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Comparison · NCT02623972-sae

Arm A: Eribulin followed by AC vs Arm B: AC followed by Eribulin: 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. Arm A: Eribulin followed by AC vs Arm B: AC followed by Eribulin: serious adverse events. Trial comparisons, record NCT02623972-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02623972-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3130.1420.556wilson
Risk in group 20.1670.03010.564wilson
Risk difference, group 1 minus group 20.146-0.2860.425newcombe hybrid score
Risk ratio, group 1 over group 21.880.27212.9log
Odds ratio, group 1 over group 22.270.20824.9log
Number needed to harm, for one more participant with a serious adverse event on Arm A: Eribulin followed by AC than on Arm B: AC followed by Eribulin6.86from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm A: Eribulin followed by AC
* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle~* Two research breast biopsies~* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle~* Cyclophosphamide via iv a predetermined dosage and schedule per cycle~* Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection~* Radiation Therapy~* Endocrine Therapy (if applicable)~* Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans~Eribulin: administered IV for 4 cycles~Adriamycin: administered IV with cyclophosphamide for 4 cycles~Cyclophosphamide: administered IV with adriamycin for 4 cycles
516EG000
Group 2Arm B: AC followed by Eribulin
* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle~* Cyclophosphamide via iv a predetermined dosage and schedule per cycle~* Two research breast biopsies~* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle~* Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection~* Radiation Therapy~* Endocrine Therapy (if applicable)~* Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans~Eribulin: administered IV for 4 cycles~Adriamycin: administered IV with cyclophosphamide for 4 cycles~Cyclophosphamide: administered IV with adriamycin for 4 cycles
16EG001

Harm

What it counts
Total, serious adverse events
Time frame
All-Cause Mortality measurement is anticipated to last for at least 5 years. It is assessed every cycle for 8 cycles during treatment. After protocol therapy, every 3 months for 1 year, then every 6 months for 4 years, then annually until death. Adverse events(SAEs and OAEs) are assessed every cycle for 8 cycles. After protocol therapy, assessed approximately 4 weeks following completion of therapy. The median(range) number of competed cycles of therapy was 8(7-8). As such up to 24 weeks.

Source ClinicalTrials.gov

Trial

Title
A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer
NCT number
NCT02623972
Phases
PHASE2
Conditions
Inflammatory Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Interventions
Eribulin, Adriamycin, Cyclophosphamide
Lead sponsor
Dana-Farber Cancer Institute
Results first posted
2022-12-28

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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