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 @ 7:17 PM
Ignite Modification Date: 2025-12-25 @ 4:54 PM
NCT ID: NCT00178503
Description: None
Frequency Threshold: 1
Time Frame: over 4 weeks of the trial
Study: NCT00178503
Study Brief: Methylphenidate for Attention Deficit Hyperactivity Disorder and Autism in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MPH Trial-Placebo Participants with ASD-ADHD who will undergo 1 week of placebo in the MPH treatment phase None None 0 24 13 24 View
MPH Trial: Low Dose Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase None None 0 24 15 24 View
MPH Trial: Med Dose Participants with ASD-ADHD who will undergo 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase None None 0 24 17 24 View
MPH Trial: High Dose Participants with ASD-ADHD who will undergo 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase None None 0 24 15 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Repetitive Behaviors SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Repetitive Language SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Unusual Blinking SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Stomach ache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Loss of Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Racing heart SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever SYSTEMATIC_ASSESSMENT Immune system disorders None View
Sadness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Euphoria SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hair or skin pulling NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Facial or body tics SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Trouble sleeping SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Staring SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View