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 @ 2:42 PM
Ignite Modification Date: 2025-12-26 @ 2:42 PM
NCT ID: NCT00276406
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected for the baseline (9 days) and treatment (7 days) periods. Events occuring in more than one subject are tabulated by treatment arm.
Study: NCT00276406
Study Brief: Use of Pyridostigmine for Constipation in Diabetics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pyridostigmine Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days. None None 0 16 11 16 View
Placebo Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid. None None 0 14 5 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bluish discoloration of urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased salivation and/or sweating SYSTEMATIC_ASSESSMENT General disorders None View
Muscle twitching SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Abdominal discomfort, nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue, lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View