Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:09 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT05122650
Description: A total of 420 participants were randomized to treatment. Of those 420 participants, only 416 received at least 1 dose of study intervention. Four participants did not receive any treatment. AEs were only collected in the 416 participants who received at least 1 dose of study treatment.
Frequency Threshold: 5
Time Frame: Up to 14 weeks
Study: NCT05122650
Study Brief: A Study To Assess the Safety and Efficacy of JZP385 in the Treatment of Adults With Moderate to Severe Essential Tremor (ET)
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 will receive placebo from Day 1. 1 None 3 104 20 104 View
10 Milligram (mg) JZP385 Participants will initially receive 5 mg/day from Day 1 through Day 7, and 10 mg/day starting on Day 8. 0 None 3 104 35 104 View
20 mg JZP385 Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, and 20 mg/day starting on Day 15. 0 None 4 103 35 103 View
30 mg JZP385 Participants will initially receive 5 mg/day from Day 1 through Day 7, 10 mg/day from Day 8 through Day 14, 20 mg/day from Day 15 through Day 21, and 30 mg/day starting on Day 22. 0 None 4 105 46 105 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA27 View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA27 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA27 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA27 View
Intercostal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA27 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA27 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA27 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA27 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA27 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA27 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA27 View