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 @ 1:02 PM
Ignite Modification Date: 2025-12-25 @ 12:19 PM
NCT ID: NCT05188261
Description: An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
Frequency Threshold: 0
Time Frame: From first dose of study drug through 24 hours post-Day 1 dose
Study: NCT05188261
Study Brief: A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
300 μg IW-3300 Participants received a single dose of 300 μg IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours. 0 None 0 6 0 6 View
900 μg IW-3300 Participants received a single dose of 900 μg IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours. 0 None 0 6 1 6 View
2500 μg IW-3300 Participants received a single dose of 2500 μg IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours. 0 None 0 6 2 6 View
100 μg IW-3300 Participants received a single dose of 100 μg IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours. 0 None 0 6 1 6 View
Placebo Participants received a single dose of placebo administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours. 0 None 0 8 2 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorectal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Infrequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View