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 @ 10:41 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT00800735
Description: Safety population: All enrolled participants.
Frequency Threshold: 5
Time Frame: Adverse events from the beginning of treatment up to 24 weeks after the end of treatment were reported.
Study: NCT00800735
Study Brief: A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pegylated-interferon Alfa-2a Plus Ribavirin Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks. None None 4 30 23 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Prothrombin time prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View