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 Study in Participants With Advanced Solid Tumors (NCT01682135), a na phase 1 study. The primary outcome is Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01682135 |
| Phase | Phase 1 |
| Condition | Solid Tumor |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 28 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Chinese participants with advanced solid tumors that were resistant to standard therapy or for whom no standard therapy was available. The registry reports enrollment of 28 participants. The primary endpoint population is described as enrolled participants who received at least one dose of study drug.
Intervention
Ramucirumab, administered intravenously at escalating doses from 6 mg/kg up to 10 mg/kg. The listed regimens include 6 mg/kg every 2 weeks, 10 mg/kg every 3 weeks, and 8 mg/kg every 2 weeks. Treatment could continue until a discontinuation criterion was met.
Comparator
There was no control group. The registry identifies a single-group model and lists allocation as not applicable. The dose cohorts are not randomized, like-for-like comparison groups, so their results should not be read as controlled estimates of relative effect.
Primary question
The primary outcome asks how many participants experienced one or more drug-related adverse events or any serious adverse events, from baseline through study completion, up to 12 weeks. The study also aimed to assess how much ramucirumab entered the bloodstream and how long it took the body to eliminate it.
This is a safety-focused phase I study rather than a controlled test of clinical benefit. The registry lists secondary outcomes concerning duration of response, duration of stable disease, time to disease progression, anti-ramucirumab antibodies, and best objective response. Those outcome names indicate what was assessed, but outcome values are not reported in the registry record. The record also does not report the primary endpoint result, so it does not establish how many participants met that endpoint. The statistical interpretation must therefore distinguish the study’s stated aims and recorded cohort-level safety counts from results that are not available in the registry record.
3. Trial Design
The registry describes a phase I, single-group study of ramucirumab in participants with advanced solid tumors. Allocation is listed as not applicable and masking as none. There is no randomized control group; the listed dose cohorts therefore do not provide a like-for-like comparison. The study is marked completed, with enrollment of 28. Its recorded start was 2012-11 and its primary completion was 2015-03.
Participants were described as having tumors resistant to standard therapy or having no standard therapy available. Ramucirumab was given intravenously in escalating doses from 6 mg/kg up to 10 mg/kg. The regimen description specifies treatment every 2-3 weeks for 6 weeks as one cycle, with treatment potentially continuing until a discontinuation criterion was met. The cohort labels identify 6 mg/kg every 2 weeks, 10 mg/kg every 3 weeks, and 8 mg/kg every 2 weeks. The registry does not report how participants were assigned to these cohorts or the rationale for the sequence of dose levels.
The main stated purpose was to evaluate safety and side effects. The study also planned to measure the amount of ramucirumab in the bloodstream and how long it took the body to get rid of the drug. The primary outcome is the number of participants with one or more drug-related adverse events or any serious adverse events, with a timeframe from baseline through study completion, up to 12 weeks. The endpoint description defines the population as enrolled participants who received at least one dose.
The registry lists nine outcome measures and zero analyses. It names secondary outcomes relating to response, stable disease, progression, and anti-ramucirumab antibodies, but their results are not reported in the registry record. The detailed statistical plan, including any dose-escalation rules, is not reported in the registry record. Because there is no control group, any differences between dose cohorts would be descriptive and could not isolate a treatment effect from differences among the participants or their treatment schedules.
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: Participant study completion is defined as a participant either completing all 6 cycles of study drug or discontinuing study drug due to dose-limiting toxicities (DLT), then completing all required End-of-Therapy and End-of-Study assessments.
Overall Study
| Stage | Cohort 1 - 6 mg/kg/2w Ramucirumab | Cohort 2 - 10 mg/kg/3w Ramucirumab | Cohort 3 - 8 mg/kg/2w Ramucirumab |
|---|---|---|---|
| STARTED | 6 | 10 | 12 |
| Received at Least 1 Dose of Study Drug | 6 | 10 | 12 |
| COMPLETED | 6 | 10 | 12 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All enrolled participants who received at least one dose of 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.
Population: All randomized participants who received at least one dose of study drug.
| Characteristic | Unit | Cohort 1 - 6 mg/kg/2w Ramucirumab | Cohort 2 - 10 mg/kg/3w Ramucirumab | Cohort 3 - 8 mg/kg/2w Ramucirumab | Total |
|---|---|---|---|---|---|
| Participants analysed | 6 | 10 | 12 | 28 | |
| Age, Continuous | Years | 51.20 (SD 9.060) | 52.92 (SD 9.509) | 58.18 (SD 9.444) | 54.80 (SD 9.536) |
| Sex: Female, Male: Female | Participants | 4 | 3 | 7 | 14 |
| Sex: Female, Male: Male | Participants | 2 | 7 | 5 | 14 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 6 | 10 | 12 | 28 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: China | Participants | 6 | 10 | 12 | 28 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs), measured over Baseline through Study Completion (Up to 12 Weeks).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is a participant count: the number of participants with one or more drug-related adverse events or any serious adverse events. It combines safety events into a participant-level measure, so a participant meeting the endpoint is counted as a participant with an event rather than as a count of every event episode. The stated timeframe is baseline through study completion, up to 12 weeks.
The endpoint description says that adverse events are summarized when they begin on or after the first dose and within 30 days after the last dose, or when they occur before the first dose and worsen during therapy. It refers to investigator assessment of drug relationship for adverse events and serious adverse events summarized in the reported adverse-events module. The primary outcome’s title distinguishes drug-related adverse events from any serious adverse events; the record does not provide further detail on how the combined endpoint was operationalized.
As a general statistical concept, a participant-level safety endpoint is useful for describing how many people experienced at least one event during the specified observation window. It can make a safety summary easier to interpret than a raw event count when participants may experience repeated events. However, it does not by itself describe event frequency, duration, severity distribution, or timing. Those details require separate reporting. The primary endpoint result is not reported in the registry record, so its event count and the precision of that count cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes the study’s purpose and design but does not report the primary endpoint result. It is therefore not possible to determine from the registry record how many participants experienced one or more drug-related adverse events or any serious adverse events under the stated endpoint definition. The planned safety question is clear; its primary result is not available in the record.
The safety module does provide cohort-level counts for serious adverse events and other adverse events. For serious adverse events, the record lists one affected participant among six at risk in the 6 mg/kg every 2 weeks cohort, two among ten in the 10 mg/kg every 3 weeks cohort, and one among twelve in the 8 mg/kg every 2 weeks cohort. For other adverse events, it lists six among six, ten among ten, and twelve among twelve, respectively. These are descriptive counts by cohort, not a randomized comparison. The cohort sizes and treatment schedules differ, and the registry identifies no control group. The counts cannot establish that one regimen caused more or fewer events than another.
The registry also lists serious-event terms with percentages: fatigue at 16.7%, upper gastrointestinal haemorrhage at 10.0%, blood bilirubin increased at 10.0%, and impaired gastric emptying at 8.3%. These entries describe reported terms; the record does not provide enough detail in the listed information to infer an event-level severity pattern, timing pattern, or causal relationship for each term. The terms should not be confused with the primary endpoint, which is a participant-level count using its own stated definition.
There is no basis in the record to estimate a comparative treatment effect, because there is no control arm and no randomized allocation. Nor does the listed enrollment alone establish the precision of any safety estimate. Precision depends on the observed event count and analysis details, and the primary endpoint count is not reported in the registry record. The registry marks the study completed, but completion status does not substitute for outcome values.
The appropriate reading is therefore limited: the record documents a small phase I study, its dose cohorts, its safety focus, and selected adverse-event counts and terms. It does not report the primary endpoint result, the secondary outcome results, or a statistical analysis plan. Conclusions about efficacy, comparative safety, or the probability of uncommon harms are not supported by these registry entries alone.
9. Statistical Methods Explained
Clinical trial results can be interpreted only in light of the design and the outcome definition. This record describes a phase I, single-group study with no masking and no randomized control group. The cohort labels show different dose schedules, but the registry cautions that these are not like-for-like control arms. As a general statistical principle, randomized comparison helps balance participant characteristics across groups. Without that design, observed differences between cohorts can reflect differences in participants, dosing schedules, observation, or other factors, and should be treated descriptively.
What does a participant count represent?
The primary endpoint is a count of participants who meet a specified event definition. It asks whether each participant experienced one or more drug-related adverse events or any serious adverse events during the stated timeframe. This is different from counting every adverse-event episode. A participant with repeated events may still contribute as a participant with an event for a participant-level outcome. As a general concept, participant-level summaries help avoid treating repeated events from the same person as if they came from separate people. They do not, however, preserve all information about recurrence or event burden.
The endpoint definition also sets boundaries around which events are included. The registry describes adverse-event timing relative to the first and last doses, including events before the first dose that worsened during therapy. It identifies the relevant population as enrolled participants who received at least one dose. The primary result itself is not reported in the registry record, so no effect estimate or confidence interval for this endpoint can be interpreted from the record.
How should cohort counts be read?
For each cohort, the safety information gives participants at risk and participants affected. Such counts describe what was recorded in each group; they are not evidence of a treatment contrast. A comparison requires a defined estimand, a suitable comparator, and an analysis that accounts for the design. Here, the record identifies no control group and no randomized assignment. It also does not report adjusted comparisons. The cohort counts can be useful for describing observed events, but they cannot show that a dose schedule is safer or more hazardous than another.
As a general statistical concept, a confidence interval expresses uncertainty around an estimate under the assumptions of the method used. With small cohorts, event counts can be imprecise, and estimates may be compatible with a range of underlying event frequencies. The registry record does not provide a confidence interval for the primary safety endpoint. No confidence interval should be inferred from the cohort counts alone without an explicit analysis and its assumptions.
What does the sample-size information mean?
The stated sample-size assumptions describe planning illustrations based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such illustrations are planning calculations, not observed power and not results from this single-group study. The record does not report the study’s own sample-size justification. Because the trial has no randomized control comparison, a two-arm planning illustration should not be treated as evidence that this trial was powered to compare the listed dose cohorts. The actual sample-size values for those illustrations are not reported in the registry record.
As a general concept, power is a design-stage probability tied to a particular assumed effect, analysis, and testing procedure. It is not a property that can be established after observing the data by substituting the observed effect into a calculation. Planning illustrations can help show how assumptions affect future study requirements, but they do not convert descriptive outcomes into confirmatory evidence.
What is not specified about the analysis?
The registry lists zero analyses. The statistical analysis plan is not reported in the registry record. Details such as the planned summary measures, handling of missing observations, treatment of participants who discontinued, methods for comparing doses, and any interim analyses are not reported in the registry record. These omissions matter because analysis choices can affect which observations contribute to an estimate and how uncertainty is quantified.
Over-dispersion is a general issue for count outcomes when observed variation exceeds what a simple probability model assumes. It can make standard errors too small if not addressed. The primary endpoint is a participant count rather than a reported repeated-event rate, and the registry does not describe a model for it. There is no basis to claim that over-dispersion was assessed or that any particular method was used.
Multiplicity is also relevant in general when a study assesses several outcomes or makes several comparisons: repeated testing can increase the chance of a false-positive finding if no strategy is specified. This record lists nine outcome measures, including secondary outcomes, but does not report a multiplicity strategy or analysis results. The number of listed outcomes alone does not show whether formal hypothesis tests were conducted. Interpret each outcome as descriptive unless the registry record documents an inferential analysis and its methods.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists nine outcome measures and zero analyses. It names secondary outcomes for duration of response, duration of stable disease, time to disease progression, anti-ramucirumab antibodies, and best objective response. Results for those outcomes are not reported in the registry record. A statistical plan for testing or prioritizing multiple outcomes is also not reported in the registry record.
As a general statistical concept, multiplicity arises when investigators make several inferential comparisons or tests. If many tests are conducted, the chance of at least one apparently unusual result can increase unless the analysis plan addresses that issue. The list of outcomes does not establish that all were tested, and the record does not describe an adjustment strategy. Therefore, no claims about multiplicity control or prespecified testing can be made.
The primary endpoint population is described as enrolled participants who received at least one dose. The registry does not report how missing outcome data, withdrawal, incomplete follow-up, or participants without evaluable assessments were handled. It also does not report an intention-to-treat population or another analysis population for the secondary outcomes. These details are important because exclusions or incomplete observation can change the set of participants represented in an estimate.
The endpoint timeframe is baseline through study completion, up to 12 weeks, while the adverse-event description also specifies a window relative to the first and last doses. The record does not explain how events with incomplete timing information were handled. Missing-data methods, interim analyses, and the statistical analysis plan are not reported in the registry record. In the absence of those details and outcome values, the record supports a description of planned endpoints and listed safety counts, not a reconstruction of the full analysis.
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 |
|---|---|---|---|
| Cohort 1 - 6mg/kg/2w Ramucirumab | 1 | 6 | 16.7% |
| Cohort 2 - 10mg/kg/3w Ramucirumab | 2 | 10 | 20.0% |
| Cohort 3 - 8mg/kg/2w Ramucirumab | 1 | 12 | 8.3% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cohort 1 - 6mg/kg/2w Ramucirumab | 6 of 6 |
| Cohort 2 - 10mg/kg/3w Ramucirumab | 10 of 10 |
| Cohort 3 - 8mg/kg/2w Ramucirumab | 12 of 12 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1 - 6mg/kg/2w Ramucirumab | Cohort 2 - 10mg/kg/3w Ramucirumab | Cohort 3 - 8mg/kg/2w Ramucirumab |
|---|---|---|---|---|
| Impaired gastric emptying | Gastrointestinal disorders | 0 of 6 | 0 of 10 | 1 of 12 |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 6 | 1 of 10 | 0 of 12 |
| Fatigue | General disorders | 1 of 6 | 0 of 10 | 0 of 12 |
| Blood bilirubin increased | Investigations | 0 of 6 | 1 of 10 | 0 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1 - 6mg/kg/2w Ramucirumab | Cohort 2 - 10mg/kg/3w Ramucirumab | Cohort 3 - 8mg/kg/2w Ramucirumab |
|---|---|---|---|---|
| Fatigue | General disorders | 6 of 6 | 8 of 10 | 5 of 12 |
| Hypertension | Vascular disorders | 3 of 6 | 7 of 10 | 5 of 12 |
| Aspartate aminotransferase increased | Investigations | 2 of 6 | 5 of 10 | 7 of 12 |
| Alanine aminotransferase increased | Investigations | 2 of 6 | 5 of 10 | 5 of 12 |
| Proteinuria | Renal and urinary disorders | 3 of 6 | 3 of 10 | 6 of 12 |
| Decreased appetite | Metabolism and nutrition disorders | 2 of 6 | 5 of 10 | 3 of 12 |
| Vomiting | Gastrointestinal disorders | 2 of 6 | 4 of 10 | 2 of 12 |
| Sinus bradycardia | Cardiac disorders | 0 of 6 | 3 of 10 | 4 of 12 |
| Dizziness | Nervous system disorders | 3 of 6 | 1 of 10 | 3 of 12 |
| Headache | Nervous system disorders | 1 of 6 | 2 of 10 | 4 of 12 |
Serious events with the highest arm-level rate: fatigue (16.7%), upper gastrointestinal haemorrhage (10.0%), blood bilirubin increased (10.0%), impaired gastric emptying (8.3%).
The serious adverse-event figures are cohort-level participant counts. The registry lists one affected participant among six at risk in the 6 mg/kg every 2 weeks cohort, two among ten in the 10 mg/kg every 3 weeks cohort, and one among twelve in the 8 mg/kg every 2 weeks cohort. The record separately lists other adverse events for each cohort: six among six, ten among ten, and twelve among twelve, respectively. These counts describe what was recorded in the safety module; they do not establish a causal comparison between regimens.
The listed serious-event terms and percentages are fatigue at 16.7%, upper gastrointestinal haemorrhage at 10.0%, blood bilirubin increased at 10.0%, and impaired gastric emptying at 8.3%. The record does not clarify in the listed information whether these term-level percentages refer to participants or event episodes, so they should be read as registry-listed percentages rather than converted into counts. It also does not report a death count; deaths are not reported in the registry record.
Serious adverse events are not identical to the primary endpoint. The primary endpoint combines drug-related adverse events with any serious adverse events and covers a defined observation period. Its result is not reported in the registry record. Cohort safety entries therefore should not be treated as a substitute for the missing primary endpoint result.
12. What the Result Does, and Does Not, Mean
This study contributes a registry record of a phase I investigation of intravenous ramucirumab in Chinese participants with advanced solid tumors. It documents the safety focus, dose schedules, outcome definitions, enrollment, and selected cohort-level adverse-event counts. It also records a completed status. Those details describe the study and its available safety reporting; they do not establish a comparative treatment effect.
The primary endpoint asks how many participants experienced one or more drug-related adverse events or any serious adverse events. Its result is not reported in the registry record. The registry also does not report values for the listed secondary outcomes involving response, stable disease, progression, or antibodies. Consequently, the record does not provide a basis for estimating the frequency of the primary endpoint across the study population or for evaluating the secondary outcomes.
The serious adverse-event counts and listed terms offer descriptive information for the individual cohorts. They do not show that a particular regimen caused an event, and they do not permit a controlled comparison among dose schedules. The cohorts were not randomized control groups, and no control arm is listed. Without a comparator, observed safety counts cannot distinguish effects of treatment from other explanations. The entries also do not characterize the full range of event timing, duration, recurrence, or outcome.
As a general principle, a registry record is most informative when design, outcome definitions, analysis methods, and results can be considered together. Here, the statistical analysis plan, missing-data methods, multiplicity approach, and primary result are not reported in the registry record. These limitations restrict assessment of precision and possible bias. They also prevent a reader from verifying how the stated endpoint was summarized.
The appropriate conclusion is narrow: the record describes a completed, single-group phase I study and reports selected adverse-event information, but it does not provide the primary endpoint result or secondary outcome results. It should not be interpreted as proving clinical benefit, proving absence of harm, or establishing that one dose schedule is preferable to another.
13. Why This Trial Matters Statistically
This trial is statistically notable because it illustrates the distinction between a study’s stated purpose and the evidence available in its registry record. The purpose was to evaluate safety and side effects and to measure the amount of ramucirumab in the bloodstream and how long the body took to eliminate it. Yet the primary safety endpoint result is not reported in the registry record. Without that result, readers cannot assess the endpoint’s observed frequency or its precision.
The study also demonstrates why design labels matter. It is a phase I, single-group trial with no randomized control group. The listed dose cohorts may describe how safety information was organized, but they do not function as controlled comparators. A numerical difference between cohorts, even if one were calculated, would not by itself identify a causal dose effect. The cohort structure and any assignment process are not described in enough detail to support such an inference.
The record includes participant counts for serious and other adverse events, alongside serious-event terms and percentages. This makes it possible to describe selected safety observations while also showing the limits of those observations: the primary endpoint combines event categories in a specific way, and the result for that combined outcome is unavailable. The distinction between participant-level endpoints and term-level listings is important for clear interpretation.
More broadly, the entry underscores the role of transparent analysis reporting. The registry lists outcome measures but no analyses, and does not report the statistical plan, missing-data procedures, or multiplicity strategy. These details affect how readers judge completeness, precision, and the strength of any inferential claim. The record is therefore useful for understanding the trial’s design and selected reporting, while also making clear that its posted information is insufficient for a full statistical evaluation of the planned outcomes.
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 is that the result for the stated primary safety endpoint is not reported in the registry record. The record therefore does not show how many participants met the endpoint or provide an uncertainty estimate for it. The listed serious and other adverse-event counts are not a replacement for that combined endpoint result.
The study has a single-group design, no masking, and no randomized control arm. The dose cohorts are not like-for-like controls, and the registry does not report how participants entered each cohort. This restricts interpretation of differences across schedules and precludes a controlled estimate of relative safety or efficacy.
The record describes dose escalation from 6 mg/kg up to 10 mg/kg and lists three cohort schedules, but the dose-escalation rules and rationale for the cohort sequence are not reported in the registry record. The reported enrollment does not by itself establish that the study could characterize uncommon adverse events precisely. No sample-size justification for the trial is reported in the registry record.
The statistical analysis plan, interim analyses, missing-data methods, and multiplicity strategy are not reported in the registry record. Although nine outcome measures are listed, results for the named secondary outcomes are not reported. The record also does not provide the primary endpoint confidence interval or explain how incomplete follow-up was treated. Deaths are not reported in the registry record. These gaps limit assessment of outcome completeness, statistical precision, and the robustness of any interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study in Participants With Advanced Solid Tumors — NCT01682135.
- Registry record last updated 2016-08-26; status last verified 2016-07.
- Results first posted 2016-08-26.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed phase I, single-group study of intravenous ramucirumab in Chinese participants with advanced solid tumors resistant to standard therapy or with no standard therapy available. Enrollment was 28. The recorded start was 2012-11 and primary completion was 2015-03. Masking is listed as none, and allocation as not applicable.
The primary outcome is the number of participants with one or more drug-related adverse events or any serious adverse events, from baseline through study completion, up to 12 weeks. Its result is not reported in the registry record. Cohort-level serious and other adverse-event counts and selected serious-event terms are listed. Secondary outcomes concern response, stable disease, progression, and anti-ramucirumab antibodies; their results are not reported in the registry record. The statistical analysis plan, missing-data methods, and multiplicity strategy are also not reported in the registry record.