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Comparison · NCT02125461-sae

Durvalumab (MEDI4736) vs Placebo: 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. Durvalumab (MEDI4736) vs Placebo: serious adverse events. Trial comparisons, record NCT02125461-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02125461-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.2910.2520.333wilson
Risk in group 20.2310.1810.289wilson
Risk difference, group 1 minus group 20.0598-0.01020.125newcombe hybrid score
Risk ratio, group 1 over group 21.260.9581.65log
Odds ratio, group 1 over group 21.360.951.96log
Number needed to harm, for one more participant with a serious adverse event on Durvalumab (MEDI4736) than on Placebo16.7from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Durvalumab (MEDI4736)Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.138475EG000
Group 2PlaceboPatients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.54234EG001

Harm

What it counts
Total, serious adverse events
Time frame
Serious and Other (non-serious) treatment-emergent adverse event (TEAE) data collected during the 12-month treatment period. All-cause mortality (death due to any cause) collected for entire duration of the study. Assessed until 11 Jan 2021 DCO for completion of long-term survival; approximately 5 years from last patient enrolled.

Source ClinicalTrials.gov

Trial

Title
A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
NCT number
NCT02125461
Phases
PHASE3
Conditions
Non-Small Cell Lung Cancer
Interventions
MEDI4736, PLACEBO
Lead sponsor
AstraZeneca
Results first posted
2019-01-30

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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