Comparison · NCT02513394-sae
Palbociclib Plus Endocrine Therapy (Arm A) vs Endocrine Therapy Alone (Arm B): 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. Palbociclib Plus Endocrine Therapy (Arm A) vs Endocrine Therapy Alone (Arm B): serious adverse events. Trial comparisons, record NCT02513394-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02513394-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 | 0.13 | 0.118 | 0.143 | wilson | |
| Risk in group 2 | 0.0789 | 0.0696 | 0.0893 | wilson | |
| Risk difference, group 1 minus group 2 | 0.051 | 0.0352 | 0.0668 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.65 | 1.41 | 1.92 | log | |
| Odds ratio, group 1 over group 2 | 1.74 | 1.46 | 2.07 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Palbociclib Plus Endocrine Therapy (Arm A) than on Endocrine Therapy Alone (Arm B) | 19.6 | 15 | 28.4 | 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 | Palbociclib Plus Endocrine Therapy (Arm A) | Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years. | 369 | 2,841 | EG000 |
| Group 2 | Endocrine Therapy Alone (Arm B) | Standard adjuvant endocrine therapy for a duration of at least 5 years. | 229 | 2,902 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 years
Source ClinicalTrials.gov
Trial
- Title
- PALbociclib CoLlaborative Adjuvant Study
- NCT number
- NCT02513394
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Palbociclib, Standard Adjuvant Endocrine Therapy
- Lead sponsor
- Alliance Foundation Trials, LLC.
- Results first posted
- 2022-04-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02513394?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/NCT02513394-sae