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 A Phase 2 Study of Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Junction (GEJ) Cancer (NCT02443883), a randomized phase 2 study. The primary outcome is Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02443883 |
| Phase | Phase 2 |
| Condition | Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 164 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants with advanced gastric cancer whose disease had progressed during or following prior chemotherapy were eligible for the study described in the registry summary. The listed conditions are gastric adenocarcinoma and gastroesophageal junction adenocarcinoma. The primary pharmacokinetic analysis population was narrower: randomized participants who received at least one dose of ramucirumab and had evaluable ramucirumab pharmacokinetic data. The number in that analysis population is not reported in the registry record.
Intervention
The intervention was ramucirumab, assigned in one of four regimens. Regimen 1 used 8 mg/kg on days 1 and 15 of each 28-day cycle. Regimen 2 used 12 mg/kg on days 1 and 15 of each 28-day cycle. Regimen 3 used 6 mg/kg on days 1, 8, 15 and 22 of each 28-day cycle. Regimen 4 used 8 mg/kg on days 1 and 8 of each 21-day cycle. Treatment continued until discontinuation criteria were met.
Comparator
The study randomized participants among the four ramucirumab schedules. The registry record does not describe a placebo or non-ramucirumab arm. The schedules therefore form the relevant regimen comparisons. The record does not specify a single primary pairwise contrast or state that the primary endpoint was intended to establish superiority or non-inferiority between schedules.
Primary question
The primary endpoint was the minimum observed serum concentration of ramucirumab, expressed as a geometric mean with geometric coefficient of variation. Predose measurements were scheduled on days 29, 43, 71 and 85. The endpoint addresses drug exposure under the assigned schedules. Numerical concentration results, estimates of variation and statistical comparisons among regimens are not reported in the registry record, so the size and precision of any observed regimen differences cannot be described.
3. Trial Design
This was a randomized, open-label, parallel-group Phase 2 trial. Its official title describes evaluation of pharmacokinetics and safety across four ramucirumab dosing regimens in second-line gastric or gastroesophageal junction adenocarcinoma. The study was registered with an enrollment of 164. The registry record lists the study as completed, with a start date of 2015-07-07 and a primary completion date of 2016-11-18.
Participants were assigned to one of four schedules, all using intravenous ramucirumab. Regimen 1 was 8 mg/kg on days 1 and 15 of each 28-day cycle. Regimen 2 was 12 mg/kg on days 1 and 15 of each 28-day cycle. Regimen 3 was 6 mg/kg on days 1, 8, 15 and 22 of each 28-day cycle. Regimen 4 was 8 mg/kg on days 1 and 8 of each 21-day cycle. Each schedule continued until discontinuation criteria were met. The record does not give the criteria themselves.
Masking was none, so the trial was open label. A parallel design means participants were allocated to a regimen rather than crossing between regimens as part of the listed design. Randomization can help balance participant characteristics across assigned groups on average, while open-label conduct means treatment assignment was not masked. The registry record does not report the randomization method, allocation ratio, stratification factors or procedures used to conceal assignment.
The primary endpoint concerned pharmacokinetics, specifically the minimum observed serum concentration of ramucirumab at scheduled predose assessments. Safety and immunogenicity were also among the listed areas of assessment. The posted record identifies three outcome measures and two secondary outcomes, but does not list a complete statistical analysis plan or numerical primary-endpoint results.
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: Study completion was defined as death due to any cause or disease progression.
Overall Study
| Stage | Ramucirumab Regimen 1 | Ramucirumab Regimen 2 | Ramucirumab Regimen 3 | Ramucirumab Regimen 4 |
|---|---|---|---|---|
| STARTED | 40 | 42 | 41 | 41 |
| Received at Least One Dose of Study Drug | 38 | 42 | 41 | 40 |
| COMPLETED | 34 | 38 | 40 | 36 |
| NOT COMPLETED | 6 | 4 | 1 | 5 |
Reasons for not completing this period:
| Reason | Ramucirumab Regimen 1 | Ramucirumab Regimen 2 | Ramucirumab Regimen 3 | Ramucirumab Regimen 4 |
|---|---|---|---|---|
| Adverse Event | 0 | 1 | 0 | 0 |
| Lost to Follow-up | 3 | 2 | 1 | 0 |
| Physician Decision | 1 | 1 | 0 | 3 |
| Withdrawal by Subject | 1 | 0 | 0 | 2 |
| Randomized, but never treated | 1 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants who received at least one dose of ramucirumab and had evaluable ramucirumab PK data.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All randomized participants.
| Characteristic | Unit | Ramucirumab Regimen 1 | Ramucirumab Regimen 2 | Ramucirumab Regimen 3 | Ramucirumab Regimen 4 | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 40 | 42 | 41 | 41 | 164 | |
| Age, Continuous | years | 58.5 (SD 14.0) | 58.7 (SD 10.4) | 60.5 (SD 12.3) | 56.2 (SD 12.9) | 58.5 (SD 12.4) |
| Sex: Female, Male: Female | Participants | 11 | 10 | 6 | 9 | 36 |
| Sex: Female, Male: Male | Participants | 29 | 32 | 35 | 32 | 128 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 6 | 3 | 6 | 7 | 22 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 32 | 37 | 33 | 32 | 134 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 2 | 2 | 2 | 8 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 0 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 32 | 35 | 35 | 33 | 135 |
| Race (NIH/OMB): More than one race | Participants | 6 | 7 | 5 | 6 | 24 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 | 1 | 3 |
| Region of Enrollment: New Zealand | Participants | 2 | 1 | 1 | 3 | 7 |
| Region of Enrollment: Argentina | Participants | 5 | 1 | 2 | 6 | 14 |
| Region of Enrollment: Romania | Participants | 4 | 6 | 10 | 7 | 27 |
| Region of Enrollment: Turkey | Participants | 3 | 4 | 2 | 2 | 11 |
| Region of Enrollment: Hungary | Participants | 0 | 3 | 3 | 1 | 7 |
| Region of Enrollment: United States | Participants | 2 | 3 | 2 | 1 | 8 |
| Region of Enrollment: Poland | Participants | 6 | 6 | 7 | 5 | 24 |
| Region of Enrollment: United Kingdom | Participants | 7 | 10 | 8 | 6 | 31 |
| Region of Enrollment: Slovakia | Participants | 3 | 1 | 2 | 1 | 7 |
| Region of Enrollment: Australia | Participants | 1 | 2 | 0 | 5 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab, measured over Day 29, 43, 71 and 85: predose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | microgram per milliliter (µg/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the minimum observed serum concentration, or Cmin, of ramucirumab. It was measured in serum and reported using a geometric mean and geometric coefficient of variation. Predose sampling was scheduled on days 29, 43, 71 and 85. The endpoint population consisted of randomized participants who received at least one dose of ramucirumab and had evaluable pharmacokinetic data.
Pharmacokinetic measures describe drug concentrations over time. Cmin focuses on the lowest observed concentration in the relevant measurement interval; predose sampling is intended to capture concentration before a subsequent dose. Comparing these measurements across dosing schedules can help characterize exposure associated with each schedule. That is a general explanation of the endpoint, not a claim about what this trial found.
A geometric mean is a summary suited to positive measurements that may be multiplicative or right-skewed. A geometric coefficient of variation describes relative dispersion on a multiplicative scale. It is not the same as an ordinary standard deviation. The registry record defines Cmin as the minimum observed serum concentration, but does not report the values, the geometric coefficients of variation, or the number of participants contributing data at each assessment. Thus, neither the observed concentration levels nor their precision can be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that the study was randomized among four ramucirumab regimens and identifies a pharmacokinetic primary endpoint. It does not include numerical Cmin estimates, geometric coefficients of variation, confidence intervals, hypothesis tests or between-regimen effect estimates. Consequently, there is no reported primary-endpoint result from which to describe the direction, magnitude or precision of differences in minimum serum concentration.
The scheduled predose assessments were on days 29, 43, 71 and 85. These are multiple measurement times, not one interchangeable observation. A concentration at one assessment would describe exposure at that time under the assigned regimen; it would not by itself summarize all later measurements. The registry record does not report whether results were analyzed separately by assessment, combined, or modeled longitudinally. It also does not state whether a specific time point was designated as the principal comparison.
The endpoint description names a geometric mean and geometric coefficient of variation, but those summaries alone would not establish whether the regimen groups differed beyond sampling uncertainty. For an inferential comparison, readers would generally need an effect estimate and an uncertainty measure, such as a confidence interval, together with details of the analysis. Such results and details are not reported in the registry record. No p-values or adjusted comparisons are listed.
The record lists immunogenicity, described as the number of participants with anti-ramucirumab antibodies, and the rate of progression-free survival at the first 6-week tumor assessment as secondary outcomes. Their numerical results are not included in the registry record for this analysis. They therefore cannot be used to support an interpretation of benefit, harm or comparative performance.
Safety entries do include counts of participants affected in each regimen group, along with a list of serious adverse-event terms and percentages. These are descriptive registry entries, not a substitute for the missing pharmacokinetic results or a formal comparative safety analysis. The record does not report inferential comparisons for these entries. The counts should be read as summaries within the recorded groups, without attributing differences to the regimens or interpreting them as proof of a causal effect.
Overall, the record describes what the trial was designed to assess and gives selected safety counts, but it does not provide the results needed to judge the primary pharmacokinetic question. The absence of numerical endpoint results is a limit on interpretation, not evidence that concentrations were similar or different.
9. Statistical Methods Explained
The registry record identifies a geometric mean and geometric coefficient of variation for the primary pharmacokinetic endpoint. It does not state the statistical model, tests, confidence level, multiplicity procedure or missing-data approach used for the trial analyses. The explanations below describe general statistical concepts and do not imply that the trial used any particular method beyond what the record names.
What does the geometric mean summarize?
For positive measurements, the geometric mean summarizes values on a multiplicative scale. It is commonly useful when measurements are skewed or when proportional changes are more meaningful than fixed-unit changes. In general, the geometric mean is obtained by averaging logarithms of the measurements and transforming the result back to the original scale. It is not the same as the arithmetic mean, which averages the original measurements. The registry record names the geometric mean as the primary endpoint summary but does not describe the calculation or any adjustment for participant characteristics.
What does the geometric coefficient of variation convey?
A coefficient of variation expresses dispersion relative to a mean. Its geometric version describes variability on a multiplicative scale and is often paired with geometric summaries of pharmacokinetic measurements. It can help communicate how spread out concentration measurements are relative to their central value. It should not be read as an ordinary standard deviation or as a confidence interval for the geometric mean. The geometric coefficients of variation for this study are not reported in the registry record.
Why do the measurement times matter?
Concentrations were scheduled at predose assessments on days 29, 43, 71 and 85. Repeated measurements can describe exposure at several points during treatment, but the interpretation depends on how those measurements are analyzed. Separate summaries by time point answer a different question from a model that uses the repeated observations together. In general, repeated-measures methods account for the fact that observations from the same participant are related. The registry record does not say whether measurements were analyzed separately or jointly, how within-participant correlation was handled, or how incomplete measurement sequences were treated.
What would an uncertainty interval add?
In general, a confidence interval gives a range of values compatible with the observed data under the specified statistical model and procedure. Its width conveys precision: wider intervals indicate greater uncertainty, while narrower intervals indicate greater precision under that method. A confidence interval does not mean that a fixed proportion of individual participant values lie within its limits. No confidence intervals for Cmin or regimen contrasts are reported in the registry record, so the precision of the primary endpoint cannot be assessed from the posted results.
How should multiple outcomes and times be considered?
The primary endpoint has several scheduled assessment times, and secondary outcomes include antibody status and progression-free survival at the first 6-week tumor assessment. When many hypotheses are tested, the chance of at least one apparently notable result can rise. Statistical methods may address this multiplicity by defining a hierarchy, adjusting significance thresholds, or treating analyses as exploratory. Those are general approaches. The registry record does not report a multiplicity strategy, a hierarchy for the time points, or whether any comparisons were exploratory. It would therefore be inappropriate to infer an adjustment or a confirmatory testing plan.
What do the planning assumptions mean?
The sample-size assumptions describe planning illustrations based on a fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. For time-to-event illustrations, the method describes total events using Schoenfeld; other illustrations are expressed as participants per arm. These assumptions define hypothetical calculations, not the actual design justification for this trial. The registry record does not report the trial's own sample-size justification or state that these assumptions governed enrollment. Such planning illustrations are not observed power and do not show that the trial had a particular probability of detecting an effect after the data were collected.
What statistical analysis is actually documented?
The registry record lists zero analyses. It does not report a statistical analysis plan, a model for comparing regimens, a test statistic, a significance threshold for trial analyses, or numerical estimates for the primary endpoint. A randomized design can support comparisons among assigned groups, but randomization alone does not specify how outcomes were analyzed or establish the precision of a result. Without the analysis details and outcome estimates, the primary pharmacokinetic findings cannot be reconstructed or independently interpreted from this record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint was assessed at multiple scheduled times: predose on days 29, 43, 71 and 85. The record also lists two secondary outcomes: participants with anti-ramucirumab antibodies and the rate of progression-free survival at the first 6-week tumor assessment. Considering several outcomes or time points raises a general multiplicity issue: without a prespecified strategy, repeated testing can increase the chance of a nominally notable result occurring by chance. Whether the trial controlled multiplicity, prioritized an assessment time, or treated analyses as exploratory is not reported in the registry record.
The registry record defines the primary pharmacokinetic population as randomized participants who received at least one dose and had evaluable ramucirumab pharmacokinetic data. It does not report the number who met that definition, the numbers with measurements at each time point, or how participants without evaluable data were handled. The total registered enrollment is 164, but that figure does not establish how many contributed to each analysis.
No imputation method, missing-data assumption, sensitivity analysis or rule for excluding measurements is reported in the registry record. These omissions matter because incomplete measurements can affect both the participants represented in a summary and the precision of an estimate. The record also does not specify an intention-to-treat analysis population or describe whether secondary outcomes used the same population as the primary endpoint.
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 |
|---|---|---|---|
| Ramucirumab Regimen 1 | 10 | 38 | 26.3% |
| Ramucirumab Regimen 2 | 11 | 42 | 26.2% |
| Ramucirumab Regimen 3 | 10 | 41 | 24.4% |
| Ramucirumab Regimen 4 | 18 | 40 | 45.0% |
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 |
|---|---|
| Ramucirumab Regimen 1 | 30 of 38 |
| Ramucirumab Regimen 2 | 31 of 42 |
| Ramucirumab Regimen 3 | 36 of 41 |
| Ramucirumab Regimen 4 | 31 of 40 |
Most frequent serious adverse event terms
| Event term | Organ system | Ramucirumab Regimen 1 | Ramucirumab Regimen 2 | Ramucirumab Regimen 3 | Ramucirumab Regimen 4 |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | 1 of 38 | 1 of 42 | 0 of 41 | 4 of 40 |
| Abdominal pain | Gastrointestinal disorders | 1 of 38 | 2 of 42 | 0 of 41 | 2 of 40 |
| Dysphagia | Gastrointestinal disorders | 0 of 38 | 1 of 42 | 1 of 41 | 2 of 40 |
| Gastric haemorrhage | Gastrointestinal disorders | 0 of 38 | 0 of 42 | 3 of 41 | 0 of 40 |
| Pneumonia | Infections and infestations | 0 of 38 | 2 of 42 | 0 of 41 | 1 of 40 |
| Back pain | Musculoskeletal and connective tissue disorders | 1 of 38 | 0 of 42 | 1 of 41 | 1 of 40 |
| Anaemia | Blood and lymphatic system disorders | 0 of 38 | 1 of 42 | 0 of 41 | 1 of 40 |
| Cardiac arrest | Cardiac disorders | 1 of 38 | 1 of 42 | 0 of 41 | 0 of 40 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 38 | 0 of 42 | 1 of 41 | 1 of 40 |
| Haematemesis | Gastrointestinal disorders | 0 of 38 | 0 of 42 | 1 of 41 | 1 of 40 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ramucirumab Regimen 1 | Ramucirumab Regimen 2 | Ramucirumab Regimen 3 | Ramucirumab Regimen 4 |
|---|---|---|---|---|---|
| Fatigue | General disorders | 10 of 38 | 12 of 42 | 6 of 41 | 9 of 40 |
| Decreased appetite | Metabolism and nutrition disorders | 8 of 38 | 9 of 42 | 11 of 41 | 7 of 40 |
| Abdominal pain | Gastrointestinal disorders | 6 of 38 | 10 of 42 | 7 of 41 | 4 of 40 |
| Vomiting | Gastrointestinal disorders | 6 of 38 | 6 of 42 | 8 of 41 | 7 of 40 |
| Constipation | Gastrointestinal disorders | 2 of 38 | 5 of 42 | 7 of 41 | 7 of 40 |
| Diarrhoea | Gastrointestinal disorders | 3 of 38 | 9 of 42 | 4 of 41 | 5 of 40 |
| Nausea | Gastrointestinal disorders | 6 of 38 | 4 of 42 | 4 of 41 | 7 of 40 |
| Hypertension | Vascular disorders | 6 of 38 | 2 of 42 | 7 of 41 | 6 of 40 |
| Headache | Nervous system disorders | 4 of 38 | 6 of 42 | 5 of 41 | 3 of 40 |
| Anaemia | Blood and lymphatic system disorders | 4 of 38 | 5 of 42 | 5 of 41 | 1 of 40 |
Serious events with the highest arm-level rate: vomiting (10.0%), gastric haemorrhage (7.3%), non-cardiac chest pain (5.3%), pyrexia (5.3%), abdominal pain (5.0%).
The safety entries distinguish serious adverse events from other adverse events and report numbers at risk and numbers affected for each regimen. For serious adverse events, the recorded figures are 10 of 38 for Regimen 1, 11 of 42 for Regimen 2, 10 of 41 for Regimen 3 and 18 of 40 for Regimen 4. For other adverse events, the figures are 30 of 38, 31 of 42, 36 of 41 and 31 of 40, respectively. These are descriptive counts within the registry groups; the record does not provide comparative tests or uncertainty intervals for them.
The listed serious adverse-event terms and percentages are vomiting, 10.0%; gastric haemorrhage, 7.3%; non-cardiac chest pain, 5.3%; pyrexia, 5.3%; abdominal pain, 5.0%; and dysphagia, 5.0%. The record does not specify in these entries the denominator or whether participants could contribute to more than one term. The percentages should therefore be read as registry-listed summaries, not as mutually exclusive categories or as a basis for reconstructing additional counts. Safety counts alone do not establish that a regimen caused an event or differed statistically from another regimen.
12. What the Result Does, and Does Not, Mean
The trial addressed pharmacokinetic and safety questions for four schedules of ramucirumab in second-line gastric or gastroesophageal junction adenocarcinoma. Its primary endpoint was minimum observed serum concentration at scheduled predose assessments. This endpoint is relevant to describing drug exposure under different dosing schedules. The registry record also lists immunogenicity and progression-free survival at the first 6-week tumor assessment as secondary outcomes.
What the record does not establish is the result of the primary pharmacokinetic comparison. It contains no numerical Cmin estimates, geometric coefficients of variation, uncertainty intervals or statistical tests. Thus, the posted information does not show whether concentrations differed among schedules, how large any difference may have been, or how precisely an estimate was measured. Missing numerical results should not be interpreted as evidence of no difference.
The record likewise does not provide numerical findings for the listed secondary outcomes. Its safety entries offer counts by regimen and a list of serious adverse-event terms, but they do not include statistical comparisons or uncertainty measures. Descriptive counts can show what was recorded in the listed groups; they cannot, by themselves, separate treatment effects from chance variation or other differences among participants.
General interpretation of randomized trials depends on the outcome definitions, analysis population, methods and uncertainty around estimated effects. Here, the registry record documents randomization and the endpoint population definition, but does not report the analysis details or endpoint estimates needed for a complete evaluation. The information supports a description of the study question and selected safety observations, not a conclusion about comparative efficacy, a causal safety effect, or the performance of one regimen relative to another.
These boundaries are important because a pharmacokinetic endpoint is not itself a clinical outcome. Even if concentration results were available, they would describe drug exposure; they would not alone establish a difference in patient outcomes. No medical conclusion about treatment should be inferred from the limited numerical results recorded.
13. Why This Trial Matters Statistically
This trial is statistically notable for studying several dosing schedules within a randomized, parallel-group Phase 2 design while focusing its primary endpoint on pharmacokinetics. The schedules varied in dose, dosing frequency and cycle length. Those features make the endpoint question specific: the study sought to assess minimum serum concentrations under different regimens rather than report a single undifferentiated measure of treatment exposure.
Its endpoint also illustrates why the analysis population and measurement schedule matter. The primary population required randomization, receipt of at least one dose and evaluable pharmacokinetic data. Concentrations were scheduled at several predose times. The participants contributing to each assessment, and the method for using repeated measurements, can influence both the interpretation and precision of estimates. The record defines the population and times but does not report the analysis counts or method.
The statistical importance of a randomized design depends on the results being reported with enough detail to evaluate effects and uncertainty. The registry record includes the design and selected adverse-event counts, but does not include numerical primary pharmacokinetic estimates or inferential comparisons. That gap demonstrates a distinction between registering a research question and providing results sufficient for statistical interpretation.
The trial also highlights the difference between planning illustrations and the study's own design rationale. Planning calculations based on an assumed fraction of an observed effect are hypothetical, while the actual justification for enrollment would require documented design assumptions. That justification is not reported in the registry record. Similarly, a list of several outcomes and assessment times raises a general question about multiplicity, but the record does not state how it was addressed.
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 main limitation for statistical interpretation is the absence of numerical primary-endpoint results. Although Cmin, its summary measure, assessment times and analysis population are identified, the registry record does not report concentration estimates, geometric coefficients of variation or confidence intervals. It also does not report regimen contrasts or p-values. The direction, magnitude and precision of the pharmacokinetic findings therefore cannot be evaluated.
Details needed to understand the analysis are also not reported. These include the statistical model, treatment of repeated measurements, analysis population size, participant counts at each assessment, missing-data procedures and any multiplicity strategy. The record does not describe the randomization method, allocation ratio, stratification factors or allocation concealment. It also does not report the criteria that ended treatment.
The registry record lists two secondary outcomes but does not include their numerical results. Safety information is limited to group-level counts and selected serious adverse-event terms and percentages, without comparative inference or uncertainty intervals. The record does not clarify the denominator for the listed term percentages or how multiple terms per participant are represented.
Enrollment is recorded as 164, but enrollment alone does not indicate how many participants received treatment, had evaluable pharmacokinetic data or contributed to each outcome. The actual sample-size justification and statistical analysis plan are not reported in the registry record. These limitations restrict independent assessment and should not be filled by assumptions about the intended protocol or the missing results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase 2 Study of Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Junction (GEJ) Cancer — NCT02443883.
- Registry record last updated 2020-06-29; status last verified 2019-07.
- Results first posted 2018-03-13.
- 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 describes a completed, randomized, open-label, parallel Phase 2 study of four ramucirumab regimens for second-line gastric or gastroesophageal junction adenocarcinoma. Registered enrollment was 164. The study started on 2015-07-07 and had a primary completion date of 2016-11-18.
The primary endpoint was minimum observed serum ramucirumab concentration, summarized by geometric mean and geometric coefficient of variation at predose assessments on days 29, 43, 71 and 85. The primary population required randomization, at least one dose and evaluable pharmacokinetic data. Secondary outcomes concerned anti-ramucirumab antibodies and progression-free survival at the first 6-week tumor assessment.
The registry record includes selected adverse-event counts but does not report numerical primary or secondary outcome results, statistical analyses or key analysis procedures. The listed information therefore describes the study design and some safety observations, while leaving the primary statistical findings unavailable for interpretation.