Comparison · NCT01041417-sae
GM-CSF vs Placebo: 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. GM-CSF vs Placebo: serious adverse events. Trial comparisons, record NCT01041417-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01041417-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 | 0.113 | 0.0603 | 0.2 | wilson | |
| Risk in group 2 | 0.114 | 0.0611 | 0.203 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00142 | -0.104 | 0.101 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.988 | 0.414 | 2.36 | log | |
| Odds ratio, group 1 over group 2 | 0.986 | 0.37 | 2.63 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on GM-CSF than on Placebo | 702 | 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 | GM-CSF | Granulocyte-Macrophage Colony Stimulating Factor injection - Monday, Wednesday and Friday for 4 weeks of therapy.~500 microgram dose of GM-CSF | 9 | 80 | EG000 |
| Group 2 | Placebo | Saline injection - Monday, Wednesday and Friday for 4 weeks. | 9 | 79 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected at weeks 1, 2, 3, 4, 8 and 3 month follow-up and 6 month follow-up
Source ClinicalTrials.gov
Trial
- Title
- Granulocyte-Macrophage Stimulating Factor in the Treatment of Peripheral Arterial Disease
- NCT number
- NCT01041417
- Phases
- PHASE2
- Conditions
- Peripheral Arterial Disease
- Interventions
- Granulocyte-Macrophage Stimulating Factor (GM-CSF), Placebo
- Lead sponsor
- Emory University
- Results first posted
- 2014-12-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01041417?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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