Comparison · NCT01217606-sae
Triple Combination Therapy vs Combigan®: 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. Triple Combination Therapy vs Combigan®: serious adverse events. Trial comparisons, record NCT01217606-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01217606-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 | 0.0111 | 0.00196 | 0.0603 | wilson | |
| Risk in group 2 | 0.0105 | 0.00186 | 0.0572 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000585 | -0.047 | 0.0505 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.067 | 16.6 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.0651 | 17.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Triple Combination Therapy than on Combigan® | 1,710 | 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 | Triple Combination Therapy | Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months. | 1 | 90 | EG000 |
| Group 2 | Combigan® | Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months. | 1 | 95 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT01217606
- Phases
- PHASE3
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Interventions
- bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy), Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
- Lead sponsor
- Allergan
- Results first posted
- 2015-11-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01217606?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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