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 @ 12:22 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT00371761
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00371761
Study Brief: PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PegIntron None None None 1 13 13 13 View
Adefovir None None None 0 12 8 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
LAPAROSCOPIC SURGERY SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
REGURGITATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
ASTHENIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
CHILLS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
FEELING COLD SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
FEELING HOT SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
MALAISE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
PYREXIA SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
FOOD ALLERGY SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
ALANINE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
ALPHA 1 FOETOPROTEIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
ASPARTATE AMINOTRANSFERASE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
BLOOD BILIRUBIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
HAEMOGLOBIN INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
LIVER FUNCTION TEST ABNORMAL SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
VITAMIN C INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
WEIGHT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
ANOREXIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
DECREASED APPETITE SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
HYPERURICAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
FASCIITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
MUSCLE TIGHTNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
HAEMANGIOMA OF LIVER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
OVARIAN CYST SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
RHINITIS ALLERGIC SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
ALOPECIA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
ECZEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
DENTAL CARE SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
LEUKOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
THROMBOCYTOPENIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
CONJUNCTIVITIS SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
ABDOMINAL DISTENSION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
ABDOMINAL PAIN UPPER SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View