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 Durvalumab Long-Term Safety and Efficacy Study (NCT04078152), a non-randomized phase 4 study. The primary outcome is Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04078152 |
| Phase | Phase 4 |
| Condition | Solid Tumor |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 163 |
| Arms in the primary outcome | n/a |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
Patients with solid tumors who were receiving durvalumab or had previously received it in other protocols. The registry describes a Safety analysis set based on durvalumab exposure in this study or recent exposure in a parent study. The number enrolled was 163; cohort-specific eligibility details are not reported in the registry record.
Intervention
Durvalumab monotherapy for participants in the continuation cohort and durvalumab restart for participants in the restart cohort. The study also included a cohort that did not restart durvalumab and was followed without treatment.
Comparator
The cohorts were not randomized. The no-restart cohort is not a like-for-like control group: assignment was non-randomized, and the registry does not establish that the groups had comparable clinical characteristics or reasons for treatment status.
Primary question
How many participants experienced adverse events (AEs) and serious adverse events (SAEs) during the study’s defined safety observation period? The registry also describes aims to continue or restart treatment for eligible participants and collect overall survival information. It does not report a randomized estimate of a treatment effect.
The question is primarily descriptive and safety-focused. An AE is defined broadly as an untoward medical occurrence that does not necessarily have a causal relationship with treatment. An SAE is an AE meeting at least one specified seriousness criterion, including death, an immediately life-threatening event, or hospitalization. The primary outcome counts participants, rather than measuring event severity on a continuous scale or comparing time to an event.
The posted results should therefore be read as cohort-specific safety counts in a selected group of patients with prior durvalumab exposure. They do not establish what would have happened to the same participants under a different treatment strategy. Overall survival, response rate, and duration of response appear among the study’s other outcomes, but outcome analyses for these measures are not reported in the registry record.
3. Trial Design
This is a Phase 4, open-label, multi-center, global study of durvalumab, listed as completed. It enrolled 163 participants. The registry gives a start date of 2019-09-05 and a primary completion date of 2022-10-31. AstraZeneca is named as the sponsor. The study title identifies it as the WAVE study.
The design is non-randomized, with parallel groups and no masking. The treatment descriptions identify a durvalumab monotherapy group and a follow-up-only group. The safety results further separate participants into Cohort 1: Durvalumab Continuation, Cohort 2: Durvalumab Restart, and Cohort 3: No Restart of Durvalumab. These descriptions convey different treatment histories or follow-up strategies, not randomized assignments.
The study’s stated aims are to monitor long-term safety, allow continued treatment or retreatment for eligible participants, and collect overall survival information. Because treatment status was not randomized, differences among the cohorts could reflect differences in participant history, eligibility, clinical condition, or other factors. Those explanations cannot be distinguished from the registry information alone. The registry record does not report criteria for choosing or entering each cohort.
The primary safety observation period starts at informed consent and extends through completion of follow-up, described as 90 days after the last durvalumab dose; the approximate timeframe is 37 months. The Safety analysis set includes participants who received at least 1 dose of durvalumab in this study or enrolled within 90 days of their last dose of durvalumab or a durvalumab combination in the relevant parent study. The record states that the data are from this study only.
Although the study lists overall response rate, duration of response, and the number of participants alive among secondary outcomes, no outcome analyses are reported in the registry record. The study design and posted results therefore support a descriptive account of safety counts, not a controlled estimate of comparative efficacy or safety.
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 163 participants were enrolled in this study.
Overall Study
| Stage | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab |
|---|---|---|---|
| STARTED | 100 | 25 | 38 |
| Received Treatment in This Study/Within 90 Days Prior Enrolment in This Study(Safety Analysis Set) | 100 | 7 | 2 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 100 | 25 | 38 |
Reasons for not completing this period:
| Reason | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab |
|---|---|---|---|
| Other | 83 | 22 | 25 |
| Development of study specific withdrawal criteria | 1 | 1 | 0 |
| Withdrawal by Subject | 5 | 0 | 1 |
| Death | 10 | 2 | 12 |
| Adverse Event | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Safety analysis set included those participants who received at least 1 dose of durvalumab in this study or enrolled in this study within 90 days of the last dose of durvalumab or durvalumab combination in the respective parent clinical study. The data is from this study only, parent study data is not included in this table.
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 Full analysis set included all participants enrolled in the study, regardless of the treatment received.
| Characteristic | Unit | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab | Total |
|---|---|---|---|---|---|
| Participants analysed | 100 | 25 | 38 | 163 | |
| Age, Continuous | years | 65.5 (SD 10.31) | 66.4 (SD 9.30) | 66.1 (SD 9.95) | 65.7 (SD 10.03) |
| Sex: Female, Male: Female | Participants | 18 | 7 | 16 | 41 |
| Sex: Female, Male: Male | Participants | 82 | 18 | 22 | 122 |
| Race/Ethnicity, Customized: White | Participants | 75 | 16 | 21 | 112 |
| Race/Ethnicity, Customized: Black or African American | Participants | 0 | 1 | 1 | 2 |
| Race/Ethnicity, Customized: Asian | Participants | 25 | 8 | 16 | 49 |
| Race/Ethnicity, Customized: Hispanic or Latino | Participants | 9 | 0 | 0 | 9 |
| Race/Ethnicity, Customized: Not Hispanic or Latino | Participants | 91 | 23 | 37 | 151 |
| Race/Ethnicity, Customized: Missing | Participants | 0 | 2 | 1 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), measured over From the time of signing the informed consent form until the follow-up period is completed (90 days after the last dose of durvalumab); approximately 37 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with adverse events and serious adverse events. It is observed from signing informed consent through completion of follow-up, defined as 90 days after the last dose of durvalumab; the registry gives an approximate timeframe of 37 months.
An AE is an untoward medical occurrence in a participant administered a medicinal product. The definition explicitly does not require a causal relationship with treatment and excludes progression of the malignancy under evaluation. An SAE is an AE that meets at least one seriousness criterion: death, immediate life threat, inpatient hospitalization or prolongation of hospitalization, persistent or significant disability or incapacity, congenital abnormality or birth defect, or an important medical event requiring intervention to prevent one of these outcomes.
Counting affected participants is useful for safety monitoring because it describes how many people experienced an event during the defined observation period. The distinction between any AE and an SAE separates a broad category of medical occurrences from events meeting the stated seriousness criteria. These counts do not, by themselves, indicate whether an event was caused by durvalumab, how long it lasted, or how severe an event was beyond the SAE classification.
The endpoint is not a time-to-event measure or a comparison of event rates adjusted for differences in follow-up. The registry record does not report an inferential analysis, an adjusted estimate, or a confidence interval for the primary endpoint. The posted cohort counts should be interpreted as descriptive safety information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety results give separate counts for three cohorts. In Cohort 1: Durvalumab Continuation, 23 participants were reported with serious adverse events among 100 at risk, and 72 were reported with other adverse events among 100 at risk. In Cohort 2: Durvalumab Restart, 0 participants were reported with serious adverse events among 7 at risk, and 1 was reported with another adverse event among 7 at risk. In Cohort 3: No Restart of Durvalumab, 0 participants were reported with serious adverse events among 2 at risk, and 0 were reported with another adverse event among 2 at risk.
These numbers describe events recorded within each cohort; they are not a comparative treatment-effect estimate. The cohorts were not randomized, and their sizes differ. In particular, counts from the smaller restart and no-restart groups are based on few participants, so their descriptive results cannot establish that an event is absent from a broader patient population. The record does not report confidence intervals or tests that would quantify uncertainty around these counts.
The record also reports deaths of 10 in the continuation cohort, 2 in the restart cohort, and 12 in the no-restart cohort. These are cohort-level counts. The registry information does not establish that these deaths were caused by durvalumab, nor does it provide a comparative survival analysis. Although death is one criterion that can make an AE serious, the reported death counts should not be assumed to map directly onto the serious-event counts without further definitions.
The most frequently listed serious-event terms include Pneumonia at 3.0% and Brain oedema at 2.0%. Acute myocardial infarction, Lipase increased, Cardiac failure, and Intervertebral disc protrusion are each listed at 1.0%. The registry supplies these percentages but does not provide event counts alongside these terms in the record summarized for this analysis. They should be read as reported term-level safety information, not as evidence of causation or as a comparison between cohorts.
No primary-outcome analysis or secondary-outcome analysis is reported in the registry record. Accordingly, the results support a description of the recorded safety experience in the study, but not a conclusion about relative risks, treatment benefit, or the expected outcome for patients outside these cohorts. The non-randomized design and the selected population are central to interpreting every cohort contrast.
9. Statistical Methods Explained
The primary outcome is a count of participants with an event. The registry labels the unit as participants and defines the outcome as the number with AEs and SAEs. This is a binary outcome at the participant level: a person is counted according to whether the specified event category was recorded during the observation period. The posted results distinguish serious from other adverse events and present cohort-specific counts and numbers at risk.
What do the counts describe?
Each cohort’s at-risk count provides context for the number of participants with recorded events. For example, the continuation cohort reports 23 participants with serious adverse events among 100 at risk. The restart cohort reports 0 among 7 at risk, while the no-restart cohort reports 0 among 2 at risk. These are observed counts, not estimates adjusted for participant characteristics or differing exposure histories.
In general, a count is an intuitive way to describe how many people experienced an event, but counts depend on how many people were observed and for how long. A count alone does not show whether one cohort had more observation time, a different baseline risk, or a different opportunity to report events. The registry gives a common general observation window for the primary endpoint, but does not provide participant-level follow-up times or an analysis accounting for variation in exposure.
Why does the non-randomized design matter?
Random assignment can, in general, help balance known and unknown participant characteristics between study groups. This study was non-randomized, so its continuation, restart, and no-restart cohorts may differ for reasons related to treatment history or eligibility. A difference in event counts cannot be attributed to treatment status alone. The registry record does not report an adjusted comparison that attempts to account for these possible differences.
The study is also open-label and has no masking. In general, knowledge of treatment status can influence event observation, reporting, or decisions about follow-up. That possibility does not show that reporting was biased in this study; it is a design consideration when interpreting safety information. The record does not report procedures to assess or correct such effects.
What uncertainty is reported?
The registry gives event counts and denominators but no confidence intervals, standard errors, hypothesis tests, or model-based estimates for the primary safety outcome. In general, a confidence interval describes the statistical uncertainty around an estimate under a specified method and assumptions. Without one, the posted counts do not show the precision of an estimated event frequency. This limitation is especially important when a cohort includes only 7 or 2 participants: zero recorded events in a small group does not establish that the underlying event risk is zero.
The record reports no outcome analyses. It therefore does not provide a statistical comparison of cohorts, a treatment-effect estimate, or an inferential result for the primary endpoint. The results should be interpreted descriptively rather than as evidence from a formal test of a difference.
How should the planning illustration be read?
The associated sample-size illustration is described as planning based on the observed effect, not as the study’s own design justification. Its stated assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a fraction of the observed effect. In general, such a calculation explores the sample size that a hypothetical design might require under selected assumptions. It is not the number enrolled in this study, does not reconstruct the original protocol, and is not observed power. The registry record does not report a sample-size justification for the trial itself.
Because the primary outcome is a participant count and the posted results do not include an analysis estimate, the planning illustration should not be treated as a test of the cohort counts or as evidence that the study was adequately or inadequately powered. The registry record does not report an interim-analysis plan, a prespecified statistical analysis plan, or details of any model used for these outcomes.
What do the serious-event terms add?
The listed serious-event terms give examples of reported event categories and their registry percentages. In general, a term-level percentage is not interchangeable with the overall number of participants with any SAE: a participant may experience more than one event, and the record does not explain whether the term percentages count participants, events, or another unit. No additional event counts or cohort-specific term comparisons are reported for these listings. The percentages therefore should not be used to infer a causal relationship or to compare treatment strategies.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary safety outcome and secondary outcomes that include overall response rate, duration of response, and the number of participants alive. It reports 4 outcome measures, but no outcome analyses are reported in the registry record. Without reported tests or estimates, there is no basis for describing which outcomes were statistically significant or how multiplicity was addressed.
Multiplicity refers, in general, to the increased chance of obtaining at least one apparently notable result when many hypotheses are tested. Methods for controlling that chance, such as adjusting significance thresholds or designating a hierarchy of outcomes, are statistical-plan decisions. The registry record does not report a multiplicity strategy, a hierarchy among outcomes, or an analysis plan. No inference should be made that an adjustment was or was not performed beyond the absence of reported analyses.
The record defines a Safety analysis set: participants who received at least 1 dose of durvalumab in this study or enrolled within 90 days of their last dose of durvalumab or a durvalumab combination in the relevant parent study. It states that the data are from this study only. Handling of missing outcome data, incomplete follow-up, and participants without an evaluable safety record is not reported in the registry record. The number included in each analysis beyond the at-risk counts shown for the safety cohorts is also not reported.
In general, missingness can affect interpretation if the availability of outcome information is related to participant condition, treatment status, or event occurrence. The registry does not describe methods such as imputation, censoring, or sensitivity analyses for missing data. It also does not report whether separate analysis populations were defined for the secondary outcomes. These omissions limit assessment of how complete and comparable the outcome information was across cohorts.
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: Durvalumab Continuation | 23 | 100 | 23.0% |
| Cohort 2: Durvalumab Restart | 0 | 7 | 0.0% |
| Cohort 3: No Restart of Durvalumab | 0 | 2 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1: Durvalumab Continuation | 10 of 100 |
| Cohort 2: Durvalumab Restart | 2 of 25 |
| Cohort 3: No Restart of Durvalumab | 12 of 38 |
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 |
|---|---|
| Cohort 1: Durvalumab Continuation | 72 of 100 |
| Cohort 2: Durvalumab Restart | 1 of 7 |
| Cohort 3: No Restart of Durvalumab | 0 of 2 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab |
|---|---|---|---|---|
| Pneumonia | Infections and infestations | 3 of 100 | 0 of 7 | 0 of 2 |
| Brain oedema | Nervous system disorders | 2 of 100 | 0 of 7 | 0 of 2 |
| Acute myocardial infarction | Cardiac disorders | 1 of 100 | 0 of 7 | 0 of 2 |
| Lipase increased | Investigations | 1 of 100 | 0 of 7 | 0 of 2 |
| Cardiac failure | Cardiac disorders | 1 of 100 | 0 of 7 | 0 of 2 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 1 of 100 | 0 of 7 | 0 of 2 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 100 | 0 of 7 | 0 of 2 |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 100 | 0 of 7 | 0 of 2 |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 100 | 0 of 7 | 0 of 2 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 100 | 0 of 7 | 0 of 2 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1: Durvalumab Continuation | Cohort 2: Durvalumab Restart | Cohort 3: No Restart of Durvalumab |
|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | 17 of 100 | 0 of 7 | 0 of 2 |
| COVID-19 | Infections and infestations | 17 of 100 | 0 of 7 | 0 of 2 |
| Aspartate aminotransferase increased | Investigations | 11 of 100 | 0 of 7 | 0 of 2 |
| Fatigue | General disorders | 11 of 100 | 0 of 7 | 0 of 2 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 9 of 100 | 0 of 7 | 0 of 2 |
| Back pain | Musculoskeletal and connective tissue disorders | 9 of 100 | 0 of 7 | 0 of 2 |
| Asthenia | General disorders | 9 of 100 | 0 of 7 | 0 of 2 |
| Blood creatinine increased | Investigations | 8 of 100 | 0 of 7 | 0 of 2 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 8 of 100 | 0 of 7 | 0 of 2 |
| Cough | Respiratory, thoracic and mediastinal disorders | 8 of 100 | 0 of 7 | 0 of 2 |
Serious events with the highest arm-level rate: pneumonia (3.0%), brain oedema (2.0%), acute myocardial infarction (1.0%), lipase increased (1.0%), cardiac failure (1.0%).
The serious adverse event counts are 23 among 100 at risk in Cohort 1: Durvalumab Continuation, 0 among 7 at risk in Cohort 2: Durvalumab Restart, and 0 among 2 at risk in Cohort 3: No Restart of Durvalumab. For other adverse events, the corresponding figures are 72 among 100, 1 among 7, and 0 among 2. These are descriptive counts in the registry’s safety groups, not adjusted comparisons.
The very different group sizes matter. In particular, zero recorded serious events in groups of 7 and 2 does not demonstrate that such events cannot occur or that the groups have equivalent safety. Conversely, a larger count in the continuation cohort cannot be interpreted as a treatment-caused excess because participants were not randomized and cohort histories may differ.
The separate death counts are 10, 2, and 12 for the continuation, restart, and no-restart cohorts, respectively. The record does not report causal attribution for these deaths or a survival analysis connecting them to treatment. A death can satisfy the registry’s SAE definition, but the available information does not justify treating the death counts as a direct substitute for the reported SAE counts.
The listed serious-event terms and percentages are descriptive listings. They do not establish whether durvalumab caused an event, and the registry does not report a cohort-level comparison for those terms.
12. What the Result Does, and Does Not, Mean
The posted results show that adverse events were recorded in the study cohorts, with counts varying by event category and cohort. The largest cohort, continuation, reports 23 participants with serious adverse events and 72 with other adverse events among 100 at risk. The restart and no-restart cohorts are much smaller, with 7 and 2 participants at risk. Their low or zero counts should be interpreted in light of those small denominators rather than as definitive evidence about event frequency.
These findings do not show that durvalumab caused a particular event. The AE definition explicitly does not require a causal relationship, and the record does not report causal attribution for the listed events. Nor do the counts show that continuing, restarting, or not restarting treatment produces better or worse outcomes: treatment groups were not randomized, and the registry does not report adjusted comparisons.
The registry’s study aims include long-term safety monitoring, treatment continuation or retreatment for eligible participants, and collection of overall survival information. The posted information does not include analyses of response rate, duration of response, or survival, so those outcomes cannot be evaluated from the reported results. No inferential analysis of the primary safety outcome is reported either.
In general, a descriptive safety record can document observed events in a particular study population and help identify categories that warrant careful review. It cannot, by itself, establish comparative safety, quantify uncertainty fully without an appropriate analysis, or predict what will happen to a different group of patients. The registry record should be read as a report of observed cohort-level counts and terms, with important limits on causal and comparative interpretation.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of a safety study in which treatment groups are defined by treatment history rather than randomized assignment. That design may be appropriate for observing patients who continue or restart treatment after participation in other protocols, but it does not create a balanced comparison. The registry’s cohort counts therefore describe clinical experience rather than isolate a treatment effect.
The denominator is essential to reading each count. The continuation cohort includes 100 participants at risk, whereas the restart and no-restart cohorts include 7 and 2. These differences mean that raw counts cannot be compared as if the groups had equal information. In general, small cohorts provide limited precision, and zero events in a small cohort leave substantial uncertainty about the event experience beyond those observed participants.
The endpoint definitions also matter. AEs include medical occurrences that do not necessarily have a causal relationship to durvalumab, while SAEs are defined by seriousness criteria. Those categories support safety description, but they do not alone establish causality or severity gradations beyond the SAE classification. The event-term percentages add detail but are not accompanied by counts or a reported comparative analysis.
Finally, the absence of reported outcome analyses shapes what can be learned statistically. The study lists efficacy and survival outcomes, but the registry record does not provide analyses for them or inferential results for the primary safety outcome. The record is most useful for understanding the study structure, its safety definitions, and the limits of interpreting non-randomized cohort counts.
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 non-randomized design is the main limitation for comparative interpretation. Participants in the continuation, restart, and no-restart cohorts may differ in treatment history, eligibility, health status, or other characteristics. The registry record does not describe these characteristics in enough detail to assess comparability, and no adjusted cohort analysis is reported. Consequently, differences in counts cannot be attributed to treatment strategy.
The restart and no-restart groups are small, with 7 and 2 participants at risk, respectively. Their counts provide limited information about events that may occur in a wider population. No confidence intervals or other measures of uncertainty are reported for the safety counts. The record also does not report participant-level follow-up or a method for accounting for differences in time at risk.
The registry defines an observation period extending through 90 days after the last durvalumab dose and gives an approximate timeframe of 37 months. It does not report the distribution of actual follow-up times, exposure duration by cohort, or how incomplete follow-up was handled. Missing-data methods and sensitivity analyses are not reported in the registry record.
The serious-event term listings include percentages but do not provide event counts alongside the terms in the information summarized for this analysis. The record does not clarify whether percentages refer to participants or events, and it does not provide term-level comparisons by cohort. Causal attribution for the listed events and deaths is also not reported.
Finally, no outcome analyses are reported for the primary safety endpoint or listed secondary outcomes. The registry record does not report a statistical analysis plan, multiplicity approach, interim analyses, or the trial’s own sample-size justification. These gaps restrict assessment of precision, missingness, and the planned inferential framework.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Durvalumab Long-Term Safety and Efficacy Study — NCT04078152.
- Registry record last updated 2024-12-20; status last verified 2024-11.
- Results first posted 2024-09-04.
- 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
NCT04078152 is a completed Phase 4, open-label, non-randomized, parallel study of durvalumab in patients with solid tumors who were receiving or had previously received durvalumab in other protocols. The study enrolled 163 participants. Its stated aims were long-term safety monitoring, continued treatment or retreatment for eligible participants, and collection of overall survival information.
The primary outcome counts participants with AEs and SAEs during follow-up, described as continuing through 90 days after the last durvalumab dose, with an approximate timeframe of 37 months. Safety results are reported for continuation, restart, and no-restart cohorts. The groups were not randomized and should not be treated as like-for-like controls.
The registry lists overall response rate, duration of response, and participants alive as secondary outcomes, but no analyses are reported. The posted safety counts and serious-event terms are descriptive; causal attribution, comparative estimates, confidence intervals, and missing-data methods are not reported in the registry record.