Comparison · NCT03125902-sae
Atezolizumab + Paclitaxel vs Placebo + Paclitaxel: 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. Atezolizumab + Paclitaxel vs Placebo + Paclitaxel: serious adverse events. Trial comparisons, record NCT03125902-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03125902-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 | 0.26 | 0.221 | 0.303 | wilson | |
| Risk in group 2 | 0.182 | 0.136 | 0.238 | wilson | |
| Risk difference, group 1 minus group 2 | 0.078 | 0.00948 | 0.141 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.43 | 1.04 | 1.97 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 1.05 | 2.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Atezolizumab + Paclitaxel than on Placebo + Paclitaxel | 12.8 | 7.1 | 105 | 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 | Atezolizumab + Paclitaxel | Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. | 112 | 431 | EG000 |
| Group 2 | Placebo + Paclitaxel | Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity. | 40 | 220 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From baseline up to 64 months
Source ClinicalTrials.gov
Trial
- Title
- A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
- NCT number
- NCT03125902
- Phases
- PHASE3
- Conditions
- Triple-Negative Breast Cancer
- Interventions
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Atezolizumab Placebo, Paclitaxel
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2021-01-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03125902?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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