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 @ 12:05 PM
Ignite Modification Date: 2025-12-25 @ 11:58 AM
NCT ID: NCT03697161
Description: All adverse events collected as part of the study are reported in the Adverse Event module
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT03697161
Study Brief: A Study of OV101 in Individuals With Fragile X Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OV101 (5 mg QD) mg/day (5 mg QD) OV101 0 None 0 7 1 7 View
OV101 (5 mg TID) 15 mg/day (5 mg TID) OV101 0 None 0 8 8 8 View
OV101 (5 mg BID) 10 mg/day (5 mg BID) OV101 0 None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
AGGRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.0 View
IRRITABILITY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
STEREOTYPY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
FOOD POISONING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
VIRAL RHINITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
COMPULSIONS SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
RHINORRHOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.0 View
FEELING ABNORMAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.0 View