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 @ 10:54 PM
Ignite Modification Date: 2025-12-25 @ 8:22 PM
NCT ID: NCT01557569
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01557569
Study Brief: Clinical Efficacy of Atomoxetine for Methamphetamine Dependence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Atomoxetine Group receiving atomoxetine Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7) None None 0 6 4 6 View
Placebo Group will receive placebo instead of atomoxetine placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks. None None 0 7 2 7 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
sharp apin/tingling in limb SYSTEMATIC_ASSESSMENT Nervous system disorders None View
sleepiness/tiredness SYSTEMATIC_ASSESSMENT General disorders None View
night sweats SYSTEMATIC_ASSESSMENT General disorders None View
elevated BP (outside parameters) SYSTEMATIC_ASSESSMENT Cardiac disorders None View
elevated BP on 3 separate occasions SYSTEMATIC_ASSESSMENT Cardiac disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
insomnia SYSTEMATIC_ASSESSMENT General disorders None View
rapid heartbeat SYSTEMATIC_ASSESSMENT Cardiac disorders None View
irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
hot flash SYSTEMATIC_ASSESSMENT General disorders None View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
labored breathing SYSTEMATIC_ASSESSMENT General disorders None View
headache/pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View