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: 2025-12-24 @ 9:32 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT01953432
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
Study: NCT01953432
Study Brief: Pharmacogenetic Trial of Doxazosin for Treatment of Cocaine Abuse
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Doxazosin Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system. Doxazosin: Doxazosin is initiated at 2 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 4 weeks. Participants will be maintained on 8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15. 0 None 0 22 8 22 View
Placebo Matched placebo daily dosing. Placebo: Matched placebo daily dosing 0 None 0 21 5 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lightheadedness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cold/Viral Illness NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stomach Pain/Indigestion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Swelling NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Erectile Dysfunction NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Allergies NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Muscle twitching NON_SYSTEMATIC_ASSESSMENT General disorders None View
Numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased Drug Craving NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View