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 Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study (NCT03872427), a na phase 2 study. The primary outcome is Best Overall Response Rate by 6 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03872427 |
| Phase | Phase 2 |
| Condition | Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, NF1 Mutation Positive Malignant Peripheral Nerve Sheath Tumor |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 54 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
People with advanced, metastatic, or unresectable solid tumors, including malignant peripheral nerve sheath tumors (MPNST), with tumor types and genetic alterations described in the registry summary. The listed alterations include NF1 for MPNST and NF1, KEAP1/NRF2, or STK11/LKB1 for other solid tumors. The registry record does not give further eligibility details for each cohort.
Intervention
Telaglenastat hydrochloride, also called CB-839 HCl, taken by mouth twice daily on days 1-28. Cycles repeat every 28 days while disease progression or unacceptable toxicity has not occurred.
Comparator
There is no separate comparator group in this single-group study. The record lists no randomized allocation and no masking. Outcomes are therefore not presented as a randomized comparison with another treatment or with a control group.
Primary question
The primary endpoint asks how many participants achieve a best overall response, based on RECIST version 1.1, by 6 months from treatment start. The registry record does not report the response count or a response-rate estimate.
The study examines a biological rationale in selected tumor and mutation groups: glutaminase converts glutamine to glutamate, and the registry summary describes telaglenastat as blocking glutamine-related activity that may support cell growth. This mechanism is the study’s rationale, not a clinical outcome. The trial is registered as phase II and includes imaging with CT, MRI, or PET/CT, along with blood sample collection and biospecimen collection. The registry record does not provide cohort-specific response results, so the stated question cannot be answered from the posted results described in the record.
3. Trial Design
This is a phase II, single-group study of telaglenastat hydrochloride. The registry lists no randomized allocation and no masking. Its enrollment is 54, and the posted status is active, not recruiting. The study began on 2019-12-14, with primary completion dated 2023-10-30. These registry entries describe the study’s registration and status, not the number of participants with an evaluable primary outcome.
The treatment description specifies oral telaglenastat hydrochloride twice daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Participants also undergo CT, MRI, or PET/CT during screening and on study, and blood samples are collected during screening and on study. Biospecimen collection and a pharmacodynamic study are also listed. The registry record does not give further operational details about these procedures.
The study’s basket structure is reflected in its focus on different tumor and mutation groups: NF1-mutant MPNST and other solid tumors with NF1, KEAP1/NRF2, or STK11/LKB1 alterations. The adverse-event results are organized into Cohort 1, Cohort 2, Cohort 3, and Cohort 4. The registry record does not define the membership or mutation criteria for each numbered cohort, so those cohort labels should not be treated as interchangeable or assigned specific genetic characteristics from the posted information.
Several secondary outcomes are named, including adverse events, progression-free survival, time to progression, overall survival, overall response rate, and clinical benefit rate. The record indicates 10 outcome measures, but does not provide a complete account of the analysis methods or outcome results. With no concurrent comparator, the design can describe outcomes among treated participants, but it does not establish a randomized treatment contrast.
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: Out of the 55 patients enrolled, one patient did not receive treatment due to a death before starting the trial.
Overall Study
| Stage | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|
| STARTED | 9 | 26 | 9 | 10 |
| COMPLETED | 9 | 26 | 9 | 10 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
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.
| Characteristic | Unit | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 9 | 26 | 9 | 10 | 54 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 | 12 | 7 | 8 | 34 |
| Age, Categorical: >=65 years | Participants | 2 | 14 | 2 | 2 | 20 |
| Sex: Female, Male: Female | Participants | 4 | 17 | 4 | 5 | 30 |
| Sex: Female, Male: Male | Participants | 5 | 9 | 5 | 5 | 24 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 0 | 1 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 8 | 26 | 9 | 9 | 52 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 2 | 1 | 1 | 9 |
| Race (NIH/OMB): White | Participants | 4 | 24 | 7 | 7 | 42 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 1 | 1 |
| Region of Enrollment: United States | participants | 9 | 26 | 9 | 10 | 54 |
6. Primary Endpoint
The registry lists the primary outcome as Best Overall Response Rate by 6 Months, measured over Up to 6 months from treatment start date.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is best overall response rate by 6 months. It is defined as the count of participants achieving a best overall response based on RECIST version 1.1 by 6 months from treatment start. The endpoint is recorded in participants, so the underlying outcome is a count of people who meet the response definition during the stated period. The registry record does not report the observed count, a response-rate estimate, or its uncertainty.
Response endpoints are used in oncology studies to describe tumor response according to prespecified criteria. RECIST version 1.1 provides standardized rules for classifying response from tumor assessments. As a general statistical point, a fixed assessment window makes clear the period during which the endpoint is being evaluated, but interpretation also depends on how assessments, missing evaluations, and response classifications are handled. Those details are not reported in the registry record.
The named primary endpoint should be distinguished from the secondary outcomes. Overall response rate is also listed as a secondary outcome, alongside progression-free survival, time to progression, overall survival, clinical benefit rate, and adverse events. The record does not explain how the primary response endpoint is distinguished analytically from the secondary overall response rate. It also does not report the primary endpoint results. Therefore, the endpoint definition identifies what was intended to be measured, but does not by itself indicate how many participants responded or how precisely that outcome was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a phase II single-group study and defines best overall response by 6 months as the primary endpoint. It does not report the primary response count, an estimated response rate, or statistical analyses of that endpoint. Consequently, the posted information does not establish the observed response pattern or its precision. An endpoint definition is not a result: it describes what investigators intended to measure, not what the measurements showed.
The adverse-event data are reported by four numbered cohorts. For Cohort 1, serious adverse events affected 5 of 9 participants at risk, other adverse events affected 9 of 9, and the death count is 7. For Cohort 2, the corresponding counts are 7 of 26, 24 of 26, and 20 deaths. For Cohort 3, they are 4 of 9, 8 of 9, and 6 deaths. For Cohort 4, they are 6 of 10, 10 of 10, and 8 deaths. These are descriptive counts from the registry record. They do not establish that treatment caused an event or death, and the record does not give enough information to compare the cohorts as if they were randomized groups.
The record also lists serious adverse-event terms with percentages, including constipation and tracheal obstruction at 22.2%, death NOS and dyspnea at 20.0%, and abdominal pain and back pain at 11.1%. These entries describe reported terms and percentages; the record does not specify in the information the denominator or further grouping details for those percentages. They should not be interpreted as treatment-attributable risks without additional context.
There is no randomized control group, and the cohorts are not described as like-for-like comparisons. Differences in their counts could reflect differences in participant characteristics, tumor types, follow-up, or other factors; the registry record does not provide the information needed to separate such explanations. Likewise, a count of deaths in adverse-event reporting is not by itself an estimate of treatment-related mortality or overall survival.
The registry lists other outcomes of interest, but does not report their results in the record described. No confidence intervals, hypothesis tests, adjusted estimates, or analysis populations are reported. Without these results, statistical interpretation is limited to describing the study design, endpoint definitions, and posted adverse-event counts. The record does not support a conclusion about comparative effects or the precision of the primary response outcome.
9. Statistical Methods Explained
The statistical information in the registry record is limited. It identifies a single-group phase II design, a count-based primary response endpoint, a set of secondary outcomes, and cohort-level adverse-event counts. It does not report a detailed statistical analysis plan, inferential results, or methods for handling incomplete observations. General statistical concepts can clarify what such information would mean, but they cannot fill in methods or results that are not reported in the registry record.
What does a single-group design allow?
In a single-group design, outcomes are described among participants receiving the study treatment. Without a separate comparison group, the study does not directly estimate how outcomes would differ under another treatment or under no study treatment. A before-and-after change, if reported, would also require careful interpretation because the design does not by itself distinguish treatment effects from disease course, participant selection, or other changes over time. In this registry record, no primary response result is reported, so even a within-group response estimate is unavailable.
What does the response count represent?
The primary endpoint is a count of participants whose best overall response meets RECIST version 1.1 criteria by 6 months from treatment start. A count can be presented descriptively, while a response rate would require a defined denominator and a rule for handling participants without an evaluable assessment. The registry record defines the endpoint in participants but does not report the observed count, response-rate estimate, denominator for that estimate, or missing-assessment rule. No rate should be inferred from the total enrollment or cohort-level adverse-event counts.
How should uncertainty be understood?
In general, a confidence interval describes a range of values compatible with the observed data under a specified statistical method. It communicates sampling uncertainty and does not remove design limitations, such as the lack of a control group. No confidence interval for the primary endpoint or adverse-event results is reported in the registry record. A point estimate without an uncertainty interval, if one were posted, would give less information about precision than an estimate accompanied by an interval; neither is available for the primary endpoint in this record.
What does the sample-size illustration mean?
The planning illustration described for the study uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Its effect to detect is expressed as a stated fraction of the observed effect. For time-to-event outcomes, the illustration uses a total number of events based on the Schoenfeld method; other outcomes are expressed as participants per arm. This is a planning calculation based on an observed effect, not an observed power result. Its two-arm assumptions do not describe the actual single-group treatment design. Numerical planning estimates and the observed effect used for them are not reported in the registry record.
Why does over-dispersion matter in general?
Over-dispersion is a general issue for count outcomes when variation in the data exceeds what a chosen model expects. If present, it can make standard errors and confidence intervals from an overly restrictive model too optimistic. The primary endpoint is described as a participant count, but the registry record does not report a model for that endpoint or any dispersion assessment. It is therefore not possible to say whether over-dispersion was evaluated or relevant to the analysis.
What can be inferred from the adverse-event counts?
The adverse-event information gives affected-participant counts by cohort and distinguishes serious adverse events from other adverse events. Counts are useful descriptive summaries, but interpretation depends on definitions, observation periods, coding, and follow-up completeness. The registry record does not report those details in the information described. The serious-event percentages are listed without enough accompanying detail to identify their denominators. Neither the counts nor the listed terms alone establish causation. The record also gives no adjusted comparisons between cohorts, and the study is not a randomized comparison.
Overall, the available methods information supports a descriptive reading of the posted design and safety counts. The registry record does not report analyses for the primary response endpoint, confidence intervals, hypothesis tests, or adjustment methods. Those absences constrain conclusions about both statistical significance and precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry record names a primary endpoint and several secondary outcomes: incidence of adverse events, progression-free survival, time to progression, overall survival, overall response rate, and clinical benefit rate. It indicates 10 outcome measures overall, but the information described does not provide a complete list of all outcome measures or report results for them. The record does not report a multiplicity plan, such as how interpretation of multiple statistical tests or endpoints would be handled. Without that information, the relationship among endpoint analyses and any control of false-positive findings cannot be assessed.
Missing-data methods are not reported in the registry record. This matters for a response endpoint assessed by 6 months because participants may not all have assessments available at the relevant time. The record does not specify how unevaluable participants, missed scans, early discontinuation, or incomplete follow-up were treated in calculating the endpoint. No assumptions about those procedures should be made from the endpoint definition alone.
Analysis populations are also not reported in the registry record. The available information does not say whether the response analysis used all treated participants, only participants with measurable disease, or another defined population. Nor does it specify how participants were assigned to analysis sets. The enrollment figure does not establish the denominator used for an endpoint analysis.
Because no primary response result or inferential analysis is posted, it is not possible to assess endpoint-specific precision, multiplicity, or the effect of missing observations. These are not minor details: they determine how the outcome count is interpreted and which participants contribute to a reported estimate. The appropriate conclusion is that these methods are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Cohort 1 | 5 | 9 | 55.6% |
| Cohort 2 | 7 | 26 | 26.9% |
| Cohort 3 | 4 | 9 | 44.4% |
| Cohort 4 | 6 | 10 | 60.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1 | 7 of 9 |
| Cohort 2 | 20 of 26 |
| Cohort 3 | 6 of 9 |
| Cohort 4 | 8 of 10 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cohort 1 | 9 of 9 |
| Cohort 2 | 24 of 26 |
| Cohort 3 | 8 of 9 |
| Cohort 4 | 10 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|---|
| Death NOS | General disorders | 1 of 9 | 2 of 26 | 0 of 9 | 2 of 10 |
| Constipation | Gastrointestinal disorders | 0 of 9 | 0 of 26 | 2 of 9 | 2 of 10 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 0 of 9 | 0 of 26 | 1 of 9 | 2 of 10 |
| Pain | General disorders | 0 of 9 | 2 of 26 | 1 of 9 | 0 of 10 |
| Abdominal pain | Gastrointestinal disorders | 0 of 9 | 1 of 26 | 1 of 9 | 0 of 10 |
| General and admin site - Other - Failure To Thrive | General disorders | 0 of 9 | 1 of 26 | 0 of 9 | 1 of 10 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 1 of 9 | 0 of 26 | 0 of 9 | 1 of 10 |
| Tracheal obstruction | Gastrointestinal disorders | 2 of 9 | 0 of 26 | 0 of 9 | 0 of 10 |
| Tumor pain | General disorders | 0 of 9 | 1 of 26 | 1 of 9 | 0 of 10 |
| Acute kidney injury | Injury, poisoning and procedural complications | 0 of 9 | 1 of 26 | 0 of 9 | 0 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 2 of 9 | 10 of 26 | 5 of 9 | 3 of 10 |
| Hyponatremia | Metabolism and nutrition disorders | 5 of 9 | 7 of 26 | 4 of 9 | 4 of 10 |
| Lymphocyte count decreased | Investigations | 4 of 9 | 10 of 26 | 2 of 9 | 3 of 10 |
| Fatigue | General disorders | 5 of 9 | 9 of 26 | 1 of 9 | 3 of 10 |
| Nausea | Gastrointestinal disorders | 3 of 9 | 9 of 26 | 1 of 9 | 3 of 10 |
| ALT increased | Investigations | 2 of 9 | 11 of 26 | 1 of 9 | 0 of 10 |
| Anorexia | Metabolism and nutrition disorders | 2 of 9 | 5 of 26 | 3 of 9 | 3 of 10 |
| Constipation | Gastrointestinal disorders | 2 of 9 | 6 of 26 | 2 of 9 | 2 of 10 |
| Abdominal pain | Gastrointestinal disorders | 1 of 9 | 6 of 26 | 1 of 9 | 2 of 10 |
| Alkaline phosphatase increased | Investigations | 1 of 9 | 8 of 26 | 0 of 9 | 1 of 10 |
Serious events with the highest arm-level rate: constipation (22.2%), tracheal obstruction (22.2%), death nos (20.0%), dyspnea (20.0%), abdominal pain (11.1%).
The registry record reports serious adverse events and other adverse events as participant counts within four cohorts. In Cohort 1, serious adverse events affected 5 of 9 at risk, other adverse events affected 9 of 9, and 7 deaths are listed. In Cohort 2, the counts are 7 of 26, 24 of 26, and 20 deaths. In Cohort 3, they are 4 of 9, 8 of 9, and 6 deaths. In Cohort 4, they are 6 of 10, 10 of 10, and 8 deaths. These are descriptive counts, not estimates of comparative risk.
The record lists constipation and tracheal obstruction at 22.2%, death NOS and dyspnea at 20.0%, and abdominal pain and back pain at 11.1% among the serious adverse-event terms. The percentages should be read as the registry’s reported values; further denominator and grouping details are not reported in the registry record.
Seriousness does not mean that an event was caused by the study treatment. The registry record does not establish causality for these events or deaths. It also does not provide the follow-up duration, event-level timing, or cohort definitions needed for a more detailed safety comparison. The death counts in this adverse-event summary should not be treated as an overall-survival analysis or as treatment-attributable deaths.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase II single-group study evaluated telaglenastat hydrochloride in selected tumor and mutation groups, and that the primary endpoint was best overall response by 6 months using RECIST version 1.1. It also records adverse-event counts by four cohorts. These details clarify what the study set out to measure and what safety counts were posted.
The record does not report the primary response count or response-rate estimate, and it does not report statistical analyses of that endpoint. As a result, the posted information cannot show the observed response outcome or how precisely it was estimated. The absence of a reported result is not evidence of a particular response pattern. No treatment conclusion should be drawn from the endpoint definition alone.
The design also does not include a randomized comparator. Outcomes within a single treatment group do not establish what would have happened to similar participants under another treatment. The cohort-level safety counts are descriptive; they do not prove that telaglenastat caused an event or death, and they do not provide a valid randomized comparison among cohorts. The deaths recorded in the adverse-event information are not a substitute for reported overall-survival results.
The registry lists additional outcomes, including progression-free survival, time to progression, overall survival, overall response rate, clinical benefit rate, and adverse events. Their results and analysis details are not reported in the registry record described. The appropriate interpretation is therefore narrow: the record describes the study design, outcome definitions, and certain adverse-event counts, but does not provide enough outcome or analysis information to quantify the primary response result or make comparative statistical claims.
13. Why This Trial Matters Statistically
This study illustrates a recurring statistical challenge in precision oncology: a trial may examine several tumor and mutation groups while using a single-group design. The registry summary identifies NF1-mutant MPNST and other solid tumors with NF1, KEAP1/NRF2, or STK11/LKB1 alterations. Such a scope makes clear why cohort definitions and cohort-specific outcome reporting matter. In this record, the adverse-event data use four numbered cohorts, but their membership is not described in the information available.
The statistical distinction between an endpoint definition and an endpoint result is central. The primary endpoint specifies a RECIST-based response count within a 6-month window, yet the result itself is not reported in the registry record. Without the count, denominator, and uncertainty estimate, readers cannot assess the observed response level or its precision. A planned measurement is not evidence of an outcome.
The design also highlights the limits of interpreting results without a control group. Descriptive outcomes can characterize what was recorded among treated participants, but do not alone separate treatment-related changes from other explanations. This matters especially when reading safety counts: serious adverse events and deaths are important outcomes, but counts without attribution, follow-up context, or a comparison group do not establish a causal effect.
Finally, planning assumptions should not be confused with the actual study design or with evidence of statistical power. The described illustration assumes two equally allocated arms, whereas the registered study is single-group. This makes transparent reporting of the analysis plan and outcome results important for judging how planning calculations relate to the study that was conducted.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for statistical interpretation is that the registry record does not report the primary response result. It defines best overall response by 6 months but gives no observed count, response-rate estimate, or confidence interval. The record also does not report the results of the listed survival and clinical benefit outcomes. The available information therefore does not permit assessment of the main clinical endpoint or its precision.
The single-group design has no concurrent randomized comparator. Outcomes cannot be interpreted as a randomized treatment contrast, and the cohorts should not be treated as comparable groups without information about their composition and allocation. The registry record does not define the numbered cohorts by tumor type or mutation, limiting cohort-level interpretation.
Further details needed to interpret the endpoint are not reported in the registry record, including the analysis population, response-evaluation rules beyond the stated RECIST version, handling of unevaluable participants, missing-data procedures, and statistical analysis plan. The record also does not report a multiplicity approach for the primary and secondary outcomes.
Safety reporting is descriptive and lacks context in the information described: event timing, follow-up duration, detailed attribution, and denominators for the listed serious-event percentages are not reported in the registry record. The death counts in the adverse-event summary do not supply an overall-survival analysis. These limitations restrict conclusions to the posted design and counts; they do not establish that unreported analyses were or were not conducted outside the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Testing Whether Cancers With Specific Mutations Respond Better to Glutaminase Inhibitor, Telaglenastat Hydrochloride, Anti-Cancer Treatment, BeGIN Study — NCT03872427.
- Registry record last updated 2026-11-02; status last verified 2026-10.
- Results first posted 2025-07-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03872427 is a phase II, single-group study sponsored by the National Cancer Institute (NCI). It evaluates telaglenastat hydrochloride in selected solid tumors and MPNST associated with specified genetic alterations. Registry enrollment is 54. The study began on 2019-12-14, primary completion is dated 2023-10-30, and its status is active, not recruiting.
The primary endpoint is best overall response by 6 months, based on RECIST version 1.1. The registry record does not report the primary response result or statistical analyses. It does report adverse-event counts by four cohorts, without establishing treatment causality or a randomized comparison. Results for the other listed outcomes are not reported in the registry record described.