Comparison · NCT01864746-sae
Palbociclib vs Placebo: 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. Palbociclib vs Placebo: serious adverse events. Trial comparisons, record NCT01864746-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01864746-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 | 0.101 | 0.08 | 0.127 | wilson | |
| Risk in group 2 | 0.106 | 0.0843 | 0.133 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00528 | -0.0395 | 0.0288 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.95 | 0.685 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.945 | 0.656 | 1.36 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Palbociclib than on Placebo | 189 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Palbociclib | Palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles~Palbociclib PD-0332991: palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle | 64 | 633 | EG000 |
| Group 2 | Placebo | Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a28-day cycle for thirteen cycles~Placebo: Arm B: Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles | 65 | 611 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
For AEs and SAEs, the reporting period is from the time the patient took the first dose of the investigational product until (and including) 30 calendar days after the last administration of the investigational product (i.e., from first dose to 30 days after last dose). Serious and Other (Not Including Serious) Adverse Events were assessed for up to 14 months, and all-cause mortality was assessed up to 6 years and 6 months.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery
- NCT number
- NCT01864746
- Phases
- PHASE3
- Conditions
- Breast Cancer, Hormonreceptor Positive, Her2-normal, Postneoadjuvant Treatment With CDK 4/6 Inhibitor, CPS-EG Score
- Interventions
- Palbociclib PD-0332991, Placebo
- Lead sponsor
- GBG Forschungs GmbH
- Results first posted
- 2023-12-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01864746?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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