Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer (NCT03941093), a randomized phase 3 study. The primary outcome is Overall Survival.

2. Clinical Question

The clinical question is about the time-to-event outcome of death from any cause in this trial population. It is not a comparison of pamrevlumab alone with no treatment: both groups were assigned one of the specified chemotherapy regimens, with pamrevlumab or placebo added. The registry record identifies the study as randomized and describes the trial as evaluating efficacy and safety. It does not report separate overall-survival results for the two chemotherapy options, so the posted primary comparison should be read as the comparison between the assigned pamrevlumab and placebo groups across the stated regimens.

3. Trial Design

This was a Phase 3 randomized parallel-group trial in participants with locally advanced, unresectable pancreatic cancer. The registry record lists an enrollment of 284. It describes two treatment groups: pamrevlumab plus gemcitabine/nab-paclitaxel or FOLFIRINOX, and placebo plus gemcitabine/nab-paclitaxel or FOLFIRINOX. The registry record classifies masking as quadruple; the official title describes the study as double-blind. The record does not explain that difference in terminology.

The primary outcome was overall survival, defined as the time from randomization to death due to any cause. The stated timeframe was up to approximately 5 years, and the analysis used the Kaplan-Meier method. The intention-to-treat population included all randomized participants regardless of whether study treatment was received. The posted arm counts for the primary outcome are 143 in the pamrevlumab group and 141 in the placebo group.

The registry record lists event-free survival, progression-free survival assessed using RECIST v1.1, and best overall objective response assessed using RECIST v1.1 among the secondary outcomes. It reports a sponsor analysis of the primary comparison using a stratified log-rank test. The registry record does not report the factors used for stratification, the original sample-size justification, the planned interim analyses, or the original statistical analysis plan.

The study is marked completed. Its recorded start date is 2019-05-10, and its primary completion date is 2024-06-11. These dates describe the registry record and do not, by themselves, convey the completeness or maturity of any individual outcome. The registry record does not provide separate outcome estimates by chemotherapy regimen or detailed information about treatment exposure in the two groups.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Participants were randomized in a 1:1 ratio to one of the 2 study treatment arms: Pamrevlumab with Gemcitabine/Nab-paclitaxel or FOLFIRINOX or Placebo with Gemcitabine/Nab-paclitaxel or FOLFIRINOX.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The ITT population included all randomized participants regardless of whether or not study treatment was received.

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: The intent-to-treat (ITT) population included all randomized participants regardless of whether or not study treatment was received.

6. Primary Endpoint

The registry lists the primary outcome as Overall Survival, measured over Up to approximately 5 years.

Overall survival measures the time from randomization until death from any cause. In this trial, the registry record specifies that this time-to-event outcome was estimated using the Kaplan-Meier method and evaluated in the intention-to-treat population. Counting death from any cause avoids requiring a cause-of-death classification for the primary endpoint, while measuring time preserves information about when deaths occur rather than reducing follow-up to a simple count.

Survival analyses commonly summarize the observed time-to-event pattern with a median: the time by which the estimated survival function has reached one half. The posted median overall survival was 17.25 months in the pamrevlumab group, with a 95% confidence interval from 15.47 to 18.89 months. In the placebo group, it was 17.94 months, with a 95% confidence interval from 14.59 to 20.34 months. These are separate summaries of each group’s estimated survival experience; they do not, by themselves, provide the trial’s comparative effect estimate.

The comparative result is reported as a hazard ratio from a stratified log-rank analysis. A hazard ratio describes the relative event rate over follow-up under the analysis model, rather than a difference in median survival time. The registry record does not report the model details beyond the named test and the reported hazard ratio, so interpretation should stay with the posted estimate and its confidence interval.

7. Results Posted in the Registry

• Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX vs Placebo + Gemcitabine/Nab-paclitaxel or FOLFIRINOX: hazard ratio 1.08 (95% CI 0.83–1.41), reported p = 0.549 (as reported in the registry).

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX: 30.1% (43/143) versus 45.4% (64/141) on control; risk difference -15.3 percentage points (95% CI -26.5 to -4.2), risk ratio 0.66 (0.49–0.90); unadjusted two-proportion z-test p = 0.008.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically lower for Pamrevlumab + Gemcitabine/Nab-paclitaxel or FOLFIRINOX than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry record lists event-free survival, progression-free survival assessed using RECIST v1.1, and best overall objective response assessed using RECIST v1.1 as secondary outcomes. It gives numerical results for best overall objective response, but does not report numerical estimates for event-free survival or progression-free survival in the record summarized by the posted results. Their direction and precision therefore cannot be inferred from the primary overall-survival estimate or from the outcome names alone.

The objective-response result is a secondary comparison and is not the same endpoint as overall survival. A response assessment captures tumor response according to the stated criteria, whereas overall survival measures time to death from any cause. These outcomes can differ in their event definitions, timing, and statistical analysis. A secondary finding should not be treated as confirmation or contradiction of the primary result without considering those differences and the full analysis plan.

The objective-response recalculation is unadjusted. In general, when several outcomes or comparisons are examined, the chance of at least one apparently notable result can increase unless multiplicity is addressed. Unadjusted secondary p-values do not account for that issue. The registry record does not report a multiplicity adjustment or a hierarchy specifying how secondary outcomes were to be interpreted. As a result, secondary findings carry less confirmatory weight than a prespecified primary analysis, especially when the analysis plan and adjustment strategy are not reported.

The overall pattern across the posted secondary information is therefore incomplete rather than uniformly pointing in one direction: one secondary endpoint has numerical results, while the record lists other secondary outcomes without corresponding estimates in the posted information. It is not appropriate to fill those gaps by extrapolating from overall survival, or to use a single secondary comparison to make a broad claim about the trial. The primary endpoint remains the reported basis for the principal statistical interpretation.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Event-free Survival (EFS)
• Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Number of Participants With Best Overall Objective Response as Assessed Using RECIST v1.1

9. Statistical Interpretation

10. Statistical Methods Explained

Overall survival is a time-to-event outcome: each participant contributes information about time from randomization until death or, if death has not been observed, until the last time their survival status is known. General statistical explanation: participants without an observed event by the end of their available follow-up are usually treated as censored at the last known time. This allows the analysis to use their observed follow-up without treating them as if they had experienced the event. The registry record does not report detailed censoring rules or follow-up completeness.

What does the Kaplan-Meier method describe?

The registry record says overall survival was calculated using the Kaplan-Meier method. In general, this method estimates the probability of remaining event-free over time while accounting for participants whose follow-up ends before an event is observed. Its estimate changes at observed event times and incorporates the available follow-up at those times. A median can then be read from the estimated curve as the time at which estimated survival reaches one half, when that point is reached. The reported medians are 17.25 months for the pamrevlumab group and 17.94 months for the placebo group. Those summaries do not show the entire course of either curve.

What does the hazard ratio mean?

The registry reports a hazard ratio of 1.08 for the pamrevlumab group compared with the placebo group. In general, a hazard is the instantaneous event rate among participants still at risk at a given time. A hazard ratio compares those rates between groups under the analysis framework. A value of 1 corresponds to equal hazards; a value above 1 points toward a higher estimated hazard in the first-named group, and a value below 1 points toward a lower estimated hazard. This is not a direct ratio of the groups’ median survival times, nor does it translate directly into an absolute difference in survival probability.

The registry record identifies the sponsor’s method as a stratified log-rank test. In general, a log-rank test compares time-to-event experience across groups while taking event timing and censoring into account. Stratification means the comparison is organized across specified strata, but the factors used to define those strata are not reported in the registry record. The reported p-value is 0.549. The record does not provide further test details or an independently reported analysis.

Why does the confidence interval matter?

The 95% confidence interval for the hazard ratio extends from 0.83 to 1.41. In general, a confidence interval expresses the uncertainty around an estimate under the statistical procedure used: intervals from repeated applications of that procedure would have the stated coverage if its assumptions hold. It is not a probability statement that the particular interval contains the true value. Since this interval includes 1 and also includes values on either side, it conveys uncertainty about both the direction and magnitude of the relative hazard.

What is the role of the intention-to-treat population?

The registry defines the intention-to-treat population as all randomized participants regardless of whether study treatment was received. In general, analyzing people according to randomized assignment preserves the comparison created by randomization and estimates the effect of assignment to the study groups, subject to outcome availability and the analysis procedure. The posted primary outcome counts are 143 and 141. The registry record does not describe how missing survival information was handled or provide a detailed account of exclusions, if any.

Why can over-dispersion matter in other analyses?

General statistical explanation: over-dispersion occurs when outcome variability is greater than a statistical model expects. If ignored, standard errors can be too small and confidence intervals or tests can appear more certain than warranted. This issue is especially relevant to some count-data models; it should not be assumed to describe this time-to-event analysis. The registry record does not report an over-dispersion assessment for the primary endpoint.

For the binary secondary outcome of best overall objective response, the posted recalculation includes an unadjusted risk difference and an unadjusted p-value. General statistical explanation: a risk difference compares the proportions with the outcome, while a confidence interval describes uncertainty in that contrast. This secondary comparison is not the sponsor’s reported primary survival analysis, and the registry record lists no sponsor-reported analysis for it. The assumptions used for the separate planning illustrations are described in the sample-size discussion; they do not replace the trial’s own design assumptions, which are not reported in the registry record.

11. Confidence Intervals and Precision

The primary hazard-ratio estimate is 1.08, with a 95% confidence interval from 0.83 to 1.41. The interval is important because the point estimate alone can make a result seem more definitive than it is. It indicates that the estimated relative hazard is imprecise enough to include values below 1 as well as values above 1. The interval therefore does not pin down whether the relative hazard was lower or higher in the pamrevlumab group.

The separate median estimates also have uncertainty. The pamrevlumab group’s median was 17.25 months, with a 95% confidence interval from 15.47 to 18.89 months. The placebo group’s median was 17.94 months, with a 95% confidence interval from 14.59 to 20.34 months. These intervals describe uncertainty in each group’s median estimate; they are not a confidence interval for the difference between medians. The registry record does not report a confidence interval for that difference.

In general, a confidence interval is a range produced by a statistical procedure to reflect sampling uncertainty. Its width depends on the information available and the variability in the data, as well as the method used. A 95% confidence interval should not be read as a 95% probability that the true value lies inside this particular interval. It also does not account automatically for every possible source of bias, missing data, or model misspecification.

The reported p-value, 0.549, and the confidence interval address related but different aspects of the analysis. The p-value summarizes the test against its null hypothesis; the interval shows a range of effect estimates compatible with the data under the interval procedure. Neither establishes equivalence or proves that the groups have the same outcomes. The record does not report an equivalence margin or a noninferiority margin.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size illustrations are planning calculations based on fractions of the observed effect, not the trial’s original design justification. The assumptions stated for these illustrations are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. For time-to-event planning, the figures are total events, calculated using the Schoenfeld approach. For the other endpoint, the figures are participants per arm.

For the overall-survival comparison, the event totals are presented for planning at 80% and 90% power. In plain language, power is the chance that a study designed under specified assumptions would detect the stated effect using the specified test and significance level. The 80% column gives the total number of events required under those assumptions for an 80% chance of detection; the 90% column gives the total events required for a 90% chance. For example, planning for 100% of the observed effect gives total-event figures of 5,301 for 80% power and 7,097 for 90% power. Planning for 75% of the observed effect gives 9,424 and 12,616, respectively; planning for 50% gives 21,203 and 28,385.

For the binary response outcome, the figures are participants per arm, not total participants. Planning for 100% of the observed effect gives 156 participants per arm for 80% power and 209 for 90% power. Planning for 75% gives 284 and 379, while planning for 50% gives 649 and 868. Smaller effects require more information to distinguish them from the null under the same planning assumptions, so the illustrated requirements grow as the target effect becomes a smaller fraction of the observed effect.

These figures are planning illustrations and are not observed power. They do not describe the power achieved by the completed trial. The original design assumptions, including the trial’s planned effect size and sample-size justification, are not reported in the registry record. The illustrations should therefore be read as conditional calculations using the stated assumptions, not as evidence that the trial was designed around these values.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

d is the total number of events needed (Schoenfeld's formula) with 1:1 allocation and proportional hazards.

Worked calculation for this trial

1. Hazard ratio HR = 1.080, so ln(HR) = 0.0770.
2. d = 4 × (1.96 + 0.842)² / [ln(1.080)]² = 5,300.6, rounded up to 5,301 events in total for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
hr <- 1.08                              # observed hazard ratio
events_needed <- function(power, frac = 1) ceiling(round(4 * (z_a + qnorm(power))^2 / log(hr^frac)^2, 6))   # Schoenfeld, 1:1 allocation
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: events = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(events_needed(0.80, f), big.mark = ","), format(events_needed(0.90, f), big.mark = ",")))

# Simulation: given d total events under proportional hazards, events in the treatment arm are Binomial(d, hr / (1 + hr)).
# The score (log-rank type) statistic is (D1 - d / 2) / sqrt(d / 4).
set.seed(3941093)
d    <- events_needed(0.80)
reps <- 20000
D1 <- rbinom(reps, d, hr / (1 + hr))
z  <- (D1 - d / 2) / sqrt(d / 4)
cat(sprintf("Simulated power with %s events: %.3f (%d replicates)\n", format(d, big.mark = ","), mean(abs(z) > z_a), reps))

Output from running the code

100% of observed effect: events = 5,301 (80% power), 7,097 (90% power)
 75% of observed effect: events = 9,424 (80% power), 12,616 (90% power)
 50% of observed effect: events = 21,203 (80% power), 28,385 (90% power)
Simulated power with 5,301 events: 0.800 (20000 replicates)

The simulation uses the fact that, with d events in total and proportional hazards, the number of events in the treatment arm is binomial. It is an approximation that conditions on the total number of events, and it should land close to the target power.

14. Analyses Reported by the Sponsor

The primary result is the sponsor’s reported analysis: a stratified log-rank test with a hazard ratio of 1.08, a 95% confidence interval from 0.83 to 1.41, and p = 0.549. The registry record does not report a recalculated alternative primary hazard ratio. Accordingly, interpretation of the primary endpoint rests on the sponsor’s analysis rather than a summary-statistic re-estimation.

A recalculation from posted group summaries can be useful for some outcomes, but it may not reproduce a sponsor’s analysis when that analysis uses participant-level follow-up, stratification, censoring, or other details not present in summary statistics. For this trial, the primary comparison is explicitly reported by the sponsor and takes precedence over any simple reconstruction. The record does not report the stratification factors or enough detail to independently reproduce that analysis.

The objective-response comparison has no sponsor-reported analysis in the registry record. Its posted recalculation is an unadjusted comparison based on the reported counts. That estimate answers a different, secondary question and should not be substituted for the sponsor’s primary time-to-event result. The registry record does not provide a sponsor-reported primary analysis that conflicts with the reported hazard ratio.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity concerns arise when a study evaluates more than one outcome, comparison, subgroup, or analysis. In general, conducting multiple statistical tests without an adjustment or a prespecified testing sequence can increase the chance of at least one nominally small p-value even when no effect exists. This does not make secondary outcomes uninformative, but it affects how strongly their p-values can be interpreted as confirmatory evidence.

The registry record lists several secondary outcomes and reports an unadjusted recalculation for best overall objective response. It does not report a multiplicity adjustment, a testing hierarchy, or a detailed statistical analysis plan explaining how the family of outcomes was to be handled. The registry record also does not report whether interim analyses were planned or conducted. Those matters are not reported in the registry record and should not be inferred from the final status or the presence of posted results.

The primary population is described as intention-to-treat, including all randomized participants regardless of treatment receipt. That definition supports interpretation by randomized assignment. However, the record does not give detailed information about missing outcome data, censoring procedures, follow-up completeness, or the handling of participants whose survival status was not known throughout the stated timeframe. These details matter because time-to-event estimates depend on the observed follow-up and the assumptions used for censoring.

The registry record reports an enrollment of 284 and primary outcome arm counts of 143 and 141. These figures describe the record’s enrollment and posted analysis counts; the record does not explain any differences between enrollment and outcome counts or provide a participant-flow account. It also does not provide a missing-data sensitivity analysis. Consequently, the reported estimate should be interpreted with the available population description and without assuming unreported procedures or data completeness.

These limitations do not invalidate the reported analysis, but they constrain independent assessment of how the full set of outcomes was controlled and how incomplete follow-up was handled. The sponsor’s reported primary method and estimate remain the available primary analysis; unreported plan details cannot be reconstructed from the p-value or confidence interval.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cholangitis (5.7%), sepsis (4.9%), vomiting (4.3%), pyrexia (4.3%), biliary obstruction (3.5%).

The registry record reports serious adverse events in 75 of 142 participants at risk in the pamrevlumab group and 62 of 141 at risk in the placebo group. It reports other adverse events in 139 of 142 and 140 of 141, respectively. These are counts of participants with the stated event category among the recorded numbers at risk; they are not treatment-effect estimates and do not, on their own, show whether an event was caused by study treatment.

The listed serious adverse event terms include cholangitis at 5.7%, sepsis at 4.9%, vomiting at 4.3%, pyrexia at 4.3%, biliary obstruction at 3.5%, and pneumonia at 3.5%. The registry record also reports deaths of 118 in the pamrevlumab group and 112 in the placebo group. Those death counts are not a substitute for the time-to-event analysis, which uses event timing and follow-up.

Safety counts should be interpreted with the recorded denominators and event definitions in mind. The registry record does not provide a comparative safety analysis, exposure-adjusted rates, or details sufficient to attribute individual events to treatment. These descriptive figures should not be read as causal conclusions.

17. What the Result Does, and Does Not, Mean

The primary result describes the trial’s comparison of overall survival between participants assigned pamrevlumab plus one of the specified chemotherapy regimens and participants assigned placebo plus one of those regimens. The sponsor-reported hazard ratio is 1.08, with a 95% confidence interval from 0.83 to 1.41 and p = 0.549. The estimate is close to 1, while the interval includes values on either side of 1. The result does not provide a precise determination of the direction or size of a relative hazard difference.

This result does not establish that the treatments have identical effects. A failure to obtain a statistically persuasive difference is not the same as evidence of equivalence. The registry record does not report an equivalence or noninferiority design or margin. Nor does the result prove that pamrevlumab improves or worsens survival. It is a statistical comparison from the stated randomized groups, with uncertainty represented by the confidence interval.

The group medians provide additional descriptive information, but they are not the whole survival experience. The pamrevlumab group’s median was 17.25 months and the placebo group’s was 17.94 months. Those values should not be interpreted as the survival time of every participant, as a direct treatment effect, or as proof of a difference between groups. Their confidence intervals also indicate uncertainty in the separate median estimates.

The findings apply to the trial population and treatment comparison described in the registry record. They do not establish results for a particular chemotherapy option, because separate outcome estimates by chemotherapy regimen are not reported. The registry record also does not provide sufficient details to assess every aspect of follow-up, missing data, or the full analysis plan. Secondary outcomes and safety counts add context but do not replace the primary survival analysis or resolve its uncertainty.

Overall, the posted data support a careful, limited conclusion: the sponsor-reported primary analysis did not show a statistically persuasive difference in overall survival, and its confidence interval remains compatible with a range of relative effects. Stronger claims about benefit, harm, equivalence, or which chemotherapy option is associated with a particular result are not established by the reported information.

18. Why This Trial Matters Statistically

This trial is statistically informative because it asks a randomized comparison about a clinically important time-to-event endpoint while both groups receive one of the stated chemotherapy regimens. Randomization provides the basis for comparing assigned groups, and the intention-to-treat definition preserves that assignment in the primary population, regardless of whether study treatment was received.

The result also illustrates why an estimate should be read together with its uncertainty. The hazard-ratio point estimate is close to 1, but the confidence interval extends from 0.83 to 1.41. A single point estimate cannot convey the range of effects compatible with the analysis. The reported p-value likewise does not measure the probability that the treatment groups are identical. Considering the estimate, interval, and test together avoids treating a nonsignificant result as proof of no effect.

The trial highlights the distinction between a primary outcome and a set of secondary outcomes. Overall survival is the primary endpoint, while the registry lists event-free survival, progression-free survival, and objective response among secondary outcomes. The available record does not report all secondary estimates or a multiplicity strategy. This illustrates why outcome hierarchy and analysis planning matter when a trial evaluates several endpoints.

Finally, the record shows the limits of interpreting registry summaries without the full analysis details. The sponsor reports a stratified log-rank test, but the strata, detailed censoring procedures, and original sample-size assumptions are not reported in the registry record. Statistical interpretation can be clear about the reported estimate and still acknowledge that these omitted details constrain independent evaluation and reconstruction.

19. 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.

Several limitations specific to this record constrain interpretation. The primary comparison is reported with a hazard ratio and confidence interval, but the registry record does not identify the stratification factors used in the stratified log-rank test. It also does not provide detailed information about censoring, survival-status ascertainment, or follow-up completeness. These details would help readers assess how the time-to-event analysis was implemented.

The treatment groups could receive either gemcitabine plus nab-paclitaxel or FOLFIRINOX, but separate outcome estimates by chemotherapy regimen are not reported. The posted overall comparison therefore cannot establish whether the result differed across those regimens. The record also does not explain how treatment choices were distributed between groups.

The registry record lists secondary outcomes but does not provide numerical estimates for all of them in the posted information. It does not report a multiplicity adjustment or testing hierarchy, and it does not report the original sample-size justification, interim analyses, or detailed statistical analysis plan. These omissions limit assessment of confirmatory status and of how planned analyses compare with posted analyses.

Safety information is descriptive. The record gives counts and selected serious adverse event terms but does not provide exposure-adjusted rates or a comparative analysis adequate to determine attribution. The registry record does not explain the relationship between enrollment and the primary outcome counts or provide a detailed participant-flow account.

These limitations are reasons to keep conclusions close to the reported results, not grounds for assuming that an unreported analysis would change them. The registry record supports interpretation of the sponsor-reported primary comparison, but it does not permit complete independent reconstruction of the trial’s analytic decisions.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced, Unresectable Pancreatic Cancer — NCT03941093.
• Registry record last updated 2024-11-05; status last verified 2024-09.
• Results first posted 2024-11-05.
• 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.

23. Record Summary

NCT03941093 is a completed Phase 3 randomized parallel-group trial of pamrevlumab or placebo added to gemcitabine plus nab-paclitaxel or FOLFIRINOX in participants with locally advanced, unresectable pancreatic cancer. The registry record lists enrollment of 284 and identifies overall survival as the primary outcome, measured from randomization to death from any cause in the intention-to-treat population.

The sponsor-reported primary analysis used a stratified log-rank test. The hazard ratio was 1.08, with a 95% confidence interval from 0.83 to 1.41 and p = 0.549. Median overall survival was 17.25 months in the pamrevlumab group and 17.94 months in the placebo group. The record also lists secondary efficacy outcomes and descriptive adverse event counts, but does not report all secondary results or detailed analysis-plan information.