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Comparison · NCT04158050-sae

Anti-IL5/IL5R-therapy Group vs Anti-IgE-therapy Group: 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. Anti-IL5/IL5R-therapy Group vs Anti-IgE-therapy Group: serious adverse events. Trial comparisons, record NCT04158050-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04158050-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 10.02380.004220.123wilson
Risk in group 2000.149wilson
Risk difference, group 1 minus group 20.0238-0.1260.123newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harm, for one more participant with a serious adverse event on Anti-IL5/IL5R-therapy Group than on Anti-IgE-therapy Group42from 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 1Anti-IL5/IL5R-therapy Group
Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R~IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
142EG000
Group 2Anti-IgE-therapy Group
Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy~IL5 Antagonist or anti-IL5R-antibody or Omalizumab: mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
022EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse events were collected for the total time period in both treatment arms. The total treatment period for the anti-IL5/IL5R-therapy was a mean of 12.8 months (SD 8.5) and for the anti-IgE therapy a mean of 49.1 months (SD 35.3).

Source ClinicalTrials.gov

Trial

Title
Comparison of Biologicals in Treatment of Severe Asthma
NCT number
NCT04158050
Phases
Conditions
Asthma
Interventions
IL5 Antagonist or anti-IL5R-antibody or Omalizumab
Lead sponsor
Helsinki University Central Hospital
Results first posted
2023-12-04

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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