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 and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts (NCT00674739), a randomized phase 3 study. The primary outcome is Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00674739 |
| Phase | Phase 3 |
| Condition | Genital Warts |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 470 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Graceway Pharmaceuticals, LLC |
| Results posted | Yes |
2. Clinical Question
Population
Participants with external genital warts were enrolled in this Phase 3 trial. The primary analysis population is described as intention to treat. The registry record reports enrollment of 470 participants overall; the arm counts for the primary outcome are 178 for 2.5% imiquimod cream, 195 for 3.75% imiquimod cream, and 97 for placebo.
Intervention
The active treatments were 2.5% imiquimod cream and 3.75% imiquimod cream. Both were described as applied daily to wart areas for up to 8 weeks. The registry record does not report further details about adherence or treatment actually received.
Comparator
The comparator was placebo cream, described as applied daily to wart areas for up to 8 weeks. The study used a randomized, double-blind, placebo-controlled design. The registry record identifies quadruple masking but does not specify which roles were masked.
Primary question
The primary question was whether participants had complete clearance of all warts—those present at baseline and those that emerged later—by the end of the study. The recorded timeframe was up to 16 weeks. The objective was to compare each imiquimod group with placebo; the posted outcome is the proportion with complete clearance.
The study also aimed to collect information on recurrence and adverse events. The posted secondary outcomes cover safety variables, including adverse reactions, local skin reactions, and participants who took treatment rest periods, as well as treatment-related adverse events. Recurrence results are not reported in the registry record. The findings discussed in the statistical interpretation concern the posted clearance proportions and comparison results, not a complete account of every intended study objective.
3. Trial Design
This was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study with a parallel-group model. The registry record lists quadruple masking. It reports enrollment of 470 and a completed status. The recorded study start was 2008-05, and primary completion was 2009-07.
Three groups are represented in the primary outcome results: 2.5% imiquimod cream, 3.75% imiquimod cream, and placebo cream. The arm descriptions state that each cream was applied daily to wart areas for up to 8 weeks. The primary outcome was assessed over a timeframe of up to 16 weeks. The registry record does not give more detail on visit schedules or the precise timing of assessments within that timeframe.
The primary outcome analysis is described as an intention-to-treat analysis using last observation carried forward to impute missing data points. The primary outcome counts are 178, 195, and 97 participants in the three respective arms. These outcome counts add up to the reported enrollment, but the registry record does not explain whether every enrolled participant contributed observed data or how imputation was applied in individual cases.
The study description identifies recurrence and adverse events as secondary objectives. The posted secondary outcomes include safety variables and treatment-related adverse events. Although the registry record lists three outcome measures, it contains posted results for two secondary outcomes. Recurrence results are not reported in the registry record. Details of randomization procedures, allocation concealment, the exact meaning of quadruple masking, and protocol deviations are not reported in the registry record.
The registry record does not report the original sample-size justification or the statistical plan used to design and analyze the trial. The planning figures discussed separately are illustrations based on observed effects, not the assumptions used to plan this completed study. The trial's own design assumptions, including any planned interim analyses, 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 | 2.5% Imiquimod Cream | 3.75% Imiquimod Cream | Placebo |
|---|---|---|---|
| STARTED | 178 | 195 | 97 |
| COMPLETED | 121 | 136 | 65 |
| NOT COMPLETED | 57 | 59 | 32 |
Analysis population for the primary outcome, as defined in the registry: Intention to treat
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 | 2.5% Imiquimod Cream | 3.75% Imiquimod Cream | Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 178 | 195 | 97 | 470 | |
| Age, Categorical: <=18 years | Participants | 4 | 3 | 4 | 11 |
| Age, Categorical: Between 18 and 65 years | Participants | 173 | 189 | 91 | 453 |
| Age, Categorical: >=65 years | Participants | 1 | 3 | 2 | 6 |
| Age Continuous | years | 32.7 (SD 11.3) | 32.5 (SD 11.6) | 30.5 (SD 10.6) | 32.2 (SD 11.3) |
| Sex: Female, Male: Female | Participants | 95 | 100 | 50 | 245 |
| Sex: Female, Male: Male | Participants | 83 | 95 | 47 | 225 |
| Region of Enrollment: United States | participants | 178 | 195 | 97 | 470 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Subjects With Complete Clearance of All Warts (Both Presented at Baseline and Newly Emerged Warts) at End of Study, measured over Up to 16 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the proportion of participants with complete clearance of all warts at the end of the study. It includes warts present at baseline and newly emerged warts. The recorded timeframe is up to 16 weeks, and the outcome is analyzed in the intention-to-treat population with last observation carried forward for missing data points.
A complete-clearance endpoint captures whether the specified outcome was achieved, rather than measuring a change in wart count or the time until clearance. This makes the endpoint a binary outcome at the participant level: a participant either meets the stated complete-clearance definition or does not. This is a general description of binary endpoints, not an additional detail about the trial's protocol.
Using all warts present at baseline and those that emerged later makes the endpoint broader than clearance of baseline warts alone. It reflects the study's stated definition of complete clearance at the assessment, while the separate recurrence objective would address a later return of warts. Recurrence results are not reported in the registry record, so the clearance result cannot by itself describe recurrence.
The registry lists the endpoint as a proportion and reports a 95% confidence interval for each arm. The posted arm proportions are 0.191 for 2.5% imiquimod cream, 0.272 for 3.75% imiquimod cream, and 0.103 for placebo. The comparisons report risk differences against placebo, but the posted estimates and intervals do not align transparently with the arm-level proportions. The registry record does not explain this difference, so the arm estimates and comparison entries should be read as separate reported results rather than silently reconciled.
7. Results Posted in the Registry
- 2.5% Imiquimod Cream: 0.1% (0/178) versus 0.1% (0/97) on control; risk difference 0.0 percentage points (95% CI -0.8 to 0.8), risk ratio 1.01 (0.00–1,965); unadjusted two-proportion z-test p = 0.998.
- 3.75% Imiquimod Cream: 0.1% (0/195) versus 0.1% (0/97) on control; risk difference 0.0 percentage points (95% CI -0.8 to 0.9), risk ratio 1.31 (0.00–1,702); unadjusted two-proportion z-test p = 0.940.
Risk difference: 2.5% Imiquimod Cream
95% CI: -0.8 to 0.8 percentage points
Recalculated from the posted summary statistics
8. Statistical Interpretation
The posted arm-level proportions with complete clearance were 0.191 in the 2.5% imiquimod group, 0.272 in the 3.75% imiquimod group, and 0.103 in the placebo group. These figures describe the reported proportions under the registry's primary analysis description, which specifies the intention-to-treat population and last observation carried forward for missing data. They do not, by themselves, establish the magnitude or precision of a treatment contrast.
The comparison entries report a risk difference of 0.0 for 2.5% imiquimod versus placebo, with a 95% confidence interval from -0.008 to 0.008 and p = 0.998. For 3.75% imiquimod versus placebo, the reported risk difference is < 0.001, with a 95% confidence interval from -0.008 to 0.009 and p = 0.94. Both intervals include zero, and both p-values are close to 1. These comparison entries therefore do not indicate a clear difference on their reported risk-difference scale. However, the near-zero risk-difference estimates are not readily reconciled with the posted arm-level proportions. The registry record does not explain the discrepancy in scales or calculations.
The record does not flag a discrepancy, but the comparison results should still be interpreted cautiously because the relation between the arm proportions and comparison entries is unclear. The comparison fields also include values that do not match the scale suggested by the arm-level proportions. No unreported correction or alternate analysis is assumed in this interpretation. The sponsor's own analysis takes precedence if a difference with a recalculated result is identified; the record does not report such a discrepancy flag.
The arm-level 95% confidence intervals are 0.136 to 0.257 for 2.5% imiquimod, 0.211 to 0.34 for 3.75% imiquimod, and 0.051 to 0.181 for placebo. These intervals describe uncertainty around each arm's proportion, while the comparison intervals describe uncertainty around the posted risk differences. Overlap or non-overlap between separate arm intervals is not a substitute for a direct comparison interval.
The reported results address complete clearance at the stated assessment, not recurrence, durability beyond the assessment, or all safety outcomes. Although recurrence was an objective, recurrence results are not reported in the registry record. The available figures should therefore be interpreted as registry-posted outcome estimates with substantial uncertainty about how the comparison calculations relate to the arm summaries, not as a complete account of every study objective.
9. Statistical Methods Explained
What a proportion represents. The primary outcome is binary at the participant level: each participant either met the complete-clearance definition or did not. An arm's reported proportion summarizes the fraction classified as having complete clearance under the stated analysis. The registry reports these proportions as 0.191, 0.272, and 0.103 for the 2.5%, 3.75%, and placebo groups, respectively. This is a general explanation of binary outcome summaries, not a claim about unreported participant-level data.
What a risk difference represents. A risk difference compares two event proportions by subtracting one from the other. Positive or negative values indicate direction according to the order of the contrast; a value of zero represents no difference on that scale. The posted comparisons are labeled as risk differences against placebo. Their estimates are 0.0 for 2.5% imiquimod and < 0.001 for 3.75% imiquimod. Those values are very close to zero, but do not correspond transparently to the arm-level clearance proportions. The registry record does not explain the contrast calculation or the apparent difference in scale. No new risk difference is calculated.
What a confidence interval says. A confidence interval expresses uncertainty in an estimate: narrower intervals indicate greater precision, while wider intervals indicate less precision. A 95% confidence interval is a statistical procedure that, under its assumptions, would produce intervals containing the target value in 95% of repeated applications. This is a general explanation. It does not mean that there is a 95% probability that a particular fixed parameter lies inside the interval.
For the reported risk differences, the interval for 2.5% imiquimod is -0.008 to 0.008, and the interval for 3.75% imiquimod is -0.008 to 0.009. Both include zero. That means the posted intervals are compatible with no difference on the reported risk-difference scale, as well as with values on either side of zero. The interval alone does not resolve the mismatch between these comparison estimates and the arm-level proportions.
What a p-value means. A p-value describes how unusual results at least as incompatible with a specified null hypothesis would be if that hypothesis and the statistical model were true. It is not the probability that the null hypothesis is true, nor is it a measure of clinical importance. The posted p-values are 0.998 and 0.94 for the two comparisons. The registry record does not report the inferential test, any adjustment for multiple comparisons, or the complete model specification. The p-values should therefore be read as reported comparison statistics, not as a substitute for the estimates and their uncertainty.
How missing-data imputation matters. The primary analysis is described as intention to treat and uses last observation carried forward for missing data points. In general, this approach carries a participant's last recorded outcome forward to a later assessment when a value is missing. It can allow participants with missing endpoint data to remain represented in the analysis, but it relies on assumptions about what the missing outcome would have been. Those assumptions can affect estimated proportions. The registry record does not report the amount or pattern of missingness, the number of values imputed, or sensitivity analyses using other missing-data assumptions.
How randomized groups support comparison. In general, random assignment aims to make groups comparable at the start of a trial, so differences in outcomes can be attributed more credibly to assigned study groups than in a nonrandomized comparison. The record describes this study as randomized, but does not report allocation procedures, baseline balance details, or adherence results. Those details cannot be inferred from the posted outcome summaries.
Why over-dispersion can matter generally. For count outcomes, over-dispersion occurs when variability is greater than a statistical model expects; accounting for it can affect standard errors and confidence intervals. The primary outcome is reported as a participant proportion, not a count-rate analysis, and over-dispersion is not identified as a feature of the posted primary analysis. This is a general statistical concept, not a claim that over-dispersion occurred in this trial.
The registry record does not report whether the comparisons were adjusted for baseline factors, how multiple comparisons were handled, or whether any interim analyses were planned or conducted. These omissions limit how specifically the posted p-values and intervals can be interpreted. The original statistical analysis plan is not reported in the registry record.
10. Confidence Intervals and Precision
The arm-level estimates have 95% confidence intervals: 0.136 to 0.257 for 2.5% imiquimod cream, 0.211 to 0.34 for 3.75% imiquimod cream, and 0.051 to 0.181 for placebo. These intervals show that the estimated clearance proportions are not known with exact precision. They reflect uncertainty around each arm's estimate, rather than uncertainty in a direct contrast between two arms.
The direct comparison intervals are reported separately. For 2.5% imiquimod versus placebo, the risk-difference interval runs from -0.008 to 0.008. For 3.75% imiquimod versus placebo, it runs from -0.008 to 0.009. Both include zero, so the posted intervals do not exclude no difference on that scale. Their estimates are 0.0 and < 0.001, respectively. The associated p-values are 0.998 and 0.94.
There is an important interpretive limitation: these near-zero comparison estimates do not align transparently with the arm-level proportions. The registry record does not explain why the reported risk differences and arm summaries appear to be on different scales. It is therefore not possible to use the comparison intervals as a straightforward expression of uncertainty around the contrast implied by the arm proportions. The record does not report additional analyses that would reconcile the entries.
Confidence intervals quantify statistical precision under the analysis assumptions; they do not capture every potential source of uncertainty. In particular, the record does not report missing-data counts, sensitivity analyses, or details of the model and testing procedure. The posted intervals should be interpreted with these limitations in mind, rather than as a complete description of uncertainty in all aspects of the study.
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 | 133,963,989 | 179,339,772 |
| 75% of the observed effect | 237,846,794 | 318,409,374 |
| 50% of the observed effect | 534,454,613 | 715,483,089 |
The planning figures are illustrations based on the observed effect, not the trial's original design assumptions. The original sample-size justification is not reported in the registry record. For these non-time-to-event comparisons, the listed values are participants per arm, not total participants across both arms or total events. The general 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 set to the stated fraction of the observed effect.
The rows for 100%, 75%, and 50% of the observed effect ask how many participants per arm would be needed to detect the full observed effect or a smaller fraction of it under those assumptions. The 80% power column means the calculation targets an 80% chance of detecting an effect of the specified size if that effect is real and the assumptions hold. The 90% power column makes the corresponding target more demanding: it aims for a 90% chance under the same conditions. These are planning concepts, not guarantees about a future study.
Smaller effects generally require more participants to detect, because they are harder to distinguish from random variation. For example, the 3.75% comparison's planning figures for 100% of the observed effect are 173,660 participants per arm for 80% power and 232,480 participants per arm for 90% power. Planning for 75% or 50% of that observed effect requires still more participants per arm. The very large figures for the 2.5% comparison reflect the near-zero observed comparison estimate used in that calculation.
These planning calculations are not observed power. They do not state the probability that the completed trial detected an effect, and they do not replace the reported estimates, confidence intervals, or p-values. The registry does not report the assumptions that were actually used when the trial was designed.
12. How the Sample Size Is Derived
13. Multiplicity, Missing Data and Analysis Populations
The primary outcome description identifies an intention-to-treat population and last observation carried forward for missing data points. The registry record does not report how many participants had missing outcome data, the timing or reasons for missingness, how many observations were carried forward, or whether imputation was required in each arm. It also does not report sensitivity analyses using alternative approaches to missing data.
In general, intention-to-treat analysis seeks to retain participants in the groups to which they were assigned, regardless of treatment adherence. The record names this analysis population, but does not provide enough detail to confirm how all randomized participants were handled in every analysis. It does not report a per-protocol analysis or other analysis populations for the primary endpoint.
There are two active-treatment comparisons against placebo, and the record posts a p-value for each. When several statistical comparisons are made, the chance of at least one false-positive finding can increase unless the analysis plan accounts for multiplicity. The registry record does not report whether the comparisons were adjusted, whether a testing hierarchy was used, or what overall type I error approach was planned. No multiplicity adjustment should be assumed from the posted entries.
The record also does not report whether interim analyses were planned or conducted, nor does it describe stopping rules. It does not provide the full statistical analysis plan, the model used to generate the comparison entries, or details of any covariate adjustment. These elements are not reported in the registry record.
Because missing-data handling and multiplicity decisions can affect estimates and interpretation, their absence limits assessment of the full analysis strategy. The stated last-observation-carried-forward method is known, but the implications of its use cannot be assessed fully without information on missingness and sensitivity analyses. Likewise, the presence of two posted comparisons does not establish whether they were the only comparisons specified in the protocol.
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 |
|---|---|---|---|
| 2.5% Imiquimod Cream | 2 | 178 | 1.1% |
| 3.75% Imiquimod Cream | 2 | 195 | 1.0% |
| Placebo | 0 | 97 | 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 |
|---|---|
| 2.5% Imiquimod Cream | 17 of 178 |
| 3.75% Imiquimod Cream | 23 of 195 |
| Placebo | 2 of 197 |
Most frequent serious adverse event terms
| Event term | Organ system | 2.5% Imiquimod Cream | 3.75% Imiquimod Cream | Placebo |
|---|---|---|---|---|
| Pelvic Mass | General disorders | 0 of 178 | 1 of 195 | 0 of 97 |
| Acute abdomen | Gastrointestinal disorders | 0 of 178 | 1 of 195 | 0 of 97 |
| Cholelithiasis | Hepatobiliary disorders | 0 of 178 | 1 of 195 | 0 of 97 |
| Iron deficiency anaemia | Blood and lymphatic system disorders | 1 of 178 | 0 of 195 | 0 of 97 |
| Migraine | Nervous system disorders | 1 of 178 | 0 of 195 | 0 of 97 |
| Syncope | Nervous system disorders | 1 of 178 | 0 of 195 | 0 of 97 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 2.5% Imiquimod Cream | 3.75% Imiquimod Cream | Placebo |
|---|---|---|---|---|
| Application site pain | Skin and subcutaneous tissue disorders | 12 of 178 | 11 of 195 | 1 of 97 |
| Application site irritation | Skin and subcutaneous tissue disorders | 5 of 178 | 12 of 195 | 1 of 97 |
Serious events with the highest arm-level rate: iron deficiency anaemia (0.6%), migraine (0.6%), syncope (0.6%), pelvic mass (0.5%), acute abdomen (0.5%).
The serious adverse event figures list 2 affected participants among 178 at risk in the 2.5% imiquimod group, 2 among 195 in the 3.75% group, and 0 among 97 in the placebo group. These are reported counts, not a comparison adjusted for differences between groups. The registry record does not report death counts.
The record also lists other adverse event figures of 17 for 2.5% imiquimod, 23 for 3.75% imiquimod, and 2 for placebo. The corresponding at-risk counts are 178, 195, and 197. The placebo at-risk count of 197 differs from the placebo primary-outcome arm count of 97. The registry record does not explain that difference, so the safety denominator should not be silently replaced or treated as reconciled with the efficacy count.
Counts alone do not describe event severity beyond the serious-event classification, timing, duration, relatedness, or whether the same participant experienced more than one event. The record lists serious-event terms, but the figures do not establish that an event was caused by a study cream. These data describe what the registry reports; they are not a complete safety assessment.
15. What the Result Does, and Does Not, Mean
The posted primary outcome results describe complete clearance of all baseline and newly emerged warts at the end of the study, with a timeframe of up to 16 weeks. The arm-level proportions are 0.191 for 2.5% imiquimod, 0.272 for 3.75% imiquimod, and 0.103 for placebo. The registry also reports risk-difference comparisons with confidence intervals and p-values.
Those comparison entries require caution. Their risk-difference estimates, 0.0 and < 0.001, are close to zero, and both confidence intervals include zero. At the same time, the estimates do not align transparently with the arm-level proportions. The registry record does not explain this apparent difference. The posted comparison values should not be interpreted as a clear numerical contrast derived from the arm summaries without further explanation.
The results do not establish whether participants experienced recurrence after clearance, because recurrence results are not reported in the registry record. They also do not describe outcomes beyond the stated assessment timeframe. Safety findings are limited to the posted counts and do not establish causation, event timing, or a complete account of adverse experiences.
More generally, a trial result is an estimate under particular analysis choices and data assumptions. The primary analysis used last observation carried forward for missing data, but the registry does not report the extent of missingness or sensitivity analyses. It also does not report the full statistical plan or how multiplicity was handled. These limitations matter when interpreting the precision and scope of the findings.
The registry record therefore supports a description of the reported clearance proportions, comparison entries, and event counts. It does not support a broader conclusion about outcomes that were not posted or about how the unexplained relationship between the arm summaries and comparison statistics should be resolved.
16. Why This Trial Matters Statistically
This study illustrates why a clinical result should be read at more than one statistical level. An arm-level proportion describes the outcome observed or estimated within a group. A comparison estimate addresses the contrast between groups. Confidence intervals describe uncertainty around those estimates, while p-values summarize compatibility with a specified null hypothesis under a test and its assumptions. These quantities answer related but distinct questions.
In this record, the arm-level clearance proportions and the posted risk-difference comparisons do not align transparently. The comparison estimates are close to zero, while the proportions are reported on a different apparent scale. The registry record does not explain the relation. That makes it important to preserve the distinction between the reported arm summaries and the separately posted comparison results, rather than treating one as a simple derivation of the other.
The trial also highlights the role of analysis choices. The primary outcome used an intention-to-treat population and last observation carried forward for missing data. Without the missing-data counts or sensitivity analyses, readers cannot judge how much the imputation choice influenced the endpoint estimates. The record also does not describe how multiplicity was addressed for the active-treatment comparisons.
Finally, sample-size illustrations based on observed effects are not a substitute for the original design justification, and they are not observed power. The original planning assumptions are not reported in the registry record. Together, these points show why statistical interpretation depends not only on numerical results but also on a clear account of definitions, comparisons, uncertainty, and analysis decisions.
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 registry record does not provide the original sample-size justification, full statistical analysis plan, or detailed model specification. It does not report randomization procedures, allocation concealment, baseline balance, adherence, or the meaning of quadruple masking in terms of masked roles. These omissions limit assessment of the design and analysis beyond the information explicitly posted.
The primary analysis description identifies intention to treat and last observation carried forward, but the amount and pattern of missing data are not reported. The registry record also does not report sensitivity analyses or details sufficient to assess how imputation influenced the endpoint estimates. It does not state whether covariates were used in the comparisons.
The comparison risk differences and their intervals are not readily reconciled with the arm-level clearance proportions. The registry record does not explain the apparent scale difference or provide a further analysis that resolves it. This limits interpretation of the direct comparisons. The record does not report whether multiplicity was adjusted, or whether interim analyses were planned or conducted.
Recurrence was an objective, but recurrence results are not reported in the registry record. Safety information is also limited: deaths are not reported, and the placebo at-risk count for other adverse events is 197, whereas the primary outcome arm count is 97. The registry record does not explain this denominator difference. Event counts do not supply detail about timing, duration, relatedness, or repeated events in the same participant.
These limitations are specific to what the registry record reports. They do not establish that an unreported procedure was absent; they mean the procedure or detail is not reported in the registry record.
18. Related Tutorials
19. Related Statistical Calculators
20. Sources
- ClinicalTrials.gov: Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts — NCT00674739.
- Registry record last updated 2011-05-24; status last verified 2011-05.
- Results first posted 2011-05-18.
- 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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21. Record Summary
NCT00674739 is a completed Phase 3, randomized, double-blind, placebo-controlled, multicenter, parallel-group study of imiquimod creams for external genital warts. The registry lists enrollment of 470, a study start of 2008-05, and primary completion of 2009-07. The arms received 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream, described as applied daily for up to 8 weeks.
The primary outcome was the proportion with complete clearance of baseline and newly emerged warts by the end of the study, with a timeframe of up to 16 weeks. The primary analysis is described as intention to treat with last observation carried forward for missing data. Arm-level proportions and risk-difference comparisons are posted, but the relationship between those results is not explained clearly in the registry record. Recurrence results are not reported in the registry record.
Posted safety results include serious adverse event counts of 2, 2, and 0 across the 2.5%, 3.75%, and placebo groups. The original design assumptions, full statistical plan, missing-data details, and explanation of the placebo other-adverse-event denominator are not reported in the registry record.