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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT00870727
Description: Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with aripiprazole at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
Frequency Threshold: 0
Time Frame: Eight weeks or at the time of latest data collection.
Study: NCT00870727
Study Brief: Study of Aripiprazole in the Treatment of Pervasive Developmental 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
Arm 1. Aripiprazole Oral Product Participants will receive Aripiprazole oral product with a minimum dose of 2 mg per day to a maximum dose of 20 mg per day over 8-weeks of treatment. Aripiprazole oral product: Minimum dose of 2mg per day to a maximum of 20 mg per day over 8-weeks of treatment. 0 None 0 17 16 17 View
Arm 2. Placebo Oral Capsule Participants will receive matching (identical in size and appearance to study drug) placebo oral capsules over 8-weeks of treatment. Placebo oral capsule: Placebo will identical in size and appearance to study drug. 0 None 0 16 13 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Appetite increase SYSTEMATIC_ASSESSMENT General disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Hypersalivation SYSTEMATIC_ASSESSMENT General disorders None View
Increased thirst SYSTEMATIC_ASSESSMENT General disorders None View
Other Pain SYSTEMATIC_ASSESSMENT General disorders None View
Tiredness/Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Allergies Not Otherwise Specified SYSTEMATIC_ASSESSMENT Immune system disorders None View
Flu or upper respiratory problems SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasal congestion or Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sore throat SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weight gain SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscle/bone/joint pain/condition SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Unspecified or not otherwise listed head SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Difficulty falling asleep SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Echolalia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Emotional outburst SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypertalkativeness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased motor activity SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Restlessness/Agitation including fidgety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intermittent nosebleed SYSTEMATIC_ASSESSMENT Vascular disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach or abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Appetite decrease SYSTEMATIC_ASSESSMENT General disorders None View
Sedation/Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety/Nervousness/Worry SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Change in speech SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Concentration difficulty SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Daydreaming SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Interrupted sleep/other sleep problems SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Stereotypy SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Unspecified or not otherwise listed psych SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Generalized rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Localized rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View