Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder (NCT02046564), a randomized phase 3 study. The primary outcome is The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.

2. Clinical Question

3. Trial Design

The registry describes a phase 3, randomized, quadruple-masked, parallel-group trial sponsored by Otsuka Pharmaceutical Co., Ltd. It lists major depressive disorder as the condition and reports an enrollment of 412. The study status is completed. The recorded start was 2014-02, and primary completion was 2016-09.

Participants who responded incompletely to sertraline monotherapy were assigned to ASC-01 or placebo in addition to sertraline. ASC-01 was the aripiprazole/sertraline combination, listed at 3-12mg/100mg once daily. The placebo arm received placebo/sertraline at 0mg/100mg once daily. The record identifies the design as randomized and parallel, but does not report the allocation sequence method, allocation concealment details, or the identities of the people included in quadruple masking.

The primary endpoint was mean change from baseline in MADRS total score. The record defines the baseline as 8 weeks after the start of the sertraline treatment period and the assessment as 6 weeks after the start of the double-blind period, using LOCF. The primary outcome summaries list 208 participants for ASC-01 and 203 for placebo. These endpoint denominators differ from the safety at-risk counts, which are reported separately. The trial's detailed protocol, the original sample-size justification, and the full statistical analysis plan are not reported in the registry record.

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.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score, measured over 8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF]).

The primary endpoint was mean change from baseline in the MADRS total score. MADRS is a clinician-rated measure of depression with ten items covering symptoms such as sadness, inner tension, sleep, appetite, concentration, and suicidal thought. Each item is scored from 0 to 6, and the total ranges from 0 to 60. Higher total scores indicate worse condition.

Change scores express how much the total score shifted between the specified baseline and follow-up assessment. A negative value therefore represents a reduction in score; a larger reduction is a greater improvement on this measure. The registry specifies the outcome assessment as 6 weeks after the start of the double-blind period, with the baseline at 8 weeks after the start of sertraline treatment. Missing observations were handled using LOCF for this endpoint, although the record does not describe the details of missingness or the assumptions behind that approach.

A continuous score can retain gradations of change that are lost when outcomes are reduced to categories such as response or remission. It also describes average change across the analyzed group rather than the proportion crossing a specified threshold. The registry does not report the thresholds used to define the secondary response and remission outcomes.

7. Results Posted in the Registry

• ASC-01: mean -9.20 versus -7.20 on control; difference -2.00 (95% CI -3.39 to -0.61), standardized effect d = -0.28; z-test p = 0.005.

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.

The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • ASC-01: 37.5% (78/208) versus 25.6% (52/203) on control; risk difference 11.9 percentage points (95% CI 3.0 to 20.8), risk ratio 1.46 (1.09–1.96); unadjusted two-proportion z-test p = 0.010.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for ASC-01 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • ASC-01: 29.3% (61/208) versus 20.2% (41/203) on control; risk difference 9.1 percentage points (95% CI 0.8 to 17.4), risk ratio 1.45 (1.03–2.05); unadjusted two-proportion z-test p = 0.032.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for ASC-01 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The Clinical Global Impression - Improvement (CGI-I) Improvement Rate

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • ASC-01: 46.2% (96/208) versus 34.5% (70/203) on control; risk difference 11.7 percentage points (95% CI 2.3 to 21.1), risk ratio 1.34 (1.05–1.70); unadjusted two-proportion z-test p = 0.016.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for ASC-01 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry lists secondary measures covering MADRS response and remission, clinician-rated improvement and severity, depressive symptoms, social adaptation, apathy, and self-rated MADRS. Detailed arm-level comparisons are posted for MADRS response, MADRS remission, and CGI-I improvement. For each of these three rate outcomes, the recorded percentage is numerically higher in the ASC-01 arm than in the placebo arm. This directional pattern is consistent with the primary mean-change comparison, which also showed a larger average reduction in the ASC-01 arm.

These outcomes address related but not identical questions. A continuous change score describes average movement on a scale, whereas response, remission, and improvement rates classify participants according to outcome definitions. The registry record does not include the thresholds defining response, remission, or CGI-I improvement. Nor does it provide detailed results for the other listed secondary measures in the outcome summaries. Results for those measures are not reported in the registry record.

The unadjusted recalculated comparisons for the three posted secondary rates have confidence intervals for the risk differences that do not include zero. Their unadjusted p-values are 0.01 for response, 0.032 for remission, and 0.016 for improvement. These are nominal, unadjusted comparisons. When several outcomes are examined, the chance of finding at least one apparently notable result by chance can increase. Without a reported multiplicity procedure or prespecified testing hierarchy, secondary findings carry less confirmatory weight than a result evaluated under a defined analysis plan.

The alignment in direction across the primary outcome and these secondary measures is informative as a pattern, but does not establish that every listed measure changed, or that the secondary comparisons independently confirm the primary result. Their interpretation depends on outcome definitions, missing-data handling, and multiplicity considerations that are not fully described in the registry record.

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

• The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate
• The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate
• The Clinical Global Impression - Improvement (CGI-I) Improvement Rate
• The Mean Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S)
• The Mean Change From Baseline in the Hamilton Depression Rating Scale 17 (HAM-D17) Total Score
• The Mean Change From Baseline in the Social Adaptation Self-evaluation Scale (SASS) Total Score
• The Mean Change From Baseline in the Apathy Scale (AS) Total Score
• The Mean Change From Baseline in the Self-rating Version of Montgomery-Åsberg Depression Rating Scale (MADRS-S) Total Score

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant has a MADRS total score and the endpoint summarizes change in that score. The arm-level summaries are means, accompanied by standard errors of 0.5 in each arm. A mean describes the average change, while a standard error describes the precision of the estimated mean. It is not the same as the spread of individual participant scores.

What does the mean difference represent?

The recalculated mean difference was -2.0, defined by comparing the ASC-01 mean change with the placebo mean change. The sign matters because this measure is a change in a scale where higher scores indicate worse condition. A negative difference in change favors a larger reduction in the ASC-01 arm, while a positive difference would favor a larger reduction in the placebo arm. This is a difference between group averages; it is not the change for a typical individual and does not show how much the distributions of individual outcomes overlap.

The registry record reports the MADRS scale range as 0 to 60, with higher scores indicating worse condition. The difference is expressed in units on that scale. The standardized effect estimate, d = -0.279, is also included among the recalculated comparison statistics. Standardization expresses a mean difference relative to a measure of variability, which can make effects on different scales easier to compare in general. It does not replace interpretation in the original MADRS units.

How should the confidence interval and p-value be read?

A confidence interval gives a range of values compatible with the data and the method used to calculate it, under that method's assumptions. The 95% interval for the mean difference runs from -3.386 to -0.614. Because the whole interval is negative, it does not include zero, the value representing no difference in average change. The unadjusted p-value of 0.005 describes how unusual a result at least this incompatible with the no-difference hypothesis would be under that hypothesis and the calculation's assumptions. It is not the probability that the no-difference hypothesis is true, nor a measure of clinical importance.

These inferential quantities are unadjusted recalculations from the posted summaries. The registry has no reported analyses for the primary outcome. The statistical model, any covariate adjustment, and the original inferential procedure are not reported in the registry record. The recalculation should not be mistaken for a complete account of the sponsor's prespecified analysis.

What does LOCF imply?

LOCF means Last Observation Carried Forward: when an outcome value is missing at the scheduled assessment, an earlier recorded value is used in its place. In general, this creates an analysis dataset that treats the carried-forward value as if it represents the scheduled outcome. Its performance depends on why measurements are missing and whether earlier values remain informative about later outcomes. Missingness patterns, the number of values carried forward, and sensitivity analyses are not reported in the registry record. The primary result therefore has to be read as based on the stated LOCF approach, without enough information to assess how alternative assumptions would affect it.

Why do the endpoint counts differ from safety counts?

The primary endpoint summaries report 208 participants for ASC-01 and 203 for placebo, whereas the safety summaries report 209 and 203 at risk. These are the denominators recorded for different types of outcomes. Safety analyses commonly use a safety population, while efficacy analyses may use a separately defined analysis population; that is a general distinction, not a claim about the specific populations used in this trial. The registry record does not define the analysis populations or explain the difference in the ASC-01 denominators.

In general, randomization is intended to make treatment groups comparable at entry by allocating participants by chance, and masking is intended to limit the influence of knowledge of assigned treatment. The record identifies randomization and quadruple masking but does not give operational details of either procedure. The actual masking roles, stratification factors, and allocation method are not reported in the registry record.

11. Confidence Intervals and Precision

The estimated mean difference is -2.0 MADRS units, and its 95% confidence interval extends from -3.386 to -0.614. The interval excludes zero, so the unadjusted recalculation is inconsistent with a zero difference under the calculation used. Its width also makes clear that the exact average difference is uncertain: values across the interval remain compatible with the data and method. The interval concerns the difference between arm means, not a prediction interval for individual participant outcomes.

Standard errors of 0.5 are reported for both arm means. A standard error reflects uncertainty in an estimated mean rather than the variation among individual scores. The registry does not provide standard deviations for the arm-level change scores; the comparison includes a pooled standard deviation of 7.168 as part of its recalculated statistics. The standardized estimate is d = -0.279. These summaries give different views of the same group comparison: MADRS units preserve the scale's direct meaning, while a standardized estimate relates the difference to variability.

Confidence intervals do not account for unreported design or analysis choices, and the interval is from an unadjusted recalculation rather than a reported sponsor analysis. The registry does not report an adjusted interval, a multiplicity correction, or sensitivity intervals for missing-data assumptions. It also does not provide enough information to assess how the interval would change under other analysis populations or methods. Precision should therefore be considered in the context of the stated LOCF endpoint and the limitations of the registry record.

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 planning figures are participants per arm for each listed comparison, not total events. The planning illustration uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Its target effect is a stated fraction of the observed effect. The original design assumptions for this trial, including the assumptions used to choose its enrollment target, are not reported in the registry record.

The 80% power column describes the planned number of participants per arm for a hypothetical study to have an 80% chance of detecting the chosen effect under the stated assumptions, if that effect is the true one. The 90% power column gives the corresponding planning target for a 90% chance. These are prospective planning concepts, not guarantees about a future study's result. For continuous outcomes and the listed binary outcomes, the figures represent participants per arm; they are not total event counts.

Rows that plan for 75% or 50% of the observed effect assume a smaller difference to detect than the row based on 100% of the observed effect. Smaller effects are harder to distinguish from random variation, so the planning calculation requires more participants per arm to reach the same target power. These are illustrations based on the observed effect and listed assumptions, not the trial's original sample-size calculation. This is not observed power.

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

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2.000; pooled standard deviation σ = 7.168.
2. n = 2 × (1.96 + 0.842)² × 7.168² / -2.000² = 201.6, rounded up to 202 participants per arm 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
delta <- -2                      # observed difference in means
sigma <- 7.1681685657354                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2046564)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 202 (80% power), 270 (90% power)
 75% of observed effect: n per arm = 359 (80% power), 480 (90% power)
 50% of observed effect: n per arm = 807 (80% power), 1,080 (90% power)
power.t.test: 202.6 
Simulated power at n = 202 per arm: 0.800 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The record lists a primary outcome and multiple secondary outcomes, but does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a rule for controlling the overall type I error rate. The posted p-values for the secondary comparisons are unadjusted. In general, testing multiple outcomes without adjustment can increase the chance that one or more results appear statistically notable by chance. This makes the secondary results less conclusive than they would be under a fully specified confirmatory testing strategy.

The registry record does not report whether the primary outcome was tested before secondary outcomes, whether any outcomes were designated as key secondary endpoints, or how the sponsor planned to interpret the family of tests. It also does not report interim analyses, stopping rules, or whether any statistical analyses were changed after the study began. These details are not reported in the registry record, so they cannot be assumed.

The primary outcome uses LOCF. The record does not describe the extent or reasons for missing data, the missing-data assumptions, or sensitivity analyses. It does not report whether missing observations were handled in the same way for all other outcomes. LOCF can influence estimated changes when a carried-forward value differs from the unobserved scheduled result; the size and direction of any influence cannot be determined from the posted information.

The primary outcome counts and safety at-risk counts differ for the ASC-01 arm. The analysis populations and participant flow that would explain this difference are not reported in the registry record. The record also does not specify the primary analysis population, the treatment of protocol deviations, or whether all randomized participants were included in the primary analysis. The randomization and masking are described, but their implementation details are not reported.

These omissions limit assessment of how closely the recalculated comparisons correspond to the trial's planned analyses. They do not change the numerical results posted for the outcomes, but they constrain conclusions about confirmatory status, robustness to missing data, and the handling of multiple endpoints.

15. 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 2% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: gastric ulcer (0.5%), clavicle fracture (0.5%).

The safety summaries report serious adverse events for 0 of 209 participants at risk in the ASC-01 group and 2 of 203 at risk in the placebo group. The registry identifies gastric ulcer and clavicle fracture as the top serious-event terms, each listed at 0.5%. No deaths were reported in either group. The other adverse-event counts are 128 of 209 for ASC-01 and 107 of 203 for placebo.

These are descriptive counts over the safety reporting period recorded in the registry. They do not show, by themselves, whether an event was caused by assigned treatment. Serious adverse events are not interchangeable with all adverse events, and event counts do not describe severity, duration, or the timing of each event. The registry does not provide additional detail on event definitions, follow-up duration for safety, or individual event narratives.

The at-risk counts are the safety denominators, not the primary endpoint denominators. The registry record does not explain the difference between the ASC-01 safety and efficacy counts. These safety summaries should be read as reported observations rather than as a complete comparative assessment of safety.

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

The posted primary outcome summaries show a more negative average change in MADRS total score for ASC-01 than for placebo, with an unadjusted recalculated mean difference of -2.0. The 95% confidence interval, from -3.386 to -0.614, lies below zero, and the unadjusted p-value is 0.005. In plain terms, the observed average reduction was greater in the ASC-01 arm at the specified assessment, under the stated LOCF approach.

This result is about an average score difference in the trial population described by the registry. It does not mean that all participants had a greater reduction, that a particular participant would have the same change, or that the observed difference has a particular importance to patients. Individual outcome distributions and a threshold for a meaningful difference are not reported in the registry record.

The comparison is between ASC-01 and placebo alongside sertraline among patients who responded incompletely to sertraline monotherapy. It does not establish results for other populations, other comparators, other treatment durations, or outcomes not reported in the registry. The secondary rate outcomes generally point in the same direction among those with posted detailed comparisons, but they are unadjusted and are not a substitute for a reported multiplicity plan.

The result also cannot resolve uncertainties arising from LOCF, unreported analysis populations, or missing details of the statistical plan. The registry record does not provide a sponsor-reported primary analysis in the analysis listings. The recalculated estimate describes the posted summaries and should be interpreted as such. It is evidence about this trial's recorded endpoint, not a guarantee of an outcome for any individual or a recommendation about care.

17. Why This Trial Matters Statistically

This trial illustrates how the choice of outcome scale shapes interpretation. MADRS change retains information about the average shift in a clinician-rated depression score, while response and remission rates classify participants into categories. The primary mean difference is expressed in the scale's units, and the secondary comparisons offer a related but distinct view of outcomes. Reading both types of measures helps distinguish average change from the proportion meeting categorical criteria.

It also demonstrates why estimates need to be read alongside their uncertainty. The mean difference is accompanied by a confidence interval, which gives a range of plausible average differences under the unadjusted calculation. A p-value alone would not communicate the size or precision of the difference. The scale direction is essential too: because higher MADRS scores indicate worse condition, a more negative change corresponds to a larger reduction.

The record also highlights the limits of registry reporting for statistical appraisal. LOCF is identified, but the missing-data pattern and sensitivity analyses are not. The record identifies randomization and quadruple masking without operational detail, and it does not report a multiplicity strategy or analysis populations. Those gaps matter when deciding how strongly to treat nominal results as confirmatory.

Finally, the sample-size illustrations distinguish planning from retrospective interpretation. Their assumptions are stated and their estimates scale with the effect one aims to detect, but they are not evidence about the trial's original design choices or observed power. Together, these features provide a useful case for separating endpoint meaning, effect estimation, precision, and reporting limitations.

18. 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 registry record provides limited detail about analysis conduct. It does not report a full statistical analysis plan, the primary analysis population, the model used for the primary comparison, or whether covariates were included. The recalculated unadjusted comparison can be interpreted from the posted summaries, but it cannot establish that it matches the sponsor's intended analysis.

LOCF is specified for the primary endpoint, but the record does not describe how many outcomes were carried forward, why scheduled observations were missing, or whether alternative missing-data analyses were conducted. This leaves uncertainty about the sensitivity of the result to missing-data assumptions. The record also does not report participant flow or explain why the ASC-01 safety and primary endpoint denominators differ.

The registry gives no multiplicity procedure for the several secondary outcomes and no testing hierarchy. The detailed secondary comparisons are unadjusted, so their nominal results should not be treated as independent confirmation without a prespecified approach. Results for the other listed secondary measures are not reported in the registry record.

Although randomization and quadruple masking are recorded, the sequence generation, concealment, masking roles, and possible unmasking are not described. The original sample-size justification, protocol deviations, and any interim analyses are also not reported in the registry record. Finally, the posted information does not provide longer-term outcomes or a detailed account of individual safety events. These are limitations of what can be assessed from the registry record, not evidence that a particular procedure was or was not used.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder — NCT02046564.
• Registry record last updated 2018-05-21; status last verified 2018-05.
• Results first posted 2018-05-21.
• 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.

22. Record Summary

NCT02046564 is a completed phase 3, randomized, quadruple-masked, parallel-group trial sponsored by Otsuka Pharmaceutical Co., Ltd. It enrolled 412 patients with major depressive disorder who had responded incompletely to sertraline monotherapy. ASC-01, an aripiprazole/sertraline combination, was compared with placebo/sertraline.

The primary endpoint was mean change in MADRS total score at 6 weeks after the start of the double-blind period, using LOCF. The arm means were -9.2 for ASC-01 and -7.2 for placebo. The unadjusted recalculated mean difference was -2.0, with a 95% confidence interval from -3.386 to -0.614 and an unadjusted p-value of 0.005.

The registry lists several secondary outcomes and records serious adverse events and deaths by arm. Important details about analysis populations, multiplicity, missing-data sensitivity analyses, and the original design assumptions are not reported in the registry record.