Comparison · NCT02134353-sae
Experimental Arm A vs Arm B - Control: 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. Experimental Arm A vs Arm B - Control: serious adverse events. Trial comparisons, record NCT02134353-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02134353-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 | 0.15 | 0.108 | 0.205 | wilson | |
| Risk in group 2 | 0.136 | 0.0965 | 0.189 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0136 | -0.0538 | 0.0814 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.688 | 1.76 | log | |
| Odds ratio, group 1 over group 2 | 1.12 | 0.647 | 1.93 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Experimental Arm A than on Arm B - Control | 73.5 | 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 | Experimental Arm A | Active treatment. Inhaled Mannitol~Inhaled mannitol: Inhaled mannitol 400 mg BD for 26 weeks~Subjects randomised and treated. | 31 | 207 | EG000 |
| Group 2 | Arm B - Control | Arm B~Control BD (mannitol 50mg) for 26 weeks~Subjects randomised and treated. | 29 | 213 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 26 weeks
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects
- NCT number
- NCT02134353
- Phases
- PHASE3
- Conditions
- Cystic Fibrosis
- Interventions
- Inhaled mannitol, Placebo Comparator: Arm B - Control
- Lead sponsor
- Syntara
- Results first posted
- 2020-09-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02134353?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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