A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg (NCT01658020), a randomized phase 3 study. The primary outcome is Clinical Response in the Clinical Populations.

2. Clinical Question

The registry title refers to zabofloxacin Tablet 400mg and moxifloxacin Tablet 400mg, while the arm description records the DW224 tablet as 367mg. These descriptions are reported as written; the record does not explain the distinction. The clinical response endpoint classifies clinical outcomes as clinical cure, clinical failure, relapse, or indeterminate. The primary outcome timeframe is 10days.

The comparison is between the two assigned regimens, rather than a comparison of the drugs in isolation: the recorded schedules differ in duration and include placebo after the DW224 treatment period. The main statistical question is whether the observed response proportions and their uncertainty are compatible with a range of possible differences between groups. The registry reports the response estimate, confidence intervals, and an unadjusted p-value. It does not report a prespecified equivalence or noninferiority margin, so the results do not establish either type of conclusion.

3. Trial Design

This was a Phase 3, randomized, triple-masked, parallel-group trial sponsored by Dong Wha Pharmaceutical Co. Ltd. The condition listed is chronic obstructive pulmonary disease. The registry records enrollment of 345 participants, a start date of 2012-08, primary completion in 2014-01, and completed status.

The two arms are labeled DW224 and Avelox. The DW224 arm description is zabofloxacin 367mg tablet by mouth once daily for 5days, then placebo once daily for 2days. The Avelox description is moxifloxacin 400mg tablet by mouth once daily for 7days. The trial title refers to 400mg tablets for both drugs, but the arm description gives the DW224 tablet as 367mg; the registry record does not explain this difference. The masking label is triple, but the identities of the masked parties are not reported in the registry record.

The primary endpoint is clinical response in the per protocol population at 10days. The primary outcome description defines response in relation to clinical cure at the Test of Cure visit and notes four possible assessment classifications: cure, failure, relapse, and indeterminate. The primary arm results include 143 participants in DW224 and 131 in Avelox. The safety groups contain 175 and 167 participants, respectively. These population counts are not interchangeable: they describe different reported analysis groups.

The registry also lists secondary outcomes addressing clinical response at 36days, clinical cure in a microbiological per protocol population, microbiological response, and changes in EXACT-PRO and CAT scores. Numerical results are posted for three of the secondary outcomes; numerical results for the questionnaire score outcomes are not reported in the registry record. The original sample-size justification, detailed statistical analysis plan, allocation procedure, and identities of the masked parties 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Per protocol population

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.

6. Primary Endpoint

The registry lists the primary outcome as Clinical Response in the Clinical Populations, measured over 10days.

The primary endpoint is the percentage of participants with a clinical response in the clinical per protocol population at the 10days Test of Cure visit. The record describes the response assessment as corresponding to clinical cure and says assessments were classified as clinical cure, clinical failure, relapse, or indeterminate. The result is therefore a binary summary of whether a participant was counted as having a response, rather than a measure of the amount of symptom change.

A clinical response endpoint can provide a direct summary of the clinical status assessed at a defined visit. A fixed assessment time also gives the comparison a common reference point across the two groups. In this trial, the 10days timeframe identifies the primary assessment time; the record additionally reports a clinical response outcome at 36days as a secondary outcome.

Interpretation depends on how the classifications were turned into the response count. The registry describes the categories but does not report further detail on handling indeterminate assessments or missing primary outcomes. It identifies the primary analysis population as per protocol, but the criteria for membership in that population are not reported in the registry record. Those details matter because a percentage calculated among participants who meet protocol criteria answers a different question from a percentage among everyone randomized.

7. Results Posted in the Registry

• Avelox: 86.3% (113/131) versus 86.7% (124/143) on control; risk difference -0.5 percentage points (95% CI -8.6 to 7.7), risk ratio 0.99 (0.91–1.09); unadjusted two-proportion z-test p = 0.913.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Clinical Response in the Clinical Population

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Avelox: 71.0% (93/131) versus 76.2% (109/143) on control; risk difference -5.2 percentage points (95% CI -15.7 to 5.2), risk ratio 0.93 (0.81–1.07); unadjusted two-proportion z-test p = 0.326.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Avelox and the control. The interval gives the range of effects that remain compatible with the data.

Clinical Cure Rate in the Microbiological Per Protocol(PP) Population

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Avelox: 94.9% (37/39) versus 88.4% (38/43) on control; risk difference 6.5 percentage points (95% CI -5.3 to 18.3), risk ratio 1.07 (0.94–1.22); unadjusted two-proportion z-test p = 0.293.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Avelox and the control. The interval gives the range of effects that remain compatible with the data.

Microbiological Response Rate

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Avelox: 79.5% (31/39) versus 67.4% (29/43) on control; risk difference 12.0 percentage points (95% CI -6.8 to 30.9), risk ratio 1.18 (0.91–1.53); unadjusted two-proportion z-test p = 0.219.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Avelox and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results show varied patterns across later clinical response and microbiological outcomes. The point estimates differ in direction and size, and the confidence intervals are broad enough that the registry results do not establish a consistent, precise separation between the groups across these outcomes. These secondary endpoints relate to the primary clinical response question, but they are not interchangeable with it: they include a later assessment time, a microbiological population, and microbiological response itself.

The primary clinical response assessment is at 10days in the per protocol population. The secondary outcomes use other timeframes or populations, so they add context rather than directly replicate the primary analysis. The registry lists five secondary outcomes, including changes in EXACT-PRO and CAT scores, but numerical results are not reported in the registry record for those score outcomes. Numerical results are posted for three secondary outcomes.

Unadjusted secondary results carry less weight when several outcomes are examined because repeated testing creates more opportunities for apparently notable findings by chance. General statistical explanation: multiplicity adjustment or a prespecified hierarchy can help control the interpretation of a family of tests, but the registry record does not report such a strategy. The posted secondary comparisons are unadjusted, and no reported analyses are listed for these outcomes.

It is therefore more appropriate to treat the secondary pattern as descriptive and exploratory than as independent confirmation of the primary endpoint. This does not mean the secondary outcomes are uninformative; rather, differences in definition, timing, and population, together with the absence of a reported multiplicity plan, limit how strongly they can support a single overall conclusion.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Clinical Response in the Clinical Population
• Clinical Cure Rate in the Microbiological Per Protocol(PP) Population
• Microbiological Response Rate
• Change in EXACT-PRO Score
• Change in CAT Scores

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary: each assessed participant contributes to a response or nonresponse count under the endpoint definition. A percentage expresses the response count relative to the number of participants in that analysis group. For the primary endpoint, the posted percentages are 86.71% for DW224 and 86.26% for Avelox. The group denominators are 143 and 131, respectively. These denominators refer to the per protocol analysis population, not the total enrollment or the safety populations.

What does the risk difference represent?

The risk difference is the response proportion in one group minus the response proportion in the other, with the registry comparison labeled Avelox against DW224. It is an absolute measure: values below zero indicate a lower observed response proportion in Avelox relative to DW224, and values above zero indicate a higher observed response proportion in Avelox. The posted estimate is -0.004. Its 95% confidence interval is -0.086 to 0.076. The interval crosses zero, so the data do not isolate a direction for the difference with high precision.

A risk difference is often useful because it remains on the response-proportion scale, making the size and direction of a group contrast relatively direct to interpret. It does not, by itself, adjust for baseline characteristics or other factors. The registry identifies the comparison as an unadjusted risk difference and gives an unadjusted p-value of 0.913. An adjusted analysis, its covariates, and the analysis model are not reported in the registry record.

How should a confidence interval be read?

General statistical explanation: a confidence interval describes uncertainty in an estimate under the assumptions of the method used. It is not a guarantee that the true effect lies inside a particular calculated interval, nor does it show the probability that a treatment is better. The primary 95% interval stretches from -0.086 to 0.076 for the risk difference. Its breadth is a reminder that the estimate does not pin down a narrow range of possible group differences.

The arm-specific intervals describe uncertainty in each arm's response percentage, while the interval for the risk difference describes uncertainty in the contrast between the arms. These are different quantities. Comparing whether two arm-specific intervals overlap is not a substitute for examining the interval for the directly reported between-group contrast.

What does the p-value add?

General statistical explanation: a p-value measures how surprising data at least as incompatible with a specified null hypothesis would be if that null hypothesis and the test assumptions were true. It does not give the probability that the null hypothesis is true, and it does not measure the clinical importance of an effect. The reported unadjusted p-value is 0.913. It should be considered alongside the estimated risk difference and its confidence interval, not in isolation.

The registry does not state the full test specification or any adjustment for covariates. It also does not report a multiplicity plan for the several endpoints. The posted p-value is therefore described as unadjusted, and the statistical details beyond those expressly reported are not reported in the registry record.

Why does the analysis population matter?

The primary result is stated for the per protocol population. Such a population is defined by adherence to protocol requirements, but the exact inclusion and exclusion rules are not reported in the registry record. A per protocol analysis may address outcomes among participants meeting those requirements, but it does not have the same interpretation as an analysis of all randomized participants. The registry does not report an intention-to-treat primary result or explain how participants with missing endpoint assessments were handled.

The denominator in the primary analysis is 143 for DW224 and 131 for Avelox. Safety reporting instead lists 175 and 167 participants at risk. These figures answer different questions and should not be combined. The difference between the enrolled total and outcome-analysis counts cannot be explained from the registry record because participant flow and analysis-population rules are not reported.

What can and cannot be inferred from the comparison?

General statistical explanation: failure to reject a no-difference hypothesis does not demonstrate that two groups are equivalent. Equivalence and noninferiority require a prespecified acceptable margin and a statistical approach suited to that objective. Neither a margin nor such an objective is reported in the registry record. The reported primary comparison is therefore best described using its point estimate, interval, endpoint definition, and analysis population, without extending it to an unreported objective.

General statistical explanation: low event counts or limited group sizes can make estimates uncertain, and a confidence interval communicates that uncertainty more directly than a point estimate alone. The primary response counts are 124 of 143 for DW224 and 113 of 131 for Avelox. These counts underlie the posted percentages; no further recalculation is needed to interpret the registry result.

The registry lists clinical response at 36days, clinical cure in a microbiological per protocol population, and microbiological response among the secondary outcomes with numerical results. These analyses use different outcome definitions, assessment times, or populations. A consistent statistical comparison across outcomes would require attention to those differences and to multiplicity. The registry's reported secondary comparisons are unadjusted, and a broader statistical plan is not reported.

11. Confidence Intervals and Precision

Precision concerns how narrowly the data estimate an outcome or contrast. The primary group estimates are 86.71% for DW224 and 86.26% for Avelox. Their respective 95% confidence intervals are 81.15% to 92.28% and 80.36% to 92.16%. These intervals show uncertainty around each percentage; neither point estimate should be read as an exact underlying response rate.

For the comparison itself, the risk difference is -0.004, with a 95% confidence interval from -0.086 to 0.076. Because this interval includes zero and extends to values on both sides of zero, the result does not determine the direction of the underlying difference. The interval also permits a range of effect sizes, so the similar point estimates do not imply that all potentially relevant differences have been ruled out.

A confidence interval is more informative than the point estimate alone because it displays the uncertainty associated with the estimate under the method used. A confidence interval is not a guarantee about where the true value lies, and it does not identify which values are clinically important. The registry does not report a clinical importance threshold or a noninferiority or equivalence margin for this endpoint.

The size of the analysis groups and the per protocol population definition are relevant to interpretation. There are 143 participants in the DW224 primary analysis and 131 in the Avelox primary analysis. The registry does not report participant-level missingness or the rules used to determine eligibility for the per protocol population, so the precision intervals do not resolve uncertainty about how those analysis choices affect interpretation.

12. 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.

The planning figures express the number of participants per arm for each stated planning scenario. They are not total sample sizes and do not represent the number of events. The registry's planning description uses the observed effect as a starting point and gives illustrations for detecting 100% of that effect, 75% of the observed effect, or 50% of the observed effect. Smaller effects require more participants because a subtler difference is harder to distinguish from sampling variation.

The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The registry's general note says that time-to-event planning displays give total events, while other outcomes give participants per arm; these outcomes are not time-to-event outcomes, so the figures are participants per arm.

The 80% power column means the illustrative number of participants per arm under which the assumed design would have an 80% chance of detecting the specified effect, if the planning assumptions and effect were true. The 90% power column uses the higher chance of detection and therefore gives a larger planning requirement for the same scenario. These are planning illustrations based on the observed effect, not the trial's original design justification; that original justification is not reported in the registry record.

This is not observed power. It does not measure whether the completed trial had a particular chance of finding a result after the outcomes were observed. The trial's own sample-size assumptions, target effect, and justification are not reported in the registry record. The figures should be read as hypothetical planning scenarios, not as a retrospective score for the completed study.

13. 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 z_1−α/2 = 1.960) and the desired power (z_1−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

1. Control proportion p₀ = 0.867; treatment proportion p₁ = 0.863; average p̄ = 0.865.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.4835 = 0.9476.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.4835 = 0.4069.
4. n = (0.9476 + 0.4069)² / (-0.0045)² = 89,110.2, rounded up to 89,111 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 <- 0.867132867132867                          # control proportion
p1 <- 0.862595419847328                          # 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(1658020)
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 = 89,111 (80% power), 119,293 (90% power)
 75% of observed effect: n per arm = 157,858 (80% power), 211,326 (90% power)
 50% of observed effect: n per arm = 353,916 (80% power), 473,793 (90% power)
power.prop.test: 89110.2 
Simulated power at n = 89,111 per arm: 0.804 (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.

14. Multiplicity, Missing Data and Analysis Populations

The primary endpoint is clearly identified as clinical response in the clinical population at 10days, with the per protocol population specified. The registry also lists five secondary outcomes, including clinical response at 36days, clinical cure in the microbiological per protocol population, microbiological response, and changes in EXACT-PRO and CAT scores. The registry does not report a full analysis plan that sets out a testing order, a multiplicity adjustment, or a family of hypotheses.

The reported primary comparison includes an unadjusted p-value. The three secondary outcomes with numerical results also have unadjusted comparisons. Unadjusted results do not account for the possibility of chance findings across multiple outcome tests. How much that affects interpretation depends on the planned family of tests and the analysis strategy, neither of which is reported in the registry record. No reported analyses are listed for the secondary endpoints.

Missing-data handling is not reported in the registry record. The primary analysis is identified as per protocol, but the criteria defining that population, the number of participants excluded from it, and the treatment of participants without an assessable outcome are not stated. The outcome description includes an indeterminate category, but the record does not explain how indeterminate cases were counted in the response estimate.

The record also does not report an intention-to-treat primary analysis, sensitivity analyses for missing outcomes, or details about participant flow by analysis population. Consequently, the reported response proportions should be interpreted as results for the stated per protocol groups, with uncertainty about how missingness and population selection were managed. This is a reporting limitation, not evidence that any particular handling method was or was not used.

15. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety results list 175 participants at risk in the DW224 group and 167 in the Avelox group. Serious adverse events affected 0 participants in each group. The registry lists 17 participants with other adverse events in DW224 and 16 in Avelox. These are counts, not percentages, and the registry does not provide further detail on the types of other adverse events in the reported safety summary.

No serious adverse event terms are listed in the registry record. Death counts are not reported in the registry record. The safety group denominators differ from the primary per protocol analysis denominators, so the safety counts should not be interpreted using the primary endpoint group sizes.

These figures describe the events recorded in the registry summary. They do not, on their own, provide detailed information about event severity, timing, relatedness, duration, or participant-level patterns. The registry safety summary should therefore be read as a limited count-based report rather than a complete characterization of the safety data.

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

The posted primary result is a comparison of clinical response proportions at the 10days Test of Cure visit among participants in the per protocol population. The observed percentages were close, and the reported risk difference was -0.004. Its 95% confidence interval, -0.086 to 0.076, includes zero and allows differences in either direction. The registry result therefore provides an estimate with meaningful uncertainty rather than a definitive statement that the regimens have identical outcomes.

The result does not establish equivalence or noninferiority. Those are specific statistical claims that require a prespecified margin and an analysis designed for that question. Neither is reported in the registry record. Similarly, the unadjusted p-value of 0.913 is not the probability that the treatments are the same and does not prove the absence of a difference.

The finding applies to the endpoint, timeframe, and population actually reported. The primary outcome is a clinical-response classification at 10days, and the analysis population is per protocol. The record does not report the per protocol criteria, missing-data approach, or an intention-to-treat result. It is not possible to extend the result beyond those stated boundaries using the registry summary alone.

Secondary outcomes provide additional but not decisive context. They involve different timepoints or populations, and the registry does not report a strategy for multiplicity adjustment. Some listed secondary outcomes have no numerical results in the registry record. Those limitations make it important not to treat the secondary findings as a set of independent, confirmatory tests.

The registry reports zero participants affected by serious adverse events in each safety group and reports other adverse events in both groups. It does not report deaths or detailed event terms. These counts are useful as a brief safety summary, but they are not sufficient to characterize all aspects of safety or to make broader claims about comparative safety.

17. Why This Trial Matters Statistically

This trial is statistically instructive because a close pair of point estimates does not remove the need to examine the uncertainty around their difference. The primary group response percentages are 86.71% and 86.26%, while the risk-difference interval extends across zero and to values in both directions. Reading the point estimate together with its interval helps distinguish the observed contrast from the range of effects compatible with the data.

The record also illustrates why analysis populations matter. The primary result is reported for a per protocol population, whereas safety counts use larger group denominators. A result cannot be interpreted correctly without knowing which participants contribute to its denominator. Here the population label is given, but its criteria and the handling of missing outcomes are not reported.

Another important issue is the difference between testing for a difference and establishing equivalence or noninferiority. The reported comparison is unadjusted and no margin is reported. Consequently, the p-value and confidence interval do not support a claim that the regimens are equivalent. That distinction is especially important when the observed percentages are close.

Finally, the multiple listed outcomes call for cautious interpretation. Several address related clinical or microbiological questions, but the registry does not report a multiplicity strategy, and some listed secondary outcomes lack numerical results. Separating the primary result from exploratory secondary patterns prevents a collection of unadjusted comparisons from being mistaken for a single confirmatory conclusion.

18. 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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The registry record leaves important details about the primary analysis unspecified. Although the primary population is identified as per protocol, the criteria for that population are not reported. The record does not explain participant flow from enrollment to the primary analysis counts, or how missing and indeterminate assessments were handled. These omissions limit assessment of how population selection may affect the response estimates.

The original sample-size justification and design assumptions are not reported. The planning illustrations are based on the observed effect and stated hypothetical assumptions, so they cannot substitute for the trial's prospective design rationale. The registry also does not report the complete statistical analysis plan, including model details, any adjustment for covariates, or a prespecified equivalence or noninferiority margin.

The primary comparison is reported as an unadjusted risk difference. The record does not provide an adjusted analysis or an intention-to-treat result. Secondary comparisons are unadjusted, and a multiplicity strategy is not reported. Numerical results are not reported in the registry record for the listed EXACT-PRO and CAT score outcomes.

The clinical-response endpoint description lists cure, failure, relapse, and indeterminate classifications, but does not explain how those categories map to the binary response count. The registry also gives different descriptions of the DW224 dose: the title refers to a 400mg tablet, while the arm description states 367mg. The reason for this difference is not reported in the registry record.

Safety reporting is brief. The record reports counts for serious and other adverse events but does not provide death counts, detailed event terms, or further information on timing and relatedness. These reporting gaps constrain interpretation; they do not establish that an unreported procedure or analysis was not performed.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg — NCT01658020.
• Registry record last updated 2014-10-13; status last verified 2014-10.
• Results first posted 2014-09-17.
• 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.

22. Record Summary

NCT01658020 is a completed, randomized, triple-masked, parallel-group Phase 3 trial sponsored by Dong Wha Pharmaceutical Co. Ltd. It enrolled 345 participants with chronic obstructive pulmonary disease and compared the recorded DW224 zabofloxacin regimen with Avelox moxifloxacin.

The primary endpoint was clinical response at the 10days Test of Cure visit in the per protocol population. Response was 86.71% for DW224 and 86.26% for Avelox. The reported risk difference was -0.004, with a 95% confidence interval from -0.086 to 0.076 and an unadjusted p-value of 0.913.

The registry lists five secondary outcomes and reports numerical results for three. The statistical analysis plan, original sample-size justification, missing-data procedures, and multiplicity strategy are not reported in the registry record. The primary comparison does not establish equivalence or noninferiority.