Comparison · NCT03498716-5c9498b7
Chemotherapy vs Atezolizumab and Chemotherapy: Number of Participants With Adverse Events (AE)
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. Chemotherapy vs Atezolizumab and Chemotherapy: Number of Participants With Adverse Events (AE). Trial comparisons, record NCT03498716-5c9498b7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03498716-5c9498b7
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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 | 0.991 | 0.983 | 0.995 | wilson | |
| Risk in group 2 | 0.997 | 0.992 | 0.999 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00648 | -0.0144 | 0.000281 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.994 | 0.987 | 1 | log | |
| Odds ratio, group 1 over group 2 | 0.296 | 0.0811 | 1.08 | log | |
| Number needed to treat, for one fewer participant with the outcome on Chemotherapy than on Atezolizumab and Chemotherapy | 154 | 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 | Chemotherapy | Participants were administered paclitaxel, 80 mg/m\^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment. | 1,074 | 1,084 | OG000 |
| Group 2 | Atezolizumab and Chemotherapy | Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose. | 1,090 | 1,093 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events (AE)
- Description
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
- Time frame
- Up to 5 years
- Population
- Safety Evaluable Population included all participants who received any amount of any study drug.
Source ClinicalTrials.gov
Trial
- Title
A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer
- NCT number
- NCT03498716
- Phases
- PHASE3
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Atezolizumab, Paclitaxel, Dose-dense Doxorubicin or dose-dense Epirubicin, Cyclophosphamide
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2024-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03498716?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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