Comparison · NCT03093974-sae
CMS (Colistimethate Sodium) (SAF) vs Placebo (SAF): 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. CMS (Colistimethate Sodium) (SAF) vs Placebo (SAF): serious adverse events. Trial comparisons, record NCT03093974-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03093974-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 | 0.176 | 0.127 | 0.239 | wilson | |
| Risk in group 2 | 0.234 | 0.18 | 0.297 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0574 | -0.138 | 0.0254 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.754 | 0.502 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 0.702 | 0.422 | 1.17 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on CMS (Colistimethate Sodium) (SAF) than on Placebo (SAF) | 17.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CMS (Colistimethate Sodium) (SAF) | Inhaled colistimethate sodium twice daily. The active pharmaceutical ingredient consisting of pure CMS one million international units (MIU) / 80 mg of CMS / 33 mg colistin base activity (CBA) was provided as a powder for nebuliser solution in 10R International Organization for Standardization (ISO) glass vials.~CMS: 1 MIU equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%. Investigational Medicinal Product (IMP) glass vials were shrink wrapped in opaque white plastic and provided in boxes of 30 vials (two weeks of b.i.d dosing).~The 1 MIU/mL CMS/0.45% saline solution was transferred from the glass vial into a specific nebulizer system fitted with a 0.3 mL medication chamber, for administration by inhalation. This delivered a nominal dose of 0.3 MIU/24 mg CMS (\~10 mg CBA) from the device.~The first dose of the IMP was administered at the site under the supervision of the site staff and subjects were instructed how to prepare and self-administer the IMP at home via a specific nebulizer system, b.i.d (morning and evening) over a period of 12 months.~At least 10 minutes (min) before each administration, an inhaled short-acting bronchodilator (e.g., salbutamol /albuterol), supplied by the Sponsor, could be taken to improve tolerability. | 31 | 176 | EG000 |
| Group 2 | Placebo (SAF) | Saline solution inhaled twice daily, provided and administered at the same way of the IMP.~Placebo: 1 ml saline solution 0.45%. The placebo was made up of identical empty glass vials to which the same saline diluent was added in exactly the same way as the reconstitution of the active treatment by injecting the diluent through the rubber stopper. The glass vials were shrink wrapped with opaque white plastic to maintain the blind. | 46 | 197 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All AEs occurring from the day of the first IMP administration, i.e. Visit 2 (day 0), up to the follow-up (54 weeks after the beginning of the trial), when follow-up phone call took place.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Inhaled CMS in Bronchiectasis Subjects With Chronic P. Aeruginosa Infection. (PROMIS-I)
- NCT number
- NCT03093974
- Phases
- PHASE3
- Conditions
- Non Cystic Fibrosis Bronchiectasis
- Interventions
- CMS, Placebo
- Lead sponsor
- Zambon SpA
- Results first posted
- 2023-11-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03093974?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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