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 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT01331304
Description: None
Frequency Threshold: 5
Time Frame: Six months
Study: NCT01331304
Study Brief: Comparative Effectiveness Study for Bipolar Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Li + APT Study participants will take lithium in addition to any other medications recommended by the study physician. Lithium: 600-1200mg per day over 6 months None None 36 240 210 240 View
QTP + APT Study participants will take quetiapine in addition to any other medications recommended by the study physician. Quetiapine: 100-800mg a day over 6 months None None 27 242 221 242 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Psychiatric Hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Car/Bike Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Laparoscopic Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Alcoholism Treatment SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal Issues SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Kidney Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Heroin Overdose SYSTEMATIC_ASSESSMENT General disorders None View
Eczema Outbreak SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hospitalization reason unknown SYSTEMATIC_ASSESSMENT General disorders None View
Broken Bones SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Flu Hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Extreme Sedation Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Muscle Spasms Hospitalization SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Biliary Cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Study Medication Overdose SYSTEMATIC_ASSESSMENT General disorders None View
Pseudoseizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cyst SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Staph Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Excessive sleepiness/daytime somnolence SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Weight SYSTEMATIC_ASSESSMENT General disorders None View
Tremor SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Increased Appetite SYSTEMATIC_ASSESSMENT General disorders None View
Memory/concentration problems SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness/Lightheaded SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upset stomach/stomach pain/bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Thirst SYSTEMATIC_ASSESSMENT General disorders None View
Increased Urinary Frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stiffness/muscle aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Weakness/muscle fatigue SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Restless/fidgety (akathisia) SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory infection or other cold-like symptoms SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Muscle twitching (myoclonus) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hair Loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View