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 @ 10:20 PM
Ignite Modification Date: 2025-12-25 @ 7:53 PM
NCT ID: NCT00452335
Description: None
Frequency Threshold: 5
Time Frame: Treatment-emergent AEs: up to 4 weeks plus 7 days (from time of first dose to 7 days post-treatment)
Study: NCT00452335
Study Brief: Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
12 mcg QD Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\<6 years of age and able to swallow capsules) who are at least 12 kg body weight None None 0 27 5 27 View
12 mcg BID Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight None None 1 65 23 65 View
24 mcg BID Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight None None 0 32 14 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain None Gastrointestinal disorders MedDRA 10.1 View
Diarrhoea None Gastrointestinal disorders MedDRA 10.1 View
Nausea None Gastrointestinal disorders MedDRA 10.1 View
Vomiting None Gastrointestinal disorders MedDRA 10.1 View
Headache None Nervous system disorders MedDRA 10.1 View