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 Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH) (NCT03203850), a randomized phase 2 study. The primary outcome is Proportion of Patients Achieving Target SF ≤ 100 μg/L for the First Time.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03203850 |
| Phase | Phase 2 |
| Condition | Hereditary Hemochromatosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
The study asked whether adults with hereditary hemochromatosis assigned to deferasirox film-coated tablets or phlebotomy reached the study-defined serum ferritin target. The target was serum ferritin at or below 100 μg/L, and the primary endpoint was the proportion of participants who achieved it for the first time on or before Month 24. The study also assessed safety, including ocular events and detailed ocular measurements.
Population
Adults with hereditary hemochromatosis and iron overload who were considered at risk of iron-related morbidity. The Full Analysis Set included all subjects assigned study treatment by randomization.
Intervention
Deferasirox film-coated tablets. The recorded regimen began at 7 mg/kg/day for 3 months, after which dosing was adjusted according to serum ferritin. Treatment was interrupted after the target was achieved and was to be restarted when serum ferritin reached at least 300 μg/L.
Comparator
Phlebotomy, with frequency determined by the physician. It was interrupted after the target was achieved and was to be restarted when serum ferritin was greater than 100 μg/L, based on standard-of-care practice.
Primary question
What proportion of participants in each randomized group first reached serum ferritin at or below 100 μg/L on or before Month 24? The registry record does not report the group-specific proportions or their confidence intervals.
The study was also intended to provide additional randomized data on ocular safety during treatment with deferasirox film-coated tablets for 2 years. Its secondary outcomes included ocular treatment-emergent adverse events, visual-acuity and intraocular-pressure assessments, and broader adverse-event measures. The record describes the questions assessed, but it does not give the comparative primary endpoint results needed to quantify how often participants in each group reached the ferritin target.
3. Trial Design
This was a phase II, multicenter, open-label, randomized, parallel-group study comparing deferasirox film-coated tablets with phlebotomy in hereditary hemochromatosis. The planned study duration was 2 years. The registry lists enrollment of 45 and a terminated status. The recorded start date is 2018-01-11, and the primary completion date is 2023-04-17.
Random allocation is a design feature intended to create comparable groups on average at the start of a trial. It does not guarantee that groups will be identical in a study, particularly when enrollment is limited. The registry record does not report the allocation ratio, the method used to generate the random sequence, or any method for concealing assignments before enrollment.
The trial was open-label, so masking was not used. Participants and clinical staff could know which treatment was assigned. This matters when outcomes involve treatment decisions, reporting of symptoms, or assessments that can be affected by awareness of treatment. Some ocular outcomes were based on structured assessments, but the registry record does not report whether assessors were masked.
The treatment strategies included treatment interruption after reaching the serum ferritin target, with different restart thresholds for the two groups. Deferasirox dosing began at 7 mg/kg/day for 3 months and was then adjusted according to serum ferritin; the recorded description is truncated after the restart rule. Phlebotomy frequency was determined by the physician. These details describe the assigned strategies, but they do not establish how consistently the strategies were followed.
The registry describes the study as terminated. The reason for termination and its timing in relation to recruitment or follow-up are not reported in the registry record. The record also does not report a sample-size justification or explain whether the enrollment was changed during the study. Consequently, the design information alone cannot establish whether the study had enough information to estimate the primary outcome precisely.
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: There was a screening period of 4 weeks to assess participants eligibility.
Overall Study
| Stage | Deferasirox FCT 7mg/kg | Phlebotomy |
|---|---|---|
| STARTED | 30 | 15 |
| COMPLETED | 22 | 12 |
| NOT COMPLETED | 8 | 3 |
Reasons for not completing this period:
| Reason | Deferasirox FCT 7mg/kg | Phlebotomy |
|---|---|---|
| Subject/guardian decision | 4 | 3 |
| Adverse Event | 3 | 0 |
| Death | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Full Analysis Set (FAS) comprised all subjects to whom study treatment had been assigned by randomization.
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 | Deferasirox FCT 7mg/kg | Phlebotomy | Total |
|---|---|---|---|---|
| Participants analysed | 30 | 15 | 45 | |
| Age, Continuous | years | 51.6 (SD 8.20) | 52.1 (SD 8.13) | 51.8 (SD 8.09) |
| Sex: Female, Male: Female | Participants | 4 | 3 | 7 |
| Sex: Female, Male: Male | Participants | 26 | 12 | 38 |
| Race/Ethnicity, Customized: Caucasian | Participants | 30 | 15 | 45 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Patients Achieving Target SF ≤ 100 μg/L for the First Time, measured over Up to Month 24.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the proportion of participants who achieved the serum ferritin target of at or below 100 μg/L for the first time on or before Month 24. Serum ferritin is used in this trial as the measure linked to the study’s target for managing iron overload. The endpoint expresses whether each participant met that target within the specified treatment period, then summarizes the proportion meeting the criterion in each randomized group.
The registry’s response definition is important for interpretation. A participant counted as a responder if the target was met on or before Month 24, during the treatment phase. Participants who stopped treatment prematurely before meeting the criterion were counted as nonresponders. Participants with unknown or missing serum ferritin at Month 24 were also counted as nonresponders. Thus the endpoint is not limited to participants with a documented target measurement: the stated rules assign nonresponse to specified cases of discontinuation and missing measurement.
A proportion is useful for a binary endpoint because it describes how frequently the defined event occurred in the analyzed group. The registry specifies a 95% confidence interval for this endpoint, which would convey uncertainty around an estimated proportion. The arm-specific proportions and confidence-interval bounds are not reported in the registry record, so the size and precision of the primary endpoint estimates cannot be assessed from the recorded results.
The endpoint is a target-attainment measure over a period, not a direct summary of every participant’s serum ferritin level or of the time taken to reach the target. It also does not, on its own, summarize ocular safety or other adverse events, which were addressed through separate outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study’s central comparison is clearly defined: randomized assignment to deferasirox film-coated tablets versus phlebotomy, with the primary endpoint based on first reaching serum ferritin at or below 100 μg/L by Month 24. However, the registry record does not report the number or proportion of responders in either group, or the stated 95% confidence intervals. There is therefore no reported primary effect estimate to interpret for direction, magnitude, or precision.
Without arm-level primary results, it is not possible to describe which group had a higher observed response proportion or how large any difference was. It is also not possible to assess whether the estimates were compatible with a wide range of effects or were comparatively precise. The study’s enrollment and design characteristics do not substitute for observed outcome data, and the terminated status does not by itself indicate what the results were or why the study ended.
The response definition affects what a reported proportion would mean. The registry counts participants who discontinued before reaching the target as nonresponders and applies the same classification to participants with unknown or missing serum ferritin by Month 24. This rule incorporates these cases into the endpoint rather than excluding them from the response calculation. It does not reveal how many participants fell into either category; those counts are not reported in the registry record.
The safety information offers a separate descriptive view. In the deferasirox group, 7 participants were recorded with serious adverse events among 30 at risk; in the phlebotomy group, 0 were recorded among 15 at risk. Other adverse events were recorded for 23 among 30 at risk in the deferasirox group and 12 among 15 at risk in the phlebotomy group. These counts should be read as descriptive registry figures, not as a complete comparative analysis. The record does not report adjusted comparisons or uncertainty intervals for these safety summaries.
The listed serious-event terms each have a reported frequency of 3.3%: nausea, sudden death, COVID-19, cellulitis, erysipelas, and lower limb fracture. A term’s presence in a serious-event listing does not establish that the assigned treatment caused it. The registry also records 1 death in the deferasirox group and 0 in the phlebotomy group, without enough information to determine the circumstances or attribution. In particular, the listed event terms and the overall death counts do not provide a basis for causal conclusions.
Overall, the available registry record supports description of the trial’s design, endpoint definition, and some adverse-event counts. It does not support a quantitative conclusion about the primary comparison because the responder estimates and their confidence intervals are not reported. Statistical interpretation should distinguish clearly between what the design intended to measure and what the registry reports as results.
9. Statistical Methods Explained
The primary outcome is binary at the participant level: each participant either met the registry’s response criterion by Month 24 or did not, under the stated classification rules. The group-level outcome is the proportion classified as responders. This kind of endpoint is commonly summarized with a point estimate and a confidence interval. The registry identifies the interval as a 95% confidence interval, but does not report the group-specific estimates or interval bounds.
What does a confidence interval communicate?
General statistical explanation: A confidence interval describes uncertainty around an estimate using a method with a specified long-run coverage property when its assumptions hold. It is not a guarantee that the true value lies within a particular interval, and it does not by itself establish whether a difference is clinically important. For a comparison between groups, the interval around the contrast is especially useful for assessing the range of effects compatible with the data. In this trial, the registry record does not report the primary outcome intervals, so their precision cannot be evaluated.
How should the randomized comparison be understood?
Randomization assigns participants to treatment groups by chance and can reduce systematic differences between groups at baseline. It does not remove all uncertainty or ensure that every relevant characteristic is balanced in a limited study. The registry identifies the study as randomized and parallel-group but does not report the allocation procedure or allocation ratio. It also does not provide baseline characteristics in the information recorded for this analysis. The comparison therefore has a randomized design, but the recorded details are not sufficient to evaluate balance or the operational conduct of randomization.
The trial was open-label. Awareness of assignment can influence care decisions, participant reporting, and some assessments. This is relevant to outcomes that involve symptoms or treatment decisions. The primary response is based on serum ferritin, and the registry defines how missing or unknown Month 24 measurements and early discontinuation are classified. The record does not state whether outcome assessors were masked or describe additional safeguards against assessment bias.
What do the response rules imply?
The analysis population is the Full Analysis Set, defined in the record as all subjects to whom study treatment had been assigned by randomization. The endpoint definition counts premature discontinuation before target achievement and unknown or missing serum ferritin by Month 24 as nonresponse. This is a specified missing-outcome rule, not evidence that missing data were absent. The registry does not report the number of missing measurements, early discontinuations, or participants in the Full Analysis Set by group.
General statistical explanation: A missing-data rule can influence an estimated proportion because it determines how participants without an observed endpoint are handled. Counting such participants as nonresponders is one explicit approach. Its interpretation depends on the reason data are missing and on the clinical question. The registry record does not report reasons for missing measurements or provide sensitivity analyses using alternative assumptions, so the robustness of the endpoint to missing-data assumptions cannot be assessed.
Why do analysis details matter?
The registry lists 13 outcome measures and 0 analyses. A list of outcomes describes what was planned or tracked, while a reported analysis would provide results and clarify how the data were summarized or compared. The record does not report the statistical test or model used for the primary comparison, any covariate adjustment, or a detailed analysis plan. The specified 95% confidence interval is the available method detail for the primary endpoint, but the method used to construct it is not reported in the registry record.
General statistical explanation: The choice of method for a proportion can depend on sample size, event frequency, and the intended comparison. Confidence-interval methods can behave differently, particularly when counts are small or proportions are near their boundaries. These are general considerations; the registry record does not identify a specific interval method for this endpoint.
What can be inferred from the planning assumptions?
The recorded planning illustration uses a two-sided significance level of 0.05, equal allocation between the arms, and a normal approximation. It defines the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not observed trial results. The record describes sample-size outputs as participants per arm for 80% power or participants per arm for 90% power, except for time-to-event outcomes, where the output is a total number of events. Such planning estimates are not observed power and do not establish the precision of this trial’s actual results. The registry record does not report the trial’s own sample-size justification.
The planning description depends on an observed effect, but the primary response proportions are not reported in the registry record. No numeric planning estimate is available in the recorded details described for this analysis, so none can be interpreted or reproduced. In general, planning calculations are conditional on their assumptions; they do not show that a study achieved a target level of precision or power after it was conducted.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures, including the primary serum ferritin response and secondary safety and ocular outcomes. It reports 0 analyses. The multiplicity strategy is not reported in the registry record. In particular, the record does not state whether a hierarchy of outcomes, an adjustment for multiple comparisons, or another method was specified. Without such information, results across several outcomes should not be treated as though each were an isolated confirmatory test.
The primary endpoint’s missing-data rule is stated: participants who discontinued prematurely before meeting the target and participants with unknown or missing serum ferritin by Month 24 were counted as nonresponders. The registry defines the Full Analysis Set as all subjects assigned treatment by randomization. It does not report group-specific analysis-set counts, the number of missing Month 24 measurements, reasons for missingness, or sensitivity analyses. The effect of missing data on the primary estimate therefore cannot be quantified from the registry record.
The registry record also does not report an interim-analysis plan, stopping boundaries, or a detailed statistical analysis plan. The study’s terminated status does not supply those details, and no reason for termination is reported. The primary outcome results, confidence-interval bounds, and method used to calculate them are also not reported. These omissions limit assessment of both the planned statistical controls and the completeness of the outcome reporting.
General statistical explanation: Multiplicity arises when several outcomes or comparisons are examined, because repeated testing can increase the chance of at least one apparently notable result under a null scenario. A prespecified strategy helps readers understand which findings are confirmatory and how uncertainty should be interpreted. Missing-data sensitivity analyses can show whether conclusions depend on assumptions about unobserved outcomes. These are general principles; the registry record does not report whether such procedures were used in this study.
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 |
|---|---|---|---|
| Deferasirox FCT 7mg/kg | 7 | 30 | 23.3% |
| Phlebotomy | 0 | 15 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Deferasirox FCT 7mg/kg | 1 of 30 |
| Phlebotomy | 0 of 15 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Deferasirox FCT 7mg/kg | 23 of 30 |
| Phlebotomy | 12 of 15 |
Most frequent serious adverse event terms
| Event term | Organ system | Deferasirox FCT 7mg/kg | Phlebotomy |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 1 of 30 | 0 of 15 |
| Sudden death | General disorders | 1 of 30 | 0 of 15 |
| COVID-19 | Infections and infestations | 1 of 30 | 0 of 15 |
| Cellulitis | Infections and infestations | 1 of 30 | 0 of 15 |
| Erysipelas | Infections and infestations | 1 of 30 | 0 of 15 |
| Lower limb fracture | Injury, poisoning and procedural complications | 1 of 30 | 0 of 15 |
| Blood creatinine increased | Investigations | 1 of 30 | 0 of 15 |
| Transaminases increased | Investigations | 1 of 30 | 0 of 15 |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 30 | 0 of 15 |
| Thoracic outlet syndrome | Nervous system disorders | 1 of 30 | 0 of 15 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Deferasirox FCT 7mg/kg | Phlebotomy |
|---|---|---|---|
| Blood creatinine increased | Investigations | 10 of 30 | 1 of 15 |
| Diarrhoea | Gastrointestinal disorders | 6 of 30 | 2 of 15 |
| Back pain | Musculoskeletal and connective tissue disorders | 4 of 30 | 2 of 15 |
| Headache | Nervous system disorders | 4 of 30 | 2 of 15 |
| Hypertension | Vascular disorders | 3 of 30 | 3 of 15 |
| Nausea | Gastrointestinal disorders | 5 of 30 | 0 of 15 |
| Nasopharyngitis | Infections and infestations | 2 of 30 | 3 of 15 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 30 | 3 of 15 |
| Anaemia | Blood and lymphatic system disorders | 1 of 30 | 2 of 15 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1 of 30 | 2 of 15 |
Serious events with the highest arm-level rate: nausea (3.3%), sudden death (3.3%), covid-19 (3.3%), cellulitis (3.3%), erysipelas (3.3%).
The registry records serious adverse events for 7 participants among 30 at risk in the deferasirox FCT 7mg/kg group and 0 participants among 15 at risk in the phlebotomy group. Other adverse events were recorded for 23 participants among 30 at risk in the deferasirox group and 12 participants among 15 at risk in the phlebotomy group. The registry also records 1 death in the deferasirox group and 0 in the phlebotomy group.
These are descriptive counts. The record does not report a comparative statistical analysis or confidence intervals for these safety figures. The groups also differ in the number at risk, so the counts should be read with their recorded denominators rather than compared as if they represented equal-sized groups. No percentage or adjusted risk estimate should be inferred from the counts alone.
The listed serious adverse-event terms are nausea, sudden death, COVID-19, cellulitis, erysipelas, and lower limb fracture, each reported at 3.3%. A listed term does not establish that an event was caused by treatment. The record does not provide enough detail to link the death count to a particular event listing, establish causality, or describe the timing and clinical circumstances of these events. The terms and counts provide a limited registry summary, not a complete assessment of comparative safety.
12. What the Result Does, and Does Not, Mean
The primary endpoint was designed to describe the proportion of participants in each group who reached serum ferritin at or below 100 μg/L by Month 24. The registry record gives the response definition and identifies a 95% confidence interval, but it does not report the arm-specific response proportions or confidence intervals. The posted information therefore does not establish the observed direction, size, or precision of the primary comparison.
This absence of reported primary results should not be interpreted as evidence that the groups had equal outcomes, nor as evidence that one strategy performed better. A trial design states how a question was to be studied; an outcome estimate is needed to describe what the study observed. The terminated status and enrollment figure do not resolve that gap.
The endpoint is specifically about reaching a serum ferritin target within the stated period. It does not, by itself, describe the full course of serum ferritin values, the time to target, long-term outcomes after Month 24, or every aspect of iron-related morbidity. The registry’s rules treat early discontinuation before response and missing or unknown Month 24 serum ferritin as nonresponse. Those rules define the endpoint classification, but the record does not report how many participants were affected.
Safety counts can be described, but they do not demonstrate a causal relationship between treatment and an event. The serious-event summaries are not accompanied by comparative uncertainty estimates or an adjustment for differences between groups. The recorded death count also does not explain cause or attribution. The study’s ocular safety aims and listed ocular outcomes indicate what was assessed, but the corresponding outcome results are not reported in the registry information.
Accordingly, the record supports a description of the trial question, design, response definition, and selected adverse-event counts. It does not support a conclusion about the comparative efficacy of the assigned strategies or a definitive comparative safety assessment. Any interpretation should keep the distinction between the prespecified question and the results actually reported.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it used random allocation to compare two approaches to managing iron overload in hereditary hemochromatosis and specified a clinically interpretable target-attainment endpoint. The serum ferritin threshold and Month 24 window make the response criterion explicit. The registry also states how early discontinuation and missing or unknown Month 24 measurements were handled, which is essential for understanding the meaning of a reported proportion.
The study also paired the efficacy question with an ocular safety objective. The record describes the trial as addressing an FDA post-marketing requirement for additional randomized data to confirm the ocular safety profile of deferasirox through detailed assessments over 2 years. This makes the distinction between efficacy and safety outcomes important: the primary endpoint concerns serum ferritin target attainment, while ocular assessments and adverse events are separate outcomes.
At the same time, statistical interpretation depends on results as well as design. The registry record does not report the primary response estimates, confidence intervals, or analyses. It lists 13 outcome measures and 0 analyses, and the multiplicity approach is not reported. Thus, the record identifies the intended questions but does not allow readers to evaluate the primary effect estimate or the uncertainty around it.
The limited safety counts illustrate another statistical point: raw counts need their denominators and context. The groups have different numbers at risk, and the record supplies no comparative uncertainty analysis. The counts can inform a descriptive reading of recorded events, but should not be converted into claims about relative risk or causation without an appropriate analysis and fuller reporting.
For clinical researchers, the record highlights the importance of complete reporting: outcome estimates, interval methods, analysis populations, missing-data details, and multiplicity plans all contribute to interpreting a randomized comparison. The absence of these details is not evidence for or against a treatment effect; it limits what can be concluded from the registry record.
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 interpreting the trial is that the primary outcome results are not reported in the registry record. Although the response definition and 95% confidence-interval measure are specified, the arm-specific proportions and interval bounds are absent. The primary comparison therefore cannot be quantified or assessed for precision from this record.
The registry lists the study as terminated, but the reason for termination is not reported. It also does not report whether recruitment or follow-up ended as planned, how many participants completed treatment, or how many contributed Month 24 serum ferritin measurements. Enrollment is listed as 45, but group-specific analysis counts are not reported. No sample-size justification for the trial is reported in the registry record.
The Full Analysis Set is defined as all subjects assigned treatment by randomization, and the outcome rules classify specified missing and prematurely discontinued cases as nonresponders. However, the record does not give counts or reasons for missing measurements or early discontinuations, nor does it report sensitivity analyses. The robustness of the primary result to alternative missing-data assumptions cannot be assessed.
The design was open-label, and the record does not report masking of outcome assessors. It also does not provide the randomization method, allocation ratio, baseline characteristics, or a detailed statistical analysis plan. The multiplicity approach, interim-analysis plan, and reason for any termination-related decisions are not reported in the registry record.
Safety results are limited to selected counts and serious-event terms. Comparative analyses, confidence intervals, event timing, causal attribution, and detailed descriptions of the recorded deaths are not reported. These limitations restrict both efficacy interpretation and comparative safety assessment; they do not establish that an unreported effect was absent.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH) — NCT03203850.
- Registry record last updated 2024-10-09; status last verified 2024-05.
- Results first posted 2024-06-07.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03203850 is a terminated, randomized, open-label, parallel-group phase II study of deferasirox film-coated tablets versus phlebotomy for hereditary hemochromatosis. Enrollment is listed as 45. The recorded study start date is 2018-01-11, and the primary completion date is 2023-04-17.
The primary outcome was the proportion of participants who first achieved serum ferritin at or below 100 μg/L on or before Month 24, with a specified 95% confidence interval. The Full Analysis Set comprised all subjects assigned treatment by randomization. Premature discontinuation before reaching the target and missing or unknown serum ferritin at Month 24 were classified as nonresponse.
The registry record does not report the primary arm-level results or confidence intervals. It lists 13 outcome measures and 0 analyses. Selected serious and other adverse-event counts are reported, but the record does not provide comparative uncertainty estimates or enough detail to establish causality.