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 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:07 AM
NCT ID: NCT04998305
Description: None
Frequency Threshold: 0
Time Frame: 11 weeks
Study: NCT04998305
Study Brief: TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants who were administered the placebo during the first 2-week treatment period. 0 None 0 11 3 11 View
TJ-68 Participants who were administered TJ-68 during the first 2-week treatment period. 0 None 2 11 5 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory distress due to RSV SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis with pericecal abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Facial rash SYSTEMATIC_ASSESSMENT General disorders None View
Stomachache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated blood pressure SYSTEMATIC_ASSESSMENT General disorders None View
Flu-like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Joint pain SYSTEMATIC_ASSESSMENT General disorders None View
Scleral erythema SYSTEMATIC_ASSESSMENT Eye disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension SYSTEMATIC_ASSESSMENT General disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rash acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Abdominal bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View