Comparison · NCT01769352-sae
Prednisolone Acetate Every 1 Hour While Awake (Group 1) vs Prednisolone Acetate Four Times a Day (Group 2): 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. Prednisolone Acetate Every 1 Hour While Awake (Group 1) vs Prednisolone Acetate Four Times a Day (Group 2): serious adverse events. Trial comparisons, record NCT01769352-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01769352-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 | 0.227 | 0.101 | 0.434 | wilson | |
| Risk in group 2 | 0.2 | 0.0807 | 0.416 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0273 | -0.223 | 0.266 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.354 | 3.65 | log | |
| Odds ratio, group 1 over group 2 | 1.18 | 0.267 | 5.18 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Prednisolone Acetate Every 1 Hour While Awake (Group 1) than on Prednisolone Acetate Four Times a Day (Group 2) | 36.7 | 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 | Prednisolone Acetate Every 1 Hour While Awake (Group 1) | Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution every 1 hour while awake.~Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA every 1 hour (q1h) - Group 1. | 5 | 22 | EG000 |
| Group 2 | Prednisolone Acetate Four Times a Day (Group 2) | Patients who were given Prednisolone Acetate (PredA) 1% ophthalmic solution four times a day~Adverse events are dose dependent and they don't depend on the type of surgery patient underwent previously. Therefore both, post-cataract surgery macular edema and post-other surgery macular edema adverse events were clumped together for patients who received PredA four times a day (qid) - Group 2. | 4 | 20 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 48 Weeks
Source ClinicalTrials.gov
Trial
- Title
- Treatment of Post-surgical Cystoid Macular Edema With Topical Steroids Trial (TEMPEST-1)
- NCT number
- NCT01769352
- Phases
- PHASE2, PHASE3
- Conditions
- Post-surgical Cystoid Macular Edema (PSCME)
- Interventions
- PredA + Kelac
- Lead sponsor
- Johns Hopkins University
- Results first posted
- 2017-09-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01769352?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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