0-24 hour, the delayed period is 24-120 hour, and the overall period is 0-120 hour. These are related windows for describing symptoms and protection, not independent treatment comparisons by themselves. Secondary outcomes include complete protection, complete response, vomiting, nausea, nausea and vomiting, and use of rescue medication across those periods.
The registry record does not report the primary outcome counts by group, a between-group effect estimate, or an uncertainty interval. It therefore identifies the question and planned outcome definition but does not establish how the groups compared on total protection.
3. Trial Design
This was a phase 3 randomized, triple-masked trial sponsored by M.D. Anderson Cancer Center. The record gives an enrollment of 62 and a completed status. The start is recorded as 2008-05 and primary completion as 2014-08. The title and arm descriptions specify two treatment regimens: palonosetron and dexamethasone with dronabinol, or the same background drugs with placebo. Although the record classifies the model as single-group, its arm descriptions identify these two groups; the reason for that classification is not reported in the registry record.
Both groups received palonosetron hydrochloride and dexamethasone intravenously before chemotherapy on day one. The experimental regimen added oral dronabinol three times a day for five days, beginning before chemotherapy on day one. The comparator regimen used oral placebo on the same schedule. This comparison is designed to distinguish the added contribution of dronabinol from the shared antiemetic regimen, assuming treatment assignment and conduct were otherwise comparable.
Random allocation can reduce systematic differences between groups at the start of a trial, although it does not guarantee balance in every characteristic. Triple masking indicates that the registry labels the trial as masked at three levels, but which people were masked and how masking was maintained are not reported in the registry record. The method used to generate assignments, conceal allocation, and assess whether masking remained effective is also not reported.
The primary outcome concerns total protection over the first five days of the first cycle of chemotherapy. The record says symptoms were assessed through a Daily Assessment of Nausea and Vomiting questionnaire, with data recorded in a study diary. It describes a 10-point Likert-type scale from 0 (none) to 10 (as bad as it could be) when nausea or vomiting is present. Further details of how diary completion, missing entries, or protocol deviations were handled are not reported in the registry record.
The registry lists seven outcome measures and no analyses. Numerical group results for the efficacy outcomes are not reported in the registry record, so the design description cannot be extended into a conclusion about comparative efficacy.
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 | Dronabinol | Placebo |
|---|---|---|
| STARTED | 31 | 31 |
| COMPLETED | 30 | 29 |
| NOT COMPLETED | 1 | 2 |
Reasons for not completing this period:
| Reason | Dronabinol | Placebo |
|---|---|---|
| Deemed ineligible | 1 | 1 |
| Drug supply not available | 0 | 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 | Dronabinol | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 31 | 31 | 62 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 18 | 19 | 37 |
| Age, Categorical: >=65 years | Participants | 13 | 12 | 25 |
| Age, Continuous | years | 59 (37 to 75) | 57 (29 to 76) | 58 (29 to 76) |
| Sex: Female, Male: Female | Participants | 31 | 30 | 61 |
| Sex: Female, Male: Male | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 1 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 30 | 30 | 60 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 | 8 | 14 |
| Race (NIH/OMB): White | Participants | 25 | 22 | 47 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Region of Enrollment: United States | participants | 31 | 31 | 62 |
| Daily Assessment of Nausea and Vomiting | Participants | 30 | 29 | 59 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Total Protection in the Acute, Delayed and Overall Periods, measured over 5 Days (first 5 days of the first cycle of chemotherapy).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with total protection during the acute, delayed, and overall periods in the first five days of the first chemotherapy cycle. The registry defines total protection as having no vomiting, no rescue therapy, and no nausea. The outcome therefore combines symptom experience and use of rescue medication into a single all-or-none classification: a participant must meet all of the stated conditions to count as protected.
The outcome is assessed for the acute period (0-24 hour), the delayed period (24-120 hour), and the overall period (0-120 hour). Those periods capture different portions of the time after chemotherapy. Because the windows overlap, their outcome counts would be related rather than three independent replications of the same comparison. The registry title for the primary measure refers to participants with total protection across these periods, but it does not report the counts or clarify a single primary contrast among them.
A combined endpoint can be useful when the clinical question concerns a broad state of protection rather than one symptom alone. It also means that the endpoint does not show, by itself, which component drove a result. Separate outcomes for nausea, vomiting, and rescue medication are listed as secondary measures. The record describes daily symptom assessment using a questionnaire and diary, including a 10-point Likert-type scale from 0 (none) to 10 (as bad as it could be) if symptoms occur.
The outcome's definition and assessment period are reported, but the group-specific counts, analysis method, effect estimate, and confidence interval are not reported in the registry record. Without those results, the endpoint can be explained but not interpreted as evidence of a treatment-group difference.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the trial question, treatment regimens, masking label, and primary endpoint definition. It does not report the primary endpoint counts for either group or a statistical comparison between them. Consequently, no direction or magnitude of an efficacy difference can be described from this record. In particular, there is no reported effect estimate, confidence interval, or p-value for total protection.
This absence is important because the endpoint is a participant count, not a continuous symptom score. A comparison would need to state how many participants met the complete definition of total protection in each group and how the difference was estimated. The record instead names several periods—acute, delayed, and overall—and the stated skip information indicates that the primary outcome has several categories or time points and was not reduced to one comparison. The outcomes should not be collapsed into a single contrast by assumption.
In general, an effect estimate describes the observed contrast between groups, while a confidence interval describes the range of values compatible with the data under the analysis assumptions. A p-value addresses how inconsistent the observed data are with a specified null model; it is not a measure of the size or clinical importance of an effect. None of those numerical inferential results is reported for the primary outcome in the registry record, so those concepts cannot be applied to quantify this trial's efficacy findings.
The record reports adverse-event summaries separately. In the dronabinol group, one participant is listed with a serious adverse event among 30 at risk; in the placebo group, one is listed among 29 at risk. Other adverse events are recorded for 26 of 30 and 25 of 29, respectively, and deaths are listed as 0 in both groups. These descriptive counts do not establish whether the regimens differ in safety. The registry does not report an inferential comparison for these figures, and the counts alone do not account for event type, duration, severity beyond the serious classification, or possible differences in follow-up.
The record also lists serious-event terms with percentages, but it does not attribute those terms to either treatment group in the information available. They should not be treated as arm-specific risks or as a complete account of all serious events. Overall, the posted information supports a description of how the trial was organized and what it measured, but not a conclusion about whether adding dronabinol changed total protection or safety outcomes.
9. Statistical Methods Explained
Statistical concepts in this discussion are general unless explicitly tied to the registry record. The record identifies random allocation and triple masking, but it does not report the detailed statistical methods used for the outcome analyses. It lists no analyses, and the primary outcome comparison is not reported as a single comparison. A description of standard methods therefore cannot be mistaken for a claim about the trial's actual analysis plan.
What does randomization contribute?
In general, randomization assigns participants to treatment groups using a chance-based process. Its purpose is to reduce systematic selection differences between groups, so that a comparison is less vulnerable to confounding by characteristics measured or unmeasured at baseline. Randomization does not ensure that every characteristic is exactly balanced, especially in a small trial, and does not correct for missing outcomes, nonadherence, or biased measurement. The registry says the trial was randomized but does not report the sequence-generation method, allocation concealment method, or any assessment of baseline balance.
What does masking contribute?
In general, masking can reduce the influence of knowledge about treatment assignment on participant reports, care decisions, and outcome assessment. A placebo matching the oral study treatment can help preserve masking when the active and comparison regimens otherwise differ. The registry labels the trial triple-masked and describes an oral placebo in the comparator group. It does not identify which roles were masked, describe the appearance or administration of the treatments, or report whether masking was assessed. These details matter because nausea and vomiting are partly measured through participant reports and a study diary.
How should a binary outcome be analyzed?
The primary endpoint is expressed as a count of participants meeting a yes-or-no definition of total protection. In general, binary outcomes can be summarized by the number meeting the endpoint and the number assessed in each group. A treatment contrast may then be expressed using an absolute difference, a relative measure, or a model-based estimate. Each measure answers a different question, and a confidence interval is needed to show the precision of the estimate. The registry record does not report the primary counts, the denominators used for the efficacy analysis, the contrast selected, or an uncertainty interval. No such values can be reconstructed from the outcome description.
Binary outcomes can also be analyzed with regression models that account for selected covariates or design features. Whether the trial used an unadjusted comparison, an adjusted model, or another method is not reported in the registry record. Nor are the covariates or model diagnostics reported. It would be inappropriate to attribute any particular analysis to the investigators.
Why do the time windows matter?
The outcome is described over acute, delayed, and overall periods. In general, repeated or overlapping time windows can create correlated observations: the same participant may contribute information to more than one period, and the overall period includes time covered by the acute and delayed windows. A statistical analysis should account for the intended role of each window and should distinguish a prespecified primary comparison from supporting or secondary comparisons. The registry does not identify one period as the sole primary contrast or report a method for handling the multiple periods. The skip information states that the primary measure has several categories or time points and was not reduced to one comparison.
The symptom diary also uses an ordered 10-point scale when symptoms are present. In general, an ordinal scale preserves ordering but does not necessarily imply that the distance between adjacent scores is equal. A count of participants meeting total protection is a separate summary and should not be confused with a comparison of the full symptom scale. The registry does not report a model for the scale responses or the distribution of those responses.
What does an uncertainty interval tell readers?
In general, a confidence interval communicates statistical precision around an estimated effect under the assumptions of the selected model. A narrow interval indicates greater precision than a wide interval, but it does not by itself establish clinical importance or eliminate bias. An interval that includes a null value can still be compatible with effects in either direction, depending on its width. Since neither an effect estimate nor an interval is reported for total protection, the precision of the trial's efficacy comparison cannot be assessed from the registry record.
A p-value, when reported, is conditional on a statistical model and null hypothesis. It does not give the probability that a treatment is effective, and it should not replace the effect estimate and its precision. No primary-outcome p-value is reported in the registry record. There is therefore no basis for describing the primary finding as statistically significant or nonsignificant.
What can be inferred from the record's analysis information?
The registry lists no analyses, and the efficacy outcomes do not include reported group estimates. This absence does not establish what analyses may have been conducted outside the registry; it means that their results and specifications are not reported in the registry record. The planned sample-size justification, interim analyses, stopping rules, covariate adjustment, and statistical analysis plan are also not reported in the registry record. No power claim should be inferred from enrollment or from the design label.
For safety outcomes, the record gives event counts and risk sets by group, but no inferential comparison. General cautions apply: a descriptive difference in counts can reflect chance, unequal exposure or follow-up, or differences in how events were recorded. A comparison would need a defined analysis population, event definitions, observation period, and uncertainty assessment. Those details are not reported for the serious and other adverse-event summaries. Thus, the appropriate interpretation is descriptive rather than causal or inferential.
10. Multiplicity, Missing Data and Analysis Populations
The registry names a primary outcome covering acute, delayed, and overall periods, and lists secondary outcomes for complete protection, complete response, vomiting, nausea, nausea and vomiting, and rescue medication across those periods. These multiple outcomes and windows create several possible comparisons. In general, testing many outcomes can increase the chance of at least one apparently unusual result if each is interpreted without regard to the others. Methods such as prespecifying a primary contrast, hierarchical testing, or adjusting for multiple comparisons can address aspects of this issue, but the chosen approach must be reported to interpret results appropriately.
The record does not report a multiplicity strategy, a hierarchy among the periods and secondary outcomes, or which comparisons were confirmatory. It also does not report a single primary comparison; the record's skip information indicates the primary outcome has several categories or time points and was not reduced to one comparison. The statistical plan and any changes to it are not reported in the registry record.
Missing-data methods are also not reported. The primary outcome depends on symptom and rescue-therapy information recorded in a study diary. In general, incomplete diaries can complicate classification: an absent entry does not necessarily mean that a symptom or rescue treatment did not occur. The handling of missing diary entries, withdrawals, protocol deviations, and participants who did not complete follow-up is not reported. The efficacy analysis population—such as whether it included all randomized participants or only those with evaluable diaries—is not reported in the registry record.
The registry enrollment is 62, while the adverse-event summaries give risk sets of 30 for the dronabinol group and 29 for the placebo group. The record does not explain how those safety risk sets relate to enrollment or to the populations used for efficacy outcomes. It would be inappropriate to infer an efficacy denominator from the safety summaries. Without the analysis populations, missing-data rules, and multiplicity approach, the strength and scope of any efficacy interpretation cannot be assessed.
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 |
|---|---|---|---|
| Dronabinol | 1 | 30 | 3.3% |
| Placebo | 1 | 29 | 3.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dronabinol | 0 of 30 |
| Placebo | 0 of 29 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Dronabinol | 26 of 30 |
| Placebo | 25 of 29 |
Most frequent serious adverse event terms
| Event term | Organ system | Dronabinol | Placebo |
|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 1 of 30 | 0 of 29 |
| Dehydration | Gastrointestinal disorders | 1 of 30 | 0 of 29 |
| Hyponatremia | Metabolism and nutrition disorders | 1 of 30 | 0 of 29 |
| Diarrhea | Gastrointestinal disorders | 1 of 30 | 0 of 29 |
| Nausea | Gastrointestinal disorders | 0 of 30 | 1 of 29 |
| Vomiting | Gastrointestinal disorders | 0 of 30 | 1 of 29 |
| Colitis | Gastrointestinal disorders | 0 of 30 | 1 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dronabinol | Placebo |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 26 of 30 | 25 of 29 |
| Headache | Nervous system disorders | 16 of 30 | 16 of 29 |
| Other | Gastrointestinal disorders | 16 of 30 | 12 of 29 |
| Fatigue | General disorders | 17 of 30 | 11 of 29 |
| Constipation | Gastrointestinal disorders | 14 of 30 | 11 of 29 |
| Vomiting | Gastrointestinal disorders | 11 of 30 | 11 of 29 |
| Dizziness | Nervous system disorders | 14 of 30 | 7 of 29 |
| Diarrhea | Gastrointestinal disorders | 13 of 30 | 6 of 29 |
| Insomnia | Psychiatric disorders | 15 of 30 | 4 of 29 |
| Other | Blood and lymphatic system disorders | 7 of 30 | 11 of 29 |
Serious events with the highest arm-level rate: nausea (3.4%), vomiting (3.4%), colitis (3.4%), neutropenia (3.3%), dehydration (3.3%).
The registry lists one participant with a serious adverse event among 30 at risk in the dronabinol group, and one among 29 at risk in the placebo group. It reports other adverse events for 26 of 30 and 25 of 29, respectively. Deaths are recorded as 0 in each group. These are descriptive counts as reported; no statistical comparison or uncertainty interval for these summaries is reported in the registry record.
The record also lists nausea and vomiting at 3.4% each, and colitis at 3.4%, with neutropenia, dehydration, and hyponatremia each at 3.3%, among the top serious-event terms. These percentages are not identified by treatment group in the record, so they should not be read as arm-specific rates. The listed terms do not, by themselves, show how many participants in either group experienced each event or whether one person could contribute more than one term.
In general, adverse-event counts depend on the event definitions, follow-up period, exposure, and completeness of reporting. A serious adverse event is not the same category as any adverse event, and a count does not indicate the event's duration or its relation to treatment. The registry does not report those details or an analysis of comparative safety. The figures therefore describe the recorded summaries, not a definitive comparison of safety between regimens.
12. What the Result Does, and Does Not, Mean
The record makes clear what the investigators set out to compare: dronabinol added to palonosetron and dexamethasone versus palonosetron and dexamethasone with placebo. It also defines a patient-centered composite endpoint based on no nausea, no vomiting, and no rescue therapy during the first five days of the first chemotherapy cycle. These details help readers understand the trial's clinical and statistical question.
However, the registry record does not report the efficacy counts or a treatment effect estimate for total protection. It does not give a confidence interval or p-value for that endpoint. Therefore, the posted information cannot establish whether the groups differed, how large any difference was, or how precisely a difference was estimated. The absence of reported results is not evidence that the groups had the same outcomes, and it is not evidence that one regimen was better.
The same caution applies to safety. The registry reports serious and other adverse-event counts, including one serious event in each group and no deaths recorded in either group. These summaries are not accompanied by a comparative analysis, and the listed serious-event terms are not assigned to individual groups. The counts alone cannot establish a causal relation to treatment or rule out uncommon harms.
In general, interpreting a randomized trial requires the numerical outcomes, clear denominators, a prespecified analysis, and information about missing data and follow-up. Randomization and masking are strengths of design, but they do not substitute for reported results. The trial record identifies the design and measurement plan but leaves important parts of the statistical interpretation unresolved: the efficacy effect, its precision, the multiplicity approach, the analysis population, and the handling of incomplete diary data are not reported in the registry record.
Accordingly, the appropriate conclusion is limited. The registry describes a randomized comparison and its outcomes, while the available posted results do not support an efficacy conclusion. The adverse-event summaries can be read descriptively, with the same caution about incomplete analysis detail. No medical conclusion about the regimens follows from the information.
13. Why This Trial Matters Statistically
This trial raises a useful statistical issue: a clearly defined clinical question does not by itself produce an interpretable treatment comparison. The registry specifies two regimens, a randomized and triple-masked design, and a composite endpoint for total protection. Yet it does not report the outcome counts or a single comparison across the stated acute, delayed, and overall periods. Readers can identify the intended question but cannot quantify the answer from the registry record.
The endpoint also illustrates the trade-off in composite outcomes. Requiring absence of nausea, vomiting, and rescue therapy captures a broad notion of protection. At the same time, a single composite classification can conceal which component matters most to the observed result. The registry lists separate secondary outcomes for symptoms and rescue medication, but their results and the hierarchy among them are not reported. Clear reporting of component outcomes and the prespecified primary contrast would help distinguish an overall summary from its parts.
Multiplicity is particularly relevant when an outcome is described across several time windows and additional outcomes are listed. In general, the inferential meaning of a result depends on whether comparisons were prespecified and how repeated testing was addressed. The registry record does not report those details. This is not a reason to assume that analyses were invalid; it is a limit on what can be evaluated from the record.
Finally, the adverse-event summaries show why denominators and definitions matter. The registry reports risk sets for safety outcomes and counts of affected participants, but it does not report the efficacy analysis population, missing-data handling, or an inferential safety comparison. Statistical interpretation depends not only on outcome labels but also on who was analyzed, how observations were classified, and how uncertainty was quantified. Those details are not reported in the registry record, so design features alone cannot resolve the unanswered results questions.
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 principal limitation for interpretation is that the registry record does not report numerical results for the primary efficacy outcome. It gives no group-specific total-protection counts, effect estimate, confidence interval, or p-value. The primary outcome covers acute, delayed, and overall periods, and the record does not identify one reported contrast among them. Consequently, efficacy magnitude and precision cannot be evaluated.
Further limitations concern methods that are not reported in the registry record. These include the sample-size justification, the detailed statistical analysis plan, interim analyses, the method of randomization, allocation concealment, and the identities of the masked roles. The record also does not explain its single-group model classification despite giving two arm descriptions. These gaps do not establish that the study lacked such procedures; they mean that they cannot be assessed from the registry record.
The outcome relies on participant symptom reporting and diary data, but diary completeness, missing-data handling, and the efficacy analysis population are not described. The record does not state how participants with incomplete diaries, withdrawals, or protocol deviations were classified. It also does not report how multiplicity across the outcome periods and secondary measures was handled. These omissions limit assessment of bias, precision, and the confirmatory status of any comparison.
Safety reporting is likewise limited to descriptive summaries. Serious and other adverse-event counts are reported by group, but no comparative analysis or uncertainty interval is given. The top serious-event terms are listed with percentages but are not attributed to treatment groups. The event observation period and fuller event-level details are not reported in the registry record. Enrollment is recorded as 62, while safety risk sets are reported separately; the relation between those populations is not explained. These limitations call for restraint: the record supports a description of the trial structure and available safety counts, not a complete assessment of comparative efficacy or safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer — NCT00553059.
- Registry record last updated 2020-10-09; status last verified 2020-10.
- Results first posted 2020-10-09.
- 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 completed phase 3 trial was randomized and triple-masked. It compared palonosetron and dexamethasone with dronabinol against palonosetron and dexamethasone with oral placebo for patients receiving moderately emetogenic chemotherapy. The registry records enrollment of 62, a start of 2008-05, and primary completion in 2014-08.
The primary endpoint was the number of participants with total protection, defined as no nausea, vomiting, or rescue therapy during the acute, delayed, and overall periods of the first five days of the first chemotherapy cycle. The registry also lists secondary symptom and rescue-medication outcomes.
Group-specific efficacy results and a statistical comparison for the primary endpoint are not reported in the registry record. Safety summaries list one serious adverse event in each group, other adverse events in both groups, and no deaths in either group. The record does not report a comparative safety analysis, efficacy analysis populations, missing-data methods, or a multiplicity strategy. It therefore documents the trial question and design, but does not permit a quantitative conclusion about the treatment comparison.