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 @ 9:32 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT03170232
Description: Non-SAE and SAEs are reported for Safety Population.
Frequency Threshold: 0
Time Frame: Non-SAEs and SAEs were reported from start of study treatment and up to 52 weeks
Study: NCT03170232
Study Brief: A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received one tablet of placebo with food twice daily for 52 weeks. 0 None 0 27 9 27 View
DNX HBr 35 mg Participants received one tablet of DNX HBr 35 mg with food twice daily for 52 weeks. 1 None 2 27 14 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Synovial cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.0 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 21.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 21.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.0 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Haematocrit decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Mean cell volume decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 21.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 21.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 21.0 View
Gynaecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 21.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.0 View
Perioral dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 21.0 View