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 @ 2:52 PM
Ignite Modification Date: 2025-12-25 @ 1:18 PM
NCT ID: NCT03836859
Description: None
Frequency Threshold: 0
Time Frame: From Day -1 to Day 42
Study: NCT03836859
Study Brief: Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
rhNGF 20μg/mL rhNGF 20μg/mL eye drop solution, formulation containing L-methionine as excipient. rhNGF 20μg/mL: Study Eye (For subjects randomized to rhNGF group) Day 1: One drop instilled into study eye (35 μL, corresponding to 0.70 μg of rhNGF). Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding to 4.20 μg of rhNGF). Total dose in the study eye will be 31 drops (1085 μL, equivalent to 21.7 μg rhNGF) over 6 days. 0 None 0 20 10 20 View
Placebo Vehicle: formulation containing L-methionine as excipient. Placebo: Vehicle: formulation containing L-methionine as excipient. 0 None 0 10 5 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 20.0 View
Aspartate aminotransferase incresed SYSTEMATIC_ASSESSMENT Investigations 20.0 View
Vital dye staining corneal present SYSTEMATIC_ASSESSMENT Investigations 20.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations 20.0 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders 20.0 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders 20.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders 20.0 View
Aphthous ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 20.0 View
Catheter site oedema SYSTEMATIC_ASSESSMENT General disorders 20.0 View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 20.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 20.0 View