Comparison · NCT00901511-11f385d0
GM-CSF Group vs Control Group: Number of Patients Requiring a Rescue WLL
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. GM-CSF Group vs Control Group: Number of Patients Requiring a Rescue WLL. Trial comparisons, record NCT00901511-11f385d0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00901511-11f385d0
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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 | 0.111 | 0.0199 | 0.435 | wilson | |
| Risk in group 2 | 0.778 | 0.453 | 0.937 | wilson | |
| Risk difference, group 1 minus group 2 | -0.667 | -0.85 | -0.208 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.143 | 0.0218 | 0.937 | log | |
| Odds ratio, group 1 over group 2 | 0.0357 | 0.00264 | 0.484 | log | |
| Number needed to treat, for one fewer participant with the outcome on GM-CSF Group than on Control Group | 1.5 | 1.18 | 4.81 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | GM-CSF Group | All participants received a scheduled bilateral WLL at baseline (month 0). All participants received inhaled granulocyte/macrophage-colony stimulating factor (GM-CSF) (Sargramostim, 250 mcg) administered once daily every other week for 12 consecutive weeks, followed by a 4-week washout period without administration, followed by administration on days 1 and 3 of every consecutive 14-day period for 6 months. Unscheduled rescue WLL was administered, as required, to any participant who experienced progression of PAP lung disease as defined in the protocol. | 1 | 9 | OG001 |
| Group 2 | Control Group | All participants received a scheduled bilateral whole lung lavage (WLL) at baseline (month 0). Unscheduled rescue WLL was administered, as required, to any participant who experienced progression of pulmonary alveolar proteinosis (PAP) lung disease as defined in the protocol. | 7 | 9 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Patients Requiring a Rescue WLL
- Description
- Number of patients requiring an unscheduled rescue WLL during the 30-months immediately following administration of the scheduled baseline WLL therapy at Study Month 0.
- Time frame
- 30 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Inhaled GM-CSF Therapy of Autoimmune PAP
- NCT number
- NCT00901511
- Phases
- PHASE2
- Conditions
- Autoimmune Pulmonary Alveolar Proteinosis
- Interventions
- Baseline WLL, Sargramostim, Rescue WLL
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Results first posted
- 2023-06-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00901511?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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