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Comparison · NCT03131154-sae

ADX-102 Ophthalmic Solution (0.5%) vs Vehicle Ophthalmic Solution: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. ADX-102 Ophthalmic Solution (0.5%) vs Vehicle Ophthalmic Solution: serious adverse events. Trial comparisons, record NCT03131154-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03131154-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.01640.00290.0872wilson
Risk in group 20.03230.008890.11wilson
Risk difference, group 1 minus group 2-0.0159-0.0950.0587newcombe hybrid score
Risk ratio, group 1 over group 20.5080.04735.46log
Odds ratio, group 1 over group 20.50.04425.66log
Number needed to treat, for one fewer participant with a serious adverse event on ADX-102 Ophthalmic Solution (0.5%) than on Vehicle Ophthalmic Solution63from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: vehicle.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1ADX-102 Ophthalmic Solution (0.5%)ADX-102 administered for approximately 4 weeks161EG000
Group 2Vehicle Ophthalmic SolutionVehicle administered for approximately 4 weeks262EG001

Harm

What it counts
Total, serious adverse events
Time frame
The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.

Source ClinicalTrials.gov

Trial

Title
SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
NCT number
NCT03131154
Phases
PHASE3
Conditions
Non-infectious Anterior Uveitis
Interventions
ADX-102 Ophthalmic Solution (0.5%), Vehicle of ADX-102 Ophthalmic Solution
Lead sponsor
Aldeyra Therapeutics, Inc.
Results first posted
2025-02-10

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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