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 @ 1:35 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT04444895
Description: The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab). The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen.
Frequency Threshold: 5
Time Frame: From the first study drug administration up to follow-up (Day 196)
Study: NCT04444895
Study Brief: A Study of Long-Term Safety and Efficacy of Lanadelumab for Prevention of Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lanadelumab 300 mg Every 2 Weeks Participants received 300 mg lanadelumab SC injection, Q2W for up to 26 weeks with an option to switch to lanadelumab 300 mg Q4W if attacks were well-controlled based on the investigator's discretion and consultation with the sponsor's medical monitor. 0 None 7 73 65 73 View
Lanadelumab 300 mg Every 4 Weeks Participants who received 300 mg lanadelumab, SC injection, Q4W as attacks were well-controlled based on the investigator's discretion and consultation with the sponsor's medical monitor at any point during the 26-week treatment period were included in this group. 0 None 1 2 1 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Arthritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26 View
Device related sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Lactic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26 View
Eye swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 26 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
Angioedema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View
Ligament sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26 View