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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT03978832
Description: Adverse events (AE) were collected through a combination of systemic and non-systemic methods. AEs were collected through self-reporting by participants, and systemic methods included scheduled laboratory testing, investigator assessments of disease severity through PANSS, CGI-S and other scales, injection site assessments, ECGs, pregnancy testing for women of child-bearing potential. The one serious AE and all AEs above the frequency reporting threshold occurred in subjects receiving PERSERIS
Frequency Threshold: 5
Time Frame: Adverse event data was collected from the time of informed consent through the end of study for each subject, Day 120, a total of up to 146 days including the screening and dosing stabilization periods.
Study: NCT03978832
Study Brief: Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Risperidone Followed by PERSERIS All participants received up to 4 monthly doses of 180 mg PERSERIS (each 180 mg dose was administered as two 90 mg SC injections). The first 3 monthly doses were administered in the abdominal region while the fourth monthly dose was administered in the back of the upper arm. PERSERIS: PERSERIS is an extended-release SC injectable suspension administered once-monthly Risperidone: Oral risperidone Outcome measures and adverse events were not reported by intervention, but by number of participants who experienced the adverse event. Based on narrative, it was possible to determine the timing of the serious adverse event. By nature of the adverse event, any injection site reported adverse events or outcome data occurred in participants who had received PERSERIS 0 None 1 23 9 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
increase in liver enzymes SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
blood prolactin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.0 View
decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.0 View
dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.0 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View