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 @ 10:33 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT01162135
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01162135
Study Brief: Digoxin for Recurrent Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Digoxin Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity None None 0 16 16 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthritis None Musculoskeletal and connective tissue disorders None View
Dizziness None General disorders None View
Change in taste None General disorders None View
Bradycardia None Cardiac disorders None View
Hyperkalemia None Blood and lymphatic system disorders None View
Hyperglycemia None Blood and lymphatic system disorders None View
Hypoglycemia None Blood and lymphatic system disorders None View
Hypophosphatemia None Blood and lymphatic system disorders None View
Incontinence None General disorders None View
Decreased appetite None General disorders None View
Cold/cough None General disorders None View
Testicular soreness None Reproductive system and breast disorders None View
Hematuria None Renal and urinary disorders None View
Lymphopenia None Blood and lymphatic system disorders None View
ALT high None Hepatobiliary disorders None View
Fatigue None General disorders None View
Hyponatremia None Blood and lymphatic system disorders None View
Hypomagnesemia None Blood and lymphatic system disorders None View
Hyperbilirubinemia None Blood and lymphatic system disorders None View
Bicarbonate low None Blood and lymphatic system disorders None View
Edema None Skin and subcutaneous tissue disorders None View
Loose stools None General disorders None View
Decreased energy None General disorders None View
Lightheadedness None General disorders None View
Neck pain None General disorders None View
Arm pain None General disorders None View
Epigastric discomfort None Gastrointestinal disorders None View
Erectile dysfunction None Reproductive system and breast disorders None View
Foot pain None General disorders None View
Numbness/cramping of lower legs None General disorders None View
Abdominal pain None General disorders None View
Urinary tract infection None Renal and urinary disorders None View
Vomiting None Gastrointestinal disorders None View
Nausea None General disorders None View
Hypertension None Blood and lymphatic system disorders None View
Headaches None General disorders None View
Back pain None General disorders None View
Vivid dreams None General disorders None View
Nocturia None Renal and urinary disorders None View
Insomnia None General disorders None View
Low libido None General disorders None View
Tooth infection None Infections and infestations None View
Upper respiratory infection None Respiratory, thoracic and mediastinal disorders None View
Side pain None General disorders None View
Heart palpitations None Cardiac disorders None View
EKG change None Cardiac disorders None View
Rib pain None General disorders None View
Shoulder pain None General disorders None View
Indigestion None Gastrointestinal disorders None View
Tooth root canal None General disorders None View
Difficulty raking deep breaths None Respiratory, thoracic and mediastinal disorders None View
Nightmares None General disorders None View
Diarrhea None Gastrointestinal disorders None View
Boil on finger None Skin and subcutaneous tissue disorders None View
Acid reflux None Gastrointestinal disorders None View
Knee achiness None Musculoskeletal and connective tissue disorders None View
Poison ivy None Skin and subcutaneous tissue disorders None View
Sinus brachycardia None Cardiac disorders None View
Constipation None Gastrointestinal disorders None View