Comparison · NCT01357616-sae
AZARGA (Test Group) vs AZOPT + TIMOLOL (Control Group): serious 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. AZARGA (Test Group) vs AZOPT + TIMOLOL (Control Group): serious adverse events. Trial comparisons, record NCT01357616-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01357616-sae
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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 | 0.00606 | 0.00107 | 0.0335 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0232 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00606 | -0.0176 | 0.0335 | 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 harm, for one more participant with a serious adverse event on AZARGA (Test Group) than on AZOPT + TIMOLOL (Control Group) | 165 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | AZARGA (Test Group) | Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension | 1 | 165 | EG000 |
| Group 2 | AZOPT + TIMOLOL (Control Group) | Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution | 0 | 162 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AE) were collected for the duration of the study (2 years, 2 months). An AE was defined as any untoward medical occurrence in a subject who was administered a study treatment, regardless of causal relationship with the treatment.
Source ClinicalTrials.gov
Trial
- Title
- Fixed Combination Brinzolamide 1%/Timolol 0.5% Versus Brinzolamide 1% + Timolol 0.5% in Open-Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT01357616
- Phases
- PHASE3
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Interventions
- Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, Brinzolamide 1% ophthalmic suspension, Timolol 0.5% ophthalmic solution
- Lead sponsor
- Alcon Research
- Results first posted
- 2014-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01357616?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT01357616-sae