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Comparison · NCT05222555-63f9a887

Tafasitamab Dose Level 1 + 25 mg Lenalidomide vs Tafasitamab Dose Level 2 + 25 mg Lenalidomide: Number of Participants With Any ≥Grade 3 TEAE

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Tafasitamab Dose Level 1 + 25 mg Lenalidomide vs Tafasitamab Dose Level 2 + 25 mg Lenalidomide: Number of Participants With Any ≥Grade 3 TEAE. Trial comparisons, record NCT05222555-63f9a887. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05222555-63f9a887

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.8330.4360.97wilson
Risk in group 20.8090.6750.896wilson
Risk difference, group 1 minus group 20.0248-0.3820.216newcombe hybrid score
Risk ratio, group 1 over group 21.030.7021.51log
Odds ratio, group 1 over group 21.180.12311.4log
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 Lenalidomide40.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Tafasitamab 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.
56OG000
Group 2Tafasitamab 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.
3847OG001

Outcome

Type
PRIMARY
Title
Number of Participants With Any ≥Grade 3 TEAE
Description
The toxicity grade of TEAEs was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) using the following definitions: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal; local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.). Grade 3: severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE.
Time frame
up to approximately 2 years
Population
Safety Analysis Set

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

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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