Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 6:33 PM
Ignite Modification Date: 2025-12-25 @ 4:03 PM
NCT ID: NCT01756157
Description: Treatment-emergent adverse events included adverse events (AEs) that were not present at baseline (that is, prior to the first dose of study drug) but started during or after the first administration of study drug in each treatment period, and AEs that were present at baseline but worsened in frequency and/or severity. ITT-S population.
Frequency Threshold: 5
Time Frame: From the time of first dose of study drug up to 7 days after the last dose of study drug within each treatment period (8 weeks)
Study: NCT01756157
Study Brief: Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment A (1000 U CINRYZE + 24000 U rHuPH20) Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly \[every 3 or 4 days\] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period. None None 0 44 42 44 View
Treatment B (2000 U CINRYZE + 48000 U rHuPH20) Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly \[every 3 or 4 days\] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period. None None 0 46 46 46 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Hereditary angioedema NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 16.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Injection site reactions NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Injection site extravasation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Injury associated with device NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View