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 @ 3:06 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT02387359
Description: A total of 1054 patients were randomized, of which two patients did not receive the study drug (6 mg) and resulted in a total of 1052 patients in the Safety population.
Frequency Threshold: 2
Time Frame: None
Study: NCT02387359
Study Brief: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Matching Placebo Placebo tablets dosed once daily for 12 weeks 0 None 5 354 16 354 View
3.0 mg Plecanatide Plecanatide 3.0 mg tablets dosed once daily for 12 weeks 0 None 4 351 37 351 View
6.0 mg Plecanatide Plecanatide 6.0 mg tablets dosed once daily for 12 weeks 2 None 2 347 28 347 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 14.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 14.1 View
Hepatic enzyme increase SYSTEMATIC_ASSESSMENT Investigations MedDRA version 14.1 View
Affective disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 14.1 View
Biplar I disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 14.1 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 14.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 14.1 View
Lymphadenitis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 14.1 View
Drowning SYSTEMATIC_ASSESSMENT General disorders MedDRA version 14.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 14.1 View
Hepatitis C SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 14.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 14.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 14.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 14.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 14.1 View