Comparison · NCT03830866-sae
Durva + SoC CCRT vs Placebo + SoC CCRT: 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. Durva + SoC CCRT vs Placebo + SoC CCRT: serious adverse events. Trial comparisons, record NCT03830866-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03830866-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 | 0.294 | 0.25 | 0.341 | wilson | |
| Risk in group 2 | 0.234 | 0.195 | 0.279 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0591 | -0.0032 | 0.121 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.987 | 1.59 | log | |
| Odds ratio, group 1 over group 2 | 1.36 | 0.983 | 1.87 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Durva + SoC CCRT than on Placebo + SoC CCRT | 16.9 | 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 | Durva + SoC CCRT | Description (Arm-group) | 113 | 385 | EG000 |
| Group 2 | Placebo + SoC CCRT | Description (Arm-group) | 90 | 384 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the time of signature of informed consent throughout the treatment period (median duration of 656 and 532 days for durvalumab and placebo respectively) up to and including the 90-day safety follow-up period following the last dose of study treatment, up to a maximum of 53 months (Data cut-off date of 03Jul2023)
Source ClinicalTrials.gov
Trial
- Title
- Study of Durvalumab With Chemoradiotherapy for Women With Locally Advanced Cervical Cancer (CALLA)
- NCT number
- NCT03830866
- Phases
- PHASE3
- Conditions
- Locally Advanced Cervical Cancer
- Interventions
- Durvalumab, Cisplatin, Carboplatin, external beam radiation therapy (EBRT) + brachytherapy
- Lead sponsor
- AstraZeneca
- Results first posted
- 2023-03-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03830866?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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