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 @ 1:41 PM
Ignite Modification Date: 2025-12-25 @ 12:37 PM
NCT ID: NCT00782795
Description: All adverse events that participants raised to study team as such, all of which were reported on to the IRB, are shown below.
Frequency Threshold: 5
Time Frame: 48 weeks
Study: NCT00782795
Study Brief: Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pioglitazone 30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks. Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks. None None 4 17 0 17 View
Sugar Pill (Placebo) 1 sugar pill (placebo) taken once daily for 48 weeks. Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks. None None 2 8 0 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
chronic vertigo exacerbation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Trauma to head SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
non-specific neck swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):