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: 2025-12-26 @ 2:43 PM
Ignite Modification Date: 2025-12-26 @ 2:43 PM
NCT ID: NCT00078806
Description: Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Frequency Threshold: 5
Time Frame: Part 1A, maximum duration on treatment was 207 days. Part 1B, maximum duration on treatment was 120 days Part 2, maximum duration on treatment was 88 days Part 3, maximum duration on treatment was 130 days Plus one month after the last dose of study drug.
Study: NCT00078806
Study Brief: Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1A: Etanercept 0.4 mg/kg Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A. None None 3 19 18 19 View
Part 1B: Etanercept 0.8 mg/kg Participants who had a partial response in Part 1A entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months. None None 1 8 4 8 View
Part 2: Placebo Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months in Part 2. None None 0 5 4 5 View
Part 2: Etanercept 0.4/0.8 mg/kg Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months in Part 2. None None 0 4 3 4 View
Part 3: Etanercept 0.4/0.8 mg/kg Participants who experienced a flare or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including treatment received in Part 2. None None 0 9 5 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Epstein-Barr viraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Tooth injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Osteopenia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 19.0 View
Skin papilloma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 19.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 19.0 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 19.0 View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 19.0 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 19.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Cheilosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View