Comparison · NCT00553410-sae
Arm A: Continuous Letrozole vs Arm B: Intermittent Letrozole: 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. Arm A: Continuous Letrozole vs Arm B: Intermittent Letrozole: serious adverse events. Trial comparisons, record NCT00553410-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00553410-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 | 0.416 | 0.397 | 0.436 | wilson | |
| Risk in group 2 | 0.435 | 0.416 | 0.455 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0188 | -0.0467 | 0.00906 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.957 | 0.896 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.926 | 0.826 | 1.04 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm A: Continuous Letrozole than on Arm B: Intermittent Letrozole | 53.1 | 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 | Arm A: Continuous Letrozole | Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily)~Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously | 1,004 | 2,411 | EG000 |
| Group 2 | Arm B: Intermittent Letrozole | Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months~Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months | 1,052 | 2,417 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- during or within 30 days after stopping study treatment
Source ClinicalTrials.gov
Trial
- Title
- Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer
- NCT number
- NCT00553410
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Letrozole, Letrozole
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Results first posted
- 2019-01-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00553410?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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