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Comparison · NCT04318080-sae

Cohort 1 vs Cohort 2: serious adverse events

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. Cohort 1 vs Cohort 2: serious adverse events. Trial comparisons, record NCT04318080-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04318080-sae

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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 10.2860.1170.546wilson
Risk in group 20.290.1610.466wilson
Risk difference, group 1 minus group 2-0.00461-0.2480.286newcombe hybrid score
Risk ratio, group 1 over group 20.9840.3642.66log
Odds ratio, group 1 over group 20.9780.2423.95log
Number needed to treat, for one fewer participant with a serious adverse event on Cohort 1 than on Cohort 2217from 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 1Cohort 1
Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks.
414EG000
Group 2Cohort 2
Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks.
931EG001

Harm

What it counts
Total, serious adverse events
Time frame
All-cause mortality was reported from randomization to 29 Aug 2024 (4 years). AEs were reported from first tislelizumab dose to 90 days post-last dose (max exposure: 168 weeks).

Source ClinicalTrials.gov

Trial

Title
Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma
NCT number
NCT04318080
Phases
PHASE2
Conditions
Classical Hodgkin Lymphoma
Interventions
Tislelizumab
Lead sponsor
BeiGene
Results first posted
2025-09-24

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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