Comparison · NCT03285477-7dd92f59
KX2-391 Ointment 1% vs Placebo: Number of Participants With Clinically Significant Safety Observations- Vital Signs
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. KX2-391 Ointment 1% vs Placebo: Number of Participants With Clinically Significant Safety Observations- Vital Signs. Trial comparisons, record NCT03285477-7dd92f59. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03285477-7dd92f59
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.0215 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0214 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0214 | 0.0215 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | KX2-391 Ointment 1% | KX2-391 Ointment 1% was applied topically once daily for 5 consecutive days on face or scalp | 0 | 175 | OG001 |
| Group 2 | Placebo | Vehicle Ointment was applied topically once daily for 5 consecutive days on face or scalp | 0 | 176 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinically Significant Safety Observations- Vital Signs
- Description
- Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
- Time frame
- From Baseline (Day 1 predose) up to Day 57
- Population
- Safety analysis population consisted of all participants who received at least 1 dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
- NCT number
- NCT03285477
- Phases
- PHASE3
- Conditions
- Actinic Keratoses
- Interventions
- Placebo, KX2-391 Ointment 1%
- Lead sponsor
- Almirall, S.A.
- Results first posted
- 2021-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03285477?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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