Comparison · NCT05144009-sae
Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) vs Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R): 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 A: Loncastuximab Tesirine + Rituximab (Lonca-R) vs Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R): serious adverse events. Trial comparisons, record NCT05144009-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05144009-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 | 0.765 | 0.527 | 0.904 | wilson | |
| Risk in group 2 | 0.667 | 0.467 | 0.82 | wilson | |
| Risk difference, group 1 minus group 2 | 0.098 | -0.185 | 0.342 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.779 | 1.69 | log | |
| Odds ratio, group 1 over group 2 | 1.63 | 0.398 | 6.63 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) than on Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 10.2 | 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 A: Loncastuximab Tesirine + Rituximab (Lonca-R) | Unfit participants (per sGA) received Lonca-R for 3 cycles (each treatment cycle was 3 weeks). A response-adapted approach was implemented, where participants achieving CR after 3 cycles received 1 additional cycle (4 cycles total), and those with PR after 3 cycles received additional cycles based on their cohort assignment (6 cycles total).~Loncastuximab tesirine was administered as an IV infusion on Day 2 of Cycle 1 and Day 1 (prior to rituximab administration) of subsequent cycles. Participants received 150 μg/kg loncastuximab tesirine for 2 cycles, followed by 75 μg/kg loncastuximab tesirine for subsequent cycles. Rituximab was administered as an IV infusion on Day 1 of each cycle at a dose of 375 mg/m\^2. | 13 | 17 | EG000 |
| Group 2 | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | Frail participants (per sGA) or participants with cardiac comorbidities received Lonca-R for 3 cycles (each treatment cycle was 3 weeks). A response-adapted approach was implemented, where participants achieving CR after 3 cycles received 1 additional cycle (4 cycles total), and those with PR or SD (Cohort B only) after 3 cycles received additional cycles based on their cohort assignment (6 cycles total).~Loncastuximab tesirine was administered as an IV infusion on Day 2 of Cycle 1 and Day 1 (prior to rituximab administration) of subsequent cycles. Participants received 150 μg/kg loncastuximab tesirine for 2 cycles, followed by 75 μg/kg loncastuximab tesirine for subsequent cycles. Rituximab was administered as an IV infusion on Day 1 of each cycle at a dose of 375 mg/m\^2. | 16 | 24 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All cause mortality: up to a maximum of 17.1 months; serious and other adverse events: up to approximately 8 months
Source ClinicalTrials.gov
Trial
- Title
- A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)
- NCT number
- NCT05144009
- Phases
- PHASE2
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Loncastuximab Tesirine, Rituximab
- Lead sponsor
- ADC Therapeutics S.A.
- Results first posted
- 2025-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05144009?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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