Comparison · NCT03155997-sae
150 mg Abemaciclib + Endocrine Therapy vs Endocrine Therapy: 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. 150 mg Abemaciclib + Endocrine Therapy vs Endocrine Therapy: serious adverse events. Trial comparisons, record NCT03155997-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03155997-sae
On this page
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 | 0.123 | 0.112 | 0.136 | wilson | |
| Risk in group 2 | 0.0721 | 0.0631 | 0.0823 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0511 | 0.0356 | 0.0667 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.71 | 1.45 | 2.02 | log | |
| Odds ratio, group 1 over group 2 | 1.81 | 1.51 | 2.17 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 150 mg Abemaciclib + Endocrine Therapy than on Endocrine Therapy | 19.6 | 15 | 28.1 | from the risk difference interval |
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 | 150 mg Abemaciclib + Endocrine Therapy | Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met. | 344 | 2,791 | EG000 |
| Group 2 | Endocrine Therapy | Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met. | 202 | 2,800 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline to 32 Months
Source ClinicalTrials.gov
Trial
- Title
- Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
- NCT number
- NCT03155997
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Abemaciclib, Standard Adjuvant Endocrine Therapy
- Lead sponsor
- Eli Lilly and Company
- Results first posted
- 2021-04-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03155997?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.govNone 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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03155997-sae