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 @ 3:46 AM
Ignite Modification Date: 2025-12-26 @ 2:33 AM
NCT ID: NCT00176202
Description: None
Frequency Threshold: 5
Time Frame: Weekly from baseline and for 6 weeks; 7 waves of data.
Study: NCT00176202
Study Brief: Risperidone and Divalproex Sodium With MRI Assessment in Pediatric Bipolar
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Risperidone Likely side effects include weight gain, muscle stiffness, sedation and tiredness. Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level. None None 0 32 8 32 View
Depakote or Divalproex Sodium Likely side effects include gastrointestinal side effects such as stomach discomfort, weight gain, agitation and sedation, fatigue or tiredness. Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level. None None 0 33 10 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
sleepiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
fatigue/tiredness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Irritable/agitated SYSTEMATIC_ASSESSMENT Nervous system disorders None View
stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View