Comparison · NCT05222555-d7f3adaf
Tafasitamab Dose Level 1 + 25 mg Lenalidomide vs Tafasitamab Dose Level 2 + 25 mg Lenalidomide: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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. Tafasitamab Dose Level 1 + 25 mg Lenalidomide vs Tafasitamab Dose Level 2 + 25 mg Lenalidomide: Number of Participants With Any Treatment-emergent Adverse Event (TEAE). Trial comparisons, record NCT05222555-d7f3adaf. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05222555-d7f3adaf
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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 | 1 | 0.61 | 1 | wilson | |
| Risk in group 2 | 0.957 | 0.858 | 0.988 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0426 | -0.349 | 0.142 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.983 | 1.11 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Tafasitamab Dose Level 1 + 25 mg Lenalidomide than on Tafasitamab Dose Level 2 + 25 mg Lenalidomide | 23.5 | 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 | Tafasitamab Dose Level 1 + 25 mg Lenalidomide | Tafasitamab was administered as an intravenous (IV) infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered once daily (QD) orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. | 6 | 6 | OG000 |
| Group 2 | Tafasitamab Dose Level 2 + 25 mg Lenalidomide | Tafasitamab was administered as an IV infusion in 28-day cycles until disease progression, unacceptable toxicity, or other criteria for treatment discontinuation were met. Lenalidomide 25 mg was administered QD orally on Days 1 to 21 of each 28-day cycle for up to 12 cycles or until criteria for treatment discontinuation were met. Following discontinuation of lenalidomide, participants continued with tafasitamab monotherapy at the assigned treatment regimen. | 45 | 47 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- Description
An adverse event (AE) was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Therefore, an AE could be any unfavorable or unintended sign (including an abnormal laboratory finding) or symptom temporally associated with the use of study treatment. A TEAE was defined as any AE that started or worsened after the first dose of study treatment until 90 days after the last dose of the study treatment. An AE that was present prior to study drug administration but increased in severity after treatment start was also included as a TEAE.
- Time frame
- up to approximately 2 years
- Population
Safety Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 postbaseline safety assessment. A valid safety assessment included death. Treatment groups were determined according to the actual treatment the participant received regardless of assigned study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients
- NCT number
- NCT05222555
- Phases
- PHASE1, PHASE2
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- Tafasitamab, Lenalidomide
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2025-07-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05222555?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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