Comparison · NCT04837482-9c092f96
AGN-190584 vs Vehicle: Number of Participants With Adverse Events
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. AGN-190584 vs Vehicle: Number of Participants With Adverse Events. Trial comparisons, record NCT04837482-9c092f96. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04837482-9c092f96
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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 | 0.744 | 0.598 | 0.851 | wilson | |
| Risk in group 2 | 0.186 | 0.0974 | 0.326 | wilson | |
| Risk difference, group 1 minus group 2 | 0.558 | 0.355 | 0.697 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4 | 2.09 | 7.66 | log | |
| Odds ratio, group 1 over group 2 | 12.7 | 4.55 | 35.6 | log | |
| Number needed to treat, for one more participant with the outcome on AGN-190584 than on Vehicle | 1.79 | 1.44 | 2.81 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | AGN-190584 | In Sequence 1, participants received AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5.~In Sequence 2, participants received Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5. | 32 | 43 | OG001 |
| Group 2 | Vehicle | In Sequence 1, participants received AGN-190584 from Visit 2 through Visit 3 followed by Vehicle from Visit 4 through Visit 5.~In Sequence 2, participants received Vehicle from Visit 2 through Visit 3 followed by AGN-190584 from Visit 4 through Visit 5. | 8 | 43 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Adverse Events
- Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The investigator assesses the relationship of each event to the use of the study intervention. A serious adverse event (SAE) is an event that results in death, is life threatening, requires inpatient hospitalization or prolongs an existing hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
- Time frame
- Enrollment to Day 71
- Population
- The safety population includes all treated participants who receive ≥ 1 administration of study intervention.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants, 40 to 55 Years of Age
- NCT number
- NCT04837482
- Phases
- PHASE3
- Conditions
- Presbyopia
- Interventions
- AGN-190584, Vehicle
- Lead sponsor
- AbbVie
- Results first posted
- 2024-10-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04837482?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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