Comparison · NCT03371017-1d8a8192
Placebo + Chemotherapy vs Atezolizumab + Chemotherapy: Number of Participants With Adverse Events (AEs)
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. Placebo + Chemotherapy vs Atezolizumab + Chemotherapy: Number of Participants With Adverse Events (AEs). Trial comparisons, record NCT03371017-1d8a8192. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03371017-1d8a8192
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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 | 0.963 | 0.934 | 0.979 | wilson | |
| Risk in group 2 | 0.959 | 0.93 | 0.976 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00354 | -0.0297 | 0.0371 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.971 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 1.1 | 0.477 | 2.53 | log | |
| Number needed to treat, for one more participant with the outcome on Placebo + Chemotherapy than on Atezolizumab + Chemotherapy | 282 | 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 | Placebo + Chemotherapy | Participants received atezolizumab matching placebo, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m\^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m\^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle= 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | 283 | 294 | OG000 |
| Group 2 | Atezolizumab + Chemotherapy | Participants received atezolizumab 1200 mg, by IV infusion on Day 1 of each cycle along with either gemcitabine, 1000 mg/m\^2, followed by carboplatin target AUC 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each cycle or capecitabine, 1000 mg/m\^2, BID, orally on Days 1 to 14, followed by a 7-day rest period in each cycle (1 Cycle = 3 weeks). Treatment was continued until PD, unacceptable toxicity, death or participant or investigator decision to discontinue treatment. | 281 | 293 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events (AEs)
- Description
An 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 that worsen during a study are also considered AEs.
- Time frame
- From treatment initiation up to 90 days after last dose (up to 71 months)
- Population
- Safety-evaluable population included participants who received any amount of any study drug (atezolizumab/placebo or chemotherapy).
Source ClinicalTrials.gov
Trial
- Title
- A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer
- NCT number
- NCT03371017
- Phases
- PHASE3
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- Atezolizumab, Placebo, Gemcitabine, Capecitabine, Carboplatin
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2025-11-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03371017?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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