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: 2025-12-25 @ 4:24 AM
Ignite Modification Date: 2025-12-26 @ 3:27 AM
NCT ID: NCT02865720
Description: None
Frequency Threshold: 5
Time Frame: From start of study drug administration up to Week 12
Study: NCT02865720
Study Brief: Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CINRYZE 1000 U Participants received 1000 U CINRYZE IV injection twice weekly for 12 weeks. 0 None 2 8 7 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hereditary angioedema NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 19.0 View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Arthropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Intervertebral disc disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Herpes virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 19.0 View
Cervicobrachial syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Device failure NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA 19.0 View
Breast disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 19.0 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View