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 Efficacy and Safety of Resatorvid in Patients With Sepsis-induced Cardiovascular and Respiratory Failure (NCT00633477), a randomized phase 3 study. The primary outcome is All-cause Mortality.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00633477 |
| Phase | Phase 3 |
| Condition | Sepsis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Takeda |
| Results posted | Yes |
2. Clinical Question
Population
People with sepsis-induced cardiovascular and respiratory failure were the intended study population. The primary endpoint description specifies participants who received study drug; further eligibility criteria and a fuller description of the enrolled population are not reported in the registry record. The record lists Sepsis as the condition and an enrollment of 18.
Intervention
The intervention was resatorvid, also identified in the official title as TAK-242. The arm description names Resatorvid 2.4 mg/kg/day. Other details about treatment administration, duration, or adherence are not reported in the registry record.
Comparator
The comparison group received placebo. The study is described as randomized, double-blind, placebo-controlled, and quadruple-masked. The registry record does not explain the allocation procedure or identify which roles were masked.
Primary question
The primary endpoint is all-cause mortality at Day 28, described as mortality regardless of cause among participants who received study drug. The registry record does not post the arm-specific mortality counts or a statistical comparison for this endpoint, so the clinical question cannot be answered from the posted results alone.
In statistical terms, the trial was designed to compare a drug intervention with placebo in a seriously ill population, using death by a stated follow-up time as the primary outcome. All-cause mortality counts deaths without restricting the endpoint to a particular cause. This can make the endpoint straightforward to interpret, while still leaving important questions about the estimate, its uncertainty, and the population included in the analysis.
The registry lists secondary outcomes of ICU Free Days, Vasopressor Free Days, and Ventilator Free Days. It does not post enough detail to reconstruct how these outcomes were defined or compared. The stated study purpose was to determine the effect of resatorvid on subjects with sepsis. The record identifies the question and broad design, but does not provide the primary outcome results needed to assess the observed comparison.
3. Trial Design
The registry describes a phase 3, randomized, parallel-group study comparing resatorvid with placebo. It was double-blind and quadruple-masked according to the study description. These labels indicate that the study used masking, but the registry record does not identify the masked roles or give the operational details of how masking was maintained. It also does not describe the randomization sequence or allocation concealment.
The listed resatorvid arm is described as Resatorvid 2.4 mg/kg/day, and the other arm is placebo. Further information about dosing procedures, treatment duration, and background care is not reported in the registry record. The listed condition is Sepsis, and the title specifies the intended population as patients with sepsis-induced cardiovascular and respiratory failure. The primary endpoint population is described more narrowly as participants who received study drug.
The registry reports an enrollment of 18. It lists the study start as 2008-02, primary completion as 2009-02, and status as terminated. The reason for termination is not reported in the registry record. Those dates and the status alone do not establish why recruitment or follow-up ended, or whether the study stopped according to a planned rule.
The primary outcome is all-cause mortality at Day 28. The record also lists ICU Free Days, Vasopressor Free Days, and Ventilator Free Days as secondary outcomes. It reports five outcome measures overall, but the outcome details and analyses needed to interpret all of them are not posted. The registry record lists zero analyses, so it does not provide a statistical comparison for the primary endpoint in this entry.
Sample-size calculations shown elsewhere on the page are planning illustrations, not evidence of the study’s planned enrollment or its original design justification. The registry record does not report the protocol’s sample-size justification, statistical analysis plan, or interim analysis procedures. No conclusion about the planned power or stopping rules should be drawn from the enrollment and status 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.
Before assignment: Participants who met 3 of the 4 systemic inflammatory response syndrome (SIRS) criteria and receiving parentaeral antimicrobial therapy for bacterial or fungal infection prior to enrollment and met the key organ failure criteria within 36 hours of planned study drug administration were randomized to receive resatorvid or placebo.
Overall Study
| Stage | Resatorvid | Placebo |
|---|---|---|
| STARTED | 7 | 11 |
| Randomized But Not Treated | 1 | 0 |
| Prematurely Discontinued Study Drug | 1 | 0 |
| Completed Study Through Day 28 | 4 | 8 |
| COMPLETED | 5 | 11 |
| NOT COMPLETED | 2 | 0 |
Reasons for not completing this period:
| Reason | Resatorvid | Placebo |
|---|---|---|
| Death | 1 | 0 |
| Randomized but not treated | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants who received study drug.
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 | Resatorvid 2.4 mg/kg/Day | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 11 | 17 | |
| Age Continuous | years | 76.7 (SD 5.28) | 77.8 (SD 13.56) | 77.4 (SD 11.14) |
| Age, Customized: 18 - <45 | Participants | 0 | 0 | 0 |
| Age, Customized: 45 - <60 | Participants | 0 | 1 | 1 |
| Age, Customized: 60 - <75 | Participants | 2 | 3 | 5 |
| Age, Customized: ≥75 | Participants | 4 | 7 | 11 |
| Sex: Female, Male: Female | Participants | 0 | 4 | 4 |
| Sex: Female, Male: Male | Participants | 6 | 7 | 13 |
| Race: American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race: Asian | Participants | 6 | 10 | 16 |
| Race: Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race: Black or African American | Participants | 0 | 0 | 0 |
| Race: White | Participants | 0 | 1 | 1 |
| Race: More than one race | Participants | 0 | 0 | 0 |
| Ethnicity: Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity: Not Hispanic or Latino | Participants | 0 | 1 | 1 |
| Ethnicity: Unknown or Not Reported | Participants | 6 | 10 | 16 |
| Weight | kg | 54.27 (SD 12.9) | 58.24 (SD 17.1) | 56.84 (SD 15.4) |
| Height | cm | 158.3 (SD 6.0) | 160.7 (SD 7.4) | 159.9 (SD 6.9) |
| Body Mass Index | kg/m2 | 21.46 (SD 3.97) | 22.59 (SD 6.12) | 22.19 (SD 5.36) |
| Smoking Classification: Never smoked | Participant | 2 | 4 | 6 |
| Smoking Classification: Current smoker | Participant | 0 | 3 | 3 |
| Smoking Classification: Ex-smoker | Participant | 3 | 4 | 7 |
| Smoking Classification: Smoking history not available | Participant | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as All-cause Mortality, measured over Day 28.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is all-cause mortality at Day 28. The registry describes it as mortality regardless of cause at that time point, measured among participants who received study drug. An all-cause endpoint counts deaths without requiring classification of the cause. As a general statistical concept, this can reduce dependence on judgments about the precise cause of each death, while still requiring clear follow-up and a defined analysis population.
A fixed follow-up time gives the endpoint a specified window in which the outcome is assessed. Here, the registry names Day 28; it does not provide further details about how that visit or time point was handled when a participant’s status was unknown. The number of participants who died in each arm, the total included in the primary analysis, and the comparison estimate are not reported in the registry record.
The endpoint is clinically important because it captures a definitive outcome, but its interpretation in a trial depends on more than the endpoint label. Readers also need the observed counts, the method used to compare arms, and a measure of uncertainty. Those results are not posted for this primary endpoint. The record therefore identifies what was intended to be measured, but does not establish the magnitude or precision of any between-arm difference.
The registry also names ICU Free Days, Vasopressor Free Days, and Ventilator Free Days as secondary outcomes. The definitions, handling of death in these measures, and statistical results are not reported in the registry record. Those details matter because outcome construction can affect what a numerical value means.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry entry identifies the trial’s primary question but does not post the numerical primary outcome results. Although the endpoint is described as all-cause mortality at Day 28 among participants who received study drug, arm-specific death counts and an inferential comparison are not reported in the registry record. The page therefore cannot characterize the observed mortality contrast, its direction, or its precision from this entry.
The enrollment is reported as 18. That is a small total for a comparison of mortality between two groups, but no conclusion about statistical power can be made from enrollment alone. The protocol’s sample-size justification and target enrollment are not reported in the registry record. The status is terminated, but the reason is not reported; it would be inappropriate to infer whether termination was related to recruitment, safety, efficacy, or another cause.
The safety information is descriptive. In the Resatorvid group, 1 of 6 participants at risk had a serious adverse event, and 4 of 6 had an other adverse event. In the Placebo group, 3 of 11 participants at risk had a serious adverse event, and 6 of 11 had an other adverse event. These are participant counts as presented in the registry, not a statistical comparison. The record does not report an analysis of these figures, and the small group counts make them particularly unsuitable as stand-alone evidence of a reliable difference.
The listed serious adverse event terms include Sepsis, Septic shcok, Anoxic encephalopathy, Intraventricular haemorrhage, Renal failure Acute, and Inflamation, each with a percentage shown in the record. The record does not explain the denominator for those percentages or map each term to an arm. They should therefore be read as listed terms, not as arm-specific risk estimates or a complete accounting of event patterns.
General statistical interpretation requires distinguishing a point estimate from its uncertainty. A confidence interval, when reported, describes a range of values compatible with the data and analysis under the method’s assumptions; it is not a guarantee that the true effect lies within that range. No confidence interval or primary effect estimate is reported. Without those elements, readers cannot assess whether the results are precise, whether clinically important differences remain plausible, or how the observed primary outcome compares between arms.
The results available in the entry should consequently be read as an incomplete registry record rather than as a conclusive estimate of the intervention effect. The study’s design labels and endpoint description do not substitute for its outcome results. The posted safety counts offer a limited descriptive view, but they do not fill the gap in the primary outcome analysis.
9. Statistical Methods Explained
The registry presents a randomized, parallel-group comparison of resatorvid and placebo. Randomization is generally used to make treatment groups comparable in expectation with respect to both measured and unmeasured characteristics. It does not guarantee balance in a particular small trial, and the registry record does not describe the randomization method, stratification, or allocation concealment. The word randomized describes the design; it is not by itself a report of how randomization was implemented.
What does masking contribute?
The record describes the study as double-blind and quadruple-masked. In general, masking is intended to limit the influence of knowledge about assigned treatment on participant behavior, care, outcome assessment, or analysis. The record does not specify which people or groups were masked, nor does it describe procedures for maintaining the mask or circumstances in which it could be broken. The labels should therefore be reported as the registry states them, without assuming the exact roles involved.
What can be inferred from the primary endpoint entry?
The primary outcome is listed as a number of participants with all-cause mortality at Day 28, in participants who received study drug. For a binary outcome, each participant is classified according to whether the event occurred within the defined period. General analyses may compare the event counts or corresponding proportions between groups, but the registry entry does not post those primary counts, an effect estimate, or a statistical test. The primary outcome is not reduced to one comparison because the record indicates that it has several categories or time points. That limitation prevents reconstruction of a single primary comparison from the posted entry.
When outcome data are available, an estimate summarizes the observed difference or other contrast chosen by the analysis. A confidence interval communicates uncertainty around that estimate under the specified model and assumptions. A p-value addresses compatibility of the data with a stated null model under a particular test; it does not measure the probability that a treatment effect is real. These are general concepts. No primary estimate, confidence interval, or p-value is reported in the registry record, so none can be interpreted for this trial.
Why does analysis population matter?
The endpoint description names participants who received study drug. That wording identifies the population stated for the primary endpoint, but does not establish whether the analysis was intention-to-treat, per-protocol, or another defined population. Those terms describe different ways of handling randomized participants and treatment adherence. The registry record does not report the full analysis-population definition, participant flow, or how any participants without an observed Day 28 status were handled.
What do the safety counts represent?
The adverse event summary gives the number at risk and the number affected for serious and other adverse events within each named group. In the Resatorvid group, 6 participants were at risk for each category; 1 had a serious adverse event and 4 had an other adverse event. In the Placebo group, 11 participants were at risk for each category; 3 had a serious adverse event and 6 had an other adverse event. The registry does not state whether participants could contribute to both categories, how events were coded, or the observation period for this summary. The counts describe participants affected, not necessarily the total number of event episodes.
The list of serious adverse event terms includes percentages but does not specify their denominator in the posted record. A percentage attached to a term cannot be assumed to represent the percentage of participants in either arm without a defined denominator. Nor does the list show the number of unique participants for each term or whether multiple terms occurred in one participant. It is therefore safest to treat these as reported terms and percentages, rather than calculate or infer comparative risks.
How should planning illustrations be read?
The sample-size section is a planning illustration computed from an observed effect, not the trial’s own design calculation. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is specified as a fraction of the observed effect. Such illustrations ask how many participants per arm might be needed under those assumptions. They do not show the number enrolled, prove that the trial had a particular power, or report observed power. The registry record does not report its original sample-size justification.
Any planning result depends on the selected effect, variability or event frequency, statistical model, and assumptions about allocation and follow-up. A smaller target effect generally requires more information to detect with the same design and error threshold; this is a general statistical relationship, not a trial-specific result. The illustrations should not be mistaken for a revised analysis plan or evidence that the study was designed around the observed outcome.
What statistical details are missing?
The registry lists zero analyses. It does not report the primary comparison method, adjustment variables, confidence intervals, handling of missing outcomes, multiplicity strategy, or interim analyses. The absence of these details does not establish that no such procedures were used in the full study documentation; it means they are not reported in the registry record. Without them, a reader cannot verify the analysis choices or reproduce the primary result from this entry.
Over-dispersion is a general issue for count outcomes when observed variation exceeds what a simple model assumes. It can lead to uncertainty estimates that are too narrow if ignored. The primary endpoint is described as a participant count for a binary mortality outcome, and the registry does not report a model or dispersion parameter. This general concept should not be read as a finding that over-dispersion occurred in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and secondary outcomes of ICU Free Days, Vasopressor Free Days, and Ventilator Free Days. It reports five outcome measures overall, but does not post the full details of the outcome definitions or analyses. The statistical plan for controlling or describing the risk of multiple comparisons is not reported in the registry record.
Multiplicity is a general concern when many outcomes, time points, or comparisons are examined: the chance of at least one apparently notable result can increase if no strategy is specified. Researchers may address this through prespecified testing sequences, adjusted thresholds, or clear separation of primary and exploratory analyses. The record does not indicate whether any of these approaches were used. No conclusion about the multiplicity handling should be inferred from the registry’s list of outcomes alone.
Missing-data procedures are also not reported in the registry record. The entry does not state how participants without a known Day 28 status were handled, whether follow-up was complete, or how missing values on secondary outcomes were treated. This matters because different assumptions about missing outcomes can lead to different estimates. The participant flow and reasons for missingness are not reported.
The endpoint description specifies participants who received study drug, but the complete analysis-population definition is not reported. The record does not state whether the primary analysis included all randomized participants, only treated participants, or another group, and it does not provide a participant disposition by arm. The registry status is terminated, but the reason and its implications for follow-up or analysis are not reported. These omissions limit assessment of selective reporting, missingness, and the reproducibility of the statistical approach.
The entry lists zero analyses, so no multiplicity-adjusted or unadjusted primary comparison can be reviewed from it. The appropriate conclusion is that these analysis details are unavailable in the registry record, not that the study necessarily lacked a prespecified plan.
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 |
|---|---|---|---|
| Resatorvid | 1 | 6 | 16.7% |
| Placebo | 3 | 11 | 27.3% |
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 |
|---|---|
| Resatorvid | 4 of 6 |
| Placebo | 6 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | Resatorvid | Placebo |
|---|---|---|---|
| Sepsis | Infections and infestations | 0 of 6 | 2 of 11 |
| Septic shcok | Infections and infestations | 1 of 6 | 0 of 11 |
| Anoxic encephalopathy | Nervous system disorders | 0 of 6 | 1 of 11 |
| Intraventricular haemorrhage | Nervous system disorders | 0 of 6 | 1 of 11 |
| Renal failure Acute | Renal and urinary disorders | 0 of 6 | 1 of 11 |
| Inflamation | General disorders | 0 of 6 | 1 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Resatorvid | Placebo |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 3 of 6 | 0 of 11 |
| Atrial Fibrilation | Cardiac disorders | 0 of 6 | 2 of 11 |
| Hepatic function abnormal | Hepatobiliary disorders | 1 of 6 | 1 of 11 |
| Atrial Flutter | Cardiac disorders | 0 of 6 | 1 of 11 |
| Ventricular Tachycardia | Cardiac disorders | 0 of 6 | 1 of 1 |
| Blood Amylase Increased | Investigations | 0 of 6 | 1 of 11 |
| Blood Bilirubin Increased | Investigations | 1 of 6 | 0 of 11 |
| Blood Cholesterol Increased | Investigations | 0 of 6 | 1 of 11 |
| Blood Methaemoglobin present | Investigations | 1 of 6 | 0 of 11 |
| Platelet count decreased | Investigations | 1 of 6 | 0 of 11 |
Serious events with the highest arm-level rate: sepsis (18.2%), septic shcok (16.7%), anoxic encephalopathy (9.1%), intraventricular haemorrhage (9.1%), renal failure acute (9.1%).
The registry’s safety summary reports participant counts by group. For Resatorvid, 6 participants were at risk for serious adverse events and 1 was affected; 6 were at risk for other adverse events and 4 were affected. For Placebo, 11 participants were at risk for serious adverse events and 3 were affected; 11 were at risk for other adverse events and 6 were affected. These are descriptive counts, not an adjusted comparison.
“At risk” is the registry’s denominator label for this summary. The record does not explain whether it means all participants in the group, those observed during a particular interval, or another safety population. It also does not give the observation period or a definition of serious versus other adverse events. The counts should be read as posted and not interpreted as event rates over a known duration.
The serious event term list includes Sepsis (18.2%), Septic shcok (16.7%), Anoxic encephalopathy (9.1%), Intraventricular haemorrhage (9.1%), Renal failure Acute (9.1%), and Inflamation (9.1%). The registry record does not specify the denominator for these percentages or identify their treatment groups. The terms may not represent mutually exclusive participants, and the entry does not say whether a participant could contribute more than one term. Deaths by group are not reported in the registry record.
Safety counts from this small enrolled study are not, on their own, a basis for determining a comparative safety profile. The record does not report a statistical analysis of these events or enough detail to evaluate exposure time, event recurrence, or potential confounding.
12. What the Result Does, and Does Not, Mean
The record describes a trial question, design, and endpoint, but it does not post the primary mortality comparison. It is therefore not possible from this registry entry to say what the observed Day 28 mortality result was, how large any difference between groups may have been, or how precisely it was estimated. This is a limit of the information in the record, not evidence for a particular direction of effect.
The study is identified as a randomized, double-blind, placebo-controlled, quadruple-masked phase 3 trial, with an enrollment of 18 and a status of terminated. These registry entries describe the design and registry status. They do not establish why the study was terminated, whether the planned enrollment was reached, or whether the study had adequate precision for the primary question. The sample-size justification and reason for termination are not reported in the registry record.
The safety summary gives counts of participants affected by serious and other adverse events. It does not provide the methods and context needed for a complete comparative interpretation, including a defined observation period and a stated statistical analysis. The term percentages lack a reported denominator and arm mapping. They should not be used to infer event rates by treatment group.
In general, an absence of a posted statistical result should not be interpreted as a null result. A null result would require an estimate and uncertainty assessment showing what the data support under an analysis. Similarly, the design label “randomized” does not guarantee that the estimates are precise, and the registry status “terminated” does not explain why the study ended.
The defensible conclusion is narrow: the registry identifies the intended comparison of resatorvid and placebo in sepsis, names all-cause mortality at Day 28 as the primary endpoint, and posts limited adverse-event counts. The primary outcome result and the analysis details needed to evaluate it are not reported in the registry record. Any stronger claim about efficacy, lack of effect, or comparative safety would go beyond the information.
13. Why This Trial Matters Statistically
This record illustrates a basic distinction in clinical-trial reporting: knowing the design and endpoint is not the same as having the result. A randomized comparison can support a useful estimate only when the outcome data, analysis population, method, and uncertainty are available for review. Here, the registry states a clear primary endpoint—Day 28 all-cause mortality—but does not report the arm-specific outcome counts or a statistical comparison.
The entry also shows why sample size and precision must be interpreted carefully. An enrollment of 18 is reported, but the registry does not report the planned target, the original sample-size justification, or the primary outcome estimate. Sample-size illustrations elsewhere on the page are planning exercises based on an observed effect and stated assumptions. They are not a record of the original design rationale and are not observed power.
Safety summaries also require context. Counts of participants affected can help describe what is listed, but interpretation depends on the population at risk, observation period, event definitions, and whether repeated events are counted. The entry provides some counts but does not report all of those details. The listed serious event percentages also have no stated denominator in this record.
For clinical researchers and statisticians, the key lesson is to separate what a registry entry directly documents from what remains unknown. A trial title, masking label, endpoint name, and termination status cannot replace the analysis plan or results. Likewise, missing results in a registry should not be converted into a claim of no effect. The record is informative about the broad trial framework, while its missing outcome and methods details sharply limit what can be concluded statistically.
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 primary limitation for interpretation is that the registry does not report the numerical Day 28 all-cause mortality results or a statistical comparison. It gives the endpoint definition and analysis population wording, but not the event counts by arm, the effect estimate, or its uncertainty. The primary outcome is not reduced to one comparison in the posted analysis because the record indicates several categories or time points.
The registry reports an enrollment of 18 but does not describe participant flow, the number randomized to each arm, the number completing follow-up, or the number included in the primary analysis. The endpoint population is described as participants who received study drug, but the full analysis-population definition is not reported. The method for handling missing Day 28 status is also not reported.
The study is marked terminated, without a reported reason. The record does not establish whether termination affected recruitment, treatment, follow-up, or analysis. It also does not report the protocol’s sample-size justification, interim monitoring, or primary statistical method. The masking labels are present, but the masked roles and implementation details are absent.
The safety data are limited to participant counts and a list of serious event terms with percentages. The meaning of the at-risk denominators, the event observation period, and the denominator behind the term percentages are not reported. The list does not identify treatment groups, and deaths by group are not reported in the registry record. These gaps preclude a detailed comparative safety analysis.
Finally, the registry lists secondary outcomes but does not provide the definitions and analyses needed to interpret them. Multiplicity procedures and missing-data methods are not reported. These limitations do not prove that the full study lacked such methods or data; they describe what cannot be evaluated from this registry entry.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of Resatorvid in Patients With Sepsis-induced Cardiovascular and Respiratory Failure — NCT00633477.
- Registry record last updated 2013-01-18; status last verified 2013-01.
- Results first posted 2013-01-09.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The registry record describes NCT00633477, a phase 3 randomized, parallel-group study comparing resatorvid with placebo in sepsis-induced cardiovascular and respiratory failure. It identifies the study as double-blind and quadruple-masked, reports an enrollment of 18, and lists the status as terminated. The study start is recorded as 2008-02 and primary completion as 2009-02.
The primary endpoint is all-cause mortality at Day 28 among participants who received study drug. ICU Free Days, Vasopressor Free Days, and Ventilator Free Days are listed as secondary outcomes. The registry does not report the primary mortality counts or a statistical comparison, and it lists zero analyses.
The safety summary reports serious and other adverse-event participant counts for Resatorvid and Placebo. It also lists serious adverse event terms with percentages, but does not state their denominator or treatment group. The reason for termination, analysis plan, sample-size justification, missing-data methods, and multiplicity procedures are not reported in the registry record.