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: 2025-12-26 @ 11:11 AM
Ignite Modification Date: 2025-12-26 @ 11:11 AM
NCT ID: NCT00597428
Description: Number of participants at risk represents the Safety Evaluable population. Safety Evaluable population includes all subjects who randomzied and dosed. ITT population (in Participant Flow) includes only subjects who dosed and provided at least one post-treatment efficacy assessment.
Frequency Threshold: 5
Time Frame: Treatment-emergent adverse events (AEs): 13 weeks (from time of first dose to 7 days post-treatment)
Study: NCT00597428
Study Brief: Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo : 0 mcg capsules twice daily (BID) None None 7 214 36 214 View
Lubiprostone Lubiprostone : 24 mcg capsules twice daily (BID) None None 7 223 49 223 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chills None General disorders MedDRA 13.1 View
Irritable bowel syndrome None Gastrointestinal disorders MedDRA 13.1 View
Intestinal obstruction None Gastrointestinal disorders MedDRA 13.1 View
Faecaloma None Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain upper None Gastrointestinal disorders MedDRA 13.1 View
Pneumonia None Infections and infestations MedDRA 13.1 View
Herpes zoster None Infections and infestations MedDRA 13.1 View
Diverticulitis None Infections and infestations MedDRA 13.1 View
Multiple sclerosis relapse None Nervous system disorders MedDRA 13.1 View
Migraine None Nervous system disorders MedDRA 13.1 View
Tricuspid valve disease None Cardiac disorders MedDRA 13.1 View
Angina pectoris None Cardiac disorders MedDRA 13.1 View
Confusional state None Psychiatric disorders MedDRA 13.1 View
Hypersensitivity None Immune system disorders MedDRA 13.1 View
Cholecystitis None Hepatobiliary disorders MedDRA 13.1 View
Pyrexia None General disorders MedDRA 13.1 View
Malaise None General disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea None Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea None Gastrointestinal disorders MedDRA 13.1 View
Flatulence None Gastrointestinal disorders MedDRA 13.1 View
Vomiting None Gastrointestinal disorders MedDRA 13.1 View