Comparison · NCT03026166-sae
Cohort 1: Rovalpituzumab Tesirine and Nivolumab vs Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab: 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. Cohort 1: Rovalpituzumab Tesirine and Nivolumab vs Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab: serious adverse events. Trial comparisons, record NCT03026166-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03026166-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 | 0.767 | 0.591 | 0.882 | wilson | |
| Risk in group 2 | 0.75 | 0.468 | 0.911 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0167 | -0.222 | 0.322 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.698 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 1.1 | 0.231 | 5.19 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort 1: Rovalpituzumab Tesirine and Nivolumab than on Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | 60 | 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 | Cohort 1: Rovalpituzumab Tesirine and Nivolumab | Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine by intravenous (IV) infusion 6 weeks apart (Day 1 of Cycles 1 and 3), and 2 doses of 360 mg nivolumab IV 3 weeks apart beginning on Cycle 2 (Day 1 of Cycles 2 and 3).~Participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 4 until disease progression. | 23 | 30 | EG000 |
| Group 2 | Cohort 2: Rovalpituzumab Tesirine and Nivolumab + Ipilimumab | Participants received 2 doses of 0.3 mg/kg rovalpituzumab tesirine IV 6 weeks apart (Day 1 of Cycles 1 and 3), nivolumab 1 mg/kg every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5), and ipilimumab 1 mg/kg IV every 3 weeks for 4 cycles beginning on Cycle 2 (Day 1 of Cycles 2-5).~After a 6-week washout, participants then received maintenance therapy with 480 mg nivolumab IV once every 4 weeks from Cycle 6 until disease progression. | 9 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the first dose of study drug until 100 days after the last dose of study drug; median duration of treatment was 65 days and 53 days in each cohort respectively. All-cause mortality is reported through the end of follow-up; maximum time on study was 115 weeks.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT03026166
- Phases
- PHASE1, PHASE2
- Conditions
- Small Cell Lung Cancer
- Interventions
- Ipilimumab, Nivolumab, Rovalpituzumab tesirine
- Lead sponsor
- AbbVie
- Results first posted
- 2020-07-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03026166?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT03026166-sae