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 @ 4:37 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT00441766
Description: The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized (started the study) AND treated.
Frequency Threshold: 5
Time Frame: None
Study: NCT00441766
Study Brief: Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AGN 203818 60 mg Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks None None 8 53 52 53 View
AGN 203818 20 mg Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks None None 0 53 48 53 View
AGN 203818 3 mg Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks None None 2 52 28 52 View
Placebo Part A: Placebo capsule every 12 hours for 4 weeks None None 1 54 39 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Adjustment Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Meningitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (10.0) View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (10.0) View
Muscular Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (10.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Blood bilirubin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Reticulocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (10.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (10.0) View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (10.0) View