Comparison · NCT00112359-sae
75 mg AZLI TID vs Placebo TID: 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. 75 mg AZLI TID vs Placebo TID: serious adverse events. Trial comparisons, record NCT00112359-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00112359-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 | 0.0625 | 0.027 | 0.138 | wilson | |
| Risk in group 2 | 0.143 | 0.0837 | 0.233 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0804 | -0.178 | 0.0157 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.438 | 0.161 | 1.19 | log | |
| Odds ratio, group 1 over group 2 | 0.4 | 0.134 | 1.19 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 75 mg AZLI TID than on Placebo TID | 12.4 | 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 | 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. | 5 | 80 | EG001 |
| 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 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs that first occurred or worsened after the first dose of study drug through 30 days after the last dose are summarized.
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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