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 @ 9:32 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT00243932
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00243932
Study Brief: Clinical Trial of High Dose CoQ10 in ALS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
2700mg CoQ10 35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75. None None 18 75 63 75 View
Placebo 35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75. None None 19 75 64 75 View
1,800 mg CoQ10 35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis. None None 10 35 35 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Peg placement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pneumonitis/pulmonary infiltrates NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Thrombosis/thrombus/embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary/Upper Respiratory - Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other NON_SYSTEMATIC_ASSESSMENT General disorders None View
Adult Respiratory Distress Syndrome (ARDS) NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac ischemia/infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hemorrhage, GI NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neurology - Other NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mood alteration NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pulmonary/Upper Respiratory - Other NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatology/Skin - Other NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
BIPAP/NIPPV NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Gastrointestinal - Other NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema: limb NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Musculoskeletal/Soft Tissue - Other NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary frequency/urgency NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Infection with unknown ANC NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other NON_SYSTEMATIC_ASSESSMENT General disorders None View