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: 2025-12-25 @ 4:25 AM
Ignite Modification Date: 2025-12-26 @ 3:28 AM
NCT ID: NCT03120520
Description: None
Frequency Threshold: 0
Time Frame: 8 weeks
Study: NCT03120520
Study Brief: An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic 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
Matching Placebo Taken orally once daily in the morning for 8 weeks Matching placebo 0 None 0 31 4 31 View
Plecanatide 0.5 mg Taken orally once daily in the morning for 8 weeks Plecanatide 0 None 0 31 7 31 View
Plecanatide 1.0 mg Taken orally once daily in the morning for 8 weeks Plecanatide 0 None 0 30 4 30 View
Plecanatide 1.5 mg Taken orally once daily in the morning for 8 weeks Plecanatide 0 None 0 32 3 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infectious Mononucleosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Gilbert's syndrome NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 14.1 View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Acute Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Pharyngitis streptococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Viral upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Abdominal Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.1 View
Decreased apetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.1 View
Skin disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View