Adverse Events Module

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 @ 10:02 PM
Ignite Modification Date: 2025-12-25 @ 7:39 PM
NCT ID: NCT01928732
Description: Adverse Events (AEs) related to the study intervention were collected from consent through completion of or termination from the study (approx. 12 months if patient completed study according to protocol, shorter if patient terminated from study participation early, longer if patient needed more time to complete assessment or treatment). All Serious Adverse Events (SAEs), regardless of relatedness, were collected from consent through 30 days post completion or termination from the study.
Frequency Threshold: 0
Time Frame: Up to approximately 12 months
Study: NCT01928732
Study Brief: Comparative Effectiveness Research in Veterans With PTSD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Behavioral: Prolonged Exposure (PE) Prolonged Exposure (PE) is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: "The world is an utterly dangerous place," and "I am completely incompetent and unable to cope with stress." In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure. 1 None 55 455 42 455 View
Behavioral: Cognitive Processing Therapy (CPT) Cognitive Processing Therapy (CPT) consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets. 2 None 63 461 65 461 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Accidental Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Muscular Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Post Procedural Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Accidental Poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Adverse Drug Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Alcohol Abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Alcohol Detoxification SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Alcohol Withdrawal Syndrome SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Aortic valve replacement SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Atypical Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Benign neoplasm of thyroid gland SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Blood Glucose Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood Glucose Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Breast Enlargement SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Calcinosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Cardiac pacemaker insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Colon Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Delivery SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 20.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Depressive Symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.0 View
Diabetic Foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Drug Administration Error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Drug Detoxification SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Drug Interaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Drug Use Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Eye Operation Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Food Poisoning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Heart valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Hernia SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Hernia Repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Homicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Hyperparathyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 20.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 20.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.0 View
Impaired Gastric Emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Incisional hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Infected Bite SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Intentional Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Kidney Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Knee Operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Localized Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Loss of Consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Neck Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Organic erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.0 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Panic Attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Panic Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Pharyngeal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Physical Assault SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Post-Procedural Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Post-traumatic stress disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Prostatic operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Road Traffic Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Scar excision SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Snake Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Spinal Fusion Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Tendon Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Ulcer haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.0 View
Vertigo positional SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.0 View
Violence-related symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abortion Spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 20.0 View
Adverse Drug Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Alcohol Abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Alcoholism SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Attention deficit/hyperactivity disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Burglary Victim SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Corneal abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Crying SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Death of Companion SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Death of Relative SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Disturbance in Attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Drug Administration Error SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Drug screen positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 20.0 View
Drug Use Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.0 View
Electric Shock SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Emotional Distress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Exaggerated startle response SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Eye Swelling SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.0 View
Facial Paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Flashback SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Hallucination, Auditory SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Homeless SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Homicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Hypervigilance SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Impaired Driving Ability SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Imprisonment SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Intentional Self-Injury SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Intrusive Thoughts SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Legal Problem SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Limb Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Loss of Employment SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Lumbar radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.0 View
Marital Problem SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Neoplasm Malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.0 View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.0 View
Panic Attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Physical Assault SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Post-traumatic Stress Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Psychiatric decompensation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Road Traffic Accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.0 View
Rotator Cuff Syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.0 View
Shoplifting SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Sick Relative SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Stress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Substance Use SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View
Suicide of Relative SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 20.0 View
Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Therapy Cessation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 20.0 View
Umbilical Hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.0 View
Violence-related symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.0 View