Comparison · NCT03033511-sae
Rovalpituzumab Tesirine/Dexamethasone 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
Cite this record
ConductScience Library. Rovalpituzumab Tesirine/Dexamethasone vs Placebo: serious adverse events. Trial comparisons, record NCT03033511-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03033511-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 | 0.427 | 0.377 | 0.478 | wilson | |
| Risk in group 2 | 0.233 | 0.193 | 0.279 | wilson | |
| Risk difference, group 1 minus group 2 | 0.193 | 0.126 | 0.258 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.83 | 1.47 | 2.28 | log | |
| Odds ratio, group 1 over group 2 | 2.45 | 1.78 | 3.36 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rovalpituzumab Tesirine/Dexamethasone than on Placebo | 5.17 | 3.87 | 7.93 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rovalpituzumab 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 | 157 | 368 | EG001 |
| Group 2 | Placebo | 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 | 87 | 373 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- 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
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03033511?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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