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 @ 10:20 PM
Ignite Modification Date: 2025-12-25 @ 7:53 PM
NCT ID: NCT02784535
Description: The adverse events (AEs) were noted after the subjects signed the Consent. Among all AEs : 2 happened in dose optimization period, 23 were recorded in phase of Atomoxetine treatment and 20 were in phase of Placebo treatment.
Frequency Threshold: 0
Time Frame: Day -10 to Day 64 of the study
Study: NCT02784535
Study Brief: Norepinephrine Transporter Blockade, Autonomic Failure (NETAF)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dose Optimization Phase -1 to -10 days Open-label, dose-optimization phase: To test two doses of Atomoxetine (10,18 mg), until they met criteria for Atomoxetine Responders. total of 48 participated in this phase. 40 participants were qualified as Atomoxetine responders. 0 None 0 48 1 48 View
Placebo Double blind Placebo group Overall subjects who received placebo capsules 0 None 1 40 13 40 View
Atomoxetine Double blind Atomoxetine 18 mg or Atomoxetine 10 mg. Depending upon the dose the participant qualified as Atomoxetine Responders. Subjects received atomoxetine capsules 18 mg or 10 mg three times a day. The dose stratification was not done Majority of the subjects received 18 mg of Atomoxetine three times a day . 1 None 2 40 13 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Patient hospitalized after found in bed disoriented and confused with fever of unknown origin SYSTEMATIC_ASSESSMENT Infections and infestations None View
Trouble swallowing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Reflux esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
upper respiratory infections SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
altered sensation, tingling, numbness , cold SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Altered bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Prostatitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Injury related to fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View