Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:10 PM
Ignite Modification Date: 2025-12-25 @ 12:50 PM
NCT ID: NCT00261495
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00261495
Study Brief: A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OROS Hydromorphone HCl Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase) None None 25 254 206 254 View
Oxycodone Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase) None None 21 250 212 250 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colonic stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mechanical ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectocele SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Reflux oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Condition aggravated SYSTEMATIC_ASSESSMENT General disorders None View
Drug withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Withdrawal syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Multiple fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Post procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Postoperative fever SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Biopsy liver SYSTEMATIC_ASSESSMENT Investigations None View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spondyloarthropathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vertebrobasilar insufficiency SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Angioplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hip arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Inguinal hernia repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Pain management SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Prosthesis implantation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Rehabilitation therapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Spinal operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Umbilical hernia repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View