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 @ 4:36 AM
Ignite Modification Date: 2025-12-26 @ 3:38 AM
NCT ID: NCT03889418
Description: Serious Adverse Events include inpatient admissions with emergency or non-elective admission types with a length of stay \>1 day.
Frequency Threshold: 5
Time Frame: Using Diagnosis Related Group (DRG) codes, adverse events were assessed during 12 months following index event
Study: NCT03889418
Study Brief: Opioid Treatment and Recovery Through a Safe Pain Management Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Electronic Medical Recorded Clinical Decision Support Electronic medical recorded clinical decision support (usual care) 4 None 39 239 24 239 View
Stepped Opioid Collaborative Care Model Usual care AND collaborative care with behavioral health integration 3 None 35 239 17 239 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders DRG View
Amputation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures DRG View
Atherosclerosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders DRG View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders DRG View
Complications of treatment NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications DRG View
Diabetes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders DRG View
Disorders of pancreas except malignancy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders DRG View
Epistaxis NON_SYSTEMATIC_ASSESSMENT General disorders DRG View
Esophagitis, Gastroenteritis and Misc Digestive Disorders NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders DRG View
Operating Room Procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures DRG View
Gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders DRG View
Gastrointestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders DRG View
Heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders DRG View
Hip and femur procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures DRG View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders DRG View
Infectious and parasitic diseases NON_SYSTEMATIC_ASSESSMENT Infections and infestations DRG View
Intracranial hemorrhage or cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders DRG View
Kidney and urinary tract infections NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders DRG View
Major chest trauma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders DRG View
Major gastrointestinal disorders and peritoneal infections NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders DRG View
Major hematological and immunological diagnoses NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders DRG View
Major small and large bowel procedures NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders DRG View
Medical back problems NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders DRG View
Minor skin disorders NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders DRG View
Disorders of nutrition, metabolism, fluids and electrolytes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders DRG View
Other kidney and urinary tract diagnoses NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders DRG View
Other skin, subcutaneous tissue and breast procedures NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures DRG View
Other vascular procedure NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures DRG View
Peritoneal adhesiolysis NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures DRG View
Post-operative and post-traumatic infections NON_SYSTEMATIC_ASSESSMENT Infections and infestations DRG View
Pulmonary edema and respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders DRG View
Red blood cell disorder NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders DRG View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders DRG View
Respiratory infections and inflammations NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders DRG View
Respiratory system diagnosis with ventilator support NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders DRG View
Seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders DRG View
Septicemia or severe sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations DRG View
Simple pneumonia and pleurisy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders DRG View
Skin graft NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders DRG View
Spinal procedures or spinal neurostimulators NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures DRG View
Syncope and collapse NON_SYSTEMATIC_ASSESSMENT Nervous system disorders DRG View
Tracheostomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures DRG View
Traumatic stupor and coma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders DRG View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders DRG View