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Comparison · NCT03033511-deaths

Rovalpituzumab Tesirine/Dexamethasone vs Placebo: deaths from any cause

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. Rovalpituzumab Tesirine/Dexamethasone vs Placebo: deaths from any cause. Trial comparisons, record NCT03033511-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03033511-deaths

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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 10.6080.5570.656wilson
Risk in group 20.5350.4840.584wilson
Risk difference, group 1 minus group 20.0730.002030.143newcombe hybrid score
Risk ratio, group 1 over group 21.1411.29log
Odds ratio, group 1 over group 21.351.011.8log
Number needed to harm, for one more death from any cause on Rovalpituzumab Tesirine/Dexamethasone than on Placebo13.77492from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Rovalpituzumab Tesirine/Dexamethasone
Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle~Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
226372EG001
Group 2Placebo
Placebo q6 wk; omitting every third cycle~Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle~Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
201376EG000

Harm

What it counts
Total, all-cause mortality
Time frame
All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.

Source ClinicalTrials.gov

Trial

Title
A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
NCT number
NCT03033511
Phases
PHASE3
Conditions
Small Cell Lung Cancer
Interventions
Placebo for dexamethasone, Placebo for rovalpituzumab tesirine, Rovalpituzumab tesirine, Dexamethasone
Lead sponsor
AbbVie
Results first posted
2020-12-21

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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