Adverse Events Module

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 @ 10:33 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT01975935
Description: None
Frequency Threshold: 5
Time Frame: March 31, 2014-May 25, 2017. 2 years, 2 months
Study: NCT01975935
Study Brief: Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Amlexanox Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks Amlexanox 0 None 1 21 15 21 View
Placebo Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks Placebo 0 None 1 21 16 21 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
NSTEMI SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Injured left leg playing football SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Head cold SYSTEMATIC_ASSESSMENT Immune system disorders None View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Worsening neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ankle edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Elevated CK SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Itchy skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View