Comparison · NCT03325816-sae
Phase I - Dose Level -1 vs Phase I - Dose Level 0: 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. Phase I - Dose Level -1 vs Phase I - Dose Level 0: serious adverse events. Trial comparisons, record NCT03325816-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03325816-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 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk in group 2 | 0.333 | 0.0968 | 0.7 | wilson | |
| Risk difference, group 1 minus group 2 | 0.333 | -0.254 | 0.694 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.5 | 8 | log | |
| Odds ratio, group 1 over group 2 | 4 | 0.211 | 75.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Phase I - Dose Level -1 than on Phase I - Dose Level 0 | 3 | 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 | Phase I - Dose Level -1 | Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 3.7 GBq (100 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate. | 2 | 3 | EG000 |
| Group 2 | Phase I - Dose Level 0 | Nivolumab will be administered 240mg every 2 weeks, intravenously until progressive disease, patient withdrawal, or toxicities. 177Lu-DOTA0-Tyr3-Octreotate dose will be 7.4 GBq (200 mCi), infused over 30 minutes, every 8 weeks for 4 doses. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab and an intravenous bolus of anti-emetics will be given. Concurrent amino acids are given in parallel by peripheral vein infusion with each dose of 177Lu-DOTA0-Tyr3-Octreotate. | 2 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 24 months
Source ClinicalTrials.gov
Trial
- Title
- Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT03325816
- Phases
- PHASE1, PHASE2
- Conditions
- Small Cell Lung Cancer, Small Cell Lung Cancer Extensive Stage
- Interventions
- Nivolumab, 177Lu-DOTA0-Tyr3-Octreotate
- Lead sponsor
- Georgetown University
- Results first posted
- 2021-03-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03325816?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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