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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT02019667
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected over a 16-21 month time period which included a 6 month +/- 2 week Phase 1 period, a 9 week +/- 2 week Washout period, a 6 month +/- 2 week Phase 2 period, followed by a 9 week +/- Washout period.
Study: NCT02019667
Study Brief: Phase 2 Clinical Trial of SGS-742 Therapy in Succinic Semialdehyde Dehydrogenase Deficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants with SSADH Deficiency while on placebo for six months Placebo 0 None 0 18 16 18 View
Washout Period Following Placebo Participants with SSADH Deficiency having received Placebo, during the 9 week washout period 0 None 0 16 3 16 View
Study Drug Participants with SSADH Deficiency receiving SGS-742 while on study drug for six months SGS-742 0 None 0 19 18 19 View
Washout Period Following Study Drug Participants with SSADH Deficiency having received SGS-742, during the 9 week washout period 0 None 0 18 6 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abnormal Urinary Analysis results NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Allergic Rhinitis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blister in the oral cavity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bloating NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bruising NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Concentration Impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ear Pain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Head lice NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperactivity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Labile NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Labile NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Muscle weakness upper limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Priapism NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Red eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleepiness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Strep throat NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Investigations None View