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 @ 9:54 PM
Ignite Modification Date: 2025-12-25 @ 7:32 PM
NCT ID: NCT04699032
Description: The Safety Set included all participants who received at least one dose of the IMP.
Frequency Threshold: 0
Time Frame: Day 1 up to Day 14
Study: NCT04699032
Study Brief: Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Severely Impaired Renal Function Participants with eGFR values \<30 mL/min/1.73 m\^2, but not requiring hemodialysis, received 5 mg SC apraglutide on Day 1. 0 None 0 8 3 8 View
Normal Renal Function Participants with eGFR values ≥90 mL/min/1.73 m\^2 received 5 mg SC apraglutide on Day 1. 0 None 0 8 2 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site hemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.0) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.0) View
Injection site papule SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.0) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.0) View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.0) View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.0) View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (24.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.0) View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (24.0) View