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 @ 10:19 PM
Ignite Modification Date: 2025-12-25 @ 7:52 PM
NCT ID: NCT05409235
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected over 6 months
Study: NCT05409235
Study Brief: Nesvategrast (OTT166) in Diabetic Retinopathy (DR)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OTT166 Cohort 1 Participants received OTT166 5% twice a day for 24 weeks in the study eye 0 None 6 75 36 75 View
OTT166 Cohort 2 Participants received OTT166 four times a day for 24 weeks in the study eye 0 None 6 76 35 76 View
Vehicle Control Cohort 1 Participants received vehicle control twice a day for 24 weeks in the study eye 0 None 1 38 13 38 View
Vehicle Control Cohort 2 Participants received vehicle control four times a day for 24 weeks in the study eye 0 None 5 36 17 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Accelerated hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cranial nerve paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alcohol abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Macular hole SYSTEMATIC_ASSESSMENT Eye disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
Diabetic retinal oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Retinal neovascularisation SYSTEMATIC_ASSESSMENT Eye disorders None View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Macular oedema SYSTEMATIC_ASSESSMENT Eye disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Diabetic retinopathy SYSTEMATIC_ASSESSMENT Eye disorders None View