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 of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer (NCT01703091), a randomized phase 2 study. The primary outcome is Progression-Free Survival (PFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01703091 |
| Phase | Phase 2 |
| Condition | Non-small Cell Lung Cancer Metastatic |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 197 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Participants had stage IV non-small cell lung cancer and disease progression during or after one prior first-line platinum-based chemotherapy, with or without maintenance therapy, for advanced or metastatic disease. The primary endpoint population was the Full Analysis Set: randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.
Intervention
Ramucirumab was given with docetaxel. The arm description specifies ramucirumab 10 mg/kg and docetaxel 60 mg/m2 on Day 1 of every 21 day cycle, both by intravenous infusion over approximately 60 minutes.
Comparator
The comparison was placebo with docetaxel. Placebo was administered on Day 1 of every 21 day cycle, alongside docetaxel 60 mg/m2 by intravenous infusion over approximately 60 minutes.
Primary question
The primary endpoint was progression-free survival, measured from baseline until measured progressive disease or death from any cause, whichever came first. The registry reports median progression-free survival with 95% confidence intervals for each arm. It does not report a sponsor comparative analysis of the endpoint in the registry record, so the arm estimates alone do not establish the size or statistical uncertainty of a treatment contrast.
The trial's central question was whether adding ramucirumab to docetaxel was associated with a different progression-free survival distribution than adding placebo to docetaxel in this study population. The design also collected tumor response and disease control outcomes, overall survival, and patient-reported measures. Those outcomes address distinct aspects of follow-up and do not substitute for the primary endpoint.
3. Trial Design
This was a randomized, double-blind, phase 2, parallel-group study. The registry lists quadruple masking. The planned comparison was ramucirumab plus docetaxel versus placebo plus docetaxel, with both groups receiving docetaxel. The enrollment listed in the record is 197. The study status is completed; the recorded start was 2012-12 and primary completion was 2014-12.
The intervention descriptions specify administration on Day 1 of every 21 day cycle. Ramucirumab was given at 10 mg/kg with docetaxel at 60 mg/m2. The comparator group received placebo with docetaxel at 60 mg/m2. Both drugs and placebo were described as intravenous infusions over approximately 60 minutes. The registry record does not report additional details about treatment duration, dose modifications, or adherence in the information available for this analysis.
The primary endpoint was median progression-free survival in months, with a 95% confidence interval. The primary endpoint population was defined as randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The registry reports 76 participants in the ramucirumab-plus-docetaxel endpoint group and 81 in the placebo-plus-docetaxel group. It also reports censored participant data counts of 13 and 9, respectively.
Secondary outcomes listed in the record include overall survival, objective tumor response rate, disease control rate, change from baseline in the EQ-5D index score, and change from baseline in the LCSS. The record lists six outcome measures, but only five secondary outcomes are posted in the results available for review. Results for the other listed measures are not reported in the registry record.
The registry record does not report the planned sample-size justification, a detailed statistical analysis plan, or interim analyses. Randomization and masking describe design features, but by themselves they do not supply the missing details of how the sponsor planned to analyze each outcome.
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 Plus Docetaxel | Placebo Plus Docetaxel |
|---|---|---|
| STARTED | 98 | 99 |
| Received at Least One Dose of Study Drug | 94 | 98 |
| COMPLETED | 89 | 95 |
| NOT COMPLETED | 9 | 4 |
Reasons for not completing this period:
| Reason | Ramucirumab Plus Docetaxel | Placebo Plus Docetaxel |
|---|---|---|
| Adverse Event | 5 | 3 |
| Physician Decision | 2 | 1 |
| Withdrawal by Subject | 1 | 0 |
| Sponsor Decision | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS) population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 13 and 9, respectively.
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 had received at least one dose of study drug.
| Characteristic | Unit | Ramucirumab + Docetaxel | Placebo + Docetaxel | Total |
|---|---|---|---|---|
| Participants analysed | 94 | 98 | 192 | |
| Age, Continuous | Years | 63.9 (29 to 78) | 64.1 (27 to 79) | 64 (27 to 79) |
| Sex: Female, Male: Female | Participants | 28 | 27 | 55 |
| Sex: Female, Male: Male | Participants | 66 | 71 | 137 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 94 | 98 | 192 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: Japan | Participants | 94 | 98 | 192 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-Free Survival (PFS), measured over Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival measures the time from baseline until measured progressive disease or death from any cause, whichever occurs first. It is a time-to-event endpoint: each participant contributes follow-up until the event or until their observation is censored. The registry defines progression using RECIST v1.1. Progression included at least a 20% increase in the sum of target-lesion diameters relative to the smallest sum on study, together with an absolute increase of at least 5 mm. A new lesion or unequivocal progression of existing nontarget lesions also qualified.
Time-to-event endpoints are used to incorporate both whether an event occurred and when it occurred. A median is the point in the estimated event-time distribution at which half the population is estimated to have had the event. It is not the average follow-up time, nor does it describe every participant's experience. The registry reports median progression-free survival and a 95% confidence interval for each arm, rather than a hazard ratio or a direct arm comparison.
Participants without objectively determined progression who were alive at the end of follow-up, or lost to follow-up, were censored at their last complete radiographic tumor assessment. If no baseline or post-baseline radiologic assessment was available, censoring was at randomization. Censoring means that the event time is not observed during the available follow-up; it does not mean the participant had no later event. The interpretation of a time-to-event estimate therefore depends on follow-up and censoring as well as on event assessment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
Median progression-free survival was 5.22 months (95% confidence interval 3.52 to 6.97) for ramucirumab plus docetaxel and 4.21 months (95% confidence interval 2.83 to 5.62) for placebo plus docetaxel. These are arm-specific estimates. The confidence intervals describe uncertainty around each median; they are not a confidence interval for the difference between arms. The registry record does not report a sponsor comparative analysis for progression-free survival, and a comparative hazard ratio or its confidence interval is not reported in the registry record.
The displayed medians place the ramucirumab-plus-docetaxel estimate above the placebo-plus-docetaxel estimate, but the medians alone do not provide a formal comparison of the time-to-event distributions. The confidence intervals also do not resolve the comparative question: arm-specific intervals should not be treated as a substitute for an interval or test designed for the treatment contrast. No conclusion about statistical significance of the primary comparison can be drawn from the posted medians alone.
The primary analysis population was not all enrolled participants. It included randomized participants who received at least one dose and whose prior therapy did not include EGFR-TKI monotherapy. The endpoint groups contain 76 and 81 participants, and the registry notes censored data for 13 and 9 participants. The reasons for censoring and the detailed distribution of follow-up are not reported in the registry record. These details matter because censoring and incomplete assessment affect how much information contributes to the estimated time-to-event curve.
The posted secondary response outcomes have positive unadjusted risk-difference estimates for ramucirumab plus docetaxel, but each interval for the risk difference includes zero. The unadjusted p-values are 0.124 for objective tumor response rate and 0.218 for disease control rate. These secondary results are exploratory in the absence of reported multiplicity control and should not be read as confirmatory evidence. They also do not replace the missing comparative analysis of the primary endpoint.
In short, the registry reports arm-level median progression-free survival and secondary response estimates, with uncertainty that should be considered alongside the limited analysis information. It does not report the sponsor's formal primary comparison, the statistical plan, or whether multiplicity adjustments were used. The available results describe the posted data, but leave important parts of the comparative interpretation unresolved.
9. Statistical Methods Explained
Progression-free survival is a time-to-event outcome because the recorded endpoint is the time until progression or death. Participants who have not experienced either event by the end of observation do not have a fully observed event time. The registry describes these observations as censored at the last complete radiographic tumor assessment, or at randomization when no radiologic assessment was available. General statistical interpretation of censored data assumes that the censoring process is handled appropriately; the specific methods and assumptions used by the sponsor are not reported in the registry record.
What does a median estimate?
A median time-to-event estimate is a summary of the estimated event-time distribution. It identifies the time at which the estimated proportion remaining event-free reaches the midpoint. Unlike a simple mean, it does not require every participant's event time to be observed. It also does not show the shape of the full distribution, the pattern of risk over time, or how treatment groups compare at every point during follow-up. Those questions require additional analyses and information beyond an arm-specific median.
The reported medians are 5.22 months for ramucirumab plus docetaxel and 4.21 months for placebo plus docetaxel. Their accompanying 95% confidence intervals are 3.52 to 6.97 and 2.83 to 5.62, respectively. A confidence interval expresses statistical uncertainty in an estimate under the method used to construct it. It is not a range containing a fixed proportion of individual participant outcomes. The registry does not state the method used to calculate the intervals.
Why is a direct comparison important?
Comparative inference needs an estimate and uncertainty measure for the contrast between randomized groups, using a method suitable for time-to-event data. A hazard ratio is one possible comparative summary, but it is not reported for the primary endpoint in the registry record. Nor is a comparative p-value for progression-free survival reported. The individual arm medians cannot be used to recover those missing sponsor results, and no new time-to-event comparison is calculated from the posted summaries.
The registry's endpoint definition sets out how progression was assessed under RECIST v1.1, including lesion-size change and new or progressing lesions. Consistent endpoint assessment is important because the timing of progression determines the event time. The record describes the endpoint criteria and the censoring rules, but does not report further operational details, such as assessment schedules or the handling of independent review. Such details are not reported in the registry record.
How should secondary comparisons be read?
Objective tumor response rate and disease control rate are binary outcomes: each participant is classified according to whether the specified response criterion was met. The posted arm results include percentages and 95% confidence intervals. The simple recalculated comparisons use the posted counts and group sizes to estimate unadjusted risk differences. For objective tumor response rate, the recalculated risk difference is 0.104, with a 95% confidence interval from -0.028 to 0.237 and an unadjusted p-value of 0.124. For disease control rate, it is 0.086, with a 95% confidence interval from -0.050 to 0.221 and an unadjusted p-value of 0.218.
These recalculations are unadjusted comparisons of posted summary counts, not the sponsor's reported analysis. An interval for a risk difference that includes zero indicates that the displayed data are compatible with no difference as well as with differences in either direction, under the calculation method. The p-values likewise do not account for any multiplicity adjustment. The registry does not report sponsor analyses for these outcomes, so the recalculated comparisons should be distinguished from any prespecified model-based analysis.
Why does multiplicity matter?
When a study examines multiple outcomes or comparisons, the chance of at least one apparently notable result can increase if each is interpreted as a separate confirmatory test. General statistical practice addresses this issue by prespecifying a testing hierarchy or applying an adjustment. The registry lists multiple secondary outcomes, but does not report whether an adjustment, hierarchy, or other multiplicity strategy was planned or applied. Consequently, unadjusted secondary p-values have less evidential weight than a primary result analyzed under a clearly specified plan.
The posted sample-size illustrations for the binary outcomes are planning calculations based on the observed effect, not the trial's own design justification. They use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with alternative effect assumptions expressed as fractions of the observed effect. These are hypothetical planning illustrations, not observed power and not evidence that the trial was designed around those effects. A sample-size justification and its assumptions are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists several secondary outcomes in addition to progression-free survival. It does not report a statistical analysis plan specifying a testing hierarchy, a family of hypotheses, or a multiplicity adjustment. Without that information, the intended confirmatory status of the secondary outcomes and the control of false-positive findings across analyses are not reported in the registry record. The posted unadjusted p-values for response outcomes should therefore be interpreted cautiously and should not be read as multiplicity-adjusted evidence.
The registry lists six outcome measures and five secondary outcomes, but results are posted for only two of those secondary outcomes. Results for overall survival, EQ-5D index score, and LCSS are not reported in the registry record. The record also lists zero analyses. It does not report a sponsor comparative analysis for the primary progression-free survival endpoint or sponsor analyses for the posted secondary comparisons.
Missing outcome results do not establish that an outcome was not measured or that an analysis was not conducted. They mean that the results are not available in the registry record. Reasons for the absence of results, and whether particular outcomes were changed or omitted, are not reported in the registry record.
The primary analysis population was the Full Analysis Set, defined as randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. This definition is narrower than enrollment alone. The primary endpoint counts were 76 for ramucirumab plus docetaxel and 81 for placebo plus docetaxel. The record reports censored participant data counts of 13 and 9. It does not provide a complete accounting of every participant's inclusion, exclusion, follow-up, or reason for censoring in the information available for these results.
For progression-free survival, censoring occurred for participants without objectively determined progression who were alive at the end of follow-up or lost to follow-up, at their last complete radiographic assessment. When no baseline or post-baseline radiologic assessment was available, censoring was at randomization. These rules clarify the stated endpoint handling, but the registry does not report sensitivity analyses for missing assessments or further details about the assumptions behind censoring.
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 + Docetaxel | 30 | 94 | 31.9% |
| Placebo + Docetaxel | 31 | 98 | 31.6% |
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 + Docetaxel | 94 of 94 |
| Placebo + Docetaxel | 98 of 98 |
Most frequent serious adverse event terms
| Event term | Organ system | Ramucirumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 8 of 94 | 6 of 98 |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 94 | 4 of 98 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 3 of 94 | 3 of 98 |
| Decreased appetite | Metabolism and nutrition disorders | 4 of 94 | 1 of 98 |
| Lung infection | Infections and infestations | 1 of 94 | 3 of 98 |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 2 of 94 | 2 of 98 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 2 of 94 | 1 of 98 |
| Diarrhoea | Gastrointestinal disorders | 1 of 94 | 1 of 98 |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | 1 of 94 | 1 of 98 |
| Vomiting | Gastrointestinal disorders | 1 of 94 | 1 of 98 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ramucirumab + Docetaxel | Placebo + Docetaxel |
|---|---|---|---|
| Neutrophil count decreased | Investigations | 73 of 94 | 69 of 98 |
| White blood cell count decreased | Investigations | 73 of 94 | 68 of 98 |
| Alopecia | Skin and subcutaneous tissue disorders | 63 of 94 | 61 of 98 |
| Decreased appetite | Metabolism and nutrition disorders | 54 of 94 | 51 of 98 |
| Malaise | General disorders | 43 of 94 | 47 of 98 |
| Stomatitis | Gastrointestinal disorders | 50 of 94 | 31 of 98 |
| Anaemia | Blood and lymphatic system disorders | 37 of 94 | 41 of 98 |
| Nausea | Gastrointestinal disorders | 34 of 94 | 39 of 98 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 46 of 94 | 18 of 98 |
| Oedema peripheral | General disorders | 34 of 94 | 28 of 98 |
Serious events with the highest arm-level rate: febrile neutropenia (8.5%), decreased appetite (4.3%), metastases to meninges (4.1%), pneumothorax (3.2%), lung infection (3.1%).
The registry reports serious adverse event figures for groups of 94 participants receiving ramucirumab plus docetaxel and 98 receiving placebo plus docetaxel. Serious adverse events affected 30 participants in the ramucirumab group and 31 in the placebo group. These are counts of participants affected, not counts of every event, and they should not be conflated with the primary endpoint population counts.
The serious adverse event terms listed most frequently across the reported results are febrile neutropenia (8.5%), decreased appetite (4.3%), metastases to meninges (4.1%), pneumothorax (3.2%), lung infection (3.1%), and general physical health deterioration (2.1%). The registry record does not give an arm-specific breakdown for these listed terms in the information, so they should not be attributed to one group or compared between groups. Death counts are not reported in the registry record.
Adverse event counts describe what was recorded during the study and do not, on their own, establish cause. Interpretation also depends on definitions, duration of observation, and completeness of reporting; additional details are not reported in the registry record. These figures are descriptive safety information and do not establish a treatment effect.
12. What the Result Does, and Does Not, Mean
The posted results show arm-specific median progression-free survival estimates and confidence intervals, along with selected response outcomes. The median estimates are 5.22 months for ramucirumab plus docetaxel and 4.21 months for placebo plus docetaxel. Their uncertainty intervals are broad enough that the arm-level values alone do not resolve the comparative question. No sponsor-reported hazard ratio, comparative confidence interval, or p-value for the primary endpoint is reported in the registry record.
The response outcomes have higher arm-level point estimates for the ramucirumab combination, but their unadjusted recalculated risk-difference intervals include zero. These comparisons do not establish a statistically reliable difference, and they are not a substitute for the missing primary comparison. The secondary outcomes also have less interpretive weight because a multiplicity plan is not reported and several listed outcomes have no posted results.
Randomization is a design feature intended to support fair group comparisons, while masking can reduce some forms of bias in conduct and assessment. Those design features do not remove uncertainty from a limited number of observations, missing outcome information, or incomplete reporting of the analysis plan. Nor do they make arm-specific medians equivalent to a direct comparative analysis.
The results do not establish that either regimen works or does not work. They describe registry-posted estimates and their reported precision, with important limits on what can be inferred about between-group differences. A fuller interpretation would require the sponsor's comparative primary analysis, details of the statistical plan and multiplicity handling, and results for the other listed outcomes. Those items are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint type matters in clinical research. Progression-free survival is a time-to-event measure with censoring, whereas response outcomes classify participants according to tumor-response criteria. Each requires an analysis suited to its structure. Arm-level response percentages and medians are useful descriptive summaries, but neither automatically supplies the uncertainty for a comparison between randomized groups.
The record also shows the distinction between a reported estimate and a complete statistical result. For the primary endpoint, the medians and their confidence intervals are available, but the sponsor's comparative analysis is not. For the posted secondary response outcomes, simple unadjusted recalculations can describe contrasts from counts, but they are not equivalent to a prespecified sponsor analysis. Statistical interpretation depends not only on point estimates, but also on uncertainty, analysis choices, and the questions specified in advance.
Multiplicity is another central issue. Multiple endpoints can be clinically and scientifically informative, yet unadjusted testing across several outcomes can make isolated findings less persuasive. Because the registry does not report the multiplicity strategy, readers cannot determine how the secondary tests were intended to relate to a confirmatory claim.
Finally, enrollment and analysis populations are not interchangeable. The primary results use a defined Full Analysis Set, and censoring affects the information available for the time-to-event estimate. Understanding those distinctions helps prevent over-reading a point estimate as a complete account of trial evidence. The record's omissions are themselves relevant: they limit how precisely the comparative findings can be interpreted.
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.
A central limitation is the absence of a sponsor-reported comparative analysis for the primary progression-free survival endpoint. The registry supplies arm-specific medians and confidence intervals, but not a treatment contrast, hazard ratio, or comparative p-value. The posted information therefore does not establish the statistical uncertainty of the difference between groups.
The analysis population is defined, and censored counts are reported, but more detail about participant flow, censoring reasons, follow-up, and missing radiographic assessments is not reported in the registry record. These details could help readers assess how much information contributed to the endpoint estimate and how censoring may affect interpretation. The registry also does not report the statistical method used to derive the median confidence intervals.
Results are absent for several listed secondary outcomes, including overall survival and the patient-reported measures. The record does not explain why these results are missing or whether the outcomes were analyzed. The statistical analysis plan, sample-size justification, interim analyses, and multiplicity strategy are also not reported in the registry record.
The recalculated comparisons for response outcomes are unadjusted calculations based on posted summary counts. They may not match the sponsor's planned or reported methods, and there are no sponsor analyses posted for these outcomes. Their p-values do not account for testing multiple outcomes. The serious adverse event terms are not reported by arm in the available information, and death counts are not reported in the registry record. These limitations restrict both comparative efficacy interpretation and detailed safety comparisons.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer — NCT01703091.
- Registry record last updated 2019-09-30; status last verified 2019-09.
- Results first posted 2016-01-20.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed randomized, double-blind, phase 2 parallel-group study of ramucirumab plus docetaxel versus placebo plus docetaxel for stage IV non-small cell lung cancer following progression after prior platinum-based therapy. Enrollment was 197. The primary outcome was median progression-free survival, reported for a Full Analysis Set with 76 participants in the ramucirumab group and 81 in the placebo group.
Median progression-free survival was 5.22 months (95% confidence interval 3.52 to 6.97) with ramucirumab plus docetaxel and 4.21 months (95% confidence interval 2.83 to 5.62) with placebo plus docetaxel. A sponsor-reported comparative analysis for this primary endpoint is not reported in the registry record. Two secondary response outcomes are posted; results for other listed secondary outcomes are not reported in the registry record. The record also lacks a reported statistical plan and multiplicity strategy, limiting confirmatory interpretation of the secondary findings.