Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:44 AM
Ignite Modification Date: 2025-12-26 @ 1:24 AM
NCT ID: NCT04987333
Description: AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
Frequency Threshold: 0
Time Frame: Day 1 to Day 43
Study: NCT04987333
Study Brief: Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1) Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low). 0 None 1 8 8 8 View
Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2) Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). 0 None 0 8 8 8 View
Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2) Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). 0 None 0 8 8 8 View
Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2) Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). 0 None 1 8 8 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Lip swelling SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site discolouration SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dysmenorrhoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Urticaria papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Hyperaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Sars-cov-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Muscle twitching SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View