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: 2025-12-25 @ 12:40 AM
Ignite Modification Date: 2025-12-25 @ 10:51 PM
NCT ID: NCT00750867
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT00750867
Study Brief: Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open Label Interventional Arm intravenous immunoglobulin (IVIg): The IVIg will be infused intravenously, monthly, 6 times, the dose will be 0.4 gram/kg for each infusion. None None 0 9 9 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
elevated blood pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
pruritic skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
increased temperature or skin flushing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
restless leg syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
decreased GFR SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ankle edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
elevated BUN SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
worsening of allergies SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
nodular lung abnormality SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
low potassium SYSTEMATIC_ASSESSMENT Endocrine disorders None View
viral infection of gastrointenstinal tract SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
elevated PSA SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
wrist strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
worsening of sleep apnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Accidental injury SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View