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: 2025-12-26 @ 10:46 PM
Ignite Modification Date: 2025-12-26 @ 10:46 PM
NCT ID: NCT00753012
Description: None
Frequency Threshold: 4.2
Time Frame: None
Study: NCT00753012
Study Brief: Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Normotensive Adults With ADHD Group 1 is comprised of adults who meet DSM-IV-TR criteria for ADHD and do not have high blood pressure. None None 0 14 11 14 View
Primary Hypertensive Adults With ADHD Group 2 is comprised of adults who meet the full DSM-IV criteria for ADHD, and who also high blood pressure being treated with stable doses of up to two FDA approved hypertensive medications to achieve a stable blood pressure of \<135/85. High blood pressure is defined as 140-159mmHg/90-99 mmHg. None None 0 8 8 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
blind spot NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
blurred vision NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
cold symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
difficulty achieving erection NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
feelings of self-consciousness NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
feeling flustered NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
foot pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
GI upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hand tremor NON_SYSTEMATIC_ASSESSMENT General disorders None View
headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
heartburn NON_SYSTEMATIC_ASSESSMENT General disorders None View
increased energy NON_SYSTEMATIC_ASSESSMENT General disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
jaw tension NON_SYSTEMATIC_ASSESSMENT General disorders None View
jittery NON_SYSTEMATIC_ASSESSMENT General disorders None View
lightheadedness NON_SYSTEMATIC_ASSESSMENT General disorders None View
lip swelling NON_SYSTEMATIC_ASSESSMENT General disorders None View
low appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
low energy NON_SYSTEMATIC_ASSESSMENT General disorders None View
muscle aches NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
muscle tension NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
muscle twitch NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
numbness NON_SYSTEMATIC_ASSESSMENT General disorders None View
racing NON_SYSTEMATIC_ASSESSMENT General disorders None View
sinus pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
tension NON_SYSTEMATIC_ASSESSMENT General disorders None View
tightness in the hand NON_SYSTEMATIC_ASSESSMENT General disorders None View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
viral illness NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View