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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT01442493
Description: All Serious Adverse Events were considered unrelated to study participation.
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01442493
Study Brief: Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patient-Centered Methadone Treatment Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes. Patient-Centered Methadone Treatment: Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event. 2 None 31 146 0 146 View
Methadone Treatment as Usual Methadone treatment provided as usual in the U.S. Methadone Treatment as usual: Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic. 4 None 36 149 0 149 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Soft Tissue Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Knee Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fibroids SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Trauma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Lupus SYSTEMATIC_ASSESSMENT Immune system disorders None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dehydration SYSTEMATIC_ASSESSMENT General disorders None View
Uterine Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tonsillectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
HIV SYSTEMATIC_ASSESSMENT Infections and infestations None View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spontaneous abortion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Diabetes Mellitus SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Altered Mental Status SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychiatric Disorder Unspecified SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Kidney stone SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Kidney Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Varices SYSTEMATIC_ASSESSMENT Vascular disorders None View
Infected catheter SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Food poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Poisoning of Unknown Origin and Type SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pulmonary Edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain in Back, Hip, Jaw, Groin SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):