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 @ 3:32 AM
Ignite Modification Date: 2025-12-26 @ 2:15 AM
NCT ID: NCT03309605
Description: None
Frequency Threshold: 5
Time Frame: From the date of signing the consent form until Day 36
Study: NCT03309605
Study Brief: Phase 1 Study of ELX-02 in Healthy Adult Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort 1 0.1 mg/kg, twice a week for 9 doses 0 None 0 6 3 6 View
Cohort 2 0.3 mg/kg, twice a week for 9 doses 0 None 0 5 5 5 View
Cohort 3 and Cohort 5 1.0 mg/kg, twice a week for 9 doses 0 None 0 12 11 12 View
Cohort 4 and Cohort 6 2.5 mg/kg, twice a week for 9 doses 0 None 0 12 12 12 View
Cohort 7 5.0 mg/kg, twice a week for 9 doses 0 None 0 6 6 6 View
All Placebo Placebo, twice a week for 9 doses 0 None 0 21 11 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.1 View
Hyperacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal distention SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site discoloration SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site hematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Vessel puncture site hematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Injection site scab SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Skin wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Audiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.1 View
Dysmenorrhea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View