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 @ 3:33 PM
Ignite Modification Date: 2025-12-25 @ 1:46 PM
NCT ID: NCT01323192
Description: None
Frequency Threshold: 2
Time Frame: 9 weeks
Study: NCT01323192
Study Brief: An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder
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 received matching placebo orally once daily for 8 weeks. None None 0 141 76 141 View
JNS001 Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks. None None 2 143 117 143 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumothorax spontaneous tension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 15.0 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 15.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 15.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 15.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 15.0 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 15.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 15.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.0 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.0 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 15.0 View