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 @ 3:24 AM
Ignite Modification Date: 2025-12-26 @ 2:04 AM
NCT ID: NCT02367105
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT02367105
Study Brief: Lifestyle Intervention and Testosterone Replacement in Obese Seniors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo + Lifestyle Therapy Placebo in combination with behavioral diet to induce \~10% weight loss and supervised aerobic and exercise training Lifestyle Therapy: Weekly behavioral diet to induce \~10% weight loss in combination with supervised aerobic and exercise training three times a week Placebo: Placebo gel for testosterone 0 None 1 41 12 41 View
Testosterone + Lifestyle Therapy Testosterone replacement in combination with behavioral diet to induce \~10% weight loss + supervised aerobic and exercise training Testosterone: Daily testosterone gel applied once daily in the morning to intact skin Lifestyle Therapy: Weekly behavioral diet to induce \~10% weight loss in combination with supervised aerobic and exercise training three times a week 0 None 1 42 6 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bleeding peptic ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ankle fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Idiopathic thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hyperosmolar hyperglycemic state SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hypoglycemia, asymptomatic and symptomatic SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dizziness/orthostasis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Elevated PSA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View