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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT00001656
Description: All adverse side effects are reported.
Frequency Threshold: 0
Time Frame: 8 week-double-blind study period
Study: NCT00001656
Study Brief: Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Olanzapine Group All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine. None None 1 13 13 13 View
Clozapine Group All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine. None None 2 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abnormal white blood count SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Enuresis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypersalivation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Difficulty concentrating SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
tachycardia >100 beats/min (supine) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia >120 beats/min (supine) SYSTEMATIC_ASSESSMENT Cardiac disorders None View