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 @ 4:49 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT00457418
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00457418
Study Brief: High-Dose PEG-Intron Pharmacokinetic Study in Patients With Melanoma (Study P04831 AM2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PEG-Intron 6 ug/kg/week, SC (first 8 weeks) 3 ug/kg/week, SC (252 weeks \[weeks 9-260\], maintenance) None None 9 32 32 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
WRIST FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
RENAL FAILURE SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
URTICARIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
CHOLECYSTITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 15.0 View
DRUG HYPERSENSITIVITY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.0 View
APPENDICITIS PERFORATED SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
LOWER LIMB FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.0 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
CARDIAC ARREST SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 15.0 View
GLAUCOMA SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
NEUTROPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 15.0 View
EAR PAIN SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 15.0 View
HYPOTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 15.0 View
DRY EYE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
VISION BLURRED SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.0 View
ABDOMINAL PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
DRY MOUTH SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
FLATULENCE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
INJECTION SITE RASH SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
INJECTION SITE REACTION SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
MUCOSAL INFLAMMATION SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
OEDEMA SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.0 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
LOCALISED INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.0 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
BLOOD TRIGLYCERIDES INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
NEUTROPHIL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
WHITE BLOOD CELL COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
HYPERTRIGLYCERIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 15.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
MUSCULOSKELETAL PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
DYSGEUSIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.0 View
AGITATION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
DEPRESSION SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
MENTAL STATUS CHANGES SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
MOOD ALTERED SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.0 View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.0 View
ERECTILE DYSFUNCTION SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
SINUS CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
HYPERHIDROSIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
NIGHT SWEATS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.0 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.0 View