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 @ 1:22 AM
Ignite Modification Date: 2025-12-25 @ 11:31 PM
NCT ID: NCT03006393
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were tracked from the time of consent through the 30-Day Post-Infusion Follow-Up Phone Call.
Study: NCT03006393
Study Brief: Dynamics of Inflammation and Its Blockade on Motivational Circuitry in Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Infliximab Participants randomized to the infliximab group received one infusion of Infliximab (Remicade) administered intravenously (IV) at 5 mg/kg body weight over a two hour period. 0 None 0 21 19 21 View
Placebo Participants randomized to the placebo group received one infusion of placebo treatment administered intravenously (IV) over a two hour period. 0 None 0 21 13 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Heartburn NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Menstruation NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bruises NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in joints NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sore throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bloody stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in leg NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Allergies NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Change in urination NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Change in blood pressure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Muscle tension NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Itchiness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Motor vehicle accident NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain in neck NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Stomach ache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
Laceration NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Change in appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View