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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:43 AM
NCT ID: NCT01441102
Description: None
Frequency Threshold: 5
Time Frame: Duration of the study, up to 24 months per participant
Study: NCT01441102
Study Brief: Dextromethorphan for Diabetic Macular Edema
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dextromethorphan Hydrobromide Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months. None None 1 7 6 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 17.1 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 17.1, 18.0 View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 17.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 17.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.1 View
Feeling jittery SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
Renal function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 17.1 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
Episcleritis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.1, 18.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 17.1 View
Arthropod Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Eye Pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Skin disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Vitreous floaters SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View