Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab. (NCT04381494), a na phase 4 study. The primary outcome is Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade.

2. Clinical Question

3. Trial Design

This was a prospective, interventional pilot study of mobile devices and digital applications for detecting early pneumonitis and other pulmonary adverse events in people with unresectable stage III non-small cell lung cancer receiving durvalumab. The registry lists the study as phase 4, with a single-group model, allocation marked not applicable, and no masking. Enrollment was 40.

Participants were to be enrolled after their treating physician had prescribed durvalumab and before they began it. The arm is labelled “Observational/Other” in its description, which says that mobile and wearable devices would be used alongside durvalumab without additional interventions. Thus, although the registry classifies the study as interventional, the described device use was not paired with a separate treatment-control arm.

The registry gives a start date of 2020-04-27 and a primary completion date of 2022-01-27. Its current status is terminated. The reason for termination and whether it affected recruitment, follow-up, or outcome reporting are not reported in the registry record. The record also does not report a planned enrollment target separate from the enrollment figure, or a rationale for the sample size.

The design can describe events observed in the enrolled group, but it cannot by itself isolate a device effect from other explanations. Without a concurrent comparison group, differences in detection or event reporting cannot be attributed to the technology using this design alone. The registry does not report a randomized allocation or a masking procedure.

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: A total of 40 participants were enrolled in this study after their treating physician prescribed durvalumab and before starting durvalumab. Data was collected via Current Wearable Health Monitoring System.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The SAF included all enrolled participants who took at least 1 dose of durvalumab.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: The Safety Analysis set (SAF) included all enrolled participants who took at least 1 dose of durvalumab.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Treatment-Emergent Adverse Event (TEAE) of Pneumonitis by Grade, measured over TEAEs were reported from the first dose of durvalumab up to 30 days after the last dose of durvalumab, a maximum of approximately 13 months.

The primary endpoint is the number of participants with a treatment-emergent adverse event of pneumonitis, classified by grade. An event was defined as a new undesirable medical condition or worsening of a pre-existing condition following or during exposure to a pharmaceutical product or device, whether or not considered causally related. For pneumonitis, the window began after the first dose of durvalumab and continued through 30 days after the last dose, up to a maximum of approximately 13 months.

Severity was assessed with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5. Grade 1 is mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life-threatening and requiring hospitalization; Grade 4, life-threatening; and Grade 5, death due to any adverse event.

Counting participants by grade gives a descriptive account of the burden and recorded severity of pneumonitis during the defined window. Such counts do not, on their own, measure how accurately or promptly the devices detected events. Pneumonitis counts by grade are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry lists the primary outcome as a count of participants with pneumonitis, grouped by severity grade. This is a binary participant-level outcome: for a given event definition and follow-up window, a participant either has a recorded event or does not. The grade categories add a description of severity. The endpoint is not a continuous measurement such as a score, and the registry does not define it as a time-to-event estimate.

What does a participant count tell readers?

As a general statistical concept, a count makes the observed event burden tangible. To interpret a count as a proportion, readers also need the relevant denominator: the number of participants assessed for that endpoint. The registry gives the primary safety population definition but does not report the pneumonitis counts by grade or endpoint-specific denominators. The enrollment figure cannot automatically be treated as the denominator for every outcome, since the safety population is defined by having taken at least 1 dose and outcome-specific availability is not described.

The event window matters to interpretation. The registry defines pneumonitis events as those occurring or worsening after the first durvalumab dose through 30 days after the last dose, with a maximum of approximately 13 months. A count within that window is specific to that observation period and event definition. It does not describe events outside the window. The registry does not report how event ascertainment was operationalized in relation to device alerts or clinical review.

Can the design estimate a device effect?

As a general statistical concept, a comparative effect requires a meaningful comparison between outcomes under different strategies. This study is listed as single-group, with allocation not applicable and no masking; there is no separate control arm in the record. A count observed in one group can describe that group, but it cannot show what would have happened to a comparable group without the devices. Differences from other settings or historical experience would not resolve that limitation unless the comparison methods and assumptions were specified. Such methods are not reported in the registry record.

The registry’s stated aim concerns improved detection, whereas the primary endpoint counts pneumonitis events by grade. Detection performance is a distinct statistical question. In general, evaluating it would require a defined reference for whether an event occurred and information about when and how it was detected. The registry record does not report a formal detection-performance analysis or a comparator for that purpose.

How should uncertainty be considered?

As a general explanation, estimates from a study are subject to sampling variation: another group of participants could yield different observed counts even under similar conditions. A confidence interval is one way to express that uncertainty around an estimate. It does not correct a design limitation, remove bias, or establish causation. The registry does not report confidence intervals for the primary pneumonitis endpoint, and the outcome counts needed to assess its precision are not reported.

The record lists no statistical analyses. It therefore does not describe a model for the primary outcome, an inferential comparison, or an adjustment strategy. None should be assumed. Because the outcome is a count of participants with an event, general methods for binary data could be relevant in a suitable analysis, but the registry does not identify a method used for this endpoint. Likewise, there is no basis in the record to infer an analysis of over-dispersion; that issue generally arises when count variability exceeds what a chosen model expects, and this endpoint is defined as participant counts with an event rather than a repeated-event rate.

The separate sample-size illustrations on the site are planning calculations based on an observed effect and stated assumptions; they are not observed power and are not the trial’s own design justification. The registry does not report a sample-size justification or enough primary endpoint results to support a pneumonitis-specific effect estimate. Planning calculations cannot supply the missing clinical results or create a comparator absent from the study design.

What does the registry leave unspecified?

The record does not report interim analyses, a detailed statistical analysis plan, or how multiplicity was handled. It also does not explain missing-data methods, endpoint-specific exclusions, or sensitivity analyses. These omissions limit assessment of the planned analysis and the robustness of any endpoint findings. They do not establish that a particular method was or was not used outside the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures, including the primary pneumonitis outcome and secondary outcomes concerning durvalumab discontinuation, treatment duration and interruptions, other pulmonary treatment-emergent adverse events, and prescription medication for pneumonitis. When a study assesses multiple outcomes, the chance of at least one apparently notable result can increase if each is tested separately. As a general statistical principle, multiplicity approaches may be used to manage that issue. The registry record does not report a multiplicity strategy, hierarchy among secondary outcomes, or adjustment procedure.

The registry lists no statistical analyses. It does not report interim analyses, a detailed analysis plan, or whether any outcomes were exploratory. The record therefore does not allow readers to determine which comparisons, if any, were planned for inference or how the family of outcomes was to be interpreted.

Missing-data handling is also not reported in the registry record. The primary safety population is defined as enrolled participants who took at least 1 dose of durvalumab, but the record does not provide pneumonitis counts by grade, endpoint-specific denominators, or details about incomplete follow-up. It does not state how participants with missing assessments or unknown event status would be treated. These gaps matter because an event proportion depends on who was observed and how missing outcomes were handled.

The record gives enrollment of 40 and adverse-event figures for 40 at risk, but these details do not establish that every outcome was available for every participant. Nor do they describe how the safety population relates to the analysis population for each secondary measure. Without those definitions and results, completeness and potential bias from missing outcome data cannot be evaluated.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pneumonia (5.0%), nausea (2.5%), vomiting (2.5%), disease progression (2.5%), muscular weakness (2.5%).

The adverse-event summary lists 5 participants with serious adverse events among 40 at risk, 20 with other adverse events among 40 at risk, and 1 death. These are aggregate safety figures. The registry does not provide enough detail in this summary to determine whether participants or events overlap across categories, so the counts should not be added together.

The listed serious adverse-event terms and percentages are pneumonia, 5.0%; nausea, 2.5%; vomiting, 2.5%; disease progression, 2.5%; muscular weakness, 2.5%; and dizziness, 2.5%. The registry labels these as top serious terms. The denominator and any term-level overlap are not reported in the registry record, so the percentages should be read as registry-listed values rather than recalculated or treated as rates.

The summary does not establish that any event was caused by durvalumab or by the devices. The primary endpoint is pneumonitis by grade, but its results are not reported in the registry record; pneumonia in the serious-event term list should not be substituted for those pneumonitis results. The record does not report whether the death was related to treatment, the device, or a particular adverse event.

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

The registry record establishes that a pilot study evaluated mobile and wearable technology alongside durvalumab in people with unresectable stage III NSCLC. It describes a single-group design and a primary endpoint counting pneumonitis events by grade. The posted safety summary also gives aggregate serious and other adverse-event counts, a death count, and selected serious-event terms.

It does not establish whether the technology improved detection. There is no separate control group, and the registry does not report a device-specific detection comparison. The primary pneumonitis counts by grade are not reported in the registry record, so the posted results do not answer how many participants experienced pneumonitis or its recorded severity. No precision estimates for that endpoint are reported either.

The adverse-event figures should not be read as proof that the device or durvalumab caused an event, nor as evidence that an event was unrelated. The registry defines treatment-emergent adverse events by their timing, whether or not considered causally related. Its aggregate summary does not assign causation to the events or explain the relationship of the reported death to treatment.

More generally, a single-group pilot can provide descriptive information and may inform questions for later evaluation, but its observed event counts cannot provide the counterfactual comparison needed to attribute a difference to device use. The registry record does not report a planned sample-size rationale, statistical analysis plan, or detection-performance analysis. The terminated status is recorded, but the reason and its impact on follow-up or reporting are not stated. As a result, the supported interpretation is narrow: the record describes the intended study and some aggregate safety information, while leaving the primary pneumonitis findings and the comparative detection question unresolved.

13. Why This Trial Matters Statistically

This trial raises a statistical distinction that is important in studies of monitoring technology: observing adverse events is not the same as showing that a monitoring tool detects them better. The registered primary outcome counts participants with pneumonitis by grade. The stated study aim is to assess improved detection of pulmonary adverse events. Answering the latter requires information about detection itself and a comparison that can separate device-associated detection from what would occur without the device.

The single-group design makes the interpretation especially important. It allows the study to describe experience among participants using the devices alongside durvalumab, but it does not create a like-for-like control. Without such a comparison, event counts cannot establish that the device changed detection or outcomes. This is a design limitation, not a failure of statistical calculation.

The record also illustrates why outcome reporting and denominators matter. Enrollment is reported, as are aggregate safety figures, but pneumonitis results by grade and endpoint-specific denominators are not reported in the registry record. Readers therefore cannot evaluate the primary outcome’s magnitude or precision. A method cannot recover information that is not reported.

Finally, a pilot’s value depends on clear reporting of feasibility, outcome definitions, completeness, and analysis plans, not merely on an event count. The registry describes the endpoint definition and follow-up window, but does not report a detailed statistical plan, missing-data handling, or multiplicity strategy. These limits help define what future comparative monitoring studies would need to specify for their detection claims to be assessed.

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 central limitation is the absence of a comparator. The registry lists a single-group study, with allocation not applicable and no masking. As a result, there is no concurrent group against which to assess detection or event patterns under device use. The design cannot by itself attribute observed findings to the technology.

The primary endpoint results are not reported in the registry record. In particular, pneumonitis counts by grade and endpoint-specific denominators are unavailable, preventing assessment of the observed primary outcome and its precision. The registry’s aggregate adverse-event summary does not fill this gap: it does not identify pneumonitis results by grade or establish the relationship between the listed adverse events and the primary endpoint.

The record reports enrollment of 40 and defines the safety population as enrolled participants who took at least 1 dose of durvalumab. It does not report how many participants were included in each outcome analysis, whether follow-up was complete, or how missing data were handled. The reason for termination and any consequences for recruitment or follow-up are also not reported in the registry record.

Further limitations of interpretation arise because the record lists no statistical analyses and does not report a detailed analysis plan, multiplicity strategy, or sample-size justification. It does not describe a device-specific detection measure. The serious-event percentages are listed without a reported denominator in the summary, and the record does not report causal attribution for the adverse events or death. These limitations constrain conclusions about both the primary outcome and the stated detection aim.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab. — NCT04381494.
• Registry record last updated 2023-06-22; status last verified 2023-05.
• Results first posted 2023-06-22.
• 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.

18. Record Summary

The registry describes a phase 4, prospective, interventional pilot with a single-group model and enrollment of 40. It evaluated mobile and wearable devices alongside durvalumab in people with unresectable stage III NSCLC. Allocation is listed as not applicable, masking as none, and status as terminated.

The primary outcome was the number of participants with treatment-emergent pneumonitis by grade, from the first durvalumab dose through 30 days after the last dose, up to a maximum of approximately 13 months. Pneumonitis-specific results by grade are not reported in the registry record. The adverse-event summary lists 5 participants with serious adverse events, 20 with other adverse events, and 1 death among 40 at risk; causal relationships are not reported.

The record lists 13 outcome measures and no statistical analyses. It does not report a separate comparator, a detection-performance analysis, a statistical analysis plan, or the reason for termination.