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 @ 2:21 AM
Ignite Modification Date: 2025-12-26 @ 12:53 AM
NCT ID: NCT03469934
Description: Participants from the Safety Analysis Set were analyzed.
Frequency Threshold: 0
Time Frame: From first dose of study drug up to Day 127
Study: NCT03469934
Study Brief: Proof of Concept Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Severe Eosinophilic Asthma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Etokimab Participants received a single dose of 300 mg etokimab administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. 0 None 0 12 6 12 View
Placebo Participants received a single dose of placebo (0.9% sodium chloride) administered on Day 1 by IV infusion over 1 hour. After completing the Day 1 assessments, all participants were followed up for 18 weeks. 0 None 0 13 5 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 20 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 20 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 20 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 20 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 20 View
Face injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 20 View
Soft tissue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 20 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA version 20 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 20 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 20 View