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 @ 4:49 AM
Ignite Modification Date: 2025-12-26 @ 3:50 AM
NCT ID: NCT02402218
Description: None
Frequency Threshold: 5
Time Frame: From treatment initiation to post-treatment week 12
Study: NCT02402218
Study Brief: CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Plus Peer-mentors With LDV/SOF In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection. Usual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with LDV/SOF. This group of patients initiated treatment with LDV/SOF. 0 None 9 45 18 45 View
Usual Care Plus Incentives With LDV/SOF In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study. Usual care plus incentives: Participants are given incentives after completing treatment goals. This group of patients initiated treatment with LDV/SOF. 0 None 9 41 19 41 View
Usual Care With LDV/SOF Participants receive standard of care for Hepatitis C in the clinic. Usual Care: Participants receive standard of care in the clinic from their health care team. This group of patients initiated treatment with LDV/SOF. 1 None 3 24 11 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Leg Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Otitis media with effusion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Syncope SYSTEMATIC_ASSESSMENT General disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Scabies SYSTEMATIC_ASSESSMENT Infections and infestations None View
Poorly-controlled diabetes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anion gap metabolic acidosis SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute Decompensated Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Kidney Stones SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hepatic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Elevated liver enzymes SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Motor Vehicle Accident SYSTEMATIC_ASSESSMENT Social circumstances None View
Pregnancy SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Alcohol withdrawal SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abcess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
acute congestive heart failure exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Transient Ischemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders None View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
cellulitis of left arm during pregnancy SYSTEMATIC_ASSESSMENT Infections and infestations None View
Emphysema/COPD/SOB SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Back Pain SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View