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 @ 2:13 AM
Ignite Modification Date: 2025-12-26 @ 12:41 AM
NCT ID: NCT01519960
Description: Safety Population
Frequency Threshold: 0
Time Frame: From Baseline to approximately 4.5 years
Study: NCT01519960
Study Brief: A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group A: PEG-IFN Monotherapy Without Advanced Fibrosis Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg. 0 None 6 101 80 101 View
Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. 0 None 1 49 18 49 View
Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg. 0 None 0 10 9 10 View
Group D: Switch to PEG-IFN Monotherapy Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up 0 None 2 33 21 33 View
Group A - Long Term Follow-up Participants without advanced fibrosis: 4.5-year extended follow-up 0 None 0 101 25 101 View
Group B - Long Term Follow-up Participants without advanced fibrosis: 4.5-year extended follow-up 0 None 0 49 6 49 View
Group C Long Term Follow-up Participants with advanced fibrosis: 4.5-year extended follow-up 0 None 0 10 0 10 View
Group D - Long Term Follow-up Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy: 4.5-year extended follow-up 0 None 0 33 27 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Nephropathy NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Osteochondrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Hepatitis B NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Latent tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Microsporum infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Body temperature increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Peritonsillar abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Chronic sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gingiviti NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Helminthic infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Respiratory tract infection viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tuberculous pleurisy NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Eczema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Lichen planus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skin depigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Urticardia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Alpha hydroxybutyrate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood creatine phosphokinase mb increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood lactate dehydrogenase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Hepatitis B DNA increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Joint swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Scoliosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Food poisoning NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Duane's syndrome NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.1 View
Seasonal allergy NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Joint injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypermetropia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Accommodation disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Amblyopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Astigmatism NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Tonsillitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Renal cyst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Xeroderma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Erythema of eyelid NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Periorbital swelling NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Aphthous ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Injection site induration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Expired product administered NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Disturbance in attention NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Mood altered NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View