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Comparison · NCT01919801-ff41ac61

Icatibant 30 mg vs Placebo: Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)

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. Icatibant 30 mg vs Placebo: Number of Participants Admitted to Hospital or Intensive Care Unit (ICU). Trial comparisons, record NCT01919801-ff41ac61. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01919801-ff41ac61

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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 10.3670.2560.493wilson
Risk in group 20.3790.2660.508wilson
Risk difference, group 1 minus group 2-0.0126-0.1820.157newcombe hybrid score
Risk ratio, group 1 over group 20.9670.6051.54log
Odds ratio, group 1 over group 20.9470.4492log
Number needed to treat, for one fewer participant with the outcome on Icatibant 30 mg than on Placebo79.1from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Icatibant 30 mgParticipants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.2260OG000
Group 2PlaceboParticipants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.2258OG001

Outcome

Type
SECONDARY
Title
Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)
Description
Number of participants with and without an occurrence of admission to the hospital (inpatient) or ICU post-treatment due to the ACE-I-induced angioedema attack were described.
Time frame
Day 0 up to Day 5
Population
mITT population.

Source ClinicalTrials.gov

Trial

Title
Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema
NCT number
NCT01919801
Phases
PHASE3
Conditions
Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Interventions
Icatibant, Placebo
Lead sponsor
Shire
Results first posted
2016-10-10

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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