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 @ 10:13 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT00934635
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00934635
Study Brief: A Positron-Emission-Tomography (PET) Study to Measure the Blockade of Dopamine Receptors (D2) in Specific Areas of the Brain in Relation to the Plasma Concentrations of Paliperidone Extended Release (ER) and Oral Risperidone in Schizophrenia Patients and Healthy Controls
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours None None 0 0 0 0 View
Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours None None 1 1 0 1 View
Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours None None 0 0 0 0 View
Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours None None 0 0 0 0 View
Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours None None 0 0 0 0 View
Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours None None 0 0 0 0 View
Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours None None 0 0 0 0 View
Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours None None 0 0 0 0 View
Control PET Scan Control None None 0 1 0 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Exacerbation of schizophrenic symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):