Comparison · NCT01416389-sae
LY2523355 + Pegfilgrastim or Filgrastim vs Ixabepilone: 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. LY2523355 + Pegfilgrastim or Filgrastim vs Ixabepilone: serious adverse events. Trial comparisons, record NCT01416389-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01416389-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 | 0.192 | 0.0851 | 0.379 | wilson | |
| Risk in group 2 | 0.308 | 0.127 | 0.576 | wilson | |
| Risk difference, group 1 minus group 2 | -0.115 | -0.405 | 0.144 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.625 | 0.201 | 1.94 | log | |
| Odds ratio, group 1 over group 2 | 0.536 | 0.116 | 2.47 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on LY2523355 + Pegfilgrastim or Filgrastim than on Ixabepilone | 8.67 | 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 | LY2523355 + Pegfilgrastim or Filgrastim | LY2523355 administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Dosage determined by calculating participant's body surface area (5 milligrams per meter squared per day \[mg/m\^2/day\]). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.~Pegfilgrastim or filgrastim administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. Dosage is determined by standard of care.~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met. | 5 | 26 | EG000 |
| Group 2 | Ixabepilone | Ixabepilone administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles.~Dosage determined by calculating participant's body surface area (40 mg/m\^2).~If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met. | 4 | 13 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Study of LY2523355 in Participants With Breast Cancer
- NCT number
- NCT01416389
- Phases
- PHASE2
- Conditions
- Metastatic Breast Cancer
- Interventions
- LY2523355, ixabepilone, pegfilgrastim, filgrastim
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2017-12-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01416389?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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