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Comparison · NCT03897205-sae

Imlifidase vs Plasma Exchange: 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. Imlifidase vs Plasma Exchange: serious adverse events. Trial comparisons, record NCT03897205-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03897205-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 10.1580.05520.376wilson
Risk in group 20.30.1080.603wilson
Risk difference, group 1 minus group 2-0.142-0.4620.148newcombe hybrid score
Risk ratio, group 1 over group 20.5260.1292.15log
Odds ratio, group 1 over group 20.4380.07022.73log
Number needed to treat, for one fewer participant with a serious adverse event on Imlifidase than on Plasma Exchange7.04from 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 1ImlifidaseParticipants randomized to imlifidase319EG000
Group 2Plasma ExchangeParticipants randomized to plasma exchange310EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the participant signed the informed consent form (ICF) until end of study, including the follow-up period). AEs occurring after the start of trial treatment and within the time of residual drug effect which is 28 days after start of trial treatment are classified as treatment emergent AEs (TEAEs).

Source ClinicalTrials.gov

Trial

Title
An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients
NCT number
NCT03897205
Phases
PHASE2
Conditions
Kidney Transplant Rejection
Interventions
Imlifidase, Plasma Exchange
Lead sponsor
Hansa Biopharma AB
Results first posted
2024-02-28

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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