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 @ 3:33 PM
Ignite Modification Date: 2025-12-25 @ 1:46 PM
NCT ID: NCT01402492
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01402492
Study Brief: Cocaine Use Reduction With Buprenorphine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BUP4+XR-NTX 4mg buprenorphine plus naltrexone for 8 weeks of treatment None None 13 100 66 100 View
BUP16+XR-NTX 16mg buprenorphine plus naltrexone for 8 weeks of treatment None None 8 100 64 100 View
PLB+XR-NTX Placebo plus naltrexone for 8 weeks of treatment None None 12 102 61 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression None Psychiatric disorders None View
Suicidal Ideation None Psychiatric disorders None View
Suicidal Behavior None Psychiatric disorders None View
Psychotic Disorder None Psychiatric disorders None View
Major Depression None Psychiatric disorders None View
Pancreatitis None Gastrointestinal disorders None View
Oesophagitis None Gastrointestinal disorders None View
Haematemesis None Gastrointestinal disorders None View
Gastric Ulcer Perforation None Gastrointestinal disorders None View
Gastric Ulcer None Gastrointestinal disorders None View
Diverticulum None Gastrointestinal disorders None View
Drug Detoxification None Surgical and medical procedures None View
Dialysis None Surgical and medical procedures None View
Sinusitis None Infections and infestations None View
Wound Infection Staphylococcal None Infections and infestations None View
Cellulitis None Infections and infestations None View
Chest Pain None General disorders None View
Non-Cardiac Chest Pain None General disorders None View
Cardiac Death None General disorders None View
Pulmonary Embolism None Respiratory, thoracic and mediastinal disorders None View
Chronic Obstructive Pulmonary Disease None Respiratory, thoracic and mediastinal disorders None View
Asthma None Respiratory, thoracic and mediastinal disorders None View
Squamous Cell Carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastases to Spine None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lumbar Spinal Stenosis None Musculoskeletal and connective tissue disorders None View
International Normalised Ratio Increased None Investigations None View
Toxicity to Various Agents None Injury, poisoning and procedural complications None View
Acute Febrile Neutrophilic Dermatosis None Skin and subcutaneous tissue disorders None View
Nephrolithiasis None Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Dry Mouth None Gastrointestinal disorders None View
Abdominal Pain None Gastrointestinal disorders None View
Toothache None Gastrointestinal disorders None View
Abdominal Discomfort None Gastrointestinal disorders None View
Abdominal Pain Upper None Gastrointestinal disorders None View
Diverticulum None Gastrointestinal disorders None View
Dental Caries None Gastrointestinal disorders None View
Sensitivity of Teeth None Gastrointestinal disorders None View
Abdominal Distension None Gastrointestinal disorders None View
Retching None Gastrointestinal disorders None View
Peptic Ulcer None Gastrointestinal disorders None View
Pancreatitis None Gastrointestinal disorders None View
Oesophagitis None Gastrointestinal disorders None View
Haematemesis None Gastrointestinal disorders None View
Gastrooesophageal Reflux Disease None Gastrointestinal disorders None View
Gastrointestinal Ulcer None Gastrointestinal disorders None View
Gastric Ulcer Perforation None Gastrointestinal disorders None View
Gastric Ulcer None Gastrointestinal disorders None View
Faeces Hard None Gastrointestinal disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Somnolence None Nervous system disorders None View
Tremor None Nervous system disorders None View
Sedation None Nervous system disorders None View
Loss of Consciousness None Nervous system disorders None View
Dysgeusia None Nervous system disorders None View
Sciatica None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Lethargy None Nervous system disorders None View
Hypoaesthesia None Nervous system disorders None View
Depressed Level of Consciousness None Nervous system disorders None View
Tension Headache None Nervous system disorders None View
Aura None Nervous system disorders None View
Parosmia None Nervous system disorders None View
Insomnia None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Anxiety None Psychiatric disorders None View
Libido Decreased None Psychiatric disorders None View
Suicidal Ideation None Psychiatric disorders None View
Euphoric Mood None Psychiatric disorders None View
Depressed Mood None Psychiatric disorders None View
Sleep Disorder None Psychiatric disorders None View
Restlessness None Psychiatric disorders None View
Intentional Self-injury None Psychiatric disorders None View
Drug Dependence None Psychiatric disorders None View
Disorentation None Psychiatric disorders None View
Suicidal Behavior None Psychiatric disorders None View
Substance-induced Mood Disorder None Psychiatric disorders None View
Psychotic Disorder None Psychiatric disorders None View
Panic Attack None Psychiatric disorders None View
Nervousness None Psychiatric disorders None View
Mental Status Changes None Psychiatric disorders None View
Major Depression None Psychiatric disorders None View
Fatigue None General disorders None View
Drug Withdrawal Syndrome None General disorders None View
Irritability None General disorders None View
Chest Pain None General disorders None View
Non-cardiac Chest Pain None General disorders None View
Influenza-like Illness None General disorders None View
Sluggishness None General disorders None View
Asthenia None General disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Muscle Spasms None Musculoskeletal and connective tissue disorders None View
Pain in Extremity None Musculoskeletal and connective tissue disorders None View
Musculoskeletal Pain None Musculoskeletal and connective tissue disorders None View
Musculoskeletal Chest Pain None Musculoskeletal and connective tissue disorders None View
Lumbar Spinal Stenosis None Musculoskeletal and connective tissue disorders None View
Limb Discomfort None Musculoskeletal and connective tissue disorders None View
Nasopharyngitis None Infections and infestations None View
Tooth Abscess None Infections and infestations None View
Sinusitis None Infections and infestations None View
Upper Respiratory Tract Infection None Infections and infestations None View
Tooth Infection None Infections and infestations None View
Periorbital Infection None Infections and infestations None View
Haemophilus Infection None Infections and infestations None View
Cellulitis None Infections and infestations None View
Wound Infection Staphylococcal None Infections and infestations None View
Hyperhidrosis None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Cold Sweats None Skin and subcutaneous tissue disorders None View
Night Sweats None Skin and subcutaneous tissue disorders None View
Acute Febrile Neutrophilic Dermatosis None Skin and subcutaneous tissue disorders None View
Astma None Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Embolism None Respiratory, thoracic and mediastinal disorders None View
Pulmonary Congestion None Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Chronic Obstructive Pulmonary Disease None Respiratory, thoracic and mediastinal disorders None View
Decreased Appetitie None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Laceration None Injury, poisoning and procedural complications None View
Toxicity to Various Agents None Injury, poisoning and procedural complications None View
Thermal Burn None Injury, poisoning and procedural complications None View
Post-traumatic Neck Syndrome None Injury, poisoning and procedural complications None View
Post-lumbar Puncture Syndrome None Injury, poisoning and procedural complications None View
Joint Dislocation None Injury, poisoning and procedural complications None View
Fall None Injury, poisoning and procedural complications None View
Ankle Fracture None Injury, poisoning and procedural complications None View
Alcohol Poisoning None Injury, poisoning and procedural complications None View
Drug Detoxification None Surgical and medical procedures None View
Tooth Extraction None Surgical and medical procedures None View
Dialysis None Surgical and medical procedures None View
Weight Increased None Investigations None View
Urine Analysis Abnormal None Investigations None View
Liver Function Test Abnormal None Investigations None View
International Normalized Ratio Increased None Investigations None View
Blood Pressure Increased None Investigations None View
Hot Flush None Vascular disorders None View
Hypertensive Crisis None Vascular disorders None View
Hypertension None Vascular disorders None View
Uterine Leiomyoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous Cell Carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastases to Spine None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung Neoplasm None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Seasonal Allergy None Immune system disorders None View
Hypersensitivity None Immune system disorders None View
Tinnitus None Ear and labyrinth disorders None View
Ear Pain None Ear and labyrinth disorders None View
Ear Discomfort None Ear and labyrinth disorders None View
Urinary Retention None Renal and urinary disorders None View
Nephrolithiasis None Renal and urinary disorders None View
Dysuria None Renal and urinary disorders None View
Cholelithiasis None Hepatobiliary disorders None View
Lacrimation Increased None Eye disorders None View
Hyperthyrodism None Endocrine disorders None View
Adrenal Mass None Endocrine disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Monocytosis None Blood and lymphatic system disorders None View