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 @ 4:12 AM
Ignite Modification Date: 2025-12-26 @ 3:10 AM
NCT ID: NCT01942720
Description: all adverse events identified on study subjects were collected from patient enrollment up to end of study duration: AE related and not related to study procedure and or product as well as anticipated and unanticipated AEs
Frequency Threshold: 0
Time Frame: Adverse events data collected from subject enrollment up to end of study
Study: NCT01942720
Study Brief: Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) 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
Capsule Endoscopy Capsule endoscopy and Ileocolonoscopy tests None None 3 74 24 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening of IBD, Nausea, vomiting, diarrhea, abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthma Excerbation, Shortness of Breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pancreatitis, Acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Athralgia Of Hands And Elbows, Arthritis Flare NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bruised Coccyx Due To Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cyst Right Great Toe NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mild Perianal Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Questionable Right Lower Quadrant Mass NON_SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsening Diabetes NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bilateral Bursitis In Hips NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blolating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bruise At Venipucture Site. Right Anticubital Space NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
C-Difficile NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Common Cold, cough NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Crohn's Flare NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Detached Retina NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
fell NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Flu NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Heartburn NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Incontinence a Little Worse And More Often NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Iron Deficiency Anemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Joint pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Light Headed NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pulled Upper Back Muscle Left Side NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal Urgency NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Right Leg Bruising Secondary To Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Strep Throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Superficial Blood Clot Left Axilla Area NON_SYSTEMATIC_ASSESSMENT General disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View