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 Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT00758459), a randomized phase 2 study. The primary outcome is Incidence of Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00758459 |
| Phase | Phase 2 |
| Condition | Chronic Obstructive Pulmonary Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 74 |
| Arms in the primary outcome | 2 |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
Participants with moderate to severe chronic obstructive pulmonary disease (COPD) were eligible for the study. The registry records an enrollment of 74 participants. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
The intervention was AZD1236, described as an oral tablet in the official study title. The registry lists it as a drug intervention. Dose, dosing schedule, and additional treatment details are not reported in the registry record.
Comparator
The comparator was placebo. The registry describes the study as placebo-controlled and lists placebo as a drug intervention. The arm descriptions contain no additional details about the placebo or how it was administered.
Primary question
The primary question was whether the number of participants experiencing an adverse event differed between AZD1236 and placebo over all study visits. The stated primary aim was to assess tolerability and safety using adverse events, vital signs, and laboratory safety assessments. The posted primary outcome counts are 13 participants in the AZD1236 arm and 17 in the placebo arm. These counts describe participants with an event; they do not by themselves establish whether any difference is reliable or attributable to treatment.
3. Trial Design
The registry describes a phase IIa, randomized, double-blind, parallel-group study comparing AZD1236 with placebo in participants with moderate to severe COPD. Its official title specifies a 6-week study. The record is marked completed and reports enrollment of 74 participants. The sponsor is AstraZeneca.
Random allocation is intended to create groups that can be compared while reducing the influence of factors that affect treatment assignment. A parallel-group design assigns participants to a study arm and follows those arms over the study period, rather than having each participant receive both interventions. Double masking means that the record describes the study as double-blind; which people were masked and how masking was maintained are not reported in the registry record.
The arm counts are 35 participants assigned to AZD1236 and 39 assigned to placebo. The registry does not provide further arm descriptions, details of the allocation process, or information about whether all randomized participants completed follow-up. The study's primary aim was safety and tolerability assessment. The registry also lists lung-function measures and a COPD questionnaire among the secondary outcomes, including FEV1, FVC, VC, IC, FEF25-75%, morning and evening PEF, and the CCQ total score.
The registry record does not report the original sample-size justification, the trial's planned statistical methods, or whether interim analyses were planned. Randomization and masking describe important elements of the design, but do not resolve questions about baseline comparability, missing observations, or the conduct of analyses. Those details are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | AZD1236 | Placebo |
|---|---|---|
| STARTED | 35 | 39 |
| COMPLETED | 32 | 35 |
| NOT COMPLETED | 3 | 4 |
Reasons for not completing this period:
| Reason | AZD1236 | Placebo |
|---|---|---|
| Adverse Event | 3 | 2 |
| Protocol Violation | 0 | 1 |
| Withdrawal by Subject | 0 | 1 |
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 | AZD1236 | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 35 | 39 | 74 | |
| Age Continuous | Year | 61.7 (48 to 76) | 61.7 (46 to 77) | 61.7 (46 to 77) |
| Sex: Female, Male: Female | Participants | 11 | 12 | 23 |
| Sex: Female, Male: Male | Participants | 24 | 27 | 51 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence of Adverse Events, measured over all study visits.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the incidence of adverse events, expressed as the number of participants who had an adverse event across all study visits. In the AZD1236 arm, 13 of 35 participants had an adverse event; in the placebo arm, 17 of 39 did. The endpoint counts participants with an event rather than counting every event experienced by each participant. The registry does not report how events were defined for this endpoint, how they were collected, or whether a participant with more than one event was counted only once, beyond describing the measure as the number of patients who had an adverse event.
Safety endpoints are used to describe unwanted events observed during a study and to compare their occurrence between groups. A count of participants affected is straightforward to interpret, but it does not convey event severity, timing, duration, or how many events each participant experienced. Those details are not part of the posted primary endpoint result. The study summary also identifies vital signs and laboratory safety assessments as part of its safety aim, but their results are not reported in the registry record.
The primary endpoint should therefore be read as a summary of participants recorded as having an adverse event during the study visits, not as a complete account of every safety measure or event characteristic.
7. Results Posted in the Registry
- AZD1236: 37.1% (13/35) versus 43.6% (17/39) on control; risk difference -6.4 percentage points (95% CI -28.8 to 15.9), risk ratio 0.85 (0.49–1.49); unadjusted two-proportion z-test p = 0.573.
Risk difference: AZD1236
95% CI: -28.8 to 15.9 percentage points
Recalculated from the posted summary statistics
8. Statistical Interpretation
The posted primary outcome counts are 13 participants with an adverse event among 35 in the AZD1236 arm and 17 among 39 in the placebo arm. The unadjusted comparison based on these counts gives p = 0.573. The confidence interval for the risk difference includes no difference and permits effects in either direction. Taken together, these results do not provide a statistically clear distinction between the groups in the primary endpoint. They also do not establish that the groups are equivalent: a result that does not distinguish them is not the same as evidence that their event rates are identical.
The counts are small, and the comparison is imprecise. The interval is broad enough to include a possible lower event risk with AZD1236 as well as a possible higher risk. Thus, the point estimate alone should not be treated as a precise estimate of the underlying difference. A p-value describes how compatible the observed data are with a specified no-difference model under the assumptions of the test; it is not the probability that the treatments are the same, nor a measure of clinical importance.
The registry lists 35 participants in the AZD1236 arm and 39 in the placebo arm, with an enrollment of 74 overall. The primary counts are numbers of participants with an event, and the comparison uses those group sizes. No adjusted analysis or analysis population is described in the registry record. The posted comparison is unadjusted, so it does not account for potential differences in participant characteristics or other covariates.
The study's stated aim was safety and tolerability, but the primary outcome is only one part of that assessment. Vital signs and laboratory safety results are not reported in the registry record. Nor are event timing, duration, severity classifications for the primary endpoint, or participant-level information. Secondary outcomes include measures of lung function and a COPD questionnaire, but their results are not reported in the registry record. Consequently, the primary result cannot answer questions about those measures or provide a comprehensive account of safety.
The registry's serious-adverse-event figures are separate from the primary endpoint counts. They list one participant with a serious adverse event in the AZD1236 arm and none in the placebo arm; the small counts warrant cautious description and do not establish a comparative pattern. Interpretation is also limited because the record does not report an analysis plan, missing-data methods, or details of how adverse events were assessed. The available results are best understood as a short-study descriptive comparison with substantial uncertainty, rather than a definitive estimate of between-group safety differences.
9. Statistical Methods Explained
The posted comparison is an unadjusted comparison of binary outcomes. Each participant is classified as having or not having the primary event, and the analysis compares the event experience in the randomized groups. This differs from an analysis of event counts per participant: the primary endpoint is the number of participants with an adverse event, not the total number of separate adverse events.
What does the risk difference describe?
A risk difference expresses the difference between the proportions with an event in two groups. Its sign indicates which group has the higher observed event proportion under the comparison's stated ordering. The posted estimate is negative for AZD1236 relative to placebo, indicating a lower observed event proportion in the AZD1236 group in this comparison. A risk difference is an absolute measure: it describes the gap between group event proportions rather than a relative multiplier. The registry record does not report a clinically meaningful threshold for interpreting that gap.
The confidence interval around a risk difference describes a range of values compatible with the observed data under the method used to construct it. The posted interval includes no difference and reaches into values consistent with effects in either direction. That range is more informative about uncertainty than the point estimate alone. It does not identify which value is true, and it does not mean that all values in the interval are equally likely.
What does the p-value add?
The unadjusted p-value is p = 0.573. In general, a p-value measures how unusual data at least as discrepant as those observed would be under a specified null model and its assumptions. It is not the probability that the null model is true, nor the probability that AZD1236 has no effect. A comparatively large p-value does not prove there is no difference; it indicates that these data do not provide strong evidence against the no-difference model using this test. The registry record does not report a prespecified analysis plan or a sponsor-reported analysis for comparison with the unadjusted calculation.
Why can the estimate be uncertain?
Precision depends in part on how much information the data contain. With relatively few participants and event counts, a small change in the observed counts can matter to the estimated group difference. The confidence interval reflects that uncertainty. Randomization helps support a fair comparison on average, but it does not guarantee that the groups have identical characteristics, particularly in a study of this size. Baseline characteristics are not reported in the registry record, so their balance cannot be assessed from the posted results.
Binary outcomes can be analyzed using several methods, and the choice can affect estimates and intervals, especially with limited data. The registry record does not describe the statistical method used for the primary analysis, any covariate adjustment, or any sensitivity analyses. The posted comparison is therefore best described as an unadjusted analysis based on the event counts and group sizes, rather than as a complete account of a prespecified trial analysis.
What is not conveyed by the primary comparison?
The primary endpoint records whether a participant had an adverse event, but does not describe the number of events per participant, their severity, or their timing. A participant with one event and a participant with several events may both contribute one person to the endpoint count. Separate serious-adverse-event figures provide limited additional information, but do not substitute for event-level details. The record does not report whether events were judged related to treatment or how event coding and review were conducted.
These are general statistical considerations, not additional methods confirmed for this trial. In particular, the original protocol's endpoint definition, analysis population, model choice, missing-data procedure, multiplicity strategy, and interim-analysis plan are not reported in the registry record. The reader should distinguish those unknown trial methods from the general interpretation of a binary outcome comparison and its uncertainty.
10. Confidence Intervals and Precision
The risk-difference confidence interval is broad and includes no difference. It also extends to values that would represent an advantage in either direction. This means the estimated contrast is not precise enough to rule out meaningfully different underlying event proportions on either side of no difference. The posted interval should be read together with the point estimate and group counts, rather than as a yes-or-no verdict.
A confidence interval is a measure of statistical uncertainty under the method and assumptions used to calculate it. In general, intervals constructed by the same method would capture the underlying parameter at their stated rate over repeated studies. For an individual study, the interval does not assign a probability to the parameter being inside its particular limits. The registry record does not state the method used for the trial's original analysis; the displayed comparison is an unadjusted recalculation from the posted summary counts.
The group sizes, 35 and 39, and the event counts, 13 and 17, give a limited amount of information for estimating a difference. The interval's width reflects that limitation. A point estimate can appear to favor one group while uncertainty remains compatible with the opposite direction. This is why the observed direction should not be treated as a settled treatment effect.
The confidence interval addresses the primary binary comparison only. It does not describe uncertainty in the unreported vital-sign, laboratory, or secondary-outcome results. Nor does it account for possible missing outcome data or choices in the original analysis plan, which are not reported in the registry record.
11. Planning a Similar Trial: Sample Size
This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.
| Effect to detect | Participants per arm, 80% power | Participants per arm, 90% power |
|---|---|---|
| 100% of the observed effect | 908 | 1,216 |
| 75% of the observed effect | 1,626 | 2,176 |
| 50% of the observed effect | 3,679 | 4,924 |
The planning figures are participants per arm, not total events. Each row illustrates a hypothetical future design based on a stated fraction of the observed effect: planning for 100% of the observed effect gives 908 participants per arm for 80% power and 1,216 for 90% power; planning for 75% gives 1,626 per arm for 80% power and 2,176 for 90% power; planning for 50% gives 3,679 per arm for 80% power and 4,924 for 90% power.
The calculations assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The target effect is the stated fraction of the observed effect. The 80% power column gives the illustrative number of participants per arm under those assumptions for a design with an 80% chance of detecting that target effect if it is the true effect. The 90% column expresses the corresponding planning target at 90% power. These are planning illustrations based on the observed effect, not observed power.
Smaller target effects require more participants to detect under otherwise unchanged assumptions, which is why the required numbers increase as the assumed fraction of the observed effect decreases. The original trial's sample-size assumptions and justification are not reported in the registry record, so these figures should not be read as the basis on which the completed study was designed. They are sensitive to the observed estimate, which is uncertain in this study, and should be interpreted as illustrations rather than as a forecast of a future study's results.
12. How the Sample Size Is Derived
Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z1−α/2 = 1.960) and the desired power (z1−β = 0.842 for 80% and 1.282 for 90%).
Formula
n is the number of participants in each arm, p0 and p1 are the control and treatment proportions, and p̄ is their average.
Worked calculation for this trial
- Control proportion p0 = 0.436; treatment proportion p1 = 0.371; average p̄ = 0.404.
- First term: z1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6939 = 1.3599.
- Second term: z1−β × √[p0(1−p0) + p1(1−p1)] = 0.842 × 0.6924 = 0.5827.
- n = (1.3599 + 0.5827)2 / (-0.0645)2 = 908.0, rounded up to 908 participants per arm for 80% power.
The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).
R code
alpha <- 0.05
z_a <- qnorm(1 - alpha / 2) # two-sided
p0 <- 0.435897435897436 # control proportion
p1 <- 0.371428571428571 # treatment proportion
n_per_arm <- function(power, frac = 1) {
q1 <- p0 + (p1 - p0) * frac # smaller effect = fraction of the observed difference
pbar <- (p0 + q1) / 2
z_b <- qnorm(power)
ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))
# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")
# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(758459)
n <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))
Output from running the code
100% of observed effect: n per arm = 908 (80% power), 1,216 (90% power)
75% of observed effect: n per arm = 1,626 (80% power), 2,176 (90% power)
50% of observed effect: n per arm = 3,679 (80% power), 4,924 (90% power)
power.prop.test: 908
Simulated power at n = 908 per arm: 0.797 (20000 replicates)The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.
13. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 secondary outcomes and 14 outcome measures. The secondary outcomes include lung-function measures such as FEV1, FVC, VC, IC, FEF25-75%, and morning and evening PEF, as well as the CCQ total score. Results for these secondary outcomes are not reported in the registry record. No analysis records are posted.
When a study examines multiple outcomes or makes multiple comparisons, the chance of obtaining at least one apparently unusual result can rise if each result is assessed separately. Multiplicity procedures are methods for controlling or describing that issue. The registry record does not report whether the study used such procedures, which outcomes were designated for formal testing beyond the stated primary outcome, or how any secondary comparisons were to be interpreted. No adjustment should be assumed.
The record also does not report how missing outcome data were handled, whether any participants withdrew, or whether the primary analysis included all randomized participants or a subset. The arm counts and endpoint counts are posted, but the analysis population and any exclusions are not described. Without those details, it is not possible to assess whether participants with missing observations differed from those whose outcomes were recorded or to determine the impact of missingness on the comparison.
Baseline characteristics, protocol deviations, and the prespecified statistical analysis plan are not reported in the registry record. The record does not say whether covariates were included, whether sensitivity analyses were conducted, or whether interim analyses were planned. These omissions limit assessment of how closely the posted estimates align with the planned trial analysis, and of how secondary findings would have been interpreted if results were available.
14. 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 |
|---|---|---|---|
| AZD1236 | 1 | 35 | 2.9% |
| Placebo | 0 | 39 | 0.0% |
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 |
|---|---|
| AZD1236 | 8 of 35 |
| Placebo | 8 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | AZD1236 | Placebo |
|---|---|---|---|
| Pharyngeal Cancer Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 35 | 0 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | AZD1236 | Placebo |
|---|---|---|---|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | 3 of 35 | 4 of 39 |
| HEADACHE | Nervous system disorders | 4 of 35 | 1 of 39 |
| VIRAL INFECTION | Infections and infestations | 1 of 35 | 3 of 39 |
Serious events with the highest arm-level rate: pharyngeal cancer stage unspecified (2.9%).
The serious-adverse-event figures list 1 participant with a serious adverse event among 35 participants in the AZD1236 arm and 0 among 39 in the placebo arm. These are counts of participants affected, not counts of every serious event. With such small counts, the difference is descriptive and does not establish a reliable comparative pattern.
The registry separately lists other adverse events for 8 participants in each arm: 8 of 35 for AZD1236 and 8 of 39 for placebo. These figures should not be added to the serious-event counts, because the record does not explain whether categories can overlap or how they were defined. The primary endpoint counts are broader counts of participants with an adverse event and are not interchangeable with the serious-event figures.
The registry lists Pharyngeal Cancer Stage Unspecified with a value of 2.9% among the top serious-event terms. The denominator and group attribution for that term are not reported in the registry record. Death counts are not reported. The record does not provide event timing, relatedness assessments, severity details beyond the serious classification, or narratives. These figures therefore offer only a limited summary of the safety information posted.
15. What the Result Does, and Does Not, Mean
The posted data show that 13 participants in the AZD1236 arm and 17 in the placebo arm were recorded as having an adverse event. The unadjusted comparison gives p = 0.573, and the confidence interval includes no difference while allowing effects in either direction. The result is therefore inconclusive about whether the underlying event proportions differed between groups. It does not establish that the proportions were equal, and it does not establish that AZD1236 reduced or increased adverse events.
The study was described as a phase IIa safety and tolerability study with a 6-week duration. Its primary endpoint is one summary of adverse events, not a comprehensive measurement of every aspect of safety. The registry also identifies vital signs and laboratory assessments as part of the safety aim, but their results are not reported in the registry record. Serious-event counts are small and should be interpreted descriptively. The listed top serious-event term does not include enough context in the record to support a treatment attribution.
The registry lists secondary lung-function and questionnaire outcomes, but their results are not reported in the registry record. No conclusion about those outcomes can be drawn from the primary adverse-event comparison. The same applies to longer-term outcomes: the posted result concerns events across study visits in a 6-week study and does not describe experience beyond that period.
More generally, an observed difference between groups in a randomized study can be affected by sampling variation. Confidence intervals help show the range of uncertainty, while the p-value addresses compatibility with a no-difference model under the analysis assumptions. Neither statistic replaces information about event severity, clinical context, or the completeness of outcome collection. The available registry results support a cautious description of the observed counts, not a clinical recommendation or a definitive treatment-effect claim.
16. Why This Trial Matters Statistically
This study illustrates why safety comparisons should be interpreted through both the observed counts and their uncertainty. The AZD1236 group had 13 participants with an adverse event and the placebo group had 17. That numerical ordering is not enough to establish a dependable difference: the unadjusted p-value is p = 0.573, and the confidence interval for the risk difference includes no difference as well as values on either side.
It also demonstrates the distinction between a broad primary adverse-event endpoint and separate safety summaries. The primary endpoint counts participants who had an event. The serious-event figures provide another view, but describe only small numbers and omit event-level context. Counts alone do not show severity patterns, timing, duration, or whether events were judged related to study treatment. A statistical comparison can summarize a measured endpoint, but cannot recover details that are not recorded in the results.
Registry reporting is also important for understanding what cannot be concluded. The record lists several secondary outcomes but does not report their results, and it does not describe the analysis plan, missing-data approach, or multiplicity handling. Readers therefore cannot use the primary comparison as a substitute for the unreported outcome results or assume that the posted calculation reproduces the trial's original analysis.
The planning illustrations offer a further statistical lesson: sample-size requirements depend on the effect a study is designed to detect. Smaller target effects require larger samples under the stated assumptions. Because the observed effect is uncertain, these figures are illustrations rather than evidence about the power or success of the completed trial.
17. 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 interpretation is limited by the small enrolled sample and the limited number of participants with recorded events. The confidence interval for the primary comparison is broad and includes no difference, so the result does not precisely determine the direction or size of a between-group difference. The posted comparison is unadjusted, and the registry record does not describe the original statistical analysis or whether covariates were considered.
The primary endpoint is a participant count across all study visits. The record does not report event-level data, timing, duration, severity beyond separate serious-event summaries, or treatment relatedness. It also does not report vital-sign or laboratory results, despite identifying those assessments as part of the safety aim. The serious-event term listing lacks a reported denominator and group attribution, and death counts are not reported.
The registry does not report baseline characteristics, participant disposition, missing-data handling, or the analysis population. It is therefore not possible to assess baseline balance, determine whether the posted counts represent all randomized participants, or evaluate the possible effect of missing observations. The record also does not report the original sample-size justification, the prespecified analysis plan, multiplicity methods, or interim-analysis plans.
Although secondary outcomes are listed, their results are not reported in the registry record. The study's 6-week duration also confines the posted safety endpoint to the study visits; longer-term information is not reported. These limitations mean that the results should be read as a narrow, uncertain comparison of the posted adverse-event counts rather than a full account of safety or other clinical outcomes.
18. Related Tutorials
19. Related Statistical Calculators
20. Sources
- ClinicalTrials.gov: Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients — NCT00758459.
- Registry record last updated 2011-08-19; status last verified 2011-07.
- Results first posted 2011-08-19.
- 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.
21. Record Summary
The registry record describes a completed, randomized, double-blind, parallel-group phase IIa study of AZD1236 versus placebo in participants with moderate to severe COPD. The official title specifies a 6-week study, and the record reports enrollment of 74 participants. The primary endpoint was the number of participants with an adverse event across all study visits.
There were 13 participants with an adverse event among 35 in the AZD1236 arm and 17 among 39 in the placebo arm. The unadjusted comparison gives p = 0.573, with a confidence interval that includes no difference and permits effects in either direction. Serious-adverse-event counts were 1 in the AZD1236 arm and 0 in the placebo arm. Further safety detail and secondary-outcome results are not reported in the registry record.