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 @ 2:36 AM
Ignite Modification Date: 2025-12-26 @ 1:13 AM
NCT ID: NCT02618434
Description: Adverse events reporting pertains to the Safety Population which include all randomized subjects who received at least 1 dose of study drug and have at least one post-randomization safety measurements.
Frequency Threshold: 5
Time Frame: Visit 3 (Day 1) to Visit 7 (Week 6)-End of Study, a total of 6 weeks
Study: NCT02618434
Study Brief: Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)
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 Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose. 0 None 1 94 13 94 View
Low Dose SPN-810 (18 mg) Subjects were randomized to receive SPN-810 9 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose. 0 None 0 56 10 56 View
High Dose SPN-810 (36 mg) Subjects were randomized to receive SPN-810 18 mg orally twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose. 0 None 4 142 23 142 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post-Traumatic Stress Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.1) View
Drug Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (18.1) View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (18.1) View
Dystonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.1) View
Blood prolactin increase SYSTEMATIC_ASSESSMENT Investigations MedDRA (18.1) View