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: 2025-12-24 @ 3:54 PM
Ignite Modification Date: 2025-12-25 @ 1:59 PM
NCT ID: NCT00336492
Description: Data for subjects who stepped up are included according to the regimen received before step-up.
Frequency Threshold: 5
Time Frame: None
Study: NCT00336492
Study Brief: A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Not Randomized Group Participants who were not randomized at Week 8 None None 5 15 10 15 View
5 mg/kg Infliximab Every 8 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks None None 4 22 19 22 View
5 mg/kg Infliximab Every 12 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks None None 5 23 22 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WhoArtCENT 200606 View
Infection Viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations WhoArtCENT 200606 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders WhoArtCENT 200606 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WhoArtCENT 200606 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations WhoArtCENT 200606 View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations WhoArtCENT 200606 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WhoArtCENT 200606 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WhoArtCENT 200606 View
Colitis Ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WhoArtCENT 200606 View
Pneumonia Lobar NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WhoArtCENT 200606 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocythemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WhoArtCENT 200606 View
Blood in Stool NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WhoArtCENT 200606 View
Stomatitis Ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WhoArtCENT 200606 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WhoArtCENT 200606 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders WhoArtCENT 200606 View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders WhoArtCENT 200606 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders WhoArtCENT 200606 View
Hepatic Enzymes Increased NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders WhoArtCENT 200606 View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations WhoArtCENT 200606 View
Inflammation NON_SYSTEMATIC_ASSESSMENT Infections and infestations WhoArtCENT 200606 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations WhoArtCENT 200606 View
Influenza-Like Symptoms NON_SYSTEMATIC_ASSESSMENT Infections and infestations WhoArtCENT 200606 View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WhoArtCENT 200606 View
Malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders WhoArtCENT 200606 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WhoArtCENT 200606 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WhoArtCENT 200606 View
Thinking Abnormal NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WhoArtCENT 200606 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WhoArtCENT 200606 View
Coughing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WhoArtCENT 200606 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WhoArtCENT 200606 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WhoArtCENT 200606 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WhoArtCENT 200606 View
Throat Tightness NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WhoArtCENT 200606 View
Upper Respiratory Tract Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WhoArtCENT 200606 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WhoArtCENT 200606 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders WhoArtCENT 200606 View
Hemorrhoids NON_SYSTEMATIC_ASSESSMENT Vascular disorders WhoArtCENT 200606 View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders WhoArtCENT 200606 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WhoArtCENT 200606 View
Colitis Ulcerative NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WhoArtCENT 200606 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WhoArtCENT 200606 View
Infection Bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations WhoArtCENT 200606 View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders WhoArtCENT 200606 View