Comparison · NCT00112359-4feaa67c
75 mg AZLI TID vs Placebo TID: Number of Participants Hospitalized at Least Once Between Day 0 and Day 42
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. 75 mg AZLI TID vs Placebo TID: Number of Participants Hospitalized at Least Once Between Day 0 and Day 42. Trial comparisons, record NCT00112359-4feaa67c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00112359-4feaa67c
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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 | 0.05 | 0.0196 | 0.122 | wilson | |
| Risk in group 2 | 0.143 | 0.0837 | 0.233 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0929 | -0.188 | 0.0000691 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.35 | 0.118 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.316 | 0.0974 | 1.02 | log | |
| Number needed to treat, for one fewer participant with the outcome on 75 mg AZLI TID than on Placebo TID | 10.8 | 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 | 75 mg AZLI TID | AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer. | 4 | 80 | OG001 |
| Group 2 | Placebo TID | Placebo (5 mg/mL lactose when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer. | 12 | 84 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Hospitalized at Least Once Between Day 0 and Day 42
- Description
- Details of all hospitalizations, including the dates of admission and discharge, were recorded on the SAE eCRF.
- Time frame
- Day 0 to Day 42
- Population
Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). Participants were summarized by the actual treatment received. No imputation methods were used for the analysis.
Source ClinicalTrials.gov
Trial
- Title
- International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
- NCT number
- NCT00112359
- Phases
- PHASE3
- Conditions
- Cystic Fibrosis
- Interventions
- AZLI 75 mg three times a day (TID), Placebo three times a day (TID)
- Lead sponsor
- Gilead Sciences
- Results first posted
- 2011-04-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00112359?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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