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 @ 10:04 PM
Ignite Modification Date: 2025-12-25 @ 7:40 PM
NCT ID: NCT02237235
Description: None
Frequency Threshold: 0
Time Frame: 9 weeks
Study: NCT02237235
Study Brief: Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MMFS-202 -302 MMFS-202: evening dose MMFS-302: morning dose MMFS-202-302: Active ingredient: L-Threonic acid Magnesium salt. 1 g (2 pills) by mouth once daily in the evening for 9 weeks Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt 1 g (2 pills) by mouth once daily in the morning for 9 weeks 0 None 0 30 27 30 View
Placebo Placebo Placebo: Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks. 0 None 0 30 28 30 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headche SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pannic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Exacerbation of Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Loose Stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cutting Self SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Stomach ache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cold symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Hand spasm SYSTEMATIC_ASSESSMENT Nervous system disorders None View
High triglycerides SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flu-like symptoms SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest Pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diahrrea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Increase in bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
fever SYSTEMATIC_ASSESSMENT General disorders None View
Sinus Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Strained neck SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization due to diabetic ketoacidosis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
strep throat SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hot flashes, sweating, chills SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness (Light headedness) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pink eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Nose and chest congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Ingrown toe nail SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
More burping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach infection NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Angioplasty NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View