Comparison · NCT00157573-sae
GM-CSF, Sargramostim Cohort 1 vs GM-CSF, Sargramostim Cohort 2: 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, Sargramostim Cohort 1 vs GM-CSF, Sargramostim Cohort 2: serious adverse events. Trial comparisons, record NCT00157573-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00157573-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 | 0.0571 | 0.0158 | 0.186 | wilson | |
| Risk in group 2 | 0.135 | 0.0591 | 0.28 | wilson | |
| Risk difference, group 1 minus group 2 | -0.078 | -0.228 | 0.0717 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.423 | 0.0877 | 2.04 | log | |
| Odds ratio, group 1 over group 2 | 0.388 | 0.0701 | 2.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on GM-CSF, Sargramostim Cohort 1 than on GM-CSF, Sargramostim Cohort 2 | 12.8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | GM-CSF, Sargramostim Cohort 1 | GM-CSF, sargramostim 250 μg/m\^2 subcutaneous injection daily on days 1 to 14 in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. | 2 | 35 | EG000 |
| Group 2 | GM-CSF, Sargramostim Cohort 2 | GM-CSF, sargramostim 150 μg/m\^2 subcutaneous injection daily for 28 days in a 28-day cycle until disease progression or unacceptable toxicity for a median of 3 cycles. GM-CSF dose escalation was permitted up to 250 μg/m\^2 per day if applicable based on toxicity and white blood cell count. | 5 | 37 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Between December 2004 and October 2008, 72 eligible and evaluable patients were enrolled. Adverse events (AEs) were collected for 30 calendar days after administration of the last dose of trial drug (Up to 234 days)
Source ClinicalTrials.gov
Trial
- Title
- GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer
- NCT number
- NCT00157573
- Phases
- PHASE2
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer
- Interventions
- GM-CSF, sargramostim
- Lead sponsor
- Massachusetts General Hospital
- Results first posted
- 2017-05-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00157573?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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